chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to two patients of unknown ages and genders. The patients' concurrent conditions, medical history and historical drugs were not reported. On 13-JUL-2017, the patients were administered improperly stored VARIVAX lot number M041080, expiration date 06-OCT-2018 (dose and route were not reported) for prophylaxis. Concomitant medication included sterile diluent. The temperature involved was from 15 to 46 grades Fahrenheit for 9 hours. A previous temperature excursion was not reported, and a data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a LPN refers to multiple patients of unknown ages and gender. On an unknown dates the patients were vaccinated with VAQTA for prophylaxis or GARDASIL 9, or PNEUMOVAX 23. The nurse reported the patients had received the vaccines after they were stored improperly at 47F to 77F over 8 hours and 30 minutes and from 32F to 35F for 16 hours and 30 minutes. No previous excursions. No adverse events noted. Call was due to data logger.  Lot numbers were unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered inadvertently doses of PROQUAD subcutaneously, Lot number reported as N000677 with and expiration date on 05-JUL-2018 for prophylaxis (strength and dose were not reported) that had been improperly stored during 1 hour at 10°F. Previously, there was a temperature excursion for 1 hour at 9°F. Concomitantly, the doses of PROQUAD were reconstituted with a properly stored sterile diluent (manufacturer unknown). The call was because of a data logger and no adverse effects were reported. This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1707USA004356:
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis (dosing details unspecified) (also reported as "it could not be confirmed as GARDASIL 9 or GARDASIL). On an unknown date, the patient experienced sore arm after the administration of vaccine.  The outcome of the event was reported as recovering/resolving (reported as "fine now"). The patient did not seek medical attention. Product quality complaint (PQC) was not reported. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 13-year-old patient. The patient's medical history, concomitant medication and concurrent conditions were not reported. On 09-MAR-2017, the patient was vaccinated with first dose of GARDASIL, lot# K006960, expiry: 19-FEB-2017, for prophylaxis. The patient then received second dose of vaccine, lot# K011562, expiry: 08-APR-2017, on 08-MAY-2015 and the third dose, lot# K016966, expiry: 10-MAY-2017, on 08-JUL-2015 (inappropriate schedule of drug administration). No adverse reactions reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: This spontaneous report as received from a physician via company representative via  refers to a patient of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details not reported) for prophylaxis. On an unknown date, the patient developed shingles within a week of receiving the vaccine. The patient had a 'bad case' and needed treatment with unspecified steroid. After a couple of month, the patient had developed scars (date not reported). The outcome of the events and causality were not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On multiple, unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # reported as N013865, expiration date 31-OCT-2018; lot # reported as N012491, expiration date 17-OCT-2018; lot # reported as N002336, expiration date 19-JUL-2018; lot # reported as N001489, expiration date 12-JUL-2018 (albumin status, dose, route and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered doses of vaccine were stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions reported. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA004945:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Within one minute of giving vaccine to right thigh, MMRV, patient began to get itchy at the site. A cool wet gauze was applied, provider notified. Thought it may be reaction to bandaid but other leg looked ok. A welt was noted to appear almost immediately within one inch of the site. Patient was given a dose of Benadryl and observed for 20-30 min in exam room/waiting room. Without any worsening symptoms she was sent home and improved within a few hours.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Nausea
Clinical narrative: 07/18/2017 0200 Awoke with chills. Went to work that morning, continue to feel bad. Nausea, headache, chills, body aches.  330 Reported to Employee Health. T99.4 F. Chills, nausea, headache, body aches. No hives, no swelling, no shortness of breath per patient. Encourage to go home and rest, take TYLENOL. 1730 follow up phone call. Had taken TYLENOL, slept. Woke in a sweat, broke fever, reported feeling better. 7/19/2017 0830 Reported to work that morning, reports slight nausea, no aches, no fever, continues to feel better.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: 07/18/2017 0200 Awoke with chills. Went to work that morning, continue to feel bad. Nausea, headache, chills, body aches.  330 Reported to Employee Health. T99.4 F. Chills, nausea, headache, body aches. No hives, no swelling, no shortness of breath per patient. Encourage to go home and rest, take TYLENOL. 1730 follow up phone call. Had taken TYLENOL, slept. Woke in a sweat, broke fever, reported feeling better. 7/19/2017 0830 Reported to work that morning, reports slight nausea, no aches, no fever, continues to feel better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Rash erythematous, Secretion discharge
Clinical narrative: Weepy red rash to face, arms, legs, abdomen, and back. Patient reports intermittent mild to moderate itching. Rash is aggravated by heat and exposure to sunlight. Rash appears Intermittently but daily. Seems to improve in the evening but returns in the morning. Per moms report, rash appeared about 5 hours after vaccines were administered and rash has continued over the past 2 months.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to multiple patients of unknown age and gender. Medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored vaccines. The vaccines involved were as follows: GARDASIL 9 (lot # M042853, expiration 17-JUL-2019; lot # M043731, expiration 22-JUN-2019, or lot #  M041212; expiration 21-JUN-2019) ROTATEQ (lot # M043563, expiration 09-JUN-2018; lot # M038208, expiration 04-MAY-2018 or lot # M041184, expiration 31-MAY-2018) LIQUID PEDVAXHIB (lot # M046134, expiration 27-SEP-2019) Temperature: 32 degrees F to 35 degrees F (34.2 degrees F) Time frame: 16 hours, 47 minutes, 30 seconds Previous temperature excursion: yes, on 01-JUN-2017: 32 degrees F to 35 degrees F (35 degrees F0 for 16 hours, 28 minutes; and on 05-JUN-2017: 32 degrees F to 35 degrees F (35 degrees F) for 72 hours; and on 13-JUN-2017: 32 degrees F to 35 degrees F (35 degrees F) for 24 hours. Call was because of a data logger. Please note that the reporter did provide a doses administered worskeet but the patient IDs were retracted and the "shot date" was illegible on the form. No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: HPVX
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a nurse via a company represenatative and refers to a unspecified female patient of unknown age. Information regarding concomitant therapy, concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose, frequency, lot# and indication not provided).  Other suspect therapies included GARDASIL 9 (dose, frequency, lot# and indication not provided). The reporter stated that it was unspecified whether product involved was GARDASIL or GARDASIL 9. On an unknown date reported as fews days after administration of therapy, the unspecified patient experienced tingling in her arms (paraesthesia). The outcome of paraesthesia was unknown. Causality assessment was not provided. No additional information was provided regarding the unspecified patient. This is one of the two reports received from the same reporter. Additional information is not expected as no consent to contact the reporter. Sender's Comments: US-009507513-1707USA006261:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M007301, expiration date 19-NOV-2017, lot # M041766, expiration date 08-MAY-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The administered doses of ROTATEQ were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 9 hours and 5 minutes. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006296: US-009507513-1707USA006295: US-009507513-1707USA006293: US-009507513-1707USA006294.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a office manage refers to a 78 year old male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 17-JUN-2009, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneous (lot number and expiration date not reported) for prophylaxis. On 24-MAY-2017, the patient experienced a "chicken pox-like rash." On an unknown date, the patient was seen by a dermatologist (no details available). The outcome of rash vesicular was reported as recovered/resolved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Vaccination failure
Clinical narrative: This spontaneous report as received from a consumer refers to her granddaughter, a 26 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown dates, when the patient 11 or 12 years old, she was vaccinated with  3 doses of GARDASIL 9 (lot # and expiry date were not reported). On an unknown date, patient was still tested positive for HPV (papilloma viral infection) other day after baby was born. The outcome of the events were reported as not recovered. Causality assessment was not provided. No PQC has been filed. Upon internal review, the event vaccination failure was determined to be medically significant.      Additional information is not expected as there is no consent to contact reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M045394 with expiration date on 14-NOV-2018 for prophylaxis (therapy type, dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006386: US-009507513-1707USA006387: US-009507513-1707USA006388.
Sex: U
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from a nurse via a company represenatative and refers to an unspecified patients. Information regarding concomitant therapy, concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular (dose, frequency, lot# and indication not provided). Other suspect therapies included GARDASIL 9 (dose, frequency, lot# and indication not provided). The reporter stated that it was unspecified that whether product involved was GARDASIL or GARDASIL 9. The reporter also stated that syncope was always a concern with GARDASIL or GARDASIL 9. The outcome of syncope was unknown. Causality assessment was not provided. No additional information was provided regarding these unspecified patients. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the reporter.; Sender's Comments: US-009507513-1707USA001763:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M010439, expiration date 08-DEC-2018, lot # N003698, expiration date 31-OCT-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of PEDVAXHIB were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 9 hours and 5 minutes. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA006294: US-009507513-1707USA006296: US-009507513-1707USA002309.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # reported as N011867, expiration date 08-NOV-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of PNEUMOVAX 23 were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA002309: US-009507513-1707USA006296: US-009507513-1707USA006293.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M003658, expiration date 02-JUN-2018; lot # L048848, expiration date 09-AUG-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of RECOMBIVAX HB were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002309: US-009507513-1707USA006294: US-009507513-1707USA006296: US-009507513-1707USA006293.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M040412, expiration date 30-JUN-2019, lot # M036059, expiration date 03-JUN-2019 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. The administered doses of GARDASIL 9 were stored in the temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 45 minutes. There were no previous temperature excursions reported. Data logger was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006295: US-009507513-1707USA006294: US-009507513-1707USA002309: US-009507513-1707USA006293:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M039202 with expiration date on 11-MAR-2018 for prophylaxis (dose, site and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006387: US-009507513-1707USA006388: US-009507513-1707USA006173.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ARDASIL 9 lot # reported as M001533 with expiration date on 16-OCT-2019 and lot # L036301 with expiration date on 17-JUN-2018 for prophylaxis (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006386: US-009507513-1707USA006388: US-009507513-1707USA006173.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse prescriber and refers to a unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042599 with expiration date on 17-JUN-2018 for prophylaxis (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 23 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006386: US-009507513-1707USA006387: US-009507513-1707USA006173.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Blood urea decreased, Body temperature increased, Eosinophil percentage, Excessive eye blinking, Haemoglobin normal
Clinical narrative: Around 11:30 p.m. father picked her up and she vomited, and then had a seizure. Father video'd this.  She had shaking of her arms and legs, decreased responsiveness, blinking of her eyes, it lasted about 2 minutes. 911 was called, by the time they arrived the seizure had stopped. Temperature was 101°. She was taken initially to Emergency room but they felt they could not treat her so the was then taken to another Hospital. Preliminary discharge summary note reviewed and forwarded to chart. Labs showed normal metabolic profile except for low BUN (3). CBC showed a low red blood cell count (3.70), hemoglobin 10.6, platelet count 385,000, white blood cell differential 66% lymphocytes, 11% monocytes, 22% neutrophils, 1% eosinophils. Admitted and observed overnight, was sleepy for the whole night. No further seizures. Pediatric Neurology was consulted. Father had shown them some other videos he had of patient stiffening her legs when excited in her bouncy chair at home. They prescribed rectal Diastat for home and she has an appointment scheduled later this month for a 2 hour EEG and Neurology follow-up visit at hospital.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hyporesponsive to stimuli, Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Platelet count normal
Clinical narrative: Around 11:30 p.m. father picked her up and she vomited, and then had a seizure. Father video'd this.  She had shaking of her arms and legs, decreased responsiveness, blinking of her eyes, it lasted about 2 minutes. 911 was called, by the time they arrived the seizure had stopped. Temperature was 101°. She was taken initially to Emergency room but they felt they could not treat her so the was then taken to another Hospital. Preliminary discharge summary note reviewed and forwarded to chart. Labs showed normal metabolic profile except for low BUN (3). CBC showed a low red blood cell count (3.70), hemoglobin 10.6, platelet count 385,000, white blood cell differential 66% lymphocytes, 11% monocytes, 22% neutrophils, 1% eosinophils. Admitted and observed overnight, was sleepy for the whole night. No further seizures. Pediatric Neurology was consulted. Father had shown them some other videos he had of patient stiffening her legs when excited in her bouncy chair at home. They prescribed rectal Diastat for home and she has an appointment scheduled later this month for a 2 hour EEG and Neurology follow-up visit at hospital.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Red blood cell count decreased, Seizure, Somnolence, Tremor, Vomiting
Clinical narrative: Around 11:30 p.m. father picked her up and she vomited, and then had a seizure. Father video'd this.  She had shaking of her arms and legs, decreased responsiveness, blinking of her eyes, it lasted about 2 minutes. 911 was called, by the time they arrived the seizure had stopped. Temperature was 101°. She was taken initially to Emergency room but they felt they could not treat her so the was then taken to another Hospital. Preliminary discharge summary note reviewed and forwarded to chart. Labs showed normal metabolic profile except for low BUN (3). CBC showed a low red blood cell count (3.70), hemoglobin 10.6, platelet count 385,000, white blood cell differential 66% lymphocytes, 11% monocytes, 22% neutrophils, 1% eosinophils. Admitted and observed overnight, was sleepy for the whole night. No further seizures. Pediatric Neurology was consulted. Father had shown them some other videos he had of patient stiffening her legs when excited in her bouncy chair at home. They prescribed rectal Diastat for home and she has an appointment scheduled later this month for a 2 hour EEG and Neurology follow-up visit at hospital.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site induration, Injection site nodule
Clinical narrative: C/o hard knot at the site and radiating redness on the arm. Did not seek medical treatment or advice.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness/tenderness/warm to touch/swelling to injection site.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: VAQTA was administered early, at 6 months of age. Mom was notified of invalid dose being administered and denied client having any signs or symptoms of concern.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pain, Peripheral swelling, Pruritus, Rash generalised
Clinical narrative: Received a phone call from client reporting that she had an allergic reactions to her Hepatitis B vaccination that was given on Wednesday, June14, 2017. She reported that she has a rash all over and is itching, her right hand is swollen and she is aching all over. States that this has happened before when she received the Hepatitis B vaccine. Stated she did take BENADRYL which has helped and has also contacted her primary physician. This was the 3rd dose of Hepatitis B but this nurse advised her to not ever get any more doses of the vaccine. Client was going to follow up with her PCP.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Aspartate aminotransferase increased, Bacterial test negative, Blood creatine phosphokinase normal, Cellulitis, Chest X-ray abnormal
Clinical narrative: Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram QRS complex normal, Electrocardiogram ST segment normal, Electrocardiogram T wave abnormal, Electrocardiogram normal, Erythema
Clinical narrative: Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mean cell volume decreased, Musculoskeletal chest pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red blood cells urine positive, Skin warm, Tenderness, Troponin I normal
Clinical narrative: Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound Doppler abnormal, White blood cells urine negative
Clinical narrative: Patient arrives to ED by POV on 06/22/2017. Chief Complaint: UPPER EXTREMITY PAIN and SWELLING. This started 06/21/2017 and persisted the following day (began 2 hours after pneumonia immunization in left arm). The quality is noted to be "pain". It is described as radiating (left neck, left pectoral region, left trapezius). Symptoms located in the area of the left shoulder and left arm. No difficulty breathing, sensory loss or motor loss. She has had redness and swelling. (No reaction in the past to PNEUMOVAX. Fever 101 06/21/2017. No chest pressure (pain when palpate left pectoralis or moves left arm). No antipyretics taken).
Age: 1.42
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Blood test, Computerised tomogram, Erythema multiforme, Full blood count, Pyrexia
Clinical narrative: Erythema Multiforme  Fever 2 seizures within a 3 week time period
Age: 1.42
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Seizure, Urine analysis
Clinical narrative: Erythema Multiforme  Fever 2 seizures within a 3 week time period
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 60 year old female patient. In MAY-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. The physician saw the patient in June 2017 and she was still having injection site pain. The outcome of injection site pain was reported as not recovered/not resolved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning to a patient of unknown age and gender. Medical history, concomitant medication and concurrent conditions were not provided. On 13-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047661, the expiration date: 02-DEC-2018 (dose and route were not reported) for prophylaxis. No adverse effects. The temperature was registered between -9°C to 8°C during 5 hours. The call was made due to data logger and there was no previous temperature excursion reported. No further information to report.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 03-JUL-2017, the patient received expired M-M-R II, lot# M032153 with expiry date of 22-APR-2017, subcutaneously, in left arm for prophylaxis (dosing details not reported). No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse concerning 5 patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dosing details, route, anatomical location were not reported) lot # M041394, expiry date: 23-MAY-2018 for prophylaxis. On an unknown date, the patients experienced redness, warmth and discomfort at injection site. The patients were treated with antihistamines: TYLENOL. The outcome of the events was unknown. The reporter did not provide the causality between the events and PNEUMOVAX 23. The reporter had requested lot check for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL 9 injection, lot number L037554; expiration date 25-DEC-2017 or lot number N001533; expiration date 16-OCT-2019 or lot number M042853; expiration date 17-JUL-2019 (strength, dose and route of administration were not reported) for prophylaxis. The temperature of excursion with the GARDASIL 9 was between 47 to 77 Fahrenheit degrees during 5 hours. Previous temperature excursion was between 47 to 77 Fahrenheit degrees during 6 hours. The temperature of excursion was detected by a data logger. No adverse effects reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1707USA006406: US-009507513-1707USA006407.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 injection, lot number L037554; expiration date 25-DEC-2017 or lot number N001007; expiration date 19-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis. The temperature of excursion with the PNEUMOVAX 23 was between 47 to 77 Fahrenheit degrees during 5 hours. Previous temperature excursion was between 47 to 77 Fahrenheit degrees during 6 hours. The temperature of excursion was detected by a data logger. No adverse effects reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1707USA006407: US-009507513-1707USA006397.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ oral liquid, orally, lot number M043836; expiration date 17-JUN-2018 or lot number M039061; expiration date 28-APR-2018  or lot number M007307; expiration date 30-NOV-2017 (strength and dose were not reported) for prophylaxis. The temperature of excursion with the ROTATEQ was between 47 to 77 Fahrenheit degrees during 5 hours. Previous temperature excursion was between 47 to 77 Fahrenheit degrees during 6 hours. The temperature of excursion was detected by a data logger. No adverse effects reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006397: US-009507513-1707USA006406.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Facial pain, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age (reported as 85, unit of measurement unspecified) and ethnicity received PREVNAR 13 (solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date, single dose, for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient already had the vaccine (noted to be possibly PREVNAR 13). It was reported that the patient was well aware of side effects. On an unspecified date, it was reported that in face and the arm were so sore; she could barely move it (arm) for several days. The outcome of the events was unknown at time of report. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the new pneumonia shot brought back feelings of the illness the patient had after taking the shot, on an unknown date, last year (2016). Patient also reported that for 3 days she ran a fever and felt as though she had a bad case of the flu on an unknown date. Patient added she was not aware of the effect it could have on the lungs. Had she known prior to having the shot, she probably would not have had the vaccine. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Ear swelling, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative.  A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA in her left arm, via an unspecified route of administration on an unspecified date at single dose for immunisation.  Concomitant medication included MENACTRA administered on the same day in the same arm. No underlying conditions were reported. The patient medical history was not reported. The patient experienced redness pain and swelling at the injection site on the same day of vaccination. In the evening it appeared as a big red square mark at the site. On the same day, a rash appeared on her left side of neck. The next morning the rash expanded up onto her lower left cheek and ear lobe was red and swollen. She was treated with oral steroids. Events took place after use of product. The outcome of the events was unknown.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative.  A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA in her left arm, via an unspecified route of administration on an unspecified date at single dose for immunisation.  Concomitant medication included MENACTRA administered on the same day in the same arm. No underlying conditions were reported. The patient medical history was not reported. The patient experienced redness pain and swelling at the injection site on the same day of vaccination. In the evening it appeared as a big red square mark at the site. On the same day, a rash appeared on her left side of neck. The next morning the rash expanded up onto her lower left cheek and ear lobe was red and swollen. She was treated with oral steroids. Events took place after use of product. The outcome of the events was unknown.
Sex: U
Vaccine: MENB
Symptoms: Anxiety, Facial pain, Hypoaesthesia, Injection site pain, Neck pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of an unknown age, gender and race received TRUMENBA (lot R56659, exp.date 31Jan2019) via an unspecified route, at 0.5ml single dose for immunization on  11Jul2017. Relevant medical history and concomitant medication were unknown. On the same date, within 30 minutes of receiving it, the patient experienced all over body aches, pain at injection site, pain radiated down the arm into the hand, radiated up the neck into the chin, numbness facial, panic attack and on unknown date anxiety. The patient had gone to the emergency room. The outcome of the events was unknown.
Sex: U
Vaccine: MENB
Symptoms: Pain, Pain assessment, Pain in extremity, Panic attack
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of an unknown age, gender and race received TRUMENBA (lot R56659, exp.date 31Jan2019) via an unspecified route, at 0.5ml single dose for immunization on  11Jul2017. Relevant medical history and concomitant medication were unknown. On the same date, within 30 minutes of receiving it, the patient experienced all over body aches, pain at injection site, pain radiated down the arm into the hand, radiated up the neck into the chin, numbness facial, panic attack and on unknown date anxiety. The patient had gone to the emergency room. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report from a contactable nurse. A 68-year-old female patient received the first dose of PREVNAR 13 (Lot Number: R49358, Expiration date: 01Apr2018), intramuscular on 26Jun2017 at 10:47, at 0.5 mg, single as pneumonia booster. Medical history included ongoing high blood pressure, ongoing hyperlipidaemia, ongoing diabetes type II, and ongoing diverticulosis. The patient had no relevant family medical history. Concomitant medications included ongoing vitamin D, ongoing metformin, ongoing DIOVAN, and ongoing FLONASE. The nurse called from the facility regarding the patient who received PREVNAR 13 on 26Jun2017 and had a reaction to it. Explained that she had a splotchy red rash from her shoulder to her elbow the next day, on 27Jun2017. She also stated that it was there when she got up that next morning after she received the vaccination. It's just splotchy, not like the whole arm was covered. It was her left arm; the injection arm. The patient did not go to the Emergency Room but went to the physician's office because it wasn't going away. No relevant tests were done. Outcome of the event was not recovered and was reported as worsened. Two doctors who looked at it thought it was a reaction to the PREVNAR 13. Both physicians felt like it was related to the vaccination.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 68-year-old female patient received the first dose of PREVNAR 13 (Lot Number: R49358, Expiration date: 01Apr2018), intramuscular on 26Jun2017 at 10:47, at 0.5 mg, single as pneumonia booster. Medical history included ongoing high blood pressure, ongoing hyperlipidaemia, ongoing diabetes type II, and ongoing diverticulosis. The patient had no relevant family medical history. Concomitant medications included ongoing vitamin D, ongoing metformin, ongoing DIOVAN, and ongoing FLONASE. The nurse called from the facility regarding the patient who received PREVNAR 13 on 26Jun2017 and had a reaction to it. Explained that she had a splotchy red rash from her shoulder to her elbow the next day, on 27Jun2017. She also stated that it was there when she got up that next morning after she received the vaccination. It's just splotchy, not like the whole arm was covered. It was her left arm; the injection arm. The patient did not go to the Emergency Room but went to the physician's office because it wasn't going away. No relevant tests were done. Outcome of the event was not recovered and was reported as worsened. Two doctors who looked at it thought it was a reaction to the PREVNAR 13. Both physicians felt like it was related to the vaccination.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received (TRUMENBA (lot. s26962) on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medication were unknown. On an unspecified date, the patient experienced fever, chest tingling, pain/soreness, headache, and fatigue. Clinical outcome was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 83 year-old male patient received the first dose of PREVNAR 13 (lot R49357,  Expire Date: May2018, NDC 00005197102) intramuscular in the left upper arm on 07Jul2017 at 17:00 at 0.5 ml single for immunisation. No other vaccine was administered on same date. Medical history included ongoing gout. Concomitant medication included ongoing allopurinol for gout since 2015. The patient experienced left wrist swelling (the wrist was double in size) and it hurt a lot (pain) over the weekend on either 08Jul2017 or 09Jul2017. At the injection site there was nothing. The patient went to his doctor on 10Jul2017 and due to the events he was prescribed paracetamol, hydrocodone bitartrate (NORCO) for pain and methylprednisolone (MEDROL) dose pack as a steroid. The patient was not recovered. It was unknown if the patient was having a flare up of his gout or reaction to vaccine.