chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a unspecified patients of unknown age and gender. On 08-OCT-2014, 13 expired doses of PNEUMOVAX 23 (dose, route were not reported) (lot # H022172 and expiration date was 16-AUG-2014) was administered to unspecified patients. No adverse events were reported. This is one of the two reports from the same source. This case was linked to MARRS# 1410USA007748. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that RECOMBIVAX HB was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, 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 10-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, 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 25-AUG-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, units, route of administration, lot# and expiration date not provided) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician concerning a 68 year old male patient with hypertension, stage 3 chronic kidney disease and type 2 diabetes. The patient's medical history included stroke and prostate cancer. On 05-JAN-2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Physician reported patient received ZOSTAVAX in 05-JAN-2009, and now had a "breat out" of zoster on 13-OCT-2014. At the time of the report the outcome was reported as not recovered. Patient received treatment with VALTREX and sought medical attention. None lab test diagnostics were performed. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered  nurse via company representative regarding a female patient of unknown demographics. Patient's concurrent conditions and medical history not reported. On 26-JUN-2014, the patient was vaccinated with PNEUMOVAX23, subcutaneous into deltoid muscle. Concomitant medications were not reported. On 26-JUN-2014, after the onset of therapy the patient experienced cellulitis accompanied with pain, stiffness and other adverse reactions that resulted in overnight hospitalization. The patient sought medical attention. The action taken with the suspect drug was not reported. The outcome of events was not reported. Relatedness of the events with PNEUMOVAX23 was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, White blood cell count increased
Clinical narrative: This spontaneous report was received from a registered  nurse via company representative regarding a female patient of unknown demographics. Patient's concurrent conditions and medical history not reported. On 26-JUN-2014, the patient was vaccinated with PNEUMOVAX23, subcutaneous into deltoid muscle. Concomitant medications were not reported. On 26-JUN-2014, after the onset of therapy the patient experienced cellulitis accompanied with pain, stiffness and other adverse reactions that resulted in overnight hospitalization. The patient sought medical attention. The action taken with the suspect drug was not reported. The outcome of events was not reported. Relatedness of the events with PNEUMOVAX23 was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Adverse reaction, Cellulitis, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report was received from a registered  nurse via company representative regarding a female patient of unknown demographics. Patient's concurrent conditions and medical history not reported. On 26-JUN-2014, the patient was vaccinated with PNEUMOVAX23, subcutaneous into deltoid muscle. Concomitant medications were not reported. On 26-JUN-2014, after the onset of therapy the patient experienced cellulitis accompanied with pain, stiffness and other adverse reactions that resulted in overnight hospitalization. The patient sought medical attention. The action taken with the suspect drug was not reported. The outcome of events was not reported. Relatedness of the events with PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Heart rate increased, Urticaria
Clinical narrative: Onset of hives, mild at first, but worsening over next 24 hours.  Hives on torso and arms.  My daughter also said her heartbeat felt fast, though resting pulse is at 75 beats per minute.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bone pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: My arm bones started hurting (similar to when a broken bone hurts in the cold), and now my shoulder feels very sore to the point where I can only lift up my arm half the distance. Also it's hard for me to move my fingers, and my elbow hurts too.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient was given Flu Mist at 9;10 am and tolerated well. Patients mom called us at 11:30 am stating he had a rash all over and it was itching. Mom advised to give Benadryl and call with updae in am or sooner if worse.  I called parent the next day and mom said the rash was better but will still give Benadryl. Mom informed to call office if any other concerns or sx. At no time were ther any breathing problems. Rash is now gone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Sore throat blood shot eyes severe chills temp 101 entire body aching.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever, sore musles, headache, dizzy and vomiting for 36 hours.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Evening after vaccination had lightheadedness. Next day 10/10/2014, patient felt weak, tingly. Headache started 10/11/2014 along with chills, sweats and fever. 10/17 reports temp 100.4. On and off vomiting, headache and body aches.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Evening after vaccination had lightheadedness. Next day 10/10/2014, patient felt weak, tingly. Headache started 10/11/2014 along with chills, sweats and fever. 10/17 reports temp 100.4. On and off vomiting, headache and body aches.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Anxiety, Chest pain, Computerised tomogram, Depression
Clinical narrative: First event was hair loss, then progressed to headaches, vertigo, weakness in extremities, visual disturbances, anxiety, depression, chest pain, irregular heartbeat, nausea, difficulty swallowing.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Headache, Heart rate irregular, Laboratory test, Muscular weakness
Clinical narrative: First event was hair loss, then progressed to headaches, vertigo, weakness in extremities, visual disturbances, anxiety, depression, chest pain, irregular heartbeat, nausea, difficulty swallowing.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Neurological examination, Nuclear magnetic resonance imaging, Vertigo, Visual impairment
Clinical narrative: First event was hair loss, then progressed to headaches, vertigo, weakness in extremities, visual disturbances, anxiety, depression, chest pain, irregular heartbeat, nausea, difficulty swallowing.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, warmth, pain, swelling.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Fever, difficulty breathing, headache, weakness, fast heartbeat, dizziness and general malaise. Took 440mg of Aleve liquid gels and then laid down to sleep about 11:00 PM.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, difficulty breathing, headache, weakness, fast heartbeat, dizziness and general malaise. Took 440mg of Aleve liquid gels and then laid down to sleep about 11:00 PM.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site vesicles
Clinical narrative: PATIENT STATED THAT THEY TOOK OFF THE BAND-AID THE MORNING AFTER VACCINE ADMINISTRATION AND THERE WAS A BLISTER PRESENT UNDERNEATH THE BAND-AID. THE BLISTER POPPED AND HE PRESENTED TO THE PHARMACY WITH INFLAMMATION AND OPEN SKIN AT THE INJECTION SITE.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Got vaccine 7:45 PM on 10/14/14 came back in with bruising around site and said it was sore.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient states she had soreness at site of injection and along entire upper right arm for 2 weeks post injection.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Skin exfoliation
Clinical narrative: Patient got Fluvirin vaccine on 09/24/14. She reported about one week after shot she is having a problem with vaccine site. Symptoms include red and peeling around the area. After 3 weeks site has large mark with peeling, darkening, and yellowing.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Cough, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: Headache, chills. By evening I was running a 101.6 temp. I have ran this fever until 10/18/14 along with headache, neck pain, and malaise. Developed a mild congested cough. Seen physician on the 18th. Temp 101.8.
Age: 42.0
Sex: F
Vaccine: FLUN4
Symptoms: Malaise, Neck pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache, chills. By evening I was running a 101.6 temp. I have ran this fever until 10/18/14 along with headache, neck pain, and malaise. Developed a mild congested cough. Seen physician on the 18th. Temp 101.8.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in upper arm and shoulder.  Not able to lift arm or move the arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called Sat 10/18/14 to say that she had a large (2-3") area of redness and swelling at the Zostavax injection site but no other symptoms. Advised to take Benadryl and monitor for fever or rash. Waited 24 hours to report...
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Herpes zoster oticus, Neuritis, Nuclear magnetic resonance imaging brain
Clinical narrative: Inflamed nerves right auditory canal; hearing loss; Zoster Oticus/Ramsey Hunt syndrome.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Severe chills, mild-to-moderate fever, muscle aches, joint aches, mild headache.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Nausea, Tremor
Clinical narrative: Pt reported initial reaction of uncontrolled bilateral shaking/tremor of arms. Tremor abated, but patient reported next three days had nausea, loss of apettite and fatigue. Pt reported 10/18/2014 - states complete resolution.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Headache, Injection site pain, Local swelling
Clinical narrative: Extreme fatigue, headache, body aches, swollen red arm, pain at injection site.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Extreme fatigue, headache, body aches, swollen red arm, pain at injection site.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Left arm started to feel hot & pain (scale of 5 out of 10) w/onset of sx @ 11:00 PM. Woke up 10/18/14 redness and increased in size to 3" X 2" in size & hot to touch. Tingling to finger tips.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Pt called and said she had a rash this morning.  Around 4x6 inches area.  She said yesterday, it has some swelling and tenderness at the injection site. She is fine now...but just want to let us know.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Livedo reticularis
Clinical narrative: Mottled rash appeared around area of injection.  Mother speculated his sensitive skin reacted to the alcohol wipe (redness did encompass this area).  I administered 2 tsp Benadryl to the patient and then asked the mother to wait in the waiting area for an additional 10-15  minutes and would re-assess. She returned 10 minutes later (12N) and the redness had improved.  She went home and I provided instructions to go the ER if there was any worsening, swelling of the face or neck, shortness of breath or vomiting.  She returned to this clinic at 3:40 to have me assess the patient's arm which was erythematous and edematous and tender to touch.  Otherwise with no symptoms.  I instructed her to administer ibuprofen, apply an ice pack to the arm and give Benadryl again at 6PM.  I re-iterated my previous instructions regarding additional signs and symptoms to look for and advised she go to the ER with any of the above or worsening symptoms.  She verbalized understanding.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Mottled rash appeared around area of injection.  Mother speculated his sensitive skin reacted to the alcohol wipe (redness did encompass this area).  I administered 2 tsp Benadryl to the patient and then asked the mother to wait in the waiting area for an additional 10-15  minutes and would re-assess. She returned 10 minutes later (12N) and the redness had improved.  She went home and I provided instructions to go the ER if there was any worsening, swelling of the face or neck, shortness of breath or vomiting.  She returned to this clinic at 3:40 to have me assess the patient's arm which was erythematous and edematous and tender to touch.  Otherwise with no symptoms.  I instructed her to administer ibuprofen, apply an ice pack to the arm and give Benadryl again at 6PM.  I re-iterated my previous instructions regarding additional signs and symptoms to look for and advised she go to the ER with any of the above or worsening symptoms.  She verbalized understanding.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Rash macular
Clinical narrative: Mottled rash appeared around area of injection.  Mother speculated his sensitive skin reacted to the alcohol wipe (redness did encompass this area).  I administered 2 tsp Benadryl to the patient and then asked the mother to wait in the waiting area for an additional 10-15  minutes and would re-assess. She returned 10 minutes later (12N) and the redness had improved.  She went home and I provided instructions to go the ER if there was any worsening, swelling of the face or neck, shortness of breath or vomiting.  She returned to this clinic at 3:40 to have me assess the patient's arm which was erythematous and edematous and tender to touch.  Otherwise with no symptoms.  I instructed her to administer ibuprofen, apply an ice pack to the arm and give Benadryl again at 6PM.  I re-iterated my previous instructions regarding additional signs and symptoms to look for and advised she go to the ER with any of the above or worsening symptoms.  She verbalized understanding.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Significant redness in the injected arm, fever >100, swelling.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cyanosis, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Developed cyanosis, numbness, pain, tingling of bilateral hands about 24 hours after vaccine administration.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia, Rash generalised, Scab, Secretion discharge
Clinical narrative: Break out as if many warts or pimples started on my fingers, chest and forehead around hair. Tingling, needle and pins in hands and feet. Toes and ankle have wart like bumps. My scalp and eyebrows have fluid that seeps out and gets yellow crusty buildup. My lower lip has a crusty buildup spot. I feel ok no fever. No unusual fatigue.  I will drink extra water.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth lasting currently.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient stated that she has a rash around breast area on left side that travels to the back and it started 2-3 days after Fluzone High Dose was administered.  She is not sure if it correlates with immunization or not.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Hypoaesthesia
Clinical narrative: INITIALLY HEADACHE, THEN NUMBNESS OF LEFT HAND (4TH & 5TH FINGERS), GOOD GRIP AND +2 PULSE. DENIES CHEST PAIN OR SOB. NO SKIN CHANGES. VSS, ALERT AND OREINTED X 4. NO WHEEZING. NP CALLED TO SITE, ASSESED PATIENT. PT AMBULATED AND NUMBNESS IN ARM DECREASED, BUT STILL NUMBNESS IN 2 FINGERS SLIGHTLY PRESENT. OBSERVED FOR 20 MIN AND VERBALIZED UNDERSTANDING TO CALL EMS IF SIGNS OF RESPIRATORY DISTRESS OR REPORT BACK TO CLINIC IF EXPERIENCES OF NUMBNESS INCREASE.
Age: 49.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Feeling abnormal, Memory impairment, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient stated that he felt dizzy and strange.  He was seated in a chair and after a minute or so his head went back, his eyes remained open, but he was completely unresponsive for 20-25 seconds. When he came out of it, he had no memory of the event and did not realize that he had been unresponsive.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Eye pruritus, Fatigue, Pain
Clinical narrative: Cough; itchy eyes; aches; fatigue; vomiting; restricted breathing.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Cough; itchy eyes; aches; fatigue; vomiting; restricted breathing.
Age: 40.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Chronic diarrhea began and has not yet stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pruritus, Pyrexia
Clinical narrative: Chills, slight fevor, itching, could not get out of bed for 30 hours, weakness.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-muscle specific kinase antibody, Antiacetylcholine receptor antibody, Antibody test negative, Blood immunoglobulin G increased, Diplopia
Clinical narrative: Diplopia (vertical), followed by muscle weakeness in throat, arm, and leg muscles.  Eventually diagnosed with seronegative (no antibodies to AChR or MuSK) Myasthenia Gravis.  Started on corticosterioids in March 2013.  Thymectomy performed on February 2014.  Received flu shot again on 10/16/2014, 10:00 AM.  Myasthenia Gravis symptoms worsened within hours or receiving shot.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Muscular weakness, Myasthenia gravis, Neurological examination abnormal, Thymectomy
Clinical narrative: Diplopia (vertical), followed by muscle weakeness in throat, arm, and leg muscles.  Eventually diagnosed with seronegative (no antibodies to AChR or MuSK) Myasthenia Gravis.  Started on corticosterioids in March 2013.  Thymectomy performed on February 2014.  Received flu shot again on 10/16/2014, 10:00 AM.  Myasthenia Gravis symptoms worsened within hours or receiving shot.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Diplopia, Eyelid ptosis, Myasthenia gravis
Clinical narrative: Worsening of MG symptoms, to include diplopia (vertical plane) and ptosis.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Diplegia, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Presyncope
Clinical narrative: Numbness, tingling immediately after vaccine within about 15 minutes. Then, on 10/16/2014 experienced near fainting and paralysis in arms, legs and face.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Numbness, tingling immediately after vaccine within about 15 minutes. Then, on 10/16/2014 experienced near fainting and paralysis in arms, legs and face.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site inflammation, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Large inflamed hot swelling and rash at injection site.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Feeling hot, Lethargy, Nausea, Tremor
Clinical narrative: Patient is complaining of feeling hot, clammy, nauseas, lethargic, and shaky 30 minutes after vaccination. States that she is still feeling lethargic and shaky one hour later. All other symptoms have resolved.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, redness, itching, warmth.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Swollen arm from shoulder to elbow, very red & hard & hot.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Malaise, Swollen tongue, Throat irritation, Tongue dry
Clinical narrative: She came rushing back saying her throat feels funny. Her tongue is very swollen and dry. I asked to give her Epipen, but she refused the Epipen. She just wanted a glass of water, which I gave her. Her blood pressure was 186/90. The EMS arrived quickly on scene.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Hives all over body.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: (L) arm redness, pain - instructed to follow-up in 48 hours if not better, sooner if worse. NSAIDS, ice/heat, rest, elevate.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Increased upper airway secretion, Vomiting
Clinical narrative: 1 PM shot. 4 M symptoms onset. Chest pain, heavy phlegm, difficulty breathing, vomiting, rapid heart beat. ER administered antihistamine and EPI (patient reported adverse event to pharmacy on 10-17-14).
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Tendonitis
Clinical narrative: Patient went to doctor after receiving flu shot. Tendonitis and bursitis was reported from flu shot. Pt recovered.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Bursa injury, Mobility decreased
Clinical narrative: Pt received flu shot and could not lift shoulder next day. Went to doctor. MD said shoulder "bursa punctured" and Rx steroids were given.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Asthenia, Bursitis, Mobility decreased, Pain, Poor quality sleep
Clinical narrative: Pt received flu shot and could not lift shoulder next day. Went to doctor. MD said shoulder "bursa punctured" and Rx steroids were given.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Mobility decreased
Clinical narrative: Patient states cannot lift arm above shoulder, swelling around shoulder. Pt has iced/taken TYLENOL with no improvement.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt had slight itchy rash on shoulder (left) of injection above site.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received on 10/11/14 and noticed the usual side effects but on 10/15/14 she noticed leg pain. She had back/leg issues in the past but she said this was buttocks pain also descending into both legs. Never experienced this before. She said the pain has now reverted back to one leg and she hopes it is disipating.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site erythema, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Patient received on 10/11/14 and noticed the usual side effects but on 10/15/14 she noticed leg pain. She had back/leg issues in the past but she said this was buttocks pain also descending into both legs. Never experienced this before. She said the pain has now reverted back to one leg and she hopes it is disipating.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Within 5 min of administration of flu vaccine patient became pale and lost consciousness.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Loss of consciousness
Clinical narrative: Within 5 mts of administering flu vaccine patient lost consciousness and fell down.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Lymphadenopathy, Pain, Paraesthesia oral, Pruritus
Clinical narrative: Next morning after flu shot (left arm) 9/27/14 gland in left clavicle area swollen/sore, hands got real red burny/itchy (sunburny) and now peeling (started Oct 7 and current). Lips tingled after shot too. Hands have not stopped peeling/blistering (on triamcinolone ointment).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation
Clinical narrative: Next morning after flu shot (left arm) 9/27/14 gland in left clavicle area swollen/sore, hands got real red burny/itchy (sunburny) and now peeling (started Oct 7 and current). Lips tingled after shot too. Hands have not stopped peeling/blistering (on triamcinolone ointment).
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope. Patient fainted at the check-out counter. She was with her mother. She gained consciousness right away. She stayed for 15 minutes then walked out with her mother.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site urticaria
Clinical narrative: Pt said saw a little whelps at injection site where vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Patient is experiencing muscle pain in the left deltoid where she received the vaccine, about 1 month after receiving the vaccine.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Administration site reaction, Mass
Clinical narrative: Unknown onset of symptom. Symptom was a small bump (smaller than a pencil eraser) under skin layer located on the administration site of the 2013-2014 FLUZONE intradermal vaccine given on the left deltoid.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: 3:30pm chills/fever/aches/pain/ringing in ears/headache/shortness of breath.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: 3:30pm chills/fever/aches/pain/ringing in ears/headache/shortness of breath.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Retching, Syncope, Vomiting
Clinical narrative: Pt was admin. FLUZONE HD on 10-16-14 at 11am to 12pm. Pt states around 12am-1am on 10-17-14 had fainted and had nausea/vomiting, dry heaving. Went to hospital ER. ER stated that everything looked OK. Observed for 5 hours then released.
Age: 76.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient received both vaccinations (pneumonia and flu) in the left arm on 10/17/14. Patient came to pharmacy on 10/18/14 complaining of warmness and soreness in that arm; on the underside of the left arm. An area (7x7) was red.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Muscular weakness
Clinical narrative: Pt experienced rigors and muscle weakness approximately 24 hrs after the immunization.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Nausea, Retching, Vomiting
Clinical narrative: Difficulty breathing, then went to emergency room and then started feeling very nauseous. She then vomited a few times, then had dry heaves.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Given decreased dose than recommended by manufacturer.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored M-M-R II (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for M-M-R II was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with M-M-R II was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant reported that on an unknown date an unspecified number of patients were vaccinated with ROTATEQ (strength, dose and lot # not reported), orally. The doses of ROTATEQ were exposed to a supported temperature excursion in "March or April 2014". No adverse effects had been reported. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursions for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA0101041, 1410USA009191, 1410USA009192, 1410USA009194 and 1410USA009195 (same reporter link). Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J014981 and expiry date: 17-SEP-2015). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA010141, 1410USA009191, 1410USA009192, 1410USA009193 and 1410USA009195 (same reporter link). Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1407USA010141, 1410USA009193, 1410USA009192, 1410USA009194 and 1410USA009195 (same reporter link). Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004981 and expiry date: 17-SEP-2015). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1407USA010141, 1410USA009193, 1410USA009191, 1410USA009194 and 1410USA009195 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 02-OCT-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose/frequency: 0.5 ml, route: subcutaneous). VARIVAX (Merck) was exposed to -7 Celsius for eight hours. No adverse effects were reported. No product quality complaint (PQC) was filed for VARIVAX (Merck). This case is linked to 1410USA009206 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 03-OCT-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose/frequency: 0.5 ml, route: subcutaneous). VARIVAX (Merck) was exposed to -7 Celsius for eight hours. No adverse effects were reported. No product quality complaint (PQC) was filed for VARIVAX (Merck). This case is linked to 1410USA004928 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for RECOMBIVAX HB was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown ager and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. No adverse symptoms were reported. The temperature excursions that were reported for PNEUMOVAX 23 was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for ROTATEQ was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with ROTATEQ was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for GARDASIL was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker concerning to unspecified number of patients of unknown age and gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored VAQTA (lot number, dose and route unspecified). Concomitant medications were not reported. No adverse symptoms were reported. The temperature excursions that were reported for VAQTA was supported excursion with in-house stability data. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 20-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA010141, 1410USA009191, 1410USA009192, 1410USA009193 and 1410USA009194 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (medical assistant) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 16-SEP-2014, the patient was vaccinated with ROTATEQ Vial, lot#K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified) for unknown indication. No concomitant medications were reported. On 16-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to her mother who was a 74 year old female patient. The patient's medical history included diabetes and hypertension. The patient had no drug reactions/allergies. On 06-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml, intramuscular (IM) in left arm (lot # K009105, expired date: 21-JAN-2016). Concomitant therapies included metformin, DIOVAN, verapamil and buspirone hydrochloride. The patient developed cellulitis at the injection site beginning on 06-OCT-2014 in the evening. An unspecified physician prescribed an unspecified antibiotic to treat the cellulitis. On 12-OCT-2014 the pharmacist's mother developed stiffness on the left side of her neck. No lab diagnostics studies were performed. The patient sought medical attention by spoke to pharmacist. The outcome of adverse events was reported as not recovered. The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a pharmacist refers to her mother who was a 74 year old female patient. The patient's medical history included diabetes and hypertension. The patient had no drug reactions/allergies. On 06-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml, intramuscular (IM) in left arm (lot # K009105, expired date: 21-JAN-2016). Concomitant therapies included metformin, DIOVAN, verapamil and buspirone hydrochloride. The patient developed cellulitis at the injection site beginning on 06-OCT-2014 in the evening. An unspecified physician prescribed an unspecified antibiotic to treat the cellulitis. On 12-OCT-2014 the pharmacist's mother developed stiffness on the left side of her neck. No lab diagnostics studies were performed. The patient sought medical attention by spoke to pharmacist. The outcome of adverse events was reported as not recovered. The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUN4
Symptoms: Anxiety, Hyperhidrosis, Paraesthesia
Clinical narrative: Patient started having feelings of anxiety accompanied by diaphoresis and tingling in extremities.  He sat down to avoid passing out.  No change in diet or other social factors.  Normal life stressors as before.  Receiving deployable immunizations has been the only significant change. Has had 5-6 episodes of anxiety since first onset.  Did not seek out any medical attention until recently coming in to discuss.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Pt came in on 10/18 and stated that a couple hours after the vaccine was administerd she developed a 3 to 4 inch in diameter raised, itchy, red, warm to touch rash.  She said that the area is still red but not as bothersome as it was originally.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Anxiety, Dyspnoea, Heart rate increased
Clinical narrative: Patient was complaining that she was unable to walk, having a rapid heart beat and short of breath. Epinepherine was administered IM when patient started showing physical signs of SOB by the nurse practitioner.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Myalgia, Palpitations, Pyrexia
Clinical narrative: Muscle aches, low-grade fever (100 degrees F), sleeplessness, heart racing. Treatment consisted of 400mg Ibuprofen at 10:00 PM on 10/18/2014 and 3:30 AM on 10/19/2014.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Face oedema, Lip oedema, Pruritus generalised, Rash, Rash maculo-papular
Clinical narrative: Urticaria with macular papular rash to abdomen, edema to left upper lip and left cheek. Pruritis throughout the body. Patient was treated with Benadryl, Zantac and prednisone with resolution of urticaria, rash and almost complete resolution of edema within 3 hours. Will complete course of prednisone for 5 days.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Urticaria with macular papular rash to abdomen, edema to left upper lip and left cheek. Pruritis throughout the body. Patient was treated with Benadryl, Zantac and prednisone with resolution of urticaria, rash and almost complete resolution of edema within 3 hours. Will complete course of prednisone for 5 days.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Moderate on-going dizziness.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Chills, Malaise, Pain
Clinical narrative: My daughter was given the nasal mist.  I have always gotten vaccinated and vaccinated my children.  I have ALWAYS believed it was a myth that you could get the flu from the vaccination.  That has all changed!!  She started out with a very bad stomachache in the evening and following day.  On Thursday, October 16th, she started to run a fever, which was up to 103 degrees at times.  The fever continued on October 17th and 18th.  She has body aches, chills, shaking with the chills.  In my opinion it is as bad as the flu itself.  It truly seems like she has gotten the actual flu from the nasal mist.  I have NEVER believed you could get the flu from a vaccine.  I will NEVER give my children the nasal mist ever again.  This is horrid!!!! The vaccination sheet lists her symptoms as a mild reaction.  This is not a mild reaction!!!  She is reacting just like she has the flu.  She is absolutely as sick as she would be if she had the flu itself.  She has missed some very important events due to this.  I am not happy!!!
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: My daughter was given the nasal mist.  I have always gotten vaccinated and vaccinated my children.  I have ALWAYS believed it was a myth that you could get the flu from the vaccination.  That has all changed!!  She started out with a very bad stomachache in the evening and following day.  On Thursday, October 16th, she started to run a fever, which was up to 103 degrees at times.  The fever continued on October 17th and 18th.  She has body aches, chills, shaking with the chills.  In my opinion it is as bad as the flu itself.  It truly seems like she has gotten the actual flu from the nasal mist.  I have NEVER believed you could get the flu from a vaccine.  I will NEVER give my children the nasal mist ever again.  This is horrid!!!! The vaccination sheet lists her symptoms as a mild reaction.  This is not a mild reaction!!!  She is reacting just like she has the flu.  She is absolutely as sick as she would be if she had the flu itself.  She has missed some very important events due to this.  I am not happy!!!
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extremely limited range of motion, severe pain 8/10, shoulder, arm, elbow.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Throat swelled.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Sensation of foreign body, Throat irritation
Clinical narrative: Throat swelled.