chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Skin swelling, Swelling
Clinical narrative: Swelling in the groin area above the hip; skin is swollen and there is lump; skin is swollen and there is lump; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 18Jan2021 at first single dose for covid-19 immunisation. Medical history included: the patient had pre-existing conditions, he was hospitalized in Dec2020 and he was undergoing a lot of testing and there was possibility that he had a form of cancer and they discovered something on the next to his lungs. The reporter stated they did not have all of the diagnosis of it yet and he was waiting to be seen for specialist. The patient's concomitant medications were not reported. On 20Jan2021, the patient had a swelling. Swelling in the groin area above the hip. Skin is swollen and there is a lump. The reporter was trying to find out with the list of side effects if the lymph glands can swell and what areas of the body would you may be see swelling in the lymph nodes. The reporter wonder if there be lymph gland located for the men or the lymph gland located on the either side of the reproductive organ, in that area. What had happened to the patient, they were not sure if that was a side effect. One of the side effects the reporter knew it was listed on the website was lymph glands swell up. So the reporter just trying to find out if there were lymph glands in that same area where the patient was experience swelling right now. He did not have this issue before he got the vaccine, so it just sort of seemed this is. The reporter talked to the physician's office briefly when this happened just to see did they need to bring the patient in immediately for an appointment to check if it's (incomplete sentence). So far the patient just received topical ice packs over the area for the events. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 antibody test positive
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received the two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the 2 doses of Pfizer's COVID-19 Vaccine but on an unspecified date the physician went and test self for antibody. The physician had negative IgG and positive IgM on an unspecified date. The physician asked, What the vaccine does, is that what it is supposed to do, just make IgM not IgG. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthenopia, Blood pressure abnormal, Body temperature, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable Consumer.  A 91-year-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249, Expiry Date 31May2021 ), at single dose into the left arm on 20Jan2021 at 11:30 am for COVID-19 immunization. Medical history included problem with gallbladder in the last 4 months. Concomitant drugs were none.  The patient had never problem with flu and shingles shot.  On 20Jan2021, the day of vaccination the patient felt fine and told everyone it was a breeze. On 21Jan2021 morning she was getting ready to go to the store at 1130am, it was about 24 hours after getting the shot, and she felt dizzy, achy, her eyes ached and were weak, she felt feverish but had no fever and was a bit nauseated. The patient  also reported loss appetite the same day. On 22Jan2021 around 11am she felt a little better. She checked her temperature and blood pressure normal. She has had a little nausea in the evening and was dizzy.  On 23Jan2021 she felt a little weak but felt better and her appetite was better.   At the time of reporting the outcome of the events was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Consumer.  A 91-year-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249, Expiry Date 31May2021 ), at single dose into the left arm on 20Jan2021 at 11:30 am for COVID-19 immunization. Medical history included problem with gallbladder in the last 4 months. Concomitant drugs were none.  The patient had never problem with flu and shingles shot.  On 20Jan2021, the day of vaccination the patient felt fine and told everyone it was a breeze. On 21Jan2021 morning she was getting ready to go to the store at 1130am, it was about 24 hours after getting the shot, and she felt dizzy, achy, her eyes ached and were weak, she felt feverish but had no fever and was a bit nauseated. The patient  also reported loss appetite the same day. On 22Jan2021 around 11am she felt a little better. She checked her temperature and blood pressure normal. She has had a little nausea in the evening and was dizzy.  On 23Jan2021 she felt a little weak but felt better and her appetite was better.   At the time of reporting the outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: On the two people who died, one in (State name) and one in (State name); This is a spontaneous report from a contactable other HCP. This other HCP reported similar events for 2 patients. This is 1 of 2 report.   An unknown age male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecific date at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient was died. Cause of death unknown. Outcome of the event was fatal.  Information on the lot/batch number has been requested.; Sender's Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose.  Information is very limited.  Case will be reassessed once receiving additional information, including cause of death. 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.,Linked Report(s) : US-PFIZER INC-2021102049 same reporter/drug/event, different patient; Reported Cause(s) of Death: On the two people who died, one in (State name) and one in (State name)
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient died; This is a spontaneous report from a contactable Other Healthcare Professional (HCP). This Other HCP reported similar event for 2 patients. This is 2nd of 2 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient died on an unspecified date. Cause of death unknown. Outcome of the event was fatal. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.,Linked Report(s) : US-PFIZER INC-2021102020 same reporter/drug/event, different patient; Reported Cause(s) of Death: patient died
Sex: U
Vaccine: COVID19
Symptoms: Excessive cerumen production, Headache, Hypersomnia, Hypoacusis, Pain in extremity
Clinical narrative: for a couple minutes it was like oh my gosh can't think; Wax in ear; pain in arm; pain in head/ head it just felt like a bowling ball, It's still heavy; slept for 12hours, didn't usually sleep that much; I am having trouble because I got wax in my ears, I am having trouble hearing you; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. The patient had some wax in ears anyways. The patient got the pain in arm and pain in head. when patient was done and got home, head it just felt like a bowling ball, It's still heavy. Patient 's received a call with questions. And for a couple minutes it was like patient can't think. But that's okay now, the only think was the patient slept for 12hours, didn't usually sleep that much. The patient stated, "I am having trouble because I got wax in my ears, I am having trouble hearing you but I'll do my best." Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: for a couple minutes it was like oh my gosh can't think; Wax in ear; pain in arm; pain in head/ head it just felt like a bowling ball, It's still heavy; slept for 12hours, didn't usually sleep that much; I am having trouble because I got wax in my ears, I am having trouble hearing you; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose (Lot # EL8982) for covid-19 immunisation. The patient had some wax in ears anyways. The patient got the pain in arm and pain in head. when patient was done and got home, head it just felt like a bowling ball, It's still heavy. Patient 's received a call with questions. And for a couple minutes it was like patient can't think. But that's okay now, the only think was the patient slept for 12hours, didn't usually sleep that much. The patient stated, "I am having trouble because I got wax in my ears, I am having trouble hearing you but I'll do my best." Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination, SARS-CoV-2 test positive
Clinical narrative: Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 28Dec2020 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got pfizer dose and then they tested positive; dues for second dose but don't get it because they are positive on 11Jan2021. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2  on 28Dec2020, and was diagnosed with COVID-19 on11Jan2021.  No complete effect could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  The positive COVID-19 is more likely pre-existing/intercurrent condition, and unrelated to BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown. It was reported that the patient had a Bell's palsy a week afterwards and he/she ended up in hospital for a couple of days (unspecified). The patient asked if he/she should take the second dosage because today was the day that she was supposed to get the second one.  Information on lot number/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Nipple pain, Sensory disturbance, Temperature intolerance
Clinical narrative: nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; This is a spontaneous report from a contactable consumer. A 33-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL9261), via an unspecified route of administration in right arm 20Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation . The patient's medical history was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid-19 prior to vaccination, not been tested for COVID-19 prior to vaccination. Concomitant medications were not reported. She had her first dose of bnt162b2 (lot EJ1686) on 30Dec2020 via unknown route in the right arm. The patient's concomitant medications were not reported. She reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine (Dec2020) but it has gotten more noticeable since the second vaccine.  She has also reported that her nipples are more sensitive/tender since vaccination (20Jan2021). No treatment was given to the events. The outcome of events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient).  This 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 19Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Jan2021, the patient developed an anaphylactic reaction. She went to the doctor and he was reluctant to give her steroids which was the normal way of treating the anaphylactic reactions because he said that the steroid would interfere with the effect of the vaccine. So, he gave her diphenhydramine hydrochloride (BENADRYL). She had to go back to the emergency room later that day and they used epinephrine (EPIPEN) and she had to have an intravenous (IV) and other than that some medications, it had prednisolone in it. Then she had to go back yesterday and she had another IV and they sent her home with an EPIPEN. The event was assessed serious as medically significant. The patient had recovered from the event in Jan2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Off label use, Product use issue
Clinical narrative: The patient's concomitant medication included adalimumab (HUMIRA); The patient's concomitant medication included adalimumab (HUMIRA); 24hr headache occurred after each vaccine dose; This is a spontaneous report from a contactable nurse (patient).  A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH1284), intramuscular at deltoid right on 07Jan2021 at 10:30 at single dose for COVID-19 immunization. The patient medical history included mild coronary artery disease (CAD), allergy to sulfa and seasonal allergy, all from an unknown date and unknown if ongoing. The patient's concomitant medication included finasteride at 1 mg, clonazepam at 0.5 mg, cetirizine hydrochloride (ZYRTEC) at 10 mg, aspirin at 81 mg, fremanezumab (AJOVY) at 125 g monthly and adalimumab (HUMIRA) twice weekly. The patient previously received MMR/Flu vaccine for immunization and experienced brachial plexus neuritis (parsonage Turner syndrome). The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at deltoid right on 17Dec2020 at 10:30 at single dose for COVID-19 immunization and experienced tachycardia, elevated blood pressure (BP), headache and flushing face turned into red. In Jan2021, the patient experienced 24 hours headache. The patient outcome of the event was recovered.
Sex: U
Vaccine: FLUX
Symptoms: Apnoea
Clinical narrative: stopped breathing; Initial information received on 27-Jan-2021 regarding an unsolicited valid serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced stopped breathing (apnoea), while he/she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious stopped breathing (apnoea) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was also reported that havent had one since 1978 and cant have one. Almost died stopped breathing.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had apnoea, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 year old patient  received Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00436824) and transmitted to company on 19-Jan-2021.  This case involves a five-year-old male patient who received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Muscle tightness, Throat tightness
Clinical narrative: Dizziness, tightness in back of neck, tightness both sides of throat, tightness in TMJ both sides immediately and over the next 30-40 minutes.  Pink donut shaped 3 inch diameter patch at injection site the next day.  Immediate reactions resolved within the 40 minute period.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Patient woke up Saturday, 6 Feb, with multiple small raised welts on left shoulder around injection site.  Site was itchy.  Over the course of the day, site enlarged slightly with a little warmth, but nontender.  That day, took a dose of Benadryl and applied topical Hydrocortisone.  On Sunday, 7 Feb, area began to improve and applied more Hydrocortisone and took additional Benadryl .  Pt stopped her Allegra these 2 days as she was not sure if could take all meds together.  On Monday, 8 Feb, patient walked into our Allergy/Immunizations clinic (protocol for anyone who receives an injection and has concerns about a reaction) at our facility and I examined the area with very faint residual erythema, but nonpalpable and nontender.  No further itching by Sunday night.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Feeling hot
Clinical narrative: Redness and heat on R foot, left after 15 minutes. Upset bowel system.  Have always had opposite problem.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Swelling
Clinical narrative: Swelling and soreness day 1-3, red itchy rash day 3 at injection site-about 2? in diameter
Age: 0.58
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No further information provided./No other AE.; The customer administered GARDASIL 9 to a 7 month old patient on 1/6/2021; The nurse inadvertantly brought the wrong vaccine; Product dispensing error; This spontaneous report has been received from a registered nurse, concerning a 7 month old female patient. None pre-existing physician diagnosed allergies, birth defects, or medical conditions were reported. None concomitant medications were reported.   On 06-JAN-2021, the nurse inadvertently brought the wrong vaccine, for a dispensing error into the patient's room and administered it to the patient. It was reported that the patient was waiting for long than usual , therefore she was trying to be quick and pulled the vaccine. The patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T008101, expiration date of 01-MAY-2022 (reported as 01-MAY-2021), intramuscular (IM), in her thigh for prophylaxis. (inappropriate age, wrong product administered, product dispensing error). The nurse realized the error when she returned to the nurse's lab. The patient was asked to stay for observation, and this situation was reported immediately to the doctor, the company and the poison and infectious disease center. No adverse effects were observed or reported later.    None illness at the time of vaccination were reported. The patient was vaccinated at the private doctor's office/hospital with private funds. No temperature excursion occurred as a result of a reading from a Digital Data Logger.  It has been determined that case # US-009507513-2101USA003619, is a duplicate of case #US-009507513-2101USA004510. Therefore, case # US-009507513-2101USA004510 is being deleted from our files and the case are consolidated into case # US-009507513-2101USA003619. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008101; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered GARDASIL 9 to a 15 month old patient; No other AE; Information has been received from a registered nurse via a field representative referring to a 15 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history or drug reactions/allergies were not provided.     On an unknown date, the patient was inadvertently administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route, lot #, expiration date and anatomical location were not provided)(product administered to patient of inappropriate age). There were no other adverse event (AE) or product quality complaints (PQC). The outcome of the events was unknown. The causality assessment was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE details; Expired vaccine used; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 11-JAN-2021 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S030587, expiration date was 06-JAN-2021, route and strength were not reported) 0.5 milliliter for prophylaxis (expired vaccine used). No additional adverse event details was reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received his first two doses of GARDASIL 9 in 2019 as scheduled, but never came back for the third dose. He is inquiring about receiving the third dose now; No additional AE/PQC; This spontaneous report as received from a pharmacist regarding a 45-year-old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported.   On unknown dates in 2019, the patient was vaccinated with the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, batch/lot# and expiration date were not reported) for prophylaxis as scheduled, but the patient never came back for the third dose (inappropriate schedule of product administration). The patient was inquiring about receiving the third dose now. No additional adverse event reported (no adverse event).
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug hypersensitivity, Lip swelling, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: patchy red rash all over; patchy red rash all over; hands/feet were swollen; lips were swollen; she was allergic to in the vaccine; This spontaneous report was received from a currently 23-year-old female nurse, concerning herself. The patient stated that she was allergic to a lot of different antibiotics. Information regarding the patient's medical history, historical drug and concomitant therapies were not provided.  On 08-APR-2009 (when the patient was 11 years old), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis.  On 09-APR-2009, the patient experienced a severe reaction to the vaccine; she had symptoms of patchy red rash all over, hands and feet were swollen and lips were swollen. She spoke with her pediatrician and they were never able to determined what she was allergic to in the vaccine. She stated that she reviewed the ingredients in the varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine and believed that it could have been the neomycin content since she is "allergic to a lot of different antibiotics" (reported above)  The outcome of the patchy red rash all over, hands and feet swollen and lips swollen was not reported. No causal relationship was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Antibiotic prophylaxis, Pathological fracture prophylaxis, Product storage error
Clinical narrative: Medical assistant calling to check stability o fPEDVAXHIB and rotateq.; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified age and gender. Information regarding the patients' concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # S030965 and expiration date 03-APR-2022; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1688824 and expiration date 07-NOV-2021, both administered as prophylaxis.  The improperly stored doses of the suspect vaccines experienced the following  temperature excursions: of 54.5 degree Fahrenheit (°F) for 11 hours and 30 minutes and 34.9 °F for 30 minutes: previous temperature temperature excursions were reported for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) first 50.9°F for 2 hours 30 minutes, and 35.6°F for 1 hour.  The call was made due to a digital data logger.   This case was classified as non-valid due to no patients identifiers.
Sex: U
Vaccine: RV5
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report has been received from a consumer concerning  a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 11-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml,  Lot # 1691141, expiration date 01-NOV-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 1.3 °C for 19 minutes.           There was digital data logger involved, no previous temperature excursion was reported and no other information was available.
Sex: U
Vaccine: RV5
Symptoms: Antibiotic prophylaxis, Product storage error
Clinical narrative: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date reported as 16-FEB-2022 but upon internal validation established as 06-JAN-2022, at a dose of 2 milliliter, orally for prophylaxis.  The vaccine was stored in a temperature of 1.3 degree Celsius  for 19 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: a baseball size lump that had developed at injection site; is very red and painful; is very red and painful; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 20-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). The reporter stated that the patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) around noon at the doctors office and within 30 minutes noticed a penny size lump at the injection site. The patient drove from a medical center to the reporter's pharmacy to pick up a prescription and showed the reporter a baseball size lump that had developed at the injection site (injection site mass). The reporter stated that it appeared to be growing in size, it was very red (injection site erythema) and painful (injection site pain), and almost resembled a "tick bite". The outcome of injection site mass, injection site pain and injection site erythema was unknown.      The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and injection site mass, injection site pain and injection site erythema was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Antiviral prophylaxis, No adverse event, Product storage error
Clinical narrative: No other AE; a patient received VARIVAX after the product was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T010309, expiration date 24-MAR-2022, for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The patient did not experience any other adverse event.   The vaccine was stored in a temperature of -12.8 degree Celsius for 9 hours and 6 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691141, expiration date 01-NOV-2021, at a dose of 2 milliliter, oral for prophylaxis.        The vaccine was stored in a temperature of 1.3 degree Celsius for 19 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Sex: F
Vaccine: MMR
Symptoms: Antiviral prophylaxis, No adverse event, Product preparation error
Clinical narrative: no reaction; Will wait 4 weeks and this vaccine wil be readministered correctly; HCP stated the manufacturer of the sterile water is hospira.MMR II was reconstituted with non-merck sterile water and administered to a patient; This spontaneous report has been received from a nurse, initially reported as a medical assistant,  concerning a 6 years-old female patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 11-JAN-2021,  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage regimen, anatomical location, Lot # and expiration date were not reported). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  was reconstituted with a non-Merck sterile water instead of the Merck specific sterile diluent. The nurse reported the manufacturer.  The reporter informed that no reactions had occurred and the patient was fine. They will wait 4 weeks and the vaccine will be readministered correctly. The family was aware of this. Additionally, it was reported that the vaccine was not available for return since it was administered to the patient and no further information was provided.
Sex: U
Vaccine: RV5
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administration of ROTATEQ after temperature excursion; This spontaneous report has been received from an unspecified reporter(non healthecare professional) concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 14-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml,  Lot # 1742457, expiration date reported as 16-FEB-2022 but upon internal validation established as 06-JAN-2022 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 1.3 °C for 19 minutes.           There was digital data logger involved, no previous temperature excursion was reported and no other information was available
Sex: F
Vaccine: MMR
Symptoms: Antiviral prophylaxis, Illness, Immunisation, Pyrexia, Vaccination complication
Clinical narrative: fever; illness; the doctor even divided the dose into 2 parts to help manage the reaction; Adverse reaction to MMR; there was also some problem with the lot number; This spontaneous report was received from a other health professional regarding to herself;  a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's  concomitant therapies and historical drugs was not provided.   On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced adverse reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II)  (vaccination complication), fever (pyrexia) and  illness. There was also some problem with the lot number and she had to be vaccinated again on an unknown date. At that time, the doctor divided the dose in two parts to help manage the reaction.  The outcome of pyrexia, vaccination complication and illness was unknown.     The reporter considered vaccination complication to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) while the causality between fever and illness with the suspect vaccine was not provided.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2101USA010753:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD was administered after temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 07-DEC-2020, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 ml, subcutaneously,  Lot # T013542, expiration date 17-0CT-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 32.4 °Fahrenheit (F) for 4 hours.      There was digital data logger involved and no previous temperature excursion was reported.  This is one of multiple  reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported.; temperature excursion for the GARDASIL 9; This spontaneous report has been received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 17-DEC-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1602284 has been verified to be a valid lot number, expiration date was 26-SEP-2021) via unknown route for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was involved in temperature excursion (product storage error). The vaccine was stored at the temperature of 31.2 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. The digital data logger was involved. No product to retrieve. No other adverse event (AE) reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported.; temperature excursion for GARDASIL 9; This spontaneous report has been received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 11-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1602284 has been verified to be a valid lot number, expiration date was 26-SEP-2021) via unknown route for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was involved in temperature excursion (product storage error). The vaccine was stored at the temperature of 31.2 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. The digital data logger was involved. No product to retrieve. No other adverse event (AE) reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HEP
Symptoms: Antiviral prophylaxis, Influenza, Lethargy, Pain, Pyrexia
Clinical narrative: fever; flu symptoms; achy; lethargic; She had an adverse reaction to Hep B vaccine; This spontaneous report was received from a other health professional regarding to herself;  a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's  concomitant therapies and historical drugs was not provided.   On an unknown date the patient was vaccinated with On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced adverse reaction to  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (vaccination complication), fever (pyrexia) influenza like illness, was achy (pain) and lethargy.  The outcome of pyrexia, vaccination complication, lethargy, pain and influenza like illness was unknown.      The reporter considered vaccination complication to be related Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) while the causality between fever, influenza like  illness, pain and lethargy  with the suspect vaccine was not provided.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2101USA009976:
Sex: F
Vaccine: HEP
Symptoms: Vaccination complication
Clinical narrative: fever; flu symptoms; achy; lethargic; She had an adverse reaction to Hep B vaccine; This spontaneous report was received from a other health professional regarding to herself;  a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's  concomitant therapies and historical drugs was not provided.   On an unknown date the patient was vaccinated with On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).         On an unknown date the patient experienced adverse reaction to  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (vaccination complication), fever (pyrexia) influenza like illness, was achy (pain) and lethargy.  The outcome of pyrexia, vaccination complication, lethargy, pain and influenza like illness was unknown.      The reporter considered vaccination complication to be related Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) while the causality between fever, influenza like  illness, pain and lethargy  with the suspect vaccine was not provided.   This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2101USA009976: