chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients received improperly stored doses of VARIVAX injection (lot # K005182 with expiration date 10-APR-2016 and lot# K006136 with expiration date 29-APR-2016; dose and route were not provided). No symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 14-NOV-2015, the patients were vaccinated with doses of M-M-R II, lot # L020189, expiry date: 03-JUN-2017 (dose and route of administration were not reported). The nurse reported that the doses had been reconstituted with sodium chloride instead of sterile water diluent. She stated that the sodium chloride diluent was manufactured by Sanofi and there was 0.6 ml in each dose of diluent. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions of the patients were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored oral, ROTATEQ lot # L008057 (expiry date: 04-NOV-2017) or lot number # L008996 (expiry date: 02-JUN-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored PROQUAD (Merck) with lot number # L030587 (expiry date: 10-FEB-2017) or lot number # L032759 (expiry date: 24-FEB-2017). Concomitant medications of the patients were unknown. No adverse event reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site abscess, Pruritus, Rash, Urticaria
Clinical narrative: Rash, erythema Multiform, urticarial pruritus and abscess around injection site.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions of the patients were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored VAQTA with lot number #L013380 (expiry date: 04-NOV-2017) or lot number #K019560 (expiry date: 02-JUN-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-DEC-2015, the patient received a dose of improperly stored RECOMBIVAX HB lot # L014878, expiration date: 17-JAN-2018 (exact dose, dose number and route of administration were not reported). Concomitant medications were not provided. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions of the patients were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored RECOMBIVAX HB with lot number # L022261 (expiry date: 01-APR-2017) or lot number # L000877 (expiry date: 22-JUN-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored VARIVAX (dose, number, dosing regimen route and anatomical location were unknown) with lot number #K001390 (expiry date: 29-JAN-2016) or K026387 (expiry date: 15-DEC-2016) or L023587 (expiry date: 26-JUN-2017) or L026410 (expiry date: 15-FEB-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 08-DEC-2015, the patient was inadvertently administered an expired dose of M-M-R II, lot# J014873, expiration date: 21-NOV-2015 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patient received improperly stored doses of VARIVAX lot/batch # reported as L028275, expiration date 20-JUL-2017 (dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male child (currently 37 years old). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, as a child, the patient was vaccinated with one dose of MMR II (dose, route of administration, lot # and expiration date were not reported). On an unknown date, as a child, the patient experienced chickenpox. It was unspecified if the patient developed a chickenpox before or after receiving MMR II. It was also provided that on unknown dates, the patient was vaccinated with the doses of PROQUAD (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (dose, route of administration, lot # and expiration date were not reported), but no adverse effects were reported for either product. The outcome of chickenpox was unknown. The relatedness between chickenpox and MMR II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD, lot# 1033696 and expiration date: 28-FEB-2017 or lot# 1030591 and expiration date: 10-OCT-2017 or lot# 1024122 and expiration date: 30-DEC-2016 (dose and route of administration were not reported). The patients' concomitant therapies were not reported. There was no adverse effects reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's medical history and concomitant therapy was provided. The patient's concurrent condition included arthritis which began prior to receiving the vaccine. On 17-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On the same day, the patient was having some joint pain. Therefore she came to the office to receive a dose of cortisone (dose and route of administration unspecified) in one of her knees. The outcome of joint pain was not reported. Causality assessment was not provided. 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 physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 03-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# L023589, expiration date 26-JUN-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medication was not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # J00668, expiration date: 29-APR-2016; lot # K008931, expiration date: 04-MAR-2017, dose and route of administration were not reported). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L032761, expiration date 24-FEB-2017, dose and route of administration were not reported). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5-month-old patient of unknown gender. The patient's medical history was not reported. On 19-DEC-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot #, dose, route and site of administration were not reported) instead of PREVNAR 13. No product confusion was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L001325, expiration date: 13-JAN-2017; lot # L026410, expiration date: 15-FEB-2017; dose and route of administration were not reported). No adverse effects reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 23-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# L023589, expiration date 26-JUN-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot# L025207 and expiration date: 07-JUL-2017 (dose and route of administration were not reported). The patients' concomitant therapies were not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: Initial unsolicited report received from a consumer on 17 December 2015. This case involves a 64-year-old female patient who was vaccinated with dose of Flu vaccine; with a dose of Tdap vaccine (batch number and expiry date were unknown, dose, route of administration were not reported) both in left upper arm on 29 December 2014. The patient's medical history included allergic to Penicillin, Sulfa and ZITHROMAX. Concomitant medications were not reported. On 29 December 2014, few hours (at night/within a couple hours after inoculation) following the vaccination, the patient had developed anaphylactic reaction as: hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing. The symptoms eased and gradually subsided that night. About 7-10 days after receiving the injection she had to visit her primary doctor for another reason. About 10 days after receiving the inoculation in the left arm, her left arm was sore, still red, swollen, and warm to touch. The patient received twice dose of flu shot about 17 or 18 year ago in the left upper arm in the exact same spot, but on the same arm. She did eventually get sick with the flu shots. She had itching, swelling and soreness. She was feverish and throwing up and had flu symptoms. The flu shot on December 2014 was the third flu shot that she had ever received. The patient's laboratory data was not reported. The patient treated with two BENADRYL capsules and some cream. On 29 December 2014, the patient was recovered from the hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing and in Jan 2015, the patient was recovered from the anaphylactic reaction, left arm was sore, still red and swollen after inoculation and left arm was warm to touch after inoculation. Upon medical review, the case was considered as serious due to important medical event: anaphylactic type reaction/anaphylactic reaction. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Influenza, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Initial unsolicited report received from a consumer on 17 December 2015. This case involves a 64-year-old female patient who was vaccinated with dose of Flu vaccine; with a dose of Tdap vaccine (batch number and expiry date were unknown, dose, route of administration were not reported) both in left upper arm on 29 December 2014. The patient's medical history included allergic to Penicillin, Sulfa and ZITHROMAX. Concomitant medications were not reported. On 29 December 2014, few hours (at night/within a couple hours after inoculation) following the vaccination, the patient had developed anaphylactic reaction as: hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing. The symptoms eased and gradually subsided that night. About 7-10 days after receiving the injection she had to visit her primary doctor for another reason. About 10 days after receiving the inoculation in the left arm, her left arm was sore, still red, swollen, and warm to touch. The patient received twice dose of flu shot about 17 or 18 year ago in the left upper arm in the exact same spot, but on the same arm. She did eventually get sick with the flu shots. She had itching, swelling and soreness. She was feverish and throwing up and had flu symptoms. The flu shot on December 2014 was the third flu shot that she had ever received. The patient's laboratory data was not reported. The patient treated with two BENADRYL capsules and some cream. On 29 December 2014, the patient was recovered from the hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing and in Jan 2015, the patient was recovered from the anaphylactic reaction, left arm was sore, still red and swollen after inoculation and left arm was warm to touch after inoculation. Upon medical review, the case was considered as serious due to important medical event: anaphylactic type reaction/anaphylactic reaction. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pyrexia, Skin warm, Swelling, Urticaria, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 17 December 2015. This case involves a 64-year-old female patient who was vaccinated with dose of Flu vaccine; with a dose of Tdap vaccine (batch number and expiry date were unknown, dose, route of administration were not reported) both in left upper arm on 29 December 2014. The patient's medical history included allergic to Penicillin, Sulfa and ZITHROMAX. Concomitant medications were not reported. On 29 December 2014, few hours (at night/within a couple hours after inoculation) following the vaccination, the patient had developed anaphylactic reaction as: hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing. The symptoms eased and gradually subsided that night. About 7-10 days after receiving the injection she had to visit her primary doctor for another reason. About 10 days after receiving the inoculation in the left arm, her left arm was sore, still red, swollen, and warm to touch. The patient received twice dose of flu shot about 17 or 18 year ago in the left upper arm in the exact same spot, but on the same arm. She did eventually get sick with the flu shots. She had itching, swelling and soreness. She was feverish and throwing up and had flu symptoms. The flu shot on December 2014 was the third flu shot that she had ever received. The patient's laboratory data was not reported. The patient treated with two BENADRYL capsules and some cream. On 29 December 2014, the patient was recovered from the hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing and in Jan 2015, the patient was recovered from the anaphylactic reaction, left arm was sore, still red and swollen after inoculation and left arm was warm to touch after inoculation. Upon medical review, the case was considered as serious due to important medical event: anaphylactic type reaction/anaphylactic reaction. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 17 December 2015. This case involves a 64-year-old female patient who was vaccinated with dose of Flu vaccine; with a dose of Tdap vaccine (batch number and expiry date were unknown, dose, route of administration were not reported) both in left upper arm on 29 December 2014. The patient's medical history included allergic to Penicillin, Sulfa and ZITHROMAX. Concomitant medications were not reported. On 29 December 2014, few hours (at night/within a couple hours after inoculation) following the vaccination, the patient had developed anaphylactic reaction as: hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing. The symptoms eased and gradually subsided that night. About 7-10 days after receiving the injection she had to visit her primary doctor for another reason. About 10 days after receiving the inoculation in the left arm, her left arm was sore, still red, swollen, and warm to touch. The patient received twice dose of flu shot about 17 or 18 year ago in the left upper arm in the exact same spot, but on the same arm. She did eventually get sick with the flu shots. She had itching, swelling and soreness. She was feverish and throwing up and had flu symptoms. The flu shot on December 2014 was the third flu shot that she had ever received. The patient's laboratory data was not reported. The patient treated with two BENADRYL capsules and some cream. On 29 December 2014, the patient was recovered from the hives, itching, dizziness, blurry vision, difficulty swallowing and trouble breathing and in Jan 2015, the patient was recovered from the anaphylactic reaction, left arm was sore, still red and swollen after inoculation and left arm was warm to touch after inoculation. Upon medical review, the case was considered as serious due to important medical event: anaphylactic type reaction/anaphylactic reaction. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Bacterial test negative, Bilirubin urine, Blood glucose normal, Blood urine absent, Cerebellar ataxia
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Chest X-ray abnormal, Gait disturbance, Glucose urine absent, Granulocyte count, Granulocyte percentage
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage increased
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Nitrite urine absent, Platelet count normal, Protein urine absent, Red blood cell count normal, Red blood cells urine negative
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Red cell distribution width normal, Specific gravity urine normal, Streptococcus test negative, Tremor, Urinary sediment present
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Urine abnormality, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, Weight decreased
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: White blood cell count normal, White blood cells urine negative
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 6.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Encephalitis, Gait disturbance, Nystagmus, Tremor
Clinical narrative: Tremors, gait abnormality, nystagmus; Symptoms c/w post-infectious cerebellitis.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Sudden death
Clinical narrative: Patient suffered sudden death based on his wife's statement. The event occurred 24 hours after the vaccine administration. There has been no medical examination to determine the cause of death or to establish relation to vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient did not experience any adverse events but did receive the preservative flu vaccine as opposed to the preservative free vaccined while pregnant.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eyelid oedema, Headache, Lip swelling, Vomiting
Clinical narrative: Vomiting, headache, slight swelling of lips and eyelids. 12-15-15 PHENERGAN 25mg IM x 1 at 11.10. Pt tolerated well.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Red, hot local rxn. Maximum size 5cm x 6 1/2 cm resolved in 1 week.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Computerised tomogram abdomen normal, Diarrhoea, Lipase increased, Nausea
Clinical narrative: Initial unsolicited report received from a physician via Pfizer-sponsored interventional study on 10-Dec-2015. Manufacturer Report Number: 2015378599. The case involves a 65-year-old female patient who was vaccinated with a 0.5 ml intramuscular injection single dose of FLUZONE on 16-Oct-2015 at approximately 14:00 hours. The patient also received blinded therapy with non company drug however this product was not coded as it a non sponsored study. Patient's medical history included hypertension and hyperlipidemia both since Jan-2008, coronary artery disease (CAD) and atherosclerosis since 23-Mar-2009, herniated lumbar disc since 1990, insomnia since 1969 all were ongoing, a myocardial infarction with stenting on 23-Mar-2009, cholecystitis with cholecystectomy in 1989, alcoholism from 2000 to 2002 and hemorrhagic stroke from 11-Sep-2015 to 15-Sep-2015 and intermittent bilateral lower extremity edema from 27-May-2015 to 20-Sep-2015. The patient also had oedema peripheral from 27-May-2015 to 20-Sep-2015. Concomitant medications included Atorvastatin since 24-Oct-2013 from hyperlipidemia, Ibuprofen since 1990 for herniated lumbar disc, acetaminophen and diphenhydramine both since 1990 for insomnia, Trazodone since 22-May-2015 for insomnia, Lisinopril since 08-May-2015, Amlodipine since 13-Sep-2015 and Metoprolol tartrate since 14-Sep-2015 all three for hypertension, Furosemide since 11-Jun-2015 for intermittent bilateral lower extremity edema, and aspirin since 14-Sep-2015 for atherosclerosis all are ongoing. On 16-Oct-2015, at approximately 16:00-16:30 hours, the subject developed epigastric abdominal pain, nausea and diarrhea and was hospitalized on the same day. The event term was reported as acute pancreatitis. On 16-Oct-2015, upon arrival to the emergency room blood was collected and she was noted to have elevated lipase level at 2165 IU/L and 941 IU/L on 17-Oct-2015. On 17-Oct-2015, no acute findings were noted on the abdominal ultrasound and CAT scan. Patient received treatment with ZOFRAN 4 mg and Fentanyl 25 mg on 16-Oct 2015 and Famotidine 20 mg on 17-Oct-2015. The patient was discharged from the hospital on 17-Oct-2015 considered recovered on the same date. There was no action taken with the study medication in response to the event. The investigator reported there was not a reasonable possibility that the event, acute pancreatitis was related to the study medication or clinical trial procedure but was related to the concomitant drug, influenza virus vaccine polyvalent. Case Comment: In agreement with the investigator the company considered there was not a reasonable possibility that the event acute pancreatitis was related to the study medication or clinical trial procedure. The concomitant drug, influenza virus vaccine polyvalent, may provide a plausible explanation for the event. The follow-up information received does not alter the previous company clinical evaluation. List of documents held by  sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pancreatitis acute, Ultrasound abdomen normal
Clinical narrative: Initial unsolicited report received from a physician via Pfizer-sponsored interventional study on 10-Dec-2015. Manufacturer Report Number: 2015378599. The case involves a 65-year-old female patient who was vaccinated with a 0.5 ml intramuscular injection single dose of FLUZONE on 16-Oct-2015 at approximately 14:00 hours. The patient also received blinded therapy with non company drug however this product was not coded as it a non sponsored study. Patient's medical history included hypertension and hyperlipidemia both since Jan-2008, coronary artery disease (CAD) and atherosclerosis since 23-Mar-2009, herniated lumbar disc since 1990, insomnia since 1969 all were ongoing, a myocardial infarction with stenting on 23-Mar-2009, cholecystitis with cholecystectomy in 1989, alcoholism from 2000 to 2002 and hemorrhagic stroke from 11-Sep-2015 to 15-Sep-2015 and intermittent bilateral lower extremity edema from 27-May-2015 to 20-Sep-2015. The patient also had oedema peripheral from 27-May-2015 to 20-Sep-2015. Concomitant medications included Atorvastatin since 24-Oct-2013 from hyperlipidemia, Ibuprofen since 1990 for herniated lumbar disc, acetaminophen and diphenhydramine both since 1990 for insomnia, Trazodone since 22-May-2015 for insomnia, Lisinopril since 08-May-2015, Amlodipine since 13-Sep-2015 and Metoprolol tartrate since 14-Sep-2015 all three for hypertension, Furosemide since 11-Jun-2015 for intermittent bilateral lower extremity edema, and aspirin since 14-Sep-2015 for atherosclerosis all are ongoing. On 16-Oct-2015, at approximately 16:00-16:30 hours, the subject developed epigastric abdominal pain, nausea and diarrhea and was hospitalized on the same day. The event term was reported as acute pancreatitis. On 16-Oct-2015, upon arrival to the emergency room blood was collected and she was noted to have elevated lipase level at 2165 IU/L and 941 IU/L on 17-Oct-2015. On 17-Oct-2015, no acute findings were noted on the abdominal ultrasound and CAT scan. Patient received treatment with ZOFRAN 4 mg and Fentanyl 25 mg on 16-Oct 2015 and Famotidine 20 mg on 17-Oct-2015. The patient was discharged from the hospital on 17-Oct-2015 considered recovered on the same date. There was no action taken with the study medication in response to the event. The investigator reported there was not a reasonable possibility that the event, acute pancreatitis was related to the study medication or clinical trial procedure but was related to the concomitant drug, influenza virus vaccine polyvalent. Case Comment: In agreement with the investigator the company considered there was not a reasonable possibility that the event acute pancreatitis was related to the study medication or clinical trial procedure. The concomitant drug, influenza virus vaccine polyvalent, may provide a plausible explanation for the event. The follow-up information received does not alter the previous company clinical evaluation. List of documents held by  sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Atypical pneumonia, Bronchitis, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 17 December 2015. Manufacturer report number: 2015137326. This case involves a male patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date (two weeks ago). The patient also received a 100 mg of VIAGRA one in 3-4 days as needed on an unspecified date. The patient ongoing taking VIAGRA. The patient medical history reported as disability. The patient was disabled before starting VIAGRA. Concomitant medication was not reported. On an unspecified date (may be a week and half ago), following the vaccination, the patient experienced congestion in his lungs and sore throat which was later diagnosed with acute bronchitis. The patient got 10 day supply of Antibiotics which he finished on an unspecified date (yesterday). It was reported that, the patient do not work right now he hurt his back like 4 years ago. The patient received VIAGRA 100 mg and he stated that he has Walking Pneumonia and he is currently on antibiotics. Laboratory investigation was not reported. On an unspecified date, the patient received antibiotics as a corrective treatment. The patient was not recovered from events. Upon internal review, company assessed the event of acute bronchitis, sore throat and congestion in lungs as serious and important medical event. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Balance disorder, Body temperature fluctuation, Cerebral disorder, Chills
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Drug hypersensitivity, Fall, Fatigue
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Feeling abnormal, Gait disturbance, Haemoptysis, Headache, Hypotonia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Malaise, Memory impairment, Muscle atrophy
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Muscle spasms, Muscular weakness, Musculoskeletal pain, Myalgia, Nasal congestion
Clinical narrative: This is a spontaneous report obtained from a contactable consumer from a Pfizer-sponsored program. A 70 year old male patient received, on 05Sep2015, PREVNAR 13 in the right arm at single dose. Relevant medical history included ongoing Suppressed Immune System from 2012 and ongoing White Blood Count much higher than Red Blood Cells began in either Jul2015 or Aug2015. The patient previously, on an unspecified date, experienced an allergic reaction to menthol, penicillins, aspirin, LEVAQUIN and contrast dye. Concomitant medications were unknown. On an unspecified date, the patient experienced extreme fatigue/he was exhausted all the time, headache, muscle pain especially in legs, shoulder pain (lower part of his shoulder hurt), joint pain (starting at the bottom of ankle and kneecap and in the coccyx), neck pain, cold, joint range of motion decreased (limitation of arm movement), decreased appetite. On an unspecified date, the patient experienced chills, body temperature fluctuation, muscle spasms, pain, pleuritic pain (his lungs have been burning on and off like he is starting to have pneumonia) and he was feeling abnormal. The vaccine may be defective. He was feeling dizzy, his nose was clogged. The patient had pain at the injection site, and rash. On 08Sep2015 the patient experienced allergic to the suspension, got sick, spitting and coughing up blood, affecting memory, weakening his muscle tissue in legs, stumbling and falling. He also stated his leg muscle mass was decreasing. The patient noticed that his legs were not as powerful as they were, and they wobble when he first stand up. On 03Dec2015 the patient experienced night sweats, brain was being scrambled. The patient said he may have had brain damage with this product. Clinical outcome of pleuritic pain, brain injury, dizziness, nasal congestion, allergy and product quality issue was unknown. The patient did not recover from the other events at time of this report. Follow up (15Dec2015): New information from a Pfizer-sponsored program from the same contactable consumer included: new events provided, medical history.