chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. In 2017 (reported as within the last two weeks), the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not reported) intradermally for prevention of shingles. The patient thought that the ZOSTAVAX was administered intradermally because, on an unknown date in 2017, the patient developed a raised area in their skin at the injection site similar to what would occur with a tuberculosis (TB) test. The reported also stated that the patient had a rash at the injection site. The patient sought medical attention by calling the pharmacist. It was unknown if the patient received any treatment or if they had performed any laboratory diagnostic tests. At the time of this report, the patient had not recovered from the events. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma, Therapeutic response unexpected
Clinical narrative: Information was received on 07-JUN-2017 from a 13 year male patient's sister regarding use of GARDASIL 9 injection for genital warts (date, dose, route of administration and lot#/expiration not reported). Concomitant medication included over the counter allergy medication. Patient experienced an "unusual and unexpected, but wonder side effect after his GARDASIL 9 vaccine". The patient had been experiencing a filiform wart on the inside of his left nostril (date not reported). He also had a lot of warts on his nail beds (date not reported). The patient had tried multiple unspecified over the counter remedies for the warts to no avail. Patient had been administered his first dose of the GARDASIL 9 vaccine series "about a month ago". A week or two after the vaccine, all warts disappeared. There was no trace of them at the time of this report. Patient had not sought medical attention. No further information provided. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a  2 year old female patient.No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-JUN-2017, the patient was vaccinated with VAQTA lot # M039202, expiration 11-MAR-2018  for prophylaxis.   It was reported the patient received less than recommended dose of VAQTA due to syringe leakage. No adverse event reported. No further information was provided. 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 nurse and refers to a two unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 07-JUN-2017, the patients were administered improperly stored doses (reported as "two") of PROQUAD (albumin status: recombinant human albumin, rHA) injection (lot # M023932 with expiration date at 09-NOV-2017 and lot # M039447 with expiration date at 20-MAR-2018; for prophylaxis; doses, routes of administration and anatomical locations were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # K013708 with expiration date at 13-JUN-2017; strength and dose were not reported). On an unknown dates, the administered doses of vaccine were exposed to a temperature from -14 degrees Celsius (C) to -10 degrees Celsius (C) for 7 hours and 54 minutes and from -9 degrees Celsius (C) to 8 degrees Celsius (C) for 1 hour. There was no previous temperature excursion. Data logger was used to track the temperature. No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 06-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed a large red spot (also reported as redness) a couple inches from the site of the injection (erythema). At the reporting time, the outcome of erythema was unknown. The causality between PNEUMOVAX 23 and the event of erythema was not assessed. 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 nurse and refers to a four unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered an improperly stored doses of PROQUAD (albumin status: recombinant human albumin, rHA) injection (lot # M044018 with expiration date at 01-MAY-2018; doses, routes of administration and anatomical locations were not reported), for prophylaxis. On an unknown date, the administered doses of vaccine were exposed to a temperature of 6 degrees Fahrenheit (F) for 4 minutes. There was also reported a previous temperature excursion including exposure to a temperature of 12 degrees Fahrenheit (F) for 3 minutes (date unspecified). Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013693:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #N003702, expiration date 08-NOV-2019 (also reported as 08-NOV-2018). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012843: US-009507513-1706USA004570:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot #M038728, expiration date 25-APR-2018. No adverse effects were reported.  Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012843: US-009507513-1706USA004569:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014586:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014586:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014586:
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-MAY-2017, the patient was vaccinated with a dose of improperly stored VAQTA lot # N005274 with an expiration date of 03-APR-2018 (exact dose, route of administration and anatomical location were not provided), and a dose of RECOMBIVAX HB lot # M035487 with an expiration date of 23-FEB-2019 (exact dose, route of administration and anatomical location were not provided). Administered doses of vaccines underwent a temperature excursion of 35 degrees Fahrenheit (F) for 50 minutes which was detected by a digital data logger. There was a previous excursion reported of 33 F for 4 hours. No adverse events occurred. No product quality (PQC) complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000908:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Nurse reported patient received improperly stored RECOMBIVAX HB (lot # M044031, expiry date: 21-DEC-2019) on 30-MAY-2017 (incorrect product storage). The vaccine was exposed to 32°F to 35°F for 1 hour and 20 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effects were reported.  This is one of the two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001679:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 26-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information is not expected as there was no further information to report.; Sender's Comments:  US-009507513-1704USA015304: US-009507513-1704USA001013:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Anal incontinence, Arthralgia, Asthenia, Blood culture, Dyspnoea
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 67 year old female patient received, on 18May2017, the first dose of PREVNAR 13 (Lot. R94917) single dose, in the arm, for immunization. Relevant medical history and concomitant medications were none. On an unspecified date, the patient felt seriously ill, was really weak, barely walked and she slept the whole day. The patient developed difficulty breathing, whole body aches, knees hurt, vaccination site movement impairment (wasn't able to move the arm for a week where she received the shot), arm got numb, and serious pain in the arm where she got the shot. The patient also experienced seizure, she vomited and defecated and was unconscious for three days. The patient was hospitalized from 22May2017 to May2017 for loss of consciousness, seizure, vomiting and involuntary bowel movement. Seizure was treated with levetiracetam. Culture bacteria blood was performed on an unspecified date but the results were not available at time of this report. Clinical outcome of the events was unknown at time of this report.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Hypersomnia, Hypoaesthesia, Injection site pain, Loss of consciousness
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 67 year old female patient received, on 18May2017, the first dose of PREVNAR 13 (Lot. R94917) single dose, in the arm, for immunization. Relevant medical history and concomitant medications were none. On an unspecified date, the patient felt seriously ill, was really weak, barely walked and she slept the whole day. The patient developed difficulty breathing, whole body aches, knees hurt, vaccination site movement impairment (wasn't able to move the arm for a week where she received the shot), arm got numb, and serious pain in the arm where she got the shot. The patient also experienced seizure, she vomited and defecated and was unconscious for three days. The patient was hospitalized from 22May2017 to May2017 for loss of consciousness, seizure, vomiting and involuntary bowel movement. Seizure was treated with levetiracetam. Culture bacteria blood was performed on an unspecified date but the results were not available at time of this report. Clinical outcome of the events was unknown at time of this report.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain, Seizure, Vaccination site movement impairment, Vomiting
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 67 year old female patient received, on 18May2017, the first dose of PREVNAR 13 (Lot. R94917) single dose, in the arm, for immunization. Relevant medical history and concomitant medications were none. On an unspecified date, the patient felt seriously ill, was really weak, barely walked and she slept the whole day. The patient developed difficulty breathing, whole body aches, knees hurt, vaccination site movement impairment (wasn't able to move the arm for a week where she received the shot), arm got numb, and serious pain in the arm where she got the shot. The patient also experienced seizure, she vomited and defecated and was unconscious for three days. The patient was hospitalized from 22May2017 to May2017 for loss of consciousness, seizure, vomiting and involuntary bowel movement. Seizure was treated with levetiracetam. Culture bacteria blood was performed on an unspecified date but the results were not available at time of this report. Clinical outcome of the events was unknown at time of this report.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer (Practice manager) reported same events for 2 twins patients. This is the 2nd of 2 reports. A 19-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On 15May2017 the patient passed out as soon as she was administered, fainted, had reactions on her arms very painful, sore and swollen on 15May2017 with outcome of recovered, The outcome of the events was recovered. The same events occurred to her twin sister.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252009 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable Practice manager reported same events for two twins. This is the first of two reports.  A 19-year-old female patient of an unspecified race received TRUMENBA (lot R56659, exp.date Jan 2019) at 0,5ml single dose on unknown date for immunization. Relevant medical history and concomitant medications were unknown. On 24May2017 the patient experienced passed out, fainted and had reactions on her arms very painful, sore and swollen. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017252000 same reporter/drug/event, different patient.
Age: 18.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Dyskinesia, Eyelid function disorder
Clinical narrative: When he went to smile, smile was off. Left side of his face, eye was not blinking properly. Left forehead and eyebrow, check and lip didn't move. Left eye can't close completely.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, Heat at the injection site.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, pain and discomfort at injection site.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-06-02.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-06-09.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine site became very red extending out across back of arm about the size of an orange. It was very swollen and hot to the touch with complaints of itching and pain.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route of administration were not reported; lot # M033583, expiration date 14-APR-2019), for prophylaxis. The vaccine underwent a temperature excursion with 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013861: US-009507513-1705USA013862:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was "presumably" vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) for hepatitis b vaccination (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient had hepatitis b titers drawn on which exhibited "low or non-existent level." The outcome of the event was unknown. The relatedness between the event and hepatitis b vaccine (recombinant)(manufacturer unknown) was not provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on  01-JUN-2017 from  a registered nurse who was reporting a on a  female patient of unknown age. No medical history or concomitant medications were reported. On 14-AUG-2012, the patient received a dose of GARDASIL (no lot, expiration, dose, route or site reported) for prophylaxis. On 25-APR-2017 the patient received a dose of GARDASIL 9 (lot M043731, expires 22-JUN-2019, no dose or site reported) for prophylaxis. On 01-JUN-2017 the patient received the second dose of GARDASIL 9 (lot M043731, expires 22-JUN-2019, no dose or site reported) also for prophylaxis. No adverse effects were reported. No additional information is available. Additional information is not expected. No further details available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient had no medical history, concurrent conditions, drug and allergy history to be reported. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047660, expiration date 02-DEC-2018 (dose, route were not provided) for prophylaxis. The patient's concomitant therapies were not reported. On an unspecified date, VARIVAX was exposed to a temperature excursion of 14F (Fahrenheit) during a time frame of 2 hours 15 min, and with a previous temperature excursion of 14F during 1 hour. No adverse effects were reported. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of PEDVAXHIB (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also reported: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004962: US-009507513-1706USA004960: US-009507513-1706USA004961.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of M-M-R II (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also informed: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004961: US-009507513-1706USA004962: US-009507513-1706USA003517.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of GARDASIL 9 (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also reported: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003517: US-009507513-1706USA004962: US-009507513-1706USA004960:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of  ROTATEQ (dosage information, lot number an expiration date were not informed) orally, for prophylaxis. No adverse effects were reported. It was also reported: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004961: US-009507513-1706USA003517: US-009507513-1706USA004960.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dyspnoea, Headache, Pain, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician.  A 16-year-old female patient received TRUMENBA Lot# M74090 Expiry Date Jun2017, via an unspecified route of administration on 05Jun2017 15:00 at 0.5 ml, single for immunisation. Medical history included Intermittent asthma. The patient's concomitant medications were not reported. The patient woke up the next day, 06Jun2017, with headache, tenderness at injection site, body aches and low grade fever of 100.5. Caller reports that the symptoms progressed that day to a fever of 102 degrees F, with shortness of breath and body aches. The patient took the inhaler that helped open her up. On 07Jun2017, the patient s parents contacted the physician and reported that the child broke out in a rash, hives, her ears are swollen and red, her palms are very red, beefy red, and was more tired. The patient had no longer has a fever, headache is better, and doesn't feel like shortness of breath. Outcome of other events was not reported. The reporter thought with the fever and headaches and body aches it could be a reaction to meningococcal group b rlp2086, but then the shortness of breath and hives today could be a sign of possible allergic reaction. The patient has been treated with BENADRYL.  She states that the patient also has a prescription for prednisone but has not started taking it.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dyspnoea, Ear swelling, Erythema, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable physician.  A 16-year-old female patient received TRUMENBA Lot# M74090 Expiry Date Jun2017, via an unspecified route of administration on 05Jun2017 15:00 at 0.5 ml, single for immunisation. Medical history included Intermittent asthma. The patient's concomitant medications were not reported. The patient woke up the next day, 06Jun2017, with headache, tenderness at injection site, body aches and low grade fever of 100.5. Caller reports that the symptoms progressed that day to a fever of 102 degrees F, with shortness of breath and body aches. The patient took the inhaler that helped open her up. On 07Jun2017, the patient s parents contacted the physician and reported that the child broke out in a rash, hives, her ears are swollen and red, her palms are very red, beefy red, and was more tired. The patient had no longer has a fever, headache is better, and doesn't feel like shortness of breath. Outcome of other events was not reported. The reporter thought with the fever and headaches and body aches it could be a reaction to meningococcal group b rlp2086, but then the shortness of breath and hives today could be a sign of possible allergic reaction. The patient has been treated with BENADRYL.  She states that the patient also has a prescription for prednisone but has not started taking it.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Pain, Palmar erythema, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician.  A 16-year-old female patient received TRUMENBA Lot# M74090 Expiry Date Jun2017, via an unspecified route of administration on 05Jun2017 15:00 at 0.5 ml, single for immunisation. Medical history included Intermittent asthma. The patient's concomitant medications were not reported. The patient woke up the next day, 06Jun2017, with headache, tenderness at injection site, body aches and low grade fever of 100.5. Caller reports that the symptoms progressed that day to a fever of 102 degrees F, with shortness of breath and body aches. The patient took the inhaler that helped open her up. On 07Jun2017, the patient s parents contacted the physician and reported that the child broke out in a rash, hives, her ears are swollen and red, her palms are very red, beefy red, and was more tired. The patient had no longer has a fever, headache is better, and doesn't feel like shortness of breath. Outcome of other events was not reported. The reporter thought with the fever and headaches and body aches it could be a reaction to meningococcal group b rlp2086, but then the shortness of breath and hives today could be a sign of possible allergic reaction. The patient has been treated with BENADRYL.  She states that the patient also has a prescription for prednisone but has not started taking it.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician.  A 16-year-old female patient received TRUMENBA Lot# M74090 Expiry Date Jun2017, via an unspecified route of administration on 05Jun2017 15:00 at 0.5 ml, single for immunisation. Medical history included Intermittent asthma. The patient's concomitant medications were not reported. The patient woke up the next day, 06Jun2017, with headache, tenderness at injection site, body aches and low grade fever of 100.5. Caller reports that the symptoms progressed that day to a fever of 102 degrees F, with shortness of breath and body aches. The patient took the inhaler that helped open her up. On 07Jun2017, the patient s parents contacted the physician and reported that the child broke out in a rash, hives, her ears are swollen and red, her palms are very red, beefy red, and was more tired. The patient had no longer has a fever, headache is better, and doesn't feel like shortness of breath. Outcome of other events was not reported. The reporter thought with the fever and headaches and body aches it could be a reaction to meningococcal group b rlp2086, but then the shortness of breath and hives today could be a sign of possible allergic reaction. The patient has been treated with BENADRYL.  She states that the patient also has a prescription for prednisone but has not started taking it.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: PAIN AND SWELLING OF INJECTION SITE. REDNESS AND INFLAMMATION OF INJECTION SITE. INDURATION OF THE SKIN AT INJECTION SITE. INJECTION SITE FEELS HOT. FEVER.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: PAIN AND SWELLING OF INJECTION SITE. REDNESS AND INFLAMMATION OF INJECTION SITE. INDURATION OF THE SKIN AT INJECTION SITE. INJECTION SITE FEELS HOT. FEVER.
Age: 49.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Fatigue, Laboratory test
Clinical narrative: Profound fatigue. Physician, Dr. found negative results from physical exam and lab work.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Dyspnoea, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Anaphylactic. SOB, Tight throat, Itchiy Throat, Hives.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Pallor, Rash
Clinical narrative: Approximately 15 minutes following the administration of a dose of Tdap, MCV and HPV, child developed rash on the face which eventually spread to both arms and trunk. Upon assessment child was pale and verbalized feeling weak. Child was placed on medical recovery bed on a prone position, based on standing protocol and child's weight, 0.5 mL of epinephrine (0.5mg of a 1:1000 dilution) and 1 mL (50 mg) of BENADRYL were administered intramuscularly. EMS was called while vital signs continued to be monitored which remained stable. Child remained alert and oriented to place, person and time and was transported via ambulance to emergency room for further evaluation and treatment. Mother was advised to deviate from continuing vaccination series until it was cleared by attending physician. Mother verbalized understanding. Upon follow up on 5/27/2017, mother explained that child had fully recovered and had been released from the ER on that same day, 5/26/2017 late in the evening.
Age: 51.0
Sex: M
Vaccine: MEN
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: Patient became highly febrile, passed out at work, went to ED and got IV fluids.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of RECOMBIVAX HB lot # M032649, expiration date 11-NOV-2018 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects were reported. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 29.7 degrees Fahrenheit for 60 days before administration to the patients. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA012911: US-009507513-1705USA012910.
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a currently 11 years old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient received his first dose of GARDASIL 9 injection via intramuscular route in the left deltoid, lot # M037770 with expiration date 01-JUN-2019 (strength and dose were not reported). On an unknown date, when the patient received the vaccine, he fainted off the table and hit his head. The patient was given an ice pack for treatment, and he remained under medical supervision until he was known to be stable. There was no product quality complaint involved in this case. The outcome of the events and the relatedness between the events and GARDASIL 9 were not reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Heart rate increased, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 79-year-old male patient who was reporting on himself. The patient's medical history included bladder cancer, prostate cancer and vaccination with PREVENAR (a year and a half ago in approximately 2015). The patient's concurrent conditions included Achilles tendon tear. The patient did not have any known drug reactions or allergies. On 01-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 for prevention of pneumonia (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included unspecified NSAIDS and EXCEDRIN. In approximately May 2017, also reported as "afterwards", the patient could not lift his arm for 3 days and it was painful and swollen. On an unknown date in approximately May 2017, reported as "shortly after receiving the vaccine", the patient had unspecified bloodwork conducted at his physicians office which resulted in "high alanine aminotransferase (ALT) level of 207 (units not provided) and it dropped to 175 (units not provided) a week later" in approximately May 2017. The patient also noticed that his pulse was elevated in the 80's for about a week after getting the vaccine in approximately May 2017. It was unknown if the patient received a treatment for the events. The outcome of high ALT level was reported as recovering. The outcome of other events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.