chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Fussy x 4 hours with continuous crying after vaccines. Resolved with TYLENOL.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 19-OCT-2016 from a field representative who reported that, according to a nurse practitioner, a 68 year old male patient developed shingles after he received ZOSTAVAX. Patient started therapy with ZOSTAVAX injection "about a year and a half ago". The patient had first come into the office on 17-OCT-2016 for "ear pains and no rash". The patient did not see the nurse practitioner but another healthcare professional in the office. The patient was given an unspecified treatment for this. The patient came in on 19-OCT-2016 for "a vesicular rash on the left side of the head by the ear and lots of pain". The nurse practitioner diagnosed this rash as shingles. The patient was given a high dose of an unspecified pain medication for treatment. Patient's present status was not recovered. Limited information was provided to the reporter. No further adverse event information was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient got redness, itchiness and slight swelling at site of injection. Area of redness was approx. 2 in leng and 1 inch wide. Patient noticed s/sx about a day after vaccine administration. Used ice and spoke to her doctor. No pain experienced.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information was received on 14-OCT-2016 via a company representative calling on the behalf of a pharmacist who is the patient, a female of unknown age. Concomitant medication included SINGULAIR for an unspecified indication. Medical history was not reported. On an unknown date, the patient received a dose of ZOSTAVAX subcutaneously (lot number, expiration, dose and injection site were unknown). After the patient received the vaccine, on an unknown date, the patient experienced "a rash on her legs". The patient saw a physician on an unknown date and received an unspecified treatment. The patient has not yet recovered from rash on legs. The causality was not reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-OCT-2016 from a pharmacist who reported that an unspecified patient received a dose of ZOSTAVAX (lot number, dose, route were not reported) that had been "reconstituted and stored in refrigeration for 3-5 hours prior to administration" on 13-OCT-2016. No adverse effect reported. No other information was provided. Follow-up information was received on 18-OCT-2016 from the pharmacist who reported the lot number of the ZOSTAVAX that was administered: M019645, expiration 18-JUL-2017. No other information was provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information had been received on 19-OCT-2016 from a pharmacist regarding a 60 year old female patient with penicillin allergy and pertinent medical history of hypertension and hypothyroidism. On 16-OCT-2016, the patient received ZOSTAVAX (lot # M028798, expiration date 18-AUG-2017) 0.65ml 19400 PFU subcutaneously in the left arm. Concomitant medications included unspecified blood pressure medications and unspecified thyroid medications. On 18-OCT-2016, the patient began to experience redness at the injection site. On 19-OCT-2016, the redness was six inches in length at the injection site. Patient's present status was not recovered. Patient sought medical attention and called the pharmacist. The pharmacist advised the patient to contact her physician regarding her symptoms. Patient received unspecified treatment for her adverse event. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in May 2016, the patient was vaccinated with the first dose of ZOSTAVAX injection (exact dose, route of administration, anatomical location, lot #, expiration date were not provided). On 19-OCT-2016, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX injection (exact dose, route of administration, anatomical location, lot #, expiration date were not provided). There were no adverse effects reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reactions/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly storaged VARIVAX subcutaneously, lot # L010148, expiration date: 24-MAR-2017 (strength and dose were not provided). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient were vaccinated with GARDASIL 9 (dose, lot #, expiration date and route not reported). The patients stated the injection sites were painful for an unspecified amount of time (onset date unknown). The outcome of the event was unknown. The causality between GARDASIL 9 and the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Headache, Pain in extremity, Vomiting
Clinical narrative: Client in clinic on 10-13-16 for Tdap. Received IM in Lt. arm. Mother in clinic this AM (10-14-16) with client. States arm sore, hurts to move but able to without difficulty. Mother states started vomiting this morning and has temp of 101. Client states has headache. MOTRIN has been administered by mother. Client states stomach craps "a little bit".
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of VARIVAX (dose, lot number and expiration date were unknown), which was following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were unknown). On an unknown date, the patient developed an "injection site reaction after the PNEUMOVAX 23 injection was given". No product quality complaint (PQC). The outcome of the event was unknown. The causal relationship between PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-OCT-2016, a dose of ZOSTAVAX was reconstituted with 0.9% sodium chloride instead of provided diluent and the patient was vaccinated with this dose of ZOSTAVAX (lot # M015925, expiration date 15-JUN-2017, dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the unspecified patients were vaccinated with unspecified doses of GARDASIL 9 (dose, lot number and expiration date were unknown) following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiration date, site, dose and route of administration were not reported). On an unknown date, the patient experienced an unspecified averse event. The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected due to lack of the reporter's contact details.
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, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M004663 with expiration date 27-JAN-2018, once; dose was unknown), subcutaneously. 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: Respiratory disorder
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient. The patient had no drug reactions/allergies but had unspecified breathing problems. Concomitant medication was unknown. On 19-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # M032141 with expiration date 02-OCT-2017, 0.65 ml/once, subcutaneous). On an unknown date in October 2016 (reported as "about 1 or 2 days ago"), the patient experienced unspecified breathing problems. The patient made an unspecified contact with an unspecified physician and was prescribed oral prednisone. The outcome of the events was unknown. The pharmacist said the ZOSTAVAX was not the cause of the breathing problems. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 30-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L001311, expiration date 06-JUL-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 19-OCT-2016, the patient was vaccinated with an expired dose of PNUEMOVAX 23 (lot # L001311, expiration date 06-JUL-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30.75 hours and in 59.4F for 4.5 hours) doses of PNEUMOVAX 23 (lot # L048264, expiration date 10-JUN-2017; dose and route of administration were not reported). No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received from a medical assistant referring to an unspecified number of patient of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports 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 medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L035878, expiration date 11-AUG-2018; lot # M006710, expiration date 06-DEC-2018; lot L042259, expiration date 18-AUG-2018; lot # L042259, expiration date 18-AUG-2018; lot # L030871, expiration date 10-JUN-2018; dose and route not reported). The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a one year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with a dose of PROQUAD (dose, route and lot number were not reported) and VARIVAX (dose, route and lot number were not reported). No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M026876, expiry date: 26-JUL-2017). Pharmacist reported that the vaccine was exposed to 29F for 2.5 hours, and 9.86F for 2 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse referring to a 48 years old female patient with hypertension. The patient had drug reaction/allergy to DEMEROL. Concomitant therapies included multivitamin, hydrochlorothiazide, fluticasone, and TRAZADONE (manufacturer unknown). On an unknown date, the patient's testing showed that she had no immunity to varicella. On 04-OCT-2016, for employment purposes, the patient received a dose of VARIVAX (lot #M005971, expiration date 02-FEB-2018; dose and route were unknown). On an unknown date in October 2016 following the vaccination, the patient experienced chickenpox. The patient did seek medical attention at an unspecified urgent care facility on 27-OCT-2016. No lab diagnosis was performed. The outcome of the event was unknown. The causality assessment was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Information has been received on 07-OCT-2016 from a consumer referring to a 79 year old female patient. The patient's medical history and concomitant therapy are unknown. On 05-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 intramuscular or subcutaneous. The patient states that shortly after receiving the injection, on that same day her arm became very sore and swollen. The patient stated that she has not contacted her physician yet, but will call them today on 07-OCT-2016. The outcome of her arm became very sore and swollen was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports 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, the patients were vaccinated with doses of improperly stored PROQUAD( lot # M022402 with expiration date 01-NOV-2017, once; dose was unknown), subcutaneously. 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: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information had been received on 19-OCT-2016 from a medical assistant who reported that a patient (age and gender not reported), on an unknown date, was accidentally administered a PROQUAD vaccine instead of ZOSTAVAX due to a human error. No adverse effects were reported. No other information was available. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, lot number and expiration date were unknown), which were following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M004890, expiration date 11-OCT-2017; lot # L035511, expiration date 21-MAY-2017; lot # L033694, expiration date 16-JUL-2017; lot # L027719, expiration date 28-APR-2017; dose not reported) orally. The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M006139, expiration date 13-MAY-2017; lot # M006141, expiration date 28-MAY-2017; dose not reported) orally. The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048459, expiration date 22-FEB-2018; lot # M004116, expiration date 12-OCT-2017; lot # M007728, expiration date 21-MAR-2018; lot # L045700, expiration date 22-FEB-2018; dose and route not reported). The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. Patient's pertinent medical history and concomitant drugs were not provided. On 07-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9, lot # M004116, expiry date 12-OCT-2017 (dose, route of administration not reported). On 18-JUL-2016, the patient was vaccinated with the second dose of GARDASIL 9, lot # M004116, expiry date 12-OCT-2017 (dose, route of administration not reported). On 19-OCT-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M020103, expiry date 15-FEB-2018 (dose, route of administration not reported). No adverse effects were reported. There was no PQC involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site right thigh. Ibuprofen, recheck in office in 2 days. Ice, BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 16-MAR-2016, the patient was vaccinated with improperly stored GARDASIL (lot # L037003 exp date 27-MAY-2017) (dose and route not reported). The temperatures and times of excursion were as follows: -0.5 degree C for 128 hours, -0.3 degree C for 24 hours, 0 degree C for 34 hours, 1.11 degree C for 56 hours and 1.5 degree C for 24 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on legs, arms, and back. BENADRYL 12.5mg/5mL. 3.5mL q 6 hrs.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Vaccine was administered on 11/1/16. Pt states onset of symptoms of left arm tender was 11/2/16. Pt seen at health center today 11/3/16 for redness, swelling, tenderness and warm on left upper arm. Injection site WNL. S/S below injection site on left upper arm. Pt seen in office and placed on KEFLEX antibiotic with care instructions.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal, Blood immunoglobulin G decreased
Clinical narrative: This is a spontaneous report received from an employee and patient's mother regarding a 4-year-old male with a medical history of asthma, allergies, reflux, and chronic sinus infections who received PNEUMOVAX 23 injection on 15-AUG-2013. Concomitant medications included SINGULAIR, ADVAIR, VERAMYST, ALLEGRA, PREVACID, and  ASTELIN. On an unspecified date in October 2016 the patient had an immune panel blood test done and the titers were low for pneumococcal disease. It was reported that treatment was given but was not unspecified. The physician recommended a booster shot of PNEUMOVAX 23 and the patient is scheduled to receive this injection on 20-OCT-2016. No further information was provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram normal, Head titubation, Tremor
Clinical narrative: Approx. 8 hours after vaccines (and nonstop crying since 2 hours after vaccines), he had his first episode of head tremors. It lasted about 10 seconds and was a very mild shaking/vibration. Since then, he has had about 50 episodes of these tremors, occasionally involving his entire body but usually just his head, shoulders and arms. They have lasted as few as 5 seconds and as long as 60 seconds. Sometimes they are more severe than others, more vibration/shaking; sometimes it is a gentle tremor. Talking to him doesn't stop them. They are occurring less often and are less severe as time passes.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling in a 12-year-old male patient who received BEXSERO. In April 2016, the patient received BEXSERO .5 ml. In April 2016, less than a month after receiving BEXSERO, the patient experienced swelling, redness and pain. On an unknown date, the outcome of the swelling, redness and pain were recovered/resolved. It was unknown if the reporter considered the swelling, redness and pain to be related to BEXSERO. Additional details were provided as follows: The events lasted for 1 week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Grandmother states the girl was vaccinates on 10/20/2016. Right arm swelling and red. Arm is warm to touch and redness.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician via Pfizer referring to a patient of unknown age and gender who was immunocompromised. Concomitant medication was not reported. On an unknown date the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were unknown). It was reported that the patient had no reaction to the first dose. Subsequently on an unknown date the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) manufacturer unknown) (dose, route, lot# and expiration date were unknown). On an unknown date the patient experienced severe localized allergic reaction (non anaphylactic). Outcome of the event was unknown. The reporter considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). 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 certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates since 29-SEP-2016, the patients were vaccinated with unspecified numbers of improperly stored doses of VARIVAX, (dose and route of administration were not provided; lot # M024681 and expiration date of 18-MAY-2018). It was also reported that the administered doses experienced a temperature excursion during 316 hours at a temperature of 9.9 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. A data logger issue was involved. No adverse events and no product quality complaint (PQC) were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient had no medical history and no allergy history. On 18-OCT-2016 the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported, lot # M001747, exp 07-APR-2016 subcutaneously). The pharmacist reports that while he was administering the vaccine, the unspecified patient reported "discomfort", and the pharmacist also noted that the injection site began to "bubble". The "bubble" around the injection as being "as big as a pinky finger nail". The pharmacist "put a bandaid on the area and instructed the unspecified patient to "ice the area". The "the bubble was diminishing by the time she left the Pharmacy", but the pharmacist did not know if the symptoms fully resolved. No lab diagnostics was given. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacy intern and refers to a patient of unknown age and gender. Medical history and concomitant medications were unknown by the reporter. On 22-SEP-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L036437; expiration 18-MAY-2018) intramuscularly. An unspecified date after the vaccination, the patient experienced redness and swelling from the shoulder to the elbow on the arm where PNEUMOVAX 23 was administered. The patient also experienced the area being hot to touch. The patient sought medical attention with a doctor. The patient was treated with hydroxyzine, an EPIPEN and "possibly a steroid". The symptoms lasted for an unspecified amount of time and the outcome of the events was unknown. The pharmacy intern requested a lot check for lot L036437 of PNEUMOVAX 23. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Decreased activity, Decreased appetite, Erythema, Fatigue, Pain in extremity
Clinical narrative: Wed Oct. 19, 2016 large red welts on both arms formed. Red, swollen and warm to the touch, hurt when touched. Slight fever. Not eating normal. Tired and inactive. Thus Oct 20, 2016 took to doctor's that morning. Given BENADRYL and Ibuprofen as prescription. Fri Oct 21, 2016 still large welts but starting to go down. Sat. Oct. 22, 2016. In the morning the welts are no longer red or large. Most of the swelling is down. One arm still hurts a little. She is less tired and more active than she has been in the last 3 days. She is starting to get her appetite back. Sun Oct. 23, 2016. The rest of the swelling is gone. Her arms no longer hurting.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Wed Oct. 19, 2016 large red welts on both arms formed. Red, swollen and warm to the touch, hurt when touched. Slight fever. Not eating normal. Tired and inactive. Thus Oct 20, 2016 took to doctor's that morning. Given BENADRYL and Ibuprofen as prescription. Fri Oct 21, 2016 still large welts but starting to go down. Sat. Oct. 22, 2016. In the morning the welts are no longer red or large. Most of the swelling is down. One arm still hurts a little. She is less tired and more active than she has been in the last 3 days. She is starting to get her appetite back. Sun Oct. 23, 2016. The rest of the swelling is gone. Her arms no longer hurting.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe pain in the triceps area of arm where shot was received. This lasted 5-6 weeks before subsiding. Now, about one year later the pain has inexplicably returned. The nature of the pain is identical, although not as severe.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot Number N16561, Expire date Sep2017, NDC number 00005197101), intramuscular at 0.5 ml, single in the left deltoid on 20Sep2016 for immunisation. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot Number UI662AA, Expire date 01Apr2017), intramuscular in the right deltoid on 20Sep2016 for immunisation. The patient previously took FLUZONE for immunization (probably had received this before; assuming ever year). On an unspecified date in Sep2016, the patient experienced quite a bit of indentation in left arm/it is in her left arm where she received vaccine/significant indentation with outcome of not recovered.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot Number N16561, Expire date Sep2017, NDC number 00005197101), intramuscular at 0.5 ml, single in the left deltoid on 20Sep2016 for immunisation. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot Number UI662AA, Expire date 01Apr2017), intramuscular in the right deltoid on 20Sep2016 for immunisation. The patient previously took FLUZONE for immunization (probably had received this before; assuming ever year). On an unspecified date in Sep2016, the patient experienced quite a bit of indentation in left arm/it is in her left arm where she received vaccine/significant indentation with outcome of not recovered.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood test, Erythema, Infection, Skin warm
Clinical narrative: Pt noted to have moderate swelling, pain and inflammation at injection site within 12 hours of injection. Had continued spreading of swelling/redness and become warm to touch with pruritus over next 5 days.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt noted to have moderate swelling, pain and inflammation at injection site within 12 hours of injection. Had continued spreading of swelling/redness and become warm to touch with pruritus over next 5 days.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site warmth
Clinical narrative: Pt noted to have moderate swelling, pain and inflammation at injection site within 12 hours of injection. Had continued spreading of swelling/redness and become warm to touch with pruritus over next 5 days.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Injection site irritation, Injection site rash
Clinical narrative: Pain in site, fever at night, chills, sweats, lethargic, required KEFLEX.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site warmth, Lethargy, Pyrexia
Clinical narrative: Pain in site, fever at night, chills, sweats, lethargic, required KEFLEX.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Hyperhidrosis, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Pain in site, fever at night, chills, sweats, lethargic, required KEFLEX.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Disorientation, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Starting feeling weird shortly after waking up.  My arm was so painful and swollen I would scream out involuntarily if it was touched at all. Started having headache, body/joint aches, fever (between 99.6 and 101.6), dizziness, fatigue, and disorientation until Thursday at around 4:30pm. Arm has red swollen ring about 2-3 inches in parameter around the injection site and is still painful, although other symptoms have subsided (as on 10:30pm).
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Starting feeling weird shortly after waking up.  My arm was so painful and swollen I would scream out involuntarily if it was touched at all. Started having headache, body/joint aches, fever (between 99.6 and 101.6), dizziness, fatigue, and disorientation until Thursday at around 4:30pm. Arm has red swollen ring about 2-3 inches in parameter around the injection site and is still painful, although other symptoms have subsided (as on 10:30pm).
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Screaming, Skin reaction
Clinical narrative: Starting feeling weird shortly after waking up.  My arm was so painful and swollen I would scream out involuntarily if it was touched at all. Started having headache, body/joint aches, fever (between 99.6 and 101.6), dizziness, fatigue, and disorientation until Thursday at around 4:30pm. Arm has red swollen ring about 2-3 inches in parameter around the injection site and is still painful, although other symptoms have subsided (as on 10:30pm).
Age: 11.0
Sex: F
Vaccine: HPVX, MMRV, TDAP
Symptoms: Dizziness, Loss of consciousness, Meningitis, Pertussis
Clinical narrative: Around 930am-received HPV vaccine along with meningitis and whooping cough-it took about 2-3 minutes after the shot was given and we were leaving then my daughter said she was dizzy and couldn't see-when I tried to help her walk towards a chair to sit-she passed out-completely unconscious face was white-when Dr took her blood pressure it was 63/40.
Age: 63.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Headache, Influenza like illness, Mobility decreased, Nausea, Pain
Clinical narrative: On 10/26/2016 at 9:30 AM I came in contact with Adams flea dip/shampoo. At 10:30 AM  I came down with Flu-like symptoms that lasted for about six hours. Nausea, headache, aching all over, barely able to move. I took an ibuprofen at 12:30 and began to recover. I went to sleep at 4 pm and by 6 pm all symptoms gone. This has never happened to me in 60+ years getting the vaccine every year. Seems it was some kind of allergic reaction to the flea dip in combination with the flu shot that overwhelmed my system - I also got a tetanus shot on 10/17/2016.
Age: 28.0
Sex: M
Vaccine: FLU4, JEV1
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Feeling cold
Clinical narrative: Fever over 100 degrees F; chills; weakness; dizziness; fast heartbeat, labored breathing; diarrhea.
Age: 28.0
Sex: M
Vaccine: FLU4, JEV1
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fever over 100 degrees F; chills; weakness; dizziness; fast heartbeat, labored breathing; diarrhea.
Age: 57.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable nurse.  A 57-year-old female patient received PREVNAR 13, intramuscular in left upper deltoid on 24Oct2016 as 0.5 ml, first single dose for immunization. There was no medical history or concomitant medications.  The patient previously took QUADRIVALENT FLU VACCINE; (lot 185285 (manufacturer Seqirus)) administered intramuscularly in right upper deltoid for immunization. The patient experienced red itchy rash at the site of injection on 25Oct2016. Therapeutic measures taken as a result of red itchy rash at the site of injection was reported as just ice packs for now. The outcome of red itchy rash at the site of injection was not recovered as if the reporting on 27Oct2016.
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Initial unsolicited report received from a nurse on 21 Oct 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose and site were not reported) via intramuscular route on 2015 (unspecified date). Patient medical history revealed that he had seizure disorder. Illness at time of vaccination and concomitant medication was not reported. On 2015 (unspecified date), post vaccination; the patient had experienced seizure (shortly). Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event seizure. List of documents held by sender: none; Sender's Comments: This case is very poorly documented. The final diagnosis is not reported. The time to onset is compatible with a role of the vaccine. Reportedly patient had a medical history of seizure disorder. An alternative etiology cannot be ruled out. Further information on investigation results (EEG, MRI) ruling out alternative causes of seizure, patient's birth history, immune status at the time of vaccination, would be helpful to fully assess the case. Based on available information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 24 Oct 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, site and route not reported) on an unspecified date. Patient medical history and concomitant medication was not reported. On an unspecified date, post vaccination; the patient experienced flu (got deathly ill). Case was consider serious due to life threatning event flu. Lab data and corrective treatment was not reported. Patient's event outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 24 October 2016. This case involves a male patient who was vaccinated with a dose of (Flu shot) (batch number, expiry date, dose, site of administration were not reported) via intramuscularly route on unspecified date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On unspecified date, following the vaccination patient was diagnosed with Flu B. It was also reported that patient was very ill for 4 days. It was reported that patient required ER, doctor visit. Lab data was reported as flu test. Other lab data is not reported. Patient received corrective treatment with TAMIFLU. On unspecified date, patient recovered from the event (slowly recovered). Upon internal review, the company decided to consider the event serious because of important medical event: Influenza B virus infection. List of documents held by sender: none. Sender's Comments: This is very poorly document consumer case where patient diagnosed with influenza B infection after administration of influenza vaccine (unknown manufacturer). However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Petit mal epilepsy, Somnolence, Urinary incontinence
Clinical narrative: Initial unsolicited report received from a physician on 24 Oct 2016. This case involves a 73-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number: UI642AA, expiry date: 03 Apr 2017, dose and dose series was not reported) via intramuscular route in the left deltoid on 26 Sep 2016. Patient's was allergic to PCN. Medical history includes hypertension and high cholesterol. Illness at time of vaccination was reported as no. It was reported that, the patient had no history of seizures. Concomitant medication was not reported. On 26 Sep 2016 (by the evening), same day following the vaccination, the patient had experienced a petit mal seizure (lasting a few second), lost control of bladder during seizure and was very sleepy afterwards. Patient required ER or doctor visit. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event petit mal seizure. List of documents held by sender: none. Sender's Comments: This case concerns a 73 year old female patient who developed petit mal seizure on the same day after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of the vaccine. Further information on the patient's previous immunization history, concurrent conditions, detailed medical history and lab data to confirm alternative etiology/diagnosis etc. will be needed to completely assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 6.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4 am redness and induration at site. -No treatment mildly warm to touch.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Hives (blotchy marks) anterior and inner bilateral thighs. Complaining of itch.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Left shoulder, upper scapular and underarm and forearm pain tingling of the first two finger of the left hand.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired varicella vaccine administered.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Malaise, Pain in extremity, Rash
Clinical narrative: Rash in both arms, spreading to extreme pain in feet, hands, hips, arms, headache, vomiting. Child is still very sick.