chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Adverse reaction, Eye swelling, Injection site irritation, Injection site mass, Injection site nodule
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site irritation in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site irritation, injection site lump, pruritus, nausea and eye swelling. On an unknown date, the outcome of the injection site irritation, injection site lump, pruritus, nausea and eye swelling were unknown. It was unknown if the reporter considered the injection site irritation, injection site lump, pruritus, nausea and eye swelling to be related to BEXSERO. Additional details were reported as follows: This case was submitted as an after hours call. This case was reported by a friend of the family. The age at vaccination was not reported. The patient was a young lady (college going) who had an adverse reaction. The patient had an irritant knot below the injection site. The patient also had another knot at a remote location. The reporter asked to give a call and stated that, it seemed like a minor reaction and the patient was not reporter's patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site pruritus, Nausea, Nodule
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site irritation in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site irritation, injection site lump, pruritus, nausea and eye swelling. On an unknown date, the outcome of the injection site irritation, injection site lump, pruritus, nausea and eye swelling were unknown. It was unknown if the reporter considered the injection site irritation, injection site lump, pruritus, nausea and eye swelling to be related to BEXSERO. Additional details were reported as follows: This case was submitted as an after hours call. This case was reported by a friend of the family. The age at vaccination was not reported. The patient was a young lady (college going) who had an adverse reaction. The patient had an irritant knot below the injection site. The patient also had another knot at a remote location. The reporter asked to give a call and stated that, it seemed like a minor reaction and the patient was not reporter's patient.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Bruise arm.
Sex: F
Vaccine: FLU4
Symptoms: Accidental overdose, Pain, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received FLUARIX QUADRIVALENT. Concomitant products included FLUARIX QUADRIVALENT. On 30th August 2017, the patient received the 2nd dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 30th August 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain, accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the pain, accidental overdose and wrong vaccine administered were unknown. The reporter considered the pain to be possibly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporting pharmacist was the patient. The age at vaccination was not reported. The patient said that her pharmacist partner accidentally gave her two doses of FLUARIX QUADRIVALENT and was supposed to give one FLUARIX and one pneumococcal vaccination, which led to wrong vaccine administered and accidental overdose.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Urticaria
Clinical narrative: Hives on face began around 4:30pm, along with a headache. Hives spread to body. Symptoms resolved in about 3 hours after taking BENADRYL, taking a bath, and applying topical steroids.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Patient vaccinated by pharmacist and under 18 years old.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Hypoaesthesia, Musculoskeletal pain, Nausea
Clinical narrative: Dizziness, numbness in legs, nausea, lack of appetite, shoulder pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site bruising, Injection site pain
Clinical narrative: Patient returned to pharmacy 6 days post-vaccine w/moderate-severe bruising of left shoulder and continued pain. Pt stated that she had also had excessive bleeding after vaccination. No treatment given.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on legs, arms, abdomen per parent phone call on 9/6/17.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report has been received from a 60 year old female consumer concerning herself. The patient did not have concomitant medications, pertinent medical history or drug reactions/allergies. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not reported) subcutaneously for prevention of shingles. On 16-AUG-2017, the patient developed a "hard and knotty bump at the insertion site, which had also turned red". The patient did not receive treatment for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report has been received from a 60 year old female consumer concerning herself. The patient did not have concomitant medications, pertinent medical history or drug reactions/allergies. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not reported) subcutaneously for prevention of shingles. On 16-AUG-2017, the patient developed a "hard and knotty bump at the insertion site, which had also turned red". The patient did not receive treatment for the events. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Inflammation, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 24-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M035104 for prophylaxis. On 24-AUG-2017, 1 day after onset of therapy the patient experienced injected limb mobility decreased and injection site pain. On 25-AUG-2017 the patient experienced injection site erythema, injection site pruritus, injection site induration and injection site inflammation. The outcome of injected limb mobility decreased, injection site pruritus, injection site induration, injection site inflammation, injection site erythema and injection site pain was reported as not recovered/not resolved.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 24-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M035104 for prophylaxis. On 24-AUG-2017, 1 day after onset of therapy the patient experienced injected limb mobility decreased and injection site pain. On 25-AUG-2017 the patient experienced injection site erythema, injection site pruritus, injection site induration and injection site inflammation. The outcome of injected limb mobility decreased, injection site pruritus, injection site induration, injection site inflammation, injection site erythema and injection site pain was reported as not recovered/not resolved.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 24-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M035104 for prophylaxis. On 24-AUG-2017, 1 day after onset of therapy the patient experienced injected limb mobility decreased and injection site pain. On 25-AUG-2017 the patient experienced injection site erythema, injection site pruritus, injection site induration and injection site inflammation. The outcome of injected limb mobility decreased, injection site pruritus, injection site induration, injection site inflammation, injection site erythema and injection site pain was reported as not recovered/not resolved.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Injection site: swelling, rash, heat, red sploches, outcomes YTD.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: This spontaneous report has been received from a physician via a field representative referring to a female patient of unknown age with cold sores. Concomitant medication included anti-viral medication for cold sores. The patient's pertinent medical history and drug allergies were unknown. In approximately February 2017 (reported as about six months ago), the patient was vaccinated with ZOSTAVAX vial 19400 Plaque-Forming Unit (PFU), subcutaneous prevention of herpes zoster (dose, lot# and expiration date were not reported). In approximately February 2017, 1 day after injection, the patient had an allergic reaction and diffused rash all over the body. There was no treatment, no doctor visit and no hospitalization. No lab diagnostics were performed. The outcome of events was reported as recovered on an unknown date in 2017.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#M031574, expiration date 11-NOV-2018; lot#M040423, expiration date 03-JUL-2019) (dosage and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA003596: US-009507513-1709USA003594: US-009507513-1709USA003595:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. The concomitant therapies included sterile diluent. On 17-AUG-2017, the patient was vaccinated with a dose of expired ZOSTAVAX (lot # M041510, 0.65 ml, once, expiration date of 27-JUL-2017) subcutaneously for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 52 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient started therapy with VALTREX (strength, dose, frequency, route, lot#, expiration date and indication were not reported). On 11-AUG-2017, the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and expiration date were not reported), for prophylaxis while still taking VALTREX. No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 18-year-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.  On 15-AUG-2017, the patient was inadvertently administered an adult dose of VAQTA 50/1.0 U/ml (dose, route unknown, lot # N005605, and expiration date of 08-APR-2018) for prophylaxis. There was no adverse effect reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (2.5/0.5, lot # M044032 / expiration date 03-JUL-2019, lot # N006321 / expiration date 08-NOV-2019, lot # N005996 / expiration date 07-JUL-2019, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA003854: US-009507513-1709USA003852: US-009507513-1709USA003853:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 17-AUG-2017, the patient was vaccinated with an expired dose of M-M-R II (route was not reported), lot # L029266 with expiration date 04-AUG-2017, reconstituted with sterile diluent (lot# L022773 with expiration date 08-MAR-2018) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent condition were not reported.   Concomitant therapy included sterile diluent (manufacturer unknown) used to reconstitute vaccine (Lot# and expiration unknown). On multiple unknown dates of August 2017 (reported as over the past two weeks), the patients might have received VARIVAX (dose, route, lot# and expiry unspecified) rather than receiving ZOSTAVAX (lot# N003697, expiry expiration date: 13-MAR-2018; dose and route unspecified) (wrong vaccine administered). No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report was received on 28-AUG-2017 from a registered nurse and refers to a 15-year-old female patient. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The registered nurse reported that the female patient received GARDASIL 9 vaccine injection, intramuscularly (Dose/frequency was reported as: vaccine dose) (Site of vaccination, Lot number and expiration date were not reported) on 02-AUG-2017 for the indication of "HPV vaccine". It was the final dose in a three dose series. (The dates of vaccination with dose 1 and dose 2 were not reported.) The patient started to experience injection site soreness on an unspecified date between 03-AUG-2017 and 22-AUG-2017. On 23-AUG-2017, the patient reported that the pain is getting progressively worse. "It hurts to touch the arm or move it." No laboratory studies were performed. The patient sought medical attention reported as "yes, contacted physician." It was reported that treatment was given for the adverse experience. Treatment was not specified. The patient's present status was reported as not recovered. No further adverse experience to report. Product quality complaint was not involved. Additional information is not expected as no permission was given to request follow-up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with unknown number of doses of VARIVAX lot # M027886 with expiry date: 03-JUN-2018, lot# M041081 with expiry date: 06-OCT-2018 and lot# N009767 with expiry date: 24-MAR-2019 (dosing details, anatomical location and route were unknown) for prophylaxis, following a temperature excursion (incorrect product storage). It was reported that the vaccines were exposed to a temperature range of -14 to -10 degree centigrade for a duration of 22 hours 7 minutes and -9 to 8 degree centigrade for a duration of 23 hours 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported in any patients. There were no product quality complaints (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse, refers to 3 unspecified patients. Concomitant therapies included sterile diluent(manufacturer unknown).  On 05-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as "N00068" for prophylaxis. No adverse event were reported. This is one of several reports received from the same source. Lot number N00068 is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments: US-009507513-1709USA002520:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 12 year old female patient. No information about the patient´s medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in 2012 (reported as "about 5 years ago"), the patient was vaccinated with a dose of GARDASIL, intramuscular, (dose, lot # and expiration date were not provided) for prevention of human papillomavirus. On an unknown date in 2012 (reported as "about 5 years ago"), after receiving a dose of GARDASIL (dose number unspecified), the patient "passed out"  (loss of consciousness). It was also reported that the patient sought medical attention, but no intervention to prevent serious criteria was performed. No product quality complaint (PQC) was involved. It was reported that, on an unknown date, the patient recovered from loss of consciousness. Additionally, it was reported that the patient finished the series of GARDASIL. The causal relationship between GARDASIL and loss of consciousness was not provided. Upon internal review, the event loss of consciousness was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-MAY-2017 the patient was vaccinated with VAQTA lot # L023232 for prophylaxis. On 23-MAY-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.; Sender's Comments: US-009507513-1709USA003272: US-009507513-1709USA003273:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VAQTA lot # N008823 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA.; Sender's Comments:  US-009507513-1709USA003454: US-009507513- 1709USA003453: US-009507513-1709USA003455:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M036059 for prophylaxis. On JUN-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1709USA003437.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with VAQTA lot # L023232 for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1709USA003130: US-009507513-1709USA003273.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 25-JUL-2017 the patient was vaccinated with VAQTA lot # L023232 for prophylaxis. On 25-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1709USA003130: US-009507513-1709USA003272.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored PROQUAD lot # N013270, 0.5 ml, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced no adverse event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On JUN-2017 the patient was vaccinated with ROTATEQ lot # M019708, oral for prophylaxis. On JUN-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1709USA003223.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX HB lot # N002914 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003455: US-009507513-1709USA003454.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ lot # M042169, oral for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003455: US-009507513-1709USA003453.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # N019923 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event.  The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1709USA003145: US-009507513-1709USA003453: US-009507513-1709USA003454.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot#M047666, expiration date 24-OCT-2019; lot#N003701, expiration date 01-NOV-2019) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003595: US-009507513-1709USA003596: US-009507513-1708USA008381.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot#L026602, expiration date 19-OCT-2017; lot#M024261, expiration date 30-JUL-2018; lot#M033583, expiration date 14-APR-2019; lot#N000326, expiration date 14-OCT-2019) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008381: US-009507513-1709USA003596: US-009507513-1709USA003594.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot#M038209, expiration date 23-APR-2018; lot#M040267, expiration date 14-MAY-2018;  lot#M043836, expiration date 17-JUN-2018) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003595: US-009507513-1708USA008381: US-009507513-1709USA003594.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Headache, Hyperacusis
Clinical narrative: This is a spontaneous report from a contactable nurse at pediatric office received via a Pfizer sales representative. A 17 year-old male patient received the first dose of TRUMENBA on 14Aug2017, at 0.5 ml single, in left arm, for immunisation. Medical history included viral meningitis at the age of 4 and was hospitalized. Concomitant medications were none. On 14Aug2017, two hours after vaccination, the patient experienced chills, weakness, headache and sensitivity to noise. All the events lasted for about four hours and resolved on 14Aug2017. The patient had no residual effects. The reporter felt that during those four hours it was pretty serious, almost enough so that she was going to take him to the Emergency Room, but she did not. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist and a contactable consumer reporting for herself. An 82-year-old female patient received PREVNAR 13 (Lot# R28320, Exp date Feb2018, NDC 00005197102), via an unspecified route of administration in deltoid right, on 24Aug2017 at around 02:00 PM, at 0.5 ml single, for immunisation and FLUZONE (Lot# U1808AB, Exp date Feb2018), intramuscular in deltoid left, on 24Aug2017, at unspecified dose, for immunisation. Patient was vaccinated in a pharmacy. Relevant medical history included ongoing hypertension (diagnosed a long time ago). Concomitant medications included diltiazem (unspecified trade name) from an unspecified date and ongoing for blood pressure and ADVAIR from an unspecified date and ongoing for an unspecified indication. The patient previously received PNEUMOVAX, years before, for immunisation; FLUZONE (high dose), in 2016, for immunisation and unspecified doses of FLUZONE the years before for immunisation. The patient experienced a good size red warm spot on her arm on an unspecified date with outcome of unknown, considered as medically significant by the reporter; itching on 30Aug2017 with outcome of unknown, considered as medically significant by the reporter; her other arm was sore after the FLUZONE on an unspecified date with outcome of unknown. No therapeutic measures were taken as a result of the events. The reporter considered the event good size red warm spot on her arm as related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "red warm spot on her arm and itching" cannot be fully excluded. Local reactions including redness/ warmth and pruritus post vaccination are the known risk for PREVNAR 13. Arm sore occurred opposite to the arm vaccinated with PREVNAR 13 is not due to the use of PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling face
Clinical narrative: Initial unsolicited report received from consumer on 29-Aug-2017. This case involves 70-year-old (reported as 71 years old) male patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose was not reported) via intramuscular route in left deltoid on 28 Aug 2017. The patient's medical history revealed that patient had hypertension. Illness at time of vaccination were reported as none. Concomitant medications were not reported. On 28 Aug 2017, same day following the vaccination, the patient experienced cheeks were becoming puffy or swollen. Once he arrived home on same day, he noticed his swollen cheeks were also red. It was reported that, in morning he notes that the symptoms have remained the same. Patient had no other symptoms to report. Lab data reported as none. Corrective treatment were not reported. It was reported that, the patient was not recovered from events. List of documents held by sender: none.
Age: 53.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Right upper arm in and redness and rash.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine output decreased, Vomiting projectile
Clinical narrative: Patient received vaccines on 9/5/17 and developed projectile vomiting on 9/6/17 and having less wet diapers warranting a MD appointment on 9/7/17.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Patient received vaccines on 9/5/17 and developed projectile vomiting on 9/6/17 and having less wet diapers warranting a MD appointment on 9/7/17.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On an unspecified date, these patients were administered improperly stored PNEUMOVAX 23 (lot # M036728 with expiration date 20-MAY-2018 and lot# M043987 with expiration date 30-JUN-2018, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 1 hour. The vaccine was previously exposed to temperature excursion of 47 to 77 Fahrenheit (F) (48 F) for 30 minutes. The data logger was involved. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with M-M-R II lot# M028130 (expiry date, anatomical location, route were unknown) 1 DF (reported as "a dose") for prophylaxis. Five days later, the patient was vaccinated with VARIVAX lot # M038858 (expiry date, anatomical location, route were unknown) 1 DF for prophylaxis (inappropriate schedule of drug administration). Concomitant therapy included sterile diluent (MERCK) (details unknown). No adverse effects were reported. There was no product quality complaint (PQC) involved.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N010494 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event is unknown. The reporter considered product use issue and no adverse event to be not related to ZOSTAVAX.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Eye movement disorder, Febrile convulsion, Unresponsive to stimuli
Clinical narrative: On 9/6/2017 child had febrile seizure and was transported to hospital via ambulance; mom reports eyes rolled back, child was non-responsive for one minute and temp was 102.2.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Confusional state, Erythema, Headache, Injection site pain
Clinical narrative: Given wrong vaccine on 9/05/2017. I am a healthcare provider and work for a GI doctor. I was required to get the Hep B series. I went in for the 1st dose of the Hep B vaccine but was given the Tdap in error. I then went back on 9/8/2017 and received the 1st dose of Hep B Right arm-Red swollen arm, joint pain, body aches, headache, nausea, confusion lasting 2 days. Site pain still present at 4 days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Peripheral swelling, Wrong drug administered
Clinical narrative: Given wrong vaccine on 9/05/2017. I am a healthcare provider and work for a GI doctor. I was required to get the Hep B series. I went in for the 1st dose of the Hep B vaccine but was given the Tdap in error. I then went back on 9/8/2017 and received the 1st dose of Hep B Right arm-Red swollen arm, joint pain, body aches, headache, nausea, confusion lasting 2 days. Site pain still present at 4 days.
Age: 0.08
Sex: M
Vaccine: HEP, RV5
Symptoms: Abdominal pain, Crying, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, 12-14 blow-out diarrhea, vomiting 5-7x's/day, abdominal pain, crying x1 week. Pt did remain well hydrated and is doing well now.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Vomiting
Clinical narrative: After receiving BEXSERO she has been throwing up, chills and felt lightheaded yesterday after 2 hours of receiving shot pt. State she did not faint and has no lump or redness were vaccine was given.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Bladder catheterisation, Bladder scan, Discomfort, Headache, Injection site pain
Clinical narrative: Urinary retention, began approximately 27 hours after injection. Additional symptoms: Minor pain at injection site, moderate headache, swollen glands in neck. Urine flow ceased completely at the 32 hour point, and I was in great discomfort at the 40-hour point. Nurse in E.R. inserted foley catheter into my bladder, which provided immediate relief. Urine released:1.2 liters.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Lymphadenopathy, Urinary retention, Urine analysis, Urine flow decreased
Clinical narrative: Urinary retention, began approximately 27 hours after injection. Additional symptoms: Minor pain at injection site, moderate headache, swollen glands in neck. Urine flow ceased completely at the 32 hour point, and I was in great discomfort at the 40-hour point. Nurse in E.R. inserted foley catheter into my bladder, which provided immediate relief. Urine released:1.2 liters.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis at injection site with growing erythema 1 day post vaccination. Treated with a 10 day course of Clarithromycin 250 mg BID X10 days.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site warmth
Clinical narrative: Soreness at injection site, warm, painful, slightly bruised. Treated with OTC pain med and ice pack.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dizziness, Hallucination, visual, Headache, Hyperhidrosis
Clinical narrative: Returned to clinic 9/7/2017 at 1000 am reporting fever, nausea emesis X3, back, head and neck pain a 10/10. Patient and spouse reported visual hallucinations starting at 1200 am on 9/7. Vital signs 100/60, 101.8, 111, 16 O2 sat 99%. Patient visually shaking, but responding appropriately. Ondansetron 4mg/2cc given IM at 10:29 a.m., Acetominphen 650 mg given p.o. at 1107 a.m.  Discharged to home at 1200 with instructions to take acetominphen or ibuprofen for fever, body aches. Patient noted rash to chest at 9pm on 9/7/2017, 9/8/2017 1100 Spoke with patient. She reports a little nausea, but able to eat. Also light headed. Diaphoretic, but fever free upon awakening this a.m.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Rash
Clinical narrative: Returned to clinic 9/7/2017 at 1000 am reporting fever, nausea emesis X3, back, head and neck pain a 10/10. Patient and spouse reported visual hallucinations starting at 1200 am on 9/7. Vital signs 100/60, 101.8, 111, 16 O2 sat 99%. Patient visually shaking, but responding appropriately. Ondansetron 4mg/2cc given IM at 10:29 a.m., Acetominphen 650 mg given p.o. at 1107 a.m.  Discharged to home at 1200 with instructions to take acetominphen or ibuprofen for fever, body aches. Patient noted rash to chest at 9pm on 9/7/2017, 9/8/2017 1100 Spoke with patient. She reports a little nausea, but able to eat. Also light headed. Diaphoretic, but fever free upon awakening this a.m.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: Returned to clinic 9/7/2017 at 1000 am reporting fever, nausea emesis X3, back, head and neck pain a 10/10. Patient and spouse reported visual hallucinations starting at 1200 am on 9/7. Vital signs 100/60, 101.8, 111, 16 O2 sat 99%. Patient visually shaking, but responding appropriately. Ondansetron 4mg/2cc given IM at 10:29 a.m., Acetominphen 650 mg given p.o. at 1107 a.m.  Discharged to home at 1200 with instructions to take acetominphen or ibuprofen for fever, body aches. Patient noted rash to chest at 9pm on 9/7/2017, 9/8/2017 1100 Spoke with patient. She reports a little nausea, but able to eat. Also light headed. Diaphoretic, but fever free upon awakening this a.m.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Patient had a local reaction at the site of ZOSTAVAX injection. The area was red and warm to the touch. It was about the size of a quarter. There was no swelling.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood urea normal, C-reactive protein normal
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 year old female patient. The patient had no medical history, concomitant medications and drug reactions or allergies. Information on the patient's concurrent conditions was not reported. On 25-AUG-2017, the patient was vaccinated with M-M-R II injection 1 DF (reported as a dose) subcutaneously (lot# M045402, expiration date: 14-NOV-2018; dose number not reported) for prevention of measles, mumps and rubella. Concomitant therapy included MERCK STERILE DILUENT (dosing details, lot# and expiration date were not reported). On 25-AUG-2017 post vaccination while the patient was on her way home from the physician's office in the car with her parents, she experienced a seizure. The patient was immediately brought back to the physician's office, where she experienced another seizure which was witnessed by the physician and nurse. It was determined that the seizures were tonic-clonic seizures. A finger-stick was performed to check the patient's blood glucose level, which was 121 (units unspecified). The nurse did not feel this level was indicative of hyperglycemia and stated that the patient might have recently eaten and therefore this was a normal variation in blood glucose level. The patient also experienced three episodes of vomiting while in the physician's office. The patient was admitted to a medical center for observation where complete blood count (CBC), C-reactive protein (CRP), blood urea nitrogen (BUN), creatinine, glucose, and electrolytes were performed; all of which were normal. No treatment was given for the events. On 26-AUG-2017, the patient was discharged. The patient was advised to follow-up with a neurologist. The outcome of blood glucose abnormal was considered recovered as glucose level was normal at the medical center. The outcome of tonic-clonic seizures and vomiting was unknown. No product quality complaint was involved. Causality assessment for the events was not reported. The nurse considered tonic-clonic seizures to be life-threatening. Upon internal review, the event generalised tonic-clonic seizures was determined to be medically significant.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Generalised tonic-clonic seizure, Seizure, Vomiting
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 year old female patient. The patient had no medical history, concomitant medications and drug reactions or allergies. Information on the patient's concurrent conditions was not reported. On 25-AUG-2017, the patient was vaccinated with M-M-R II injection 1 DF (reported as a dose) subcutaneously (lot# M045402, expiration date: 14-NOV-2018; dose number not reported) for prevention of measles, mumps and rubella. Concomitant therapy included MERCK STERILE DILUENT (dosing details, lot# and expiration date were not reported). On 25-AUG-2017 post vaccination while the patient was on her way home from the physician's office in the car with her parents, she experienced a seizure. The patient was immediately brought back to the physician's office, where she experienced another seizure which was witnessed by the physician and nurse. It was determined that the seizures were tonic-clonic seizures. A finger-stick was performed to check the patient's blood glucose level, which was 121 (units unspecified). The nurse did not feel this level was indicative of hyperglycemia and stated that the patient might have recently eaten and therefore this was a normal variation in blood glucose level. The patient also experienced three episodes of vomiting while in the physician's office. The patient was admitted to a medical center for observation where complete blood count (CBC), C-reactive protein (CRP), blood urea nitrogen (BUN), creatinine, glucose, and electrolytes were performed; all of which were normal. No treatment was given for the events. On 26-AUG-2017, the patient was discharged. The patient was advised to follow-up with a neurologist. The outcome of blood glucose abnormal was considered recovered as glucose level was normal at the medical center. The outcome of tonic-clonic seizures and vomiting was unknown. No product quality complaint was involved. Causality assessment for the events was not reported. The nurse considered tonic-clonic seizures to be life-threatening. Upon internal review, the event generalised tonic-clonic seizures was determined to be medically significant.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 year old female patient. On 01-SEP-2017 the patient was vaccinated with GARDASIL 9 lot # N019923 dose 3, intramuscular for prophylaxis. On 01-SEP-2017, 1 day after onset of therapy the patient experienced syncope. The outcome of syncope was reported as recovered/resolved.
Sex: F
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non HCP Pfizer colleague. A female patient of an unspecified age (in her early 20's possible) received meningococcal group B injection intramuscular at 0.5ml, single, 3 dose series on an unspecified date during the University outbreak 2014-2015 school year for immunization for prevention of Meningitis serogroup B. The reporter was not sure if it was TRUMENBA or BEXSERO that was given. The patient medical history and concomitant medications were not reported. The patient experienced felt sick after getting the shot on an unspecified date with outcome of recovered. No follow-up attempts are possible. No further information expected.