chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Eyelid oedema, Lip swelling
Clinical narrative: 2 hours after vaccine given, patient developed (L) eyelid swelling; 3 hours after vaccine given patient developed lower lip swelling. Given ORAPRED (15mg) and BENADRYL (12.5mg) po. Transported to ER via EMS. At ER given IM EPI.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Limb mass, Peripheral swelling
Clinical narrative: (L) arm bruised, red, swollen 3x5cm lump.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in arm for 3 weeks - Had Flu shot before never hurt.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder limited range of motion since flu shot received.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received Flu vaccine too early.
Age: 60.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt was given VARICELLA in place of ZOSTAVAX.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11/7/16 - Pt received vaccine at 10:15 in (L) deltoid. - Eve warm, redness, swelling. 11/4/16 - Received call from mother RE.- Injection site from (L) acromial process to (L) elbow at 7am. Pt visited MD at 1145. Advised mother to elevate and ice intermittently. Mother will give BENADRYL and TYLENOL for a couple of days and F/U with PCP if necessary. 11/05/16-1050 call to mother Pt improving decreased SW.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt rec'd 12 mo IMM at 10/14/16. Fever (105 degree max) Began 11/03/16 at daycare. Fussy. No cough, no rash, no VI. Seen 11/04/16 for S/S. Positive L-TM = Pink with clear fluid; Tx'ing fever with alt. TYLENOL/MOTRIN. (questionable Roseola).
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Dev't of quarter-sized red spot at injection site on (L) arm. Thurs/Fri (11/3-11/4) Dev't swollen lump at injection site. Lump decreased in size from 11/3-11/4, was warm to touch. Sat (11/5), lump small sized site of injection still red, site is also itchy.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Dysphonia, Injection site rash, Rhinorrhoea, Wheezing
Clinical narrative: The next day after the flu shot he developed a rash on the injection site, wheezing, runny nose and hoarse. He had a temp of 100 degree on Friday A.M. he was seen by physician and prescribed steroids and advised to Not have another flu shot.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Painful and swollen arm (left deltoid) at injection site. Diminished after 24 hrs. but still painful. Patient applied ice.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed with cellulitis; patient given KEFLEX 500mg TIDx10d.
Age: 89.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness
Clinical narrative: Extremely dizzy and weak!
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Lethargy, Malaise
Clinical narrative: Headache, fever/chills 100.9, lethargy/malaise, dizziness/nausea - took approximately 24 hours to recover.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache, fever/chills 100.9, lethargy/malaise, dizziness/nausea - took approximately 24 hours to recover.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Received flu shot on 10/27/16. Pt noticed rash to arms, trunk, back of chest upon awakening 10/28/2016. Seen by work comp MD on 10/28/16. Dx: hypersensitivity to flu shot.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Approximately 7cm Red, firm, warm area. Noted by school nurse. Day after injection.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: Mom noticed 2.5 - 3" of induration last night and treated with ibuprofen and BENADRYL. Today (10/28) the induration measures 4". Redness grew as large as 5-6".
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Mom says injection site was warm and red with 1.5" of induration. Today in the office it measures 2.5". Will treat with BENADRYL and TYLENOL.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: The day after vaccine, induration at injection site measured 3". Mom treated with BENADRYL and ibuprofen. Reaction had resolved by 10/31/16.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Induration, Injection site induration, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Left arm warm, hot, swollen, hard from the shot area down her arm.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm
Clinical narrative: Left arm warm, hot, swollen, hard from the shot area down her arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pain, Sinus congestion
Clinical narrative: Pains in eyes, sinus congestion, chest problems. Pt felt better next morning. Only eyes side effects left.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Evening of injection (10/27/16) swelling, redness, hard core developed at site. By Friday, noon, pain was worse, I could not lift significant weight (over 10lb). Friday evening thru Sunday morning (10/28-10/30) I had chills and fever. Symptoms looked similar to cellulitis extended from shoulder to elbow.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal disorder, Pain, Pyrexia
Clinical narrative: Evening of injection (10/27/16) swelling, redness, hard core developed at site. By Friday, noon, pain was worse, I could not lift significant weight (over 10lb). Friday evening thru Sunday morning (10/28-10/30) I had chills and fever. Symptoms looked similar to cellulitis extended from shoulder to elbow.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient reported feeling nauseous and dizzy for several days after vaccination.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Swollen arm and tingling sensation radiating up to neck area.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Patient diagnosed with cellulitis. Patient could not be reached for follow up on treatment.
Age: 30.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling, Throat irritation
Clinical narrative: Swelling at injection site scratchy throat.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Joint swelling, Peripheral swelling
Clinical narrative: Swollen left arm 9:15 am 10/5 red, swollen especially at elbow. Was seen by physician around 1 pm - gave her an antibiotic.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and band of redness around injection site; itching; burning. Warm to touch.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Swelling, Vaccination complication
Clinical narrative: Flu shot given 9/29/16. Developed redness, heat, raise area within 2 days. Reported 10/3/16. Seen by work comp MD. Dx: flu shot reaction.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt. received injection to (R) deltoid. Within 10-15 minutes, started breaking out in raised, itchy, red rash over trunk and extremities. NO SOB. BENADRYL 50 mg IM given. Within 5-10 min rash almost completely resolved.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Fatigue, Feeling jittery, Headache
Clinical narrative: Patient received flu shot-9-26-16-In left arm. Day after shot, started having pain in left arm and proceeded to shoulder joint. Two days later developed numbness in left side of neck and numb spots in head. Symptoms stopped in neck and back of head and proceeded to other spots of head with headaches in forehead and still numb spots in head and then became lightheaded and confused and real nervous  (jitters) and unable to think clearly. Followed by irritable and been very very tired. Had to lay down several hrs. everyday, feeling very very bad. Consulted Physicians-10-7-16-For aches and pains. Received medications for six days. After six days-retuned to Physicians again-10-12-16,medications for six more days. Symptoms still there. Contacted Physician by phone and was instructed to take TYLENOL and rest. Symptoms are still continuing. We are concerned about our health and long term effects.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site joint pain, Irritability, Mental impairment, Nervousness
Clinical narrative: Patient received flu shot-9-26-16-In left arm. Day after shot, started having pain in left arm and proceeded to shoulder joint. Two days later developed numbness in left side of neck and numb spots in head. Symptoms stopped in neck and back of head and proceeded to other spots of head with headaches in forehead and still numb spots in head and then became lightheaded and confused and real nervous  (jitters) and unable to think clearly. Followed by irritable and been very very tired. Had to lay down several hrs. everyday, feeling very very bad. Consulted Physicians-10-7-16-For aches and pains. Received medications for six days. After six days-retuned to Physicians again-10-12-16,medications for six more days. Symptoms still there. Contacted Physician by phone and was instructed to take TYLENOL and rest. Symptoms are still continuing. We are concerned about our health and long term effects.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received flu shot-9-26-16-In left arm. Day after shot, started having pain in left arm and proceeded to shoulder joint. Two days later developed numbness in left side of neck and numb spots in head. Symptoms stopped in neck and back of head and proceeded to other spots of head with headaches in forehead and still numb spots in head and then became lightheaded and confused and real nervous  (jitters) and unable to think clearly. Followed by irritable and been very very tired. Had to lay down several hrs. everyday, feeling very very bad. Consulted Physicians-10-7-16-For aches and pains. Received medications for six days. After six days-retuned to Physicians again-10-12-16,medications for six more days. Symptoms still there. Contacted Physician by phone and was instructed to take TYLENOL and rest. Symptoms are still continuing. We are concerned about our health and long term effects.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, X-ray limb
Clinical narrative: Shoulder (Below) - Muscle Pain - inability to lift arm (stiff).
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Hyperhidrosis, Pain, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever, body ache, vomiting, sweating, body rash, red dots throughout body, 10/26-10/28. TX + BENADRYL = effective. Resolved 10/29.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Fever, body ache, vomiting, sweating, body rash, red dots throughout body, 10/26-10/28. TX + BENADRYL = effective. Resolved 10/29.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Dyspnoea, Oropharyngeal pain, Rash, Swelling face, Throat tightness
Clinical narrative: Symptoms of sore throat closing shortness of breath, facial swelling and rash.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Rash, pruritic: neck and upper back. Rash began day of flu shot (9-8-16). Went away after 1 wk.
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Keratitis, Vision blurred
Clinical narrative: Pt awoke without vision in the right side (completely blurred). Saw MD this morning and has corneal inflammation.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Erythema, Fatigue, Headache, Heart rate increased
Clinical narrative: Soreness, fatigue, redness, giant hives day 2 10/05 at 14:00, swelling, elevated BP and HR, fever, headache.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Swelling, Urticaria
Clinical narrative: Soreness, fatigue, redness, giant hives day 2 10/05 at 14:00, swelling, elevated BP and HR, fever, headache.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Fall, Head injury
Clinical narrative: Chills, HA, loss of appetite and weakness x 3 days. Fell twice and hit head as a result, resulting in ER visit to close bleeding wound.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Wound haemorrhage
Clinical narrative: Chills, HA, loss of appetite and weakness x 3 days. Fell twice and hit head as a result, resulting in ER visit to close bleeding wound.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, Mobility decreased, Neuralgia, Pain in extremity
Clinical narrative: Pain in upper arm since vaccine was administered. Sever cannot lift arm. Saw neurologist. Shot was given on the nerve. Prescribed Gabapentin. Unknown how long pain will last.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypoaesthesia, Tremor
Clinical narrative: Approx 10 hours post vaccination pt experienced: Chills numbness of fingertips and lips shaking.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient stated she woke up next day with non-itchy rash on front of torso. Was gone in evening.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administered 10/26/16 (L) deltoid. 12 hrs after developed redness, swelling, pain, itching. At 48 hrs post vaccine0redness neck to elbow (L) arm. At 55 hrs post vaccine-redness midline chest. Neck and LUE to elbow. Reports low grade fever.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Vaccine administered 10/26/16 (L) deltoid. 12 hrs after developed redness, swelling, pain, itching. At 48 hrs post vaccine0redness neck to elbow (L) arm. At 55 hrs post vaccine-redness midline chest. Neck and LUE to elbow. Reports low grade fever.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site induration, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, pain/swelling of R deltoid. Hard lump at injection site.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Low grade fever, nausea, chills/sweats, exhaustion.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Day after flu shot patient developed fine rash on trunk (front and back).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Arm and back -neck-painful-nausea-headache-fatigue-stayed in bed for two days-took a full week and a half to recover.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arm and back -neck-painful-nausea-headache-fatigue-stayed in bed for two days-took a full week and a half to recover.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: -Difficulty in moving arm; pain in arm, sometimes radiating to hands. -No pain if arm in resting position.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms. Patient received PREVNAR 13 and PNEUMOVAX 23 at his Dr's office. When he came to the Pharmacy he stated that he never had a Pneumonia vaccine and was given and extra PREVNAR 13 vaccine, even though he didn't need it.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injection site inflammation, Injection site swelling
Clinical narrative: Inflammation and swelling of site - diameter of an egg. Several days. Applied ice. Couple of days later ended up with bruise same size.
Age: 8.0
Sex: F
Vaccine: DTAP, FLU4, IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Extensive redness and swelling of entire upper arm.
Age: 38.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Day of vaccine: swelling, tenderness, enlarged lymph node. Next day redness, swelling, tenderness. 2nd node. 3rd day - swelling and redness - nodes larger and more painful. 4th day - swelling and redness decreasing. 5th day - redness and swelling resolved. 6th day- mildly tender delt. 2 nodes still lg. and tender.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt felt faint after receiving flu vaccine. She was given cool towels, beverage twist up, pulse 86, resp. 18, was alert and oriented x person, place, situation, reports that she done this before 4 years ago while driving.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Flu vaccine administered 0.5mg given. 0.25mg indicated.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: Patient states got flu shot 10/07/16, went running on 10/8, vision became blurry. Had to go to MD office, MD did MRI and physical exam. Everything came back normal. MD advised might be flu shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth right arm measuring 10cm x 7 1/2cm. Mom states it started 11/3/16. 11/7/16-phone call to mother, states arm is back to normal.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Presyncope, Tinnitus
Clinical narrative: Vasovagal episode, pale skin and ringing in ears - recovered completely after 10 mins. (LOC less than 30 seconds).
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: 3 days after shot I began to experience pain in my elbow and wrist joint. I have also felt discomfort in other joints, but primarily in my left arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest X-ray normal, Chest discomfort, Cough, Dyspnoea
Clinical narrative: Next day neck achy/back achy. 2nd day cheeks hot. 4th day cough (continuous) last 5 days called for LEVAQUIN took for 5 days. Lungs kept getting worse wheezy, 2nd week coughing wheezy short of breath. Seen Dr Cx ray 3rd week unable to breath chest tight.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Laboratory test abnormal, Neck pain, Wheezing
Clinical narrative: Next day neck achy/back achy. 2nd day cheeks hot. 4th day cough (continuous) last 5 days called for LEVAQUIN took for 5 days. Lungs kept getting worse wheezy, 2nd week coughing wheezy short of breath. Seen Dr Cx ray 3rd week unable to breath chest tight.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pruritus, Pyrexia
Clinical narrative: Right deltoid inflamed red and itchy. Occurred approximately 2 days after injection. After injection fever occurred approximately 5 hrs later. Also headache.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient had raised, red welt around injection site patient said welt warm to touch. Also reported a headache and 101 degree fever. Pt seen physician on 11-7-16 who prescribed Z-PAK.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: Patient had raised, red welt around injection site patient said welt warm to touch. Also reported a headache and 101 degree fever. Pt seen physician on 11-7-16 who prescribed Z-PAK.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pt received FLUARIX at pharmacy came back next day to receive MENACTRA and complained of pain/soreness to site of injection. States her joints also hurts. Pt. currently taking naproxen and sulfasalazine. Notice slight decrease in pain from yesterday.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Pain, Rash macular
Clinical narrative: Patient received a flu shot and Pneumonia shot on 10-26-16. Presented to Pharmacy with red blotchy skin from the upper area to elbow in arm that she received vaccination. Headache, body ache.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling. Diphenhydramine 25 mg BID.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On 02-NOV-2016, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX 19400 PFU (lot # L028284, expiration date 28-OCT-2016) (strength, dose, frequency and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M017334, expiration date: 05-OCT-2017), subcutaneously. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report has been received from a 65 year old female patient, who was reporting on herself. The patient reported no pertinent medical history and drug reactions or allergies. Concomitant therapy was not reported. On 04-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, lot#, expiration date were not reported, route of administration was not reported as intramuscular or subcutaneous). On 12-OCT-2016 (also reported as a week later), the patient experienced a rash on her arm (unspecified arm) and fever. The patient went to her physician who treated her with an unspecified anti-inflammatory medicine. No labs were performed. She stated she will see her physician again in a week (unspecified date) for further treatment, if her symptoms don't clear up. The patient did not recover from the event, at the time of the report. There was no product quality complaint involved. The patient stated that her physician was uncertain if PNEUMOVAX 23 was the cause of her rash. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L003855, expiration date 05-FEB-2017) (dose and route unknown). The vaccine was exposed to a temperature described as: "max 47.6F for 10 minutes with three previous excursions of 10 minutes each exposed to a max of 47.6F each time" (cumulative 40 minutes out of recommended). Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RUB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored ROTATEQ, (lot#, expiration date and dose were not reported) orally. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# L021214, expiration date: 10-JUN-2017 and lot# M015731, expiration date: 30-MAR-2018), subcutaneously. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Vaccination failure
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 23 year old non-pregnant, female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown dates, reported as "when she was 11 years old", the patient completed the series of GARDASIL and was vaccinated with three, 0.5 ml doses (lot# and expiry date were not reported). On 01-NOV-2016, the patient was diagnosed with HPV (vaccination failure). No treatment was given for the event. No lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The relatedness between the events and GARDASIL was unknown. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # M011665 with expiration date 17-MAY-2017, lot # M020902 with expiration date 18-JUL-2017; dose and route were unknown). The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 60 year old female patient. On 13-OCT-2016 the patient was vaccinated with ZOSTAVAX (lot # M027117, expiration date 27-JUL-2017), 0.65 ml, subcutaneous injection. On 15-OCT-2016 the patient went to the pharmacy and reported to a pharmacist that she developed a large area of redness and swelling at the injection site at an unspecified time after receiving ZOSTAVAX. The patient began an unspecified treatment for the redness and swelling at the injection site. The outcome of injection site erythema and injection site  swelling is unknown. No additional information was provided. Additional information is not expected as the contact information for the patient was not provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX 23 lot # L027732, expiry date: 23-FEB-2017 (dose, route and site of administration were not reported). Temperature was 0.8 Celsius degrees for 4 hours and 20 minutes. Data logger was involved. No adverse effects were reported. This is one of three reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, single, subcutaneously; lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse effect. The outcome of the adverse event was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored VARIVAX (lot # L046887 with expiration date 03-NOV-2017, lot # M025867 with expiration date 24-MAY-2018, lot # M024680 with expiration date 18-MAY-2018; dose and route were unknown). The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored VAQTA (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Muscular weakness
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 66-year-old-non-pregnant female patient with no known drug reactions or allergies. The patient's medical history was not reported. On an unknown date in October 2015, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not specified) and experienced no problems after receiving that dose. On 20-OCT-2016, the patient was vaccinated with the second dose of PNEUMOVAX 23 injection (lot# M036161, expiration date 06-MAY-2018; exact dose was not reported) intramuscularly in her right deltoid. Concomitant therapies included an unspecified influenza vaccine on an unknown date in September 2016, after which she experienced "no problem", SYNTHROID, amlodipine and unspecified eye drops. On 20-OCT-2016, 3 hours after the vaccination, the patient began experiencing difficulty raising the injection arm over her head with her elbow extended. The pharmacist reported that her injection site did not look red or swollen, but the patient was reporting weakness in the injection arm. The patient was monitored by the pharmacist at the time of this report. The reporter stated that the patient had never had any reaction to a vaccine. There was no treatment given for the events. No diagnostic lab studies were performed. The outcome of difficulty raising the injection arm over her head with her elbow extended and weakness in the injection arm was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 4 year old patient of unknown gender. His/her medical history, concurrent conditions and concomitant medications were not reported. On 13-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (0.5 ml, subcutaneously, lot # J012661, expiration date 10-JAN-2015). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored RECOMBIVAX HB 5mcg/0.5ml (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored PROQUAD (lot # L045675 with expiration date 09-MAY-2017; dose and route were unknown). The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M019707 and expiry date 25-OCT-2017) orally. No adverse effects were reported. The administered vaccine was exposed to temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. The vaccine was exposed to previous temperature excursion of 60.1 Fahrenheit for 14 hours and 15 minutes. Data digital logger was involved. No product quality complaint (PQC) was filed. This case is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot # M002268, expiration date 20-SEP-2017 (dose, route and site administration were not reported). There were no adverse effects reported. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ lot # M002252, expiry date: 28-FEB-2017 and lot# L033694, expiry date: 16-JUN-2017, orally. Temperature was 0.8 Celsius degrees for 4 hours and 20 minutes. Data logger was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to three unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23, lot # M006139, expiration date 13-MAY-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash and not specified.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, mild erythema at the left arm area below injection site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # is reported as M010671 with expiration date 02-JUN-2018, lot # M006112 with expiration date 16-NOV-2017, lot # L046320 with expiration date 29-SEP-2017, lot # M005733 with expiration date 01-OCT-2017, lot # reported as M016919 with expiration date 17-FEB-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of VAQTA (lot # M022924 with expiration date 24-JAN-2018, lot # M003618 with expiration date 18-NOV-2017, lot # reported as M031806 with expiration date 30-03-2018, lot # 022924 with expiration date 24-JAN-2018, lot # reported as M027879 with expiration date 24-JAN-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age (reported as child). On 11-OCT-2016, the patient was administered an expired dose of M-M-R II lot  K012473, expiration date 26-AUG-2016 (therapy type, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot# M032635 and expiry date 05-MAY-2018) intramuscularly. No adverse effects were reported. The administered vaccine was exposed to temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. No previous temperature excursion were reported. Data digital logger was involved. No product quality complaint (PQC) was filed. This case is one of several reports received from the same reporter. Additional information has been requested.{Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored RECOMBIVAX HB lot # L019298, expiry date: 22-JUN-2017 (dose, route and site of administration were not reported). Temperature was 0.8 Celsius degrees for 4 hours and 20 minutes. Data logger was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report was received from an physician's assistant and refers to a 81 year old male patient. His concomitant therapy and medical history were not reported. On 14-OCT-2016 the patient was vaccinated with his first dose of PNEUMOVAX 23 (dose and strength were not reported, lot # M033086, expiration date 05-MAY-2018), intramuscularly in the left upper arm. On the same day, before the patient left the office, he complained of localized pain at the injection site. On 15-OCT-2016, the patient experienced left shoulder and elbow pain, which advanced to his left thumb over the next two days. On 18-OCT_2016 (reported as today), the patient experienced less left shoulder and elbow pain, but his left thumb was extremely tender to palpation and he was unable to move it. The outcome of injection site pain, pain in elbow, shoulder pain, pain in thumb, tenderness and mobility decreased was not reported. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash. Treatment: methylprednisolone 124 mg IVP MG once, diphenhydramine 50 mg IVP MG once.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from the patient's mother referring to a 12 year old female patient. The patient had no concomitant medication, no pertinent medical history and no drug reactions/allergies. On 17-OCT-2016 the patient was vaccinated with GARDASIL (intramuscular; strength, dosage and frequency unspecified). Five minutes after receiving the injection, the patient felt dizzy and light-headed. The patient laid down in the physician's office for about ten minutes and recovered. No treatment was given for the event and no lab diagnostic studies were performed. The causality was not reported. Additional information is not expected as physician refused to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M021407, expiration date: 30-APR-2018; lot # M016193, expiration date: 24-APR-2018; lot # L038503, expiration date: 18-DEC-2017). The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours (cycles: 7 times). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a patient's parent and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient received GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as the second dose. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Malaise, Myalgia, Pyrexia
Clinical narrative: Myalgia, fever and erythema with general malaise.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: Information has been received from a physician via a company representative concerning a female patient of unknown age and her friend. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with first dose of GARDASIL (0.5 ml) (lot #, expiration date and route were not reported) at different location. On the day the patients got the vaccine, they both felt tired, fatigue and a bit nauseous. At the time of reporting, the outcome of the events was unknown. The causality was not provided. Additional information has been requested.