chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Bronchiolitis, Cough, Incomplete course of vaccination, Rhinorrhoea, Vomiting
Clinical narrative: Hacking Cough, Wheezing, runny nose, vomiting mucous. Dr. diagnosed my son with bronchiolitis. I refused the rest of the vaccination series. My son has been suffering with the wheezing and coughing for 2 months and is still ongoing. He has been on a nebulizer treatment (albuterol) for the wheezing which helps in the moment but it recurs about an hour later.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: Hacking Cough, Wheezing, runny nose, vomiting mucous. Dr. diagnosed my son with bronchiolitis. I refused the rest of the vaccination series. My son has been suffering with the wheezing and coughing for 2 months and is still ongoing. He has been on a nebulizer treatment (albuterol) for the wheezing which helps in the moment but it recurs about an hour later.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Hard lump injection site, red and itchy.
Age: 57.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient was supposed to receive MMR vaccine, but was given MMRV vaccine.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal disorder, Pain in extremity
Clinical narrative: 4 days after getting flu shot LD and hand had a sharp and sore aching pain. Started upper LD - radiated to hand. Pain continues and is worse lft. hand. Went to Dr. in one location 11-18-15 and in another location 12-15-15. Can't use hand to pick up heavy object. Started meloxicam today 12-15-15.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient reported pain an difficulty with full range of motion of arm, two months after administration (10-1-15). Patient believes vaccine administered too high up on shoulder. Pt advised to see MD, but thus far has chosen not to.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: After vaccines and blood draw patient appeared pale and also appeared to lose consciousness. Patient then proceeded to show signs of rhythmic jerking. We layed her down on table where she was already sitting. She was unresponsive for less than 30 sec. She appeared to be aware of her surroundings. Vitals were taken and patient was monitored while in lying position.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Patient received MENACTRA, HPV and FLUZONE on 1/6/16. Approx. 13 hrs later awoke at 4:30 am to vomit x 5, felt abdominal discomfort, chills and headache. Felt short of breath at time of vomiting. On exam had 3mm injection site redness/tenderness/swelling at site of MENACTRA.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Patient received MENACTRA, HPV and FLUZONE on 1/6/16. Approx. 13 hrs later awoke at 4:30 am to vomit x 5, felt abdominal discomfort, chills and headache. Felt short of breath at time of vomiting. On exam had 3mm injection site redness/tenderness/swelling at site of MENACTRA.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Influenza like illness, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Flu like sxs, generalized muscle aches. C/O pain (L) arm/shoulder, that progressed to pressure and swelling (R) side of chest, generalized hives.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Urticaria
Clinical narrative: Flu like sxs, generalized muscle aches. C/O pain (L) arm/shoulder, that progressed to pressure and swelling (R) side of chest, generalized hives.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test, Dizziness, Dysphemia, Electrocardiogram
Clinical narrative: Rapid heartbeat, dizzy, sweating. Feeling faint raised blood pressure, headache, stuttering, shaking.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Foetal death, Headache, Heart rate increased, Hyperhidrosis, Tremor
Clinical narrative: Rapid heartbeat, dizzy, sweating. Feeling faint raised blood pressure, headache, stuttering, shaking.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Allergy test negative, Cold sweat, Crying, Injection site erythema, Pyrexia
Clinical narrative: 45 minutes after receiving vaccinations the child started crying and became inconsolable then developed a fever, clamminess and vaccine site appeared red and swollen. Was seen in the ER and released.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vaccination site swelling
Clinical narrative: 45 minutes after receiving vaccinations the child started crying and became inconsolable then developed a fever, clamminess and vaccine site appeared red and swollen. Was seen in the ER and released.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Pt reported 3 weeks of redness, erythema after injection, and now ongoing pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 71 year old female patient. The patient's concurrent condition included Crohn's disease. Her medical history was not reported. The patient has no drug reaction or allergies. On 04-JAN-2016 the patient was vaccinated with ZOSTAVAX (lot # L028281, expiry date: 28-OCT-2016) subcutaneously at a dose of 0.65 ml. Concomitant therapies included REMICADE (stopped 3 months back on an unknown date), probiotics (unspecified) and ASACOL. On an unknown date in January 2016 the patient experienced redness, itching and "a white spot, like a rash" after receiving ZOSTAVAX. On 07-JAN-2016 the patient sought medical attention from the pharmacist. She was treated with Over the Counter (OTC) BENADRYL for itching as needed. No lab diagnostics tests were performed. The outcome of redness, itching and "a white spot, like a rash" was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Patient had wheal and erythema - no notation of date or time of onset. At today's visit - 6 days from vaccination - pt still had 3 cm wheal and 5 cm ery - no acute distress.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Injection site erythema, Pyrexia, White blood cell count normal
Clinical narrative: Patient went next day to urgent care -> had shortness of breath, fever, blood ok per MD, 6 cm diameter redness around shot area non productive cough.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's pertinent medical history was not reported. The patient had no drug reactions or allergies. On 05-DEC-2015, the patient was vaccinated subcutaneously in the left arm with 0.65 ml dose of ZOSTAVAX (lot # L031272, expiry date 19-NOV-2016). Concomitant medications were not reported. On an unknown date in December 2015, the patient experienced infection of the injection site. The patient sought medical attention and was seen by a family doctor, who placed the patient on an unspecified antibiotic. The outcome of the event and ZOSTAVAX was not reported. The is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Full blood count, Pyrexia, Rash
Clinical narrative: Date 1-6-16. Fever. Rash 1-10-16.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives on 12/9/15 following the flu vaccine given on 12/4/15. Seen 12/22/15. SOLU-MEDROL 125mg given IM 1/8 hives returned after a few days increased itching HS. 1/8/16 MD ordered Loratadine 10mg AM, BENADRYL HS.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 27-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Nausea
Clinical narrative: Large welt at site of injection that is warm to the touch, painful, and red. Pt states she is nausea.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Possible reaction to Varicella injection. Site of injection is red, hard to the touch, warm to the touch, itchy and redness is spreading.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Redness and swelling at site of injection excessive crying and fussiness.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Computerised tomogram, Limb discomfort, Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: In March, right side leg and arm couldn't lay on it. Can't put full weight on it so use canes to carry something. Takes 2 TYLENOL PM (500 mg acetaminophen and 25 mg diphenhydramine). Had doctor appointments CAT, MRI, ultrasound in March, also on March 20 had follow-up appointment with urologist due to blood in urine before vax. On 5/11 went back for back x-rays. Also had appointments in 9/24. Had to increase dosage of some medications after vax. At this point can not do things by himself.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Walking aid user, Weight bearing difficulty
Clinical narrative: In March, right side leg and arm couldn't lay on it. Can't put full weight on it so use canes to carry something. Takes 2 TYLENOL PM (500 mg acetaminophen and 25 mg diphenhydramine). Had doctor appointments CAT, MRI, ultrasound in March, also on March 20 had follow-up appointment with urologist due to blood in urine before vax. On 5/11 went back for back x-rays. Also had appointments in 9/24. Had to increase dosage of some medications after vax. At this point can not do things by himself.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Tremor
Clinical narrative: Pt became dizzy immediately after receiving PCV23. Patient was given cold compresses while sitting in chair then began to shake. Patient was placed on floor 911 was called. After shaking stopped patient reported severe headache to back of her head. Pt. transported to hospital by EMS.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 23-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This one of the several reports received from the same reporter. Additional information has been requested. +
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 15-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Patient vaccinated with PCV-13 and flu 1-8-16, developed fever body aches and nausea that night.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to multiple unspecified patients with unknown demographics. No medical history was reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with a dose of an improperly stored oral, ROTATEQ, (dose, route and frequency: unknown, lot number: L002042, expiry date: 28-JUL-2016). No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician referring to a 65-70 year old female patient who was enrolled in market research. Historical condition and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date and dose unspecified, route: injection). The concomitant medication was unknown. In approximately 2014 (1-1.5 year ago), the physician mentioned the patient complained of having some body aches and a fever a few days after receiving the vaccine. The outcome of the events was reported as resolved with sequelae. The causality between the events and ZOSTAVAX was not provided. Additional information is not expected because the physician would not given consent to provide contact information.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 17-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report has been received from a male patient of unknown age referring to himself. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported). The patient reported that the patient had been getting the PNEUMOVAX 23 every few years (dates were not specified). The patient stated that he had received the PNEUMOVAX 23 a total of 5 times. The patient stated that every few years he got revaccinated with various vaccinations including the PNEUMOVAX 23. Additional information is not expected as there is no contact information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's pertinent medical history was not reported. The patient had no drug reactions or allergies. On 19-DEC-2015, the patient was vaccinated subcutaneously in the right arm with 0.65 ml dose of ZOSTAVAX (lot # L031272, expiry date 19-NOV-2016). Concomitant medications were not reported. On an unknown date in December 2015, the patient experienced infection of the injection site. The patient sought medical attention and came back to the pharmacy and showed the pharmacist the injection site on her right arm. The patient did not go to her family physician at the time of the report. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area warm to touch, red bump, hard area. Pt used ice on injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient od unknown age and gender. On 27-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter,. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 02-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K027566, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 20-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 30-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 30-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot K025766, expiry date 08-JUN-2015. This one of the several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: FLUN4, HPV9
Symptoms: Headache
Clinical narrative: After administration of HPV9 (1st dose) and FLUMIST (2nd dose) patient woke up for 2 nights complaining of severe headaches.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a 92 (units not provided) old female referring to herself. Patient's concurrent conditions included lymphoma and Congestive heart failure. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. Concomitant therapies included LOPRESSOR, BELSEREN, LASIX and chemotherapy. On an unknown date the patient developed an itchy rash only on her torso. She stated that the rash is on the front of her torso and back (itchy rash). Patient received treatment with cortisone treatment and sought medical attention with cortisone cream. No lab diagnostic test were performed. Action taken with the suspect therapy was not reported. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, X-ray normal
Clinical narrative: Left shoulder pain after flu shot. No pain at time of injection at all.  Significant continuous pain began within 1 hour of injection. Pain is now mostly felt when reaching or lifting certain ways and is more intermittent in nature.  Have taken NSAIDs with variable results as treatment.
Age: 0.27
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Rash, Rash generalised, Rash pruritic, Skin irritation
Clinical narrative: Small rash began to break out on the back of patient's neck.  Over the course of the next week, the rash covered his entire body and was extremely irritation and itchy.  He was later diagnosed with severe eczema.
Age: 0.27
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Small rash began to break out on the back of patient's neck.  Over the course of the next week, the rash covered his entire body and was extremely irritation and itchy.  He was later diagnosed with severe eczema.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site irritation
Clinical narrative: Almost immediate formation of hive like irritation at site of injection.  Administered 10ml of 12.5mg/5ml diphenhydramine for dose of 25mg.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Abnormal behaviour, Discomfort, Fatigue, Injection site erythema, Irritability
Clinical narrative: Mother phones public health office in the AM of 1/7/2016 to report suspected reaction to influenza vaccine. Reports child to be fatigued, fussy, not her self, axillary temperature of 102-103 degrees F, and red pinpoint at injection site. Child also had PCV13, Pediarix, and Hib that same day. None of the other sites are red or significant. Mother reports has been giving child recommended dose of acetaminophen on schedule. Encouraged hydration, cool sponge bath, and notified mother of symptoms that would be significant enough to bring child to ER. Mother reports understanding. Public Health nurse phones mother again at 4:45 PM on 1/7/2016 to check on child. Mother reports child's fever has gone down and is now at 100.8 degrees F. Child is now acting more like herself and eating and drinking normally. Mother will call with any additional questions.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Mother phones public health office in the AM of 1/7/2016 to report suspected reaction to influenza vaccine. Reports child to be fatigued, fussy, not her self, axillary temperature of 102-103 degrees F, and red pinpoint at injection site. Child also had PCV13, Pediarix, and Hib that same day. None of the other sites are red or significant. Mother reports has been giving child recommended dose of acetaminophen on schedule. Encouraged hydration, cool sponge bath, and notified mother of symptoms that would be significant enough to bring child to ER. Mother reports understanding. Public Health nurse phones mother again at 4:45 PM on 1/7/2016 to check on child. Mother reports child's fever has gone down and is now at 100.8 degrees F. Child is now acting more like herself and eating and drinking normally. Mother will call with any additional questions.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Heart rate increased, Hypotension, Injection site swelling, Peripheral swelling
Clinical narrative: Low BP (85/60), increased pulse, cold, clammy, entire injection arm was swollen.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Laboratory test normal, Pain in extremity
Clinical narrative: Started with arm pain that got more and more painful and radiated to fingers and chest. She went into the ER on 1/3/16 in the morning to get chest pain checked out and was admitted to hospital for a day until the following evening to rule out heart attack which was negative.
Age: 50.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: Fatigue, fever (measured at 102 deg), pain and redness at injection site and general pain. Took Tylenol every 4hrs for 18 hrs. When condition did not improve, went to urgent care center (01/09/2016 @4:00 pm). Received prescription for antibiotics, which resolved fever and body aches but not injection site arm pain. Arm pain worsened over next 12 hours. Went to ED on 01/10/2016 for further treatment. Diagnosed with cellulitis and treated for infection (WBC was 18) with IV antibiotics and treated for pain with morphine. Received prescription for a course of a different antibiotic.  Symptoms have largely resolved since Sunday night. Pain in arm at injection site has improved. Redness decreasing but still present.
Age: 50.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Fatigue, fever (measured at 102 deg), pain and redness at injection site and general pain. Took Tylenol every 4hrs for 18 hrs. When condition did not improve, went to urgent care center (01/09/2016 @4:00 pm). Received prescription for antibiotics, which resolved fever and body aches but not injection site arm pain. Arm pain worsened over next 12 hours. Went to ED on 01/10/2016 for further treatment. Diagnosed with cellulitis and treated for infection (WBC was 18) with IV antibiotics and treated for pain with morphine. Received prescription for a course of a different antibiotic.  Symptoms have largely resolved since Sunday night. Pain in arm at injection site has improved. Redness decreasing but still present.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site; feeling of nausea; fatigue; very limited movement of arm that was injected - scale of 1-10 (10 = worse) the pain is 10 from neck to finger tips of arm that was injected.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity
Clinical narrative: Redness and swelling at injection site; feeling of nausea; fatigue; very limited movement of arm that was injected - scale of 1-10 (10 = worse) the pain is 10 from neck to finger tips of arm that was injected.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Blood test, Computerised tomogram, Concussion, Fall, Head injury
Clinical narrative: Daughter passed out completed immediately when shot was administered; fell to floor; hit head; had to be brought to emergency room; diagnosed as a concussion.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Immediate post-injection reaction, Laboratory test, Loss of consciousness
Clinical narrative: Daughter passed out completed immediately when shot was administered; fell to floor; hit head; had to be brought to emergency room; diagnosed as a concussion.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient is stated nerve pain that required the intervention of orthopedic doctor.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: Patient seen in the emergency department after receiving a pneumonia vaccine that was injected above the muscle into the subacromial bursa, likely causing a traumatic bursitis.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Acupuncture, Mobility decreased, Pain in extremity
Clinical narrative: Approximately two days after my flu shot, I started having trouble lifting my right arm.  It got progressively worse, with a lot of pain and I was unable to move it normally or perform normal activities.  I have had acupuncture, taken antiinflammatories, seen my doctor twice and had a cortisone shot and physical therapy and massage.
Age: 23.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest discomfort, Eructation, Wheezing
Clinical narrative: Pt returned to clinic 2 hrs after Flu Mist with complaints of globus sensation/chest tightness that started about 1 hr after Flu Mist.)  No other new exposures that day, no hx of egg allergy or asthma.  Faint wheeze noted on exam (had rhinitis sx thought to be related to rhinitis preceding Flu Mist) that self-resolved. She was noted to also be burping a lot- per patient this is normal for her and is being worked up for dyspepsia. She did receive Epi and Zyrtec in clinic, discharged with Zantac po. Reports sx resolved in clinic with no recurrence.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Pruritic red rash left deltoid at site of injection.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Dizziness
Clinical narrative: Upset stomach, weakness, dizziness. Patient drank fluids--broth and Gatorade. Symptoms continued for three days, with severe dizziness reported on third day.
Age: 32.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Felt feverish, noticed several red raised bumps on back and over the next two days red itchy bumps appeared on face, head, torso, arms, legs. Approx 20.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, FLU4, MMR, VARCEL
Symptoms: Seizure like phenomena
Clinical narrative: Seizure like activity, lasted one and half minutes.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and pharmacy intern refers to unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. ON 22-DEC-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 or lot# L019298 with expiration date 22-JUN-2017 (dose and route were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to multiple unspecified patients with unknown demographics. No medical history was reported. On multiple unspecified dates, the multiple unspecified patients were vaccinated with a dose of an improperly stored GARDASIL 9, (dose, route and frequency: unknown, lot number L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 18-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date o8-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-JAN-2016, the patient was vaccinated with an improperly stored doses od GARDASIL injection (lot # K011562, expiration date 08-APR-2017, dose, anatomical location and route of administration were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a pharmacist and pharmacy intern refers to 3 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 25-DEC-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 and lot# L019298 with expiration date 22-JUN-2017 (dose, route, lot # and expiration date were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and pharmacy intern refers to unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-DEC-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 or lot# L019298 with expiration date 22-JUN-2017 (dose, route, lot # and expiration date were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 21-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 22-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 29-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Next morning noticed that site of injection was red, area 1/2". By Wednesday night rash spread 3x1 1/2" was hot and itching. Went to ER on 1/7 and doctor specified it was vax reaction. They thought it was blood poisoning at one point. Prescribed BENADRYL. On 1/8 follow-up with doctor. By 1/9 area no longer hot/red. Redness still there but not hot or itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient came to office on 1/08/16 with swelling and pain at injection site on left arm.
Age: 0.54
Sex: M
Vaccine: HEPA
Symptoms: Flushing, Rash erythematous, Rash generalised
Clinical narrative: Baby soon developed a generalized red, raised rash, cheeks became quite flushed, no respiratory difficulties.
Age: 17.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse reaction. Patient was pregnant at time of vaccination and didn't know until a few days later. Had a previous dose of Varicella vaccine on August 25, 2015.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Pt reported lump to the left deltoid area where the injection site.  No fever.
Age: 74.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Influenza, Muscular weakness, Pain
Clinical narrative: Severe flu symptoms. Particularly muscle weakness, pain. Ongoing, better but still a little weak. Expected something, but this was tough, and I'm pretty fit.
Age: 74.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Influenza, Muscular weakness
Clinical narrative: Severe flu symptoms. Particularly muscle weakness, pain. Ongoing, better but still a little weak. Expected something, but this was tough, and I'm pretty fit.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Grip strength decreased, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a 53-year-old female patient who received BOOSTRIX (batch number KJ4MS, expiry date 19th November 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 32BH5, expiry date 30th June 2016). Concurrent medical conditions included attention deficit disorder and sulfonamide allergy (causes angioedema). Concomitant products included alprazolam, Dextroamphetamine, amiloride and hydrochlorothiazide and zolpidem. On 22nd December 2015, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. In December 2015, less than a month after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site discomfort (serious criteria disability), weakness (serious criteria disability), injected limb mobility decreased (serious criteria disability), grip strength decreased (serious criteria disability) and joint clicking (serious criteria disability). On an unknown date, the outcome of the injection site discomfort, weakness, injected limb mobility decreased and grip strength decreased were not recovered/not resolved and the outcome of the joint clicking was unknown. The reporter considered the injection site discomfort, weakness, injected limb mobility decreased, grip strength decreased and joint clicking to be possibly related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant. On 31st December 2015, the patient visited physician assistant's office and reported that she experienced injection site discomfort at both the sites. The patient also experienced difficulty with movement, specifically described as difficulty in hooking bra along with trouble in raising her arms, range of motion issues, shoulder popping, shoulder weakness and lack of grip strength. The specific date of onset for all the events were unknown, it could be between 22nd December 2015 and 31st December 2015. The events were worsening at the time of reporting and the healthcare professional felt as though they were disabling. The reported batch number (328HS) for FLUARIX QUADRIVALENT did not exist and was updated to 32BH5 as per sales database.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Joint crepitation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a 53-year-old female patient who received BOOSTRIX (batch number KJ4MS, expiry date 19th November 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 32BH5, expiry date 30th June 2016). Concurrent medical conditions included attention deficit disorder and sulfonamide allergy (causes angioedema). Concomitant products included alprazolam, Dextroamphetamine, amiloride and hydrochlorothiazide and zolpidem. On 22nd December 2015, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. In December 2015, less than a month after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site discomfort (serious criteria disability), weakness (serious criteria disability), injected limb mobility decreased (serious criteria disability), grip strength decreased (serious criteria disability) and joint clicking (serious criteria disability). On an unknown date, the outcome of the injection site discomfort, weakness, injected limb mobility decreased and grip strength decreased were not recovered/not resolved and the outcome of the joint clicking was unknown. The reporter considered the injection site discomfort, weakness, injected limb mobility decreased, grip strength decreased and joint clicking to be possibly related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a physician assistant. On 31st December 2015, the patient visited physician assistant's office and reported that she experienced injection site discomfort at both the sites. The patient also experienced difficulty with movement, specifically described as difficulty in hooking bra along with trouble in raising her arms, range of motion issues, shoulder popping, shoulder weakness and lack of grip strength. The specific date of onset for all the events were unknown, it could be between 22nd December 2015 and 31st December 2015. The events were worsening at the time of reporting and the healthcare professional felt as though they were disabling. The reported batch number (328HS) for FLUARIX QUADRIVALENT did not exist and was updated to 32BH5 as per sales database.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Bloody stools.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Pain, Urticaria
Clinical narrative: Pt's mother states pt broke out in hives and had bad GI upset and body aches starting the night after receiving the immunization. Pt took BENADRYL and have improved.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash on arm where shot administered, warm to the touch. Recommend tx: cold compress, anti-inflammatory or antihistamine.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Patient had pain after shot was given. Patient use ice and TYLENOL to ease the pain but they didn't help as much. On 01/11/16, the pain was bad as the first day.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, FLU3, HPV9
Symptoms: Blood pressure increased, Body temperature increased, Chills, Feeling cold, Feeling hot
Clinical narrative: Approximately 1-2 minutes after receiving GARDASIL-9 HPV vaccine and seasonal influenza vaccine, patient felt hot and then cold/shivering, elevated heart rate, temp. 100.2 Fahrenheit, elevated blood pressure, flushed face, slight puffiness in cheeks. This lasted approx. 2 hours.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, FLU3, HPV9
Symptoms: Flushing, Heart rate increased, Swelling face
Clinical narrative: Approximately 1-2 minutes after receiving GARDASIL-9 HPV vaccine and seasonal influenza vaccine, patient felt hot and then cold/shivering, elevated heart rate, temp. 100.2 Fahrenheit, elevated blood pressure, flushed face, slight puffiness in cheeks. This lasted approx. 2 hours.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, FLU3, HPV9
Symptoms: Flushing, Heart rate increased, Swelling
Clinical narrative: Approximately 1-2 minutes after receiving GARDASIL-9 HPV vaccine and seasonal influenza vaccine, patient felt hot and then cold/shivering, elevated heart rate, temp. 100.2 Fahrenheit, elevated blood pressure, flushed face, slight puffiness in cheeks. This lasted approx. 2 hours.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-OCT-2015 the patient was vaccinated with improperly stored dose of GARDASIL (lot # K011562, expiration date 08-APR-2017, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Eye swelling, Hypoaesthesia, Swelling face
Clinical narrative: Numbness of area - any place on body. Redness in different shapes and size. Eye and face area swelling. 3-6 day.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Ear discomfort, Eye discharge, VIIth nerve paralysis
Clinical narrative: On Wed: 11/18/15 started feeling pressure deep down within my left ear. Continue on through Thurs. Night and I heard a light pop. Fri 11/20 brush my teeth for bedtime. I couldn't hold water in my mouth. 11/21 my left eye drain water. 11/22 I notice my lips was uneven. 11/23 my face losing shape, diagnosed: Bell's Palsy treatment: Methylprednisolone and acyclovir.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Road traffic accident, Seizure
Clinical narrative: Pt was given Tdap vaccine on 12/5/15 and stated everything went fine with vaccine. 3 days later on 11/8/15 pt had a seizure and was involved in a car accident. Pt went to ER and had another seizure. Pt is now under care of neurologist.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Brain oedema, CSF protein normal, Nuclear magnetic resonance imaging brain abnormal, Road traffic accident
Clinical narrative: Pt was given Tdap vaccine on 12/5/15 and stated everything went fine with vaccine. 3 days later on 11/8/15 pt had a seizure and was involved in a car accident. Pt went to ER and had another seizure. Pt is now under care of neurologist.
Age: 63.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Seizure
Clinical narrative: Pt was given Tdap vaccine on 12/5/15 and stated everything went fine with vaccine. 3 days later on 11/8/15 pt had a seizure and was involved in a car accident. Pt went to ER and had another seizure. Pt is now under care of neurologist.
Sex: U
Vaccine: HEPA, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 07-JAN-2016, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L026406 exp date 15-JUL-2017) (dose and route not reported) and a dose of PROQUAD (Merck) (lot # reported as L040411 exp date 13-APR-2017) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Decreased appetite, Fatigue
Clinical narrative: Fatigue, weakness, decrease in appetite.
Sex: U
Vaccine: HPV4
Symptoms: Death, Unevaluable event
Clinical narrative: This spontaneous report as received from a physician via an issue of a magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that, the GARDASIL had absolutely no effect on cervical cancer (vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillain-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Disability
Clinical narrative: This spontaneous report as received via social media from an unspecified reporter, who obtained the information from the articles published on a web page, refers to many female patients of unknown age. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with unknown doses of GARDASIL (lot #, expiry date, route and site of administration were not reported). Concomitant medications were not reported. On unknown dates, many of patients experienced disability. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL (it was reported that vaccine "disabled many women"). This is one of two reports received from the same reporter. Additional information has been requested.