chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports that on the evening of 9/15/2023, a few hours after she received her vaccination she began to feel chills and developed a fever. The following morning she noticed that her arm was red around the injection site, and noticeably swollen. The patient came back into the pharmacy with the area of her left upper arm swollen, but not near the deltoid muscle where the shot was administered. She stated that it causes discomfort to touch the swollen area and periodically itches. Patient has been using ibuprofen and was recommended use an OTC allergy medication as well as alternating heat and cold to reduce the swelling. Patient was also instructed to follow up with her medical provider if the swelling worsens or does not improve over the next few days.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia, Sialoadenitis, Swelling face
Clinical narrative: Myalgias, fever, swelling of left cheek, Sialoadenitis
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: 6yo male patient here with mother and brother to check reaction to influenza vaccination. Patient received influenza vaccine on 9/18/23 in the left deltoid and now has a 17cm wide inflammatory reaction at the site. Patient is afebrile and has a little itching at site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT REQUESTED FLUZONE HD AS SHE WAS ABOUT TO TURN 65. TECHNICALLY A VACCINE ERROR AS SHE WAS 64 AT THE TIME OF VACCINATION. NO SIDE EFFECTS OR ISSUES ARE KNOWN.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Cough, congestion, headache
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: no adverse event; Interchange of vaccine products; This spontaneous report was received from a nurse referred to a 52-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient had already received 2 previous doses of A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX). On 06-FEB-2023, the patient was vaccinated with the first dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) as prophylaxis. On 12-MAR-2023, the patient was vaccinated with the second dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) as prophylaxis. On 17-AUG-2023, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 milliliter, lot #W036194, expiration date: 29-SEP-2025, as prophylaxis (strength, and route of administration were not provided), which was used to complete a Hepatitis B series as the third dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) (Interchange of vaccine products). No further adverse event (no adverse event) was reported.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored vaccine administered; This spontaneous report was received from a medical assistant concerning a 5-year-old female patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.   On 02-AUG-2023, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# X006983, reported as x006983, which was captured as batch# upon internal validation, expiry date: 07-MAR-2025) was stored at -12.48 degree Celsius (C) for 1 hour 30 minutes and 0 seconds. There was no previous temperature excursion. On the same day, after temperature excursion, the patient was vaccinated with second dose of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0.5 mL subcutaneously via left thigh as prophylaxis (product storage error). There were no symptoms reported. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-AUG-2023, the patient was vaccinated with an improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot # w029724 has been verified to be a valid lot number hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and established as 08-JAN-2025) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage, time frame of the excursion, if a digital data logger was involved and if the vaccine experienced a previous temperature excursion were not reported.   No adverse event reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; Pharmacist reported that an adult patient received MMR II on 8/27/2023, and then two weeks later received VARIVAX on 9/10/2023. Whenever patient filled out vaccine paperwork, she selected no that she has not received any vaccines lately. However, aft; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 27-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 10-SEP-2023 (also reported as two weeks later), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W011622, expiration date was reported and validated as 06-APR-2024) as prophylaxis (inappropriate schedule of product administration). It was reported that whenever the patient filled out vaccine paperwork, she selected no, that she had not received any vaccines lately. However, after the fact pharmacist reviewing records and noticed patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) two weeks before. No additional adverse event reported.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Cold sweat, Heart rate, Hypertension, Mydriasis
Clinical narrative: HIGH BLOOD PRESSURE; CLAMMINESS; DILATED PUPILS; DELAYED RESPONSES TO STIMULATION; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. Non-company suspect drugs included: nirmatrelvir/ritonavir (oral, batch number: GK8531 expiry: UNKNOWN, form of admin was not reported) dose and frequency were not reported from 12-SEP-2023 to 13-SEP-2023 for covid-19 treatment. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride.  On 2023, the patient experienced suspected covid-19 infection. On 12-SEP-2023, the patient experienced high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation. Laboratory data included: Blood pressure High, and Heart rate High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Slow response to stimuli, Suspected COVID-19
Clinical narrative: HIGH BLOOD PRESSURE; CLAMMINESS; DILATED PUPILS; DELAYED RESPONSES TO STIMULATION; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 31-AUG-2021 for covid-19 prophylaxis. Non-company suspect drugs included: nirmatrelvir/ritonavir (oral, batch number: GK8531 expiry: UNKNOWN, form of admin was not reported) dose and frequency were not reported from 12-SEP-2023 to 13-SEP-2023 for covid-19 treatment. Concomitant medications included dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride.  On 2023, the patient experienced suspected covid-19 infection. On 12-SEP-2023, the patient experienced high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation. Laboratory data included: Blood pressure High, and Heart rate High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from high blood pressure, clamminess, dilated pupils, and delayed responses to stimulation, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Pharmacist called to ask for medical information on GARDASIL 9. Pregnant women inadvertently received GARDASIL 9. Pharmacist stated that a pregnant patient received GARDASIL 9 on an unknown date. Pharmacist stated they don't know what dose patient r; No additional AE reported; This prospective spontaneous report has been received from a pharmacist, regarding a pregnant female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unreported date, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) (Exposure during pregnancy).  Pharmacist stated they don't know what dose patient received or what trimester of pregnancy was the patient on. No information regarding last menstrual period or date of conception was reported. By the time of the report pregnancy outcome and fetal outcome was pending and unknown.    No additional adverse event was reported.
Sex: U
Vaccine: UNK
Symptoms: Condition aggravated, Leukaemia recurrent, White blood cell count increased
Clinical narrative: two weeks after the second shot my leukemia came back with a vengeance; two weeks after the second shot my leukemia came back with a vengeance; This spontaneous case was reported by a patient and describes the occurrence of LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) (seriousness criterion medically significant) and CONDITION AGGRAVATED (two weeks after the second shot my leukemia came back with a vengeance). The patient was treated with BOSUTINIB (BOSULIF) at an unspecified dose and frequency. At the time of the report, LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) and CONDITION AGGRAVATED (two weeks after the second shot my leukemia came back with a vengeance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: White cell count went from 6,000 to 30,000 in two weeks..         No relevant concomitant medications were reported. When patient was put on the Bosulif and took care of it, but patient went from a maintenance dose from 1 pill a day to 3 with the new drug cause that covid, it was the Moderna not the Pfizer vaccine.  Company comment:  This spontaneous case concerns a patient (unknown age and gender), with medical history of leukaemia, who experienced the unexpected, serious (medically significant) event of Leukaemia. Condition aggravated was also considered. The event occurred approximately 2 weeks after a dose of mRNA  1273 original vaccine; no information about previous immunisation schedule was provided. The report stated that after the second shot patient´s leukemia "came back with a vengeance" which required treatment with Bosutinib and patient´s maintenance dose changed "from 1 pill a day to 3". Patient´s white cell count went from 6,000 to 30,000 in two weeks. No further clinical details were provided for medical reviewing. Patient´s medical history remains as risk factor for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; site where she got vaccine is red; painful on the inside of her arm; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 49-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 11Aug2023 as dose number unknown, 0.5ml single (Lot number: GN1898, Expiration Date: 30Sep2024) at the age of 49 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Diabetes", start date: Jun2022 (unspecified if ongoing); "Hypothyroidism", start date: Jun2022 (unspecified if ongoing); "hypertensive disorder", start date: 11Aug2023 (unspecified if ongoing); "Anemic", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: TDAP intramuscular taken for immunisation, on 11Aug2023 as dose number unknown, 0.5ml single. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection site reaction of pain, swelling and itching"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "site where she got vaccine is red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful on the inside of her arm". The events "injection site reaction of pain, swelling and itching", "site where she got vaccine is red" and "painful on the inside of her arm" required physician office visit.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; site where she got vaccine is red; painful on the inside of her arm; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 49-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 11Aug2023 as dose number unknown, 0.5ml single (Lot number: GN1898, Expiration Date: 30Sep2024) at the age of 49 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Diabetes", start date: Jun2022 (unspecified if ongoing); "Hypothyroidism", start date: Jun2022 (unspecified if ongoing); "hypertensive disorder", start date: 11Aug2023 (unspecified if ongoing); "Anemic", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: TDAP intramuscular taken for immunisation, on 11Aug2023 as dose number unknown, 0.5ml single. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection site reaction of pain, swelling and itching"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "site where she got vaccine is red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful on the inside of her arm". The events "injection site reaction of pain, swelling and itching", "site where she got vaccine is red" and "painful on the inside of her arm" required physician office visit.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: nausea; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs"; Bnt162b2 (Dose 2, single), for COVID-19 immunization, reaction(s): "Chills", "nausea", "Fever"; Bnt162b5;bnt162b5 omi ba.4-5 (Dose 3, single), for COVID-19 immunization, reaction(s): "Chills", "nausea", "Fever". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Patient, almost 72 years of age, has had 5 previous shots of the Pfizer COVID vaccines. She was calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The subsequent doses it was always the nausea and the chills and things like that, fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300612 Same reporter, patient, product, events different dose;US-PFIZER INC-202300300609 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300299983 same patient/vaccine, different vaccine dose/event;
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: got Covid 1st time in Sep2021; got Covid 1st time in Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 82-year-old male patient received bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "got Covid 1st time in Sep2021". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 125/80, notes: blood pressure is in normal bounds, it was 125/80; SARS-CoV-2 test: Negative, notes: Negative now on Covid.  Clinical information: 84 years old great health. Over the last 3-4 years he had Covid 3 times. He has always had the Pfizer vaccine for Covid and has stayed up to date on the vaccines. 10-12 days ago, he had the third round of Covid. In the second round, he was advised to wait some period, either 2 months or 6 months, after ending the Covid to get the booster shot due to his body building an immune response. He is negative now on Covid. He was told he can take the new vaccine now instead of waiting. Why can he take it next week instead of waiting a certain period since his body has built immunity. There was no information stating there is a certain amount of time that must be observed after infection before a patient can get the vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300301887 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301888 same patient/drug/AE, different dose number/event onset date;
Sex: U
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE VESICLES (non-serious), outcome "unknown" and all described as "Patient had a reaction at the site of injection: swelling, redness and blistering.". Additional information: Reporter is asking if these are significant side effects.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site vesicles
Clinical narrative: Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE VESICLES (non-serious), outcome "unknown" and all described as "Patient had a reaction at the site of injection: swelling, redness and blistering.". Additional information: Reporter is asking if these are significant side effects.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was diagnosed with covid on the 3rd of this month; she was diagnosed with covid on the 3rd of this month; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Sep2023, outcome "not recovered" and all described as "she was diagnosed with covid on the 3rd of this month". Clinical course: Patient was diagnosed with covid on the 3rd of this month (03Sep2023). She said she tested positive again on Tuesday (12Sep2023) and still had symptoms. She wanted to know if she still can receive the new Pfizer covid 19 vaccine. She stated that she had never had a negative reaction to any previous covid 19 vaccines. She was a 73-year-old person and also had received the flu shot. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Sep2023) Positive; (12Sep2023) Positive.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Eye irritation, Headache, Injection site pain, Myalgia, Tinnitus
Clinical narrative: my ear buzzed; my vision was burning; injection site hurts; My head started to hurt; all my muscles are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "My head started to hurt"; MYALGIA (non-serious) with onset Sep2023, outcome "not recovered", described as "all my muscles are hurting"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "injection site hurts"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "my ear buzzed"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "my vision was burning".  Additional information: The patient was vaccinated with Prevnar 20 on 01Sep2023. His head started to hurt, ear buzzed, vision was burning. The doctor told the patient to go to the medical emergency section. To date, 14 days later, the patient still had the buzzing sound in his ear, burning of the eyes, all his muscles are hurting and the injection site hurts. The patient had no medical information questions beyond how to treat the symptoms he was experiencing. Patient believed that Pfizer had ruined his life with this vaccine. He was only going to treat one ailment and went out with more of them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: my ear buzzed; my vision was burning; injection site hurts; My head started to hurt; all my muscles are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "My head started to hurt"; MYALGIA (non-serious) with onset Sep2023, outcome "not recovered", described as "all my muscles are hurting"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "injection site hurts"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "my ear buzzed"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "my vision was burning".  Additional information: The patient was vaccinated with Prevnar 20 on 01Sep2023. His head started to hurt, ear buzzed, vision was burning. The doctor told the patient to go to the medical emergency section. To date, 14 days later, the patient still had the buzzing sound in his ear, burning of the eyes, all his muscles are hurting and the injection site hurts. The patient had no medical information questions beyond how to treat the symptoms he was experiencing. Patient believed that Pfizer had ruined his life with this vaccine. He was only going to treat one ailment and went out with more of them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 at 13:00 as dose 4 (booster), single at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral, start date: 29May2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabeties - MODY-2" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Drug ineffective, SARS-CoV-1 test, Suspected COVID-19
Clinical narrative: 2nd time in Aug2022; 2nd time in Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-year-old male patient received bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19", start date: Sep2021, stop date: Sep2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "2nd time in Aug2022". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 125/80, notes: blood pressure is in normal bounds, it was 125/80; SARS-CoV-1 test: Negative, notes: Negative now on Covid.  Clinical course: 84 years old great health. Over the last 3-4 years he had Covid 3 times. He has always had the Pfizer vaccine for Covid and has stayed up to date on the vaccines. 10-12 days ago, he had the third round of Covid. In the second round, he was advised to wait some period, either 2 months or 6 months, after ending the Covid to get the booster shot due to his body building an immune response. He is negative now on Covid. He was told he can take the new vaccine now instead of waiting. Why can he take it next week instead of waiting a certain period since his body has built an immunity. There was no information stating there is a certain amount of time that must be observed after infection before a patient can get the vaccine. He got Covid 1st time in Sep2021, 2nd time in Aug2022, 3rd time last week Sep2023. Every 12 months has had Covid. Already consulted his doctor son. The patient original question was about conflicted information now with next round of Covid vaccine will be available as early as next week. His conflict is he could get it next week. That does not sound right.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300966 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301888 same patient/drug/AE, different dose number/event onset date;
Sex: M
Vaccine: RSV
Symptoms: Injection site pruritus
Clinical narrative: Itching at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Drug allergy: neomycin". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset Sep2023, outcome "unknown", described as "Itching at the site of injection".  Additional information: Itching at the site of injection started on Thursday. The patient is allergic to neomycin but was told not in the shot.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Stent placement, Weight increased
Clinical narrative: Patient said she had to have a stent, unable to lose weigh, gained weight, hospitalized.; Patient said she had to have a stent, unable to lose weigh, gained weight, hospitalized.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (unknown if pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, single, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: STENT PLACEMENT (hospitalization), WEIGHT INCREASED (hospitalization), outcome "unknown" and all described as "Patient said she had to have a stent, unable to lose weigh, gained weight, hospitalized.". It was unknown if therapeutic measures were taken as a result of weight increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 01Sep2023 to 05Sep2023 as COVID 19 Treatment. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302452 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "OI" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy:Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 06Sep2023 to 11Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302455 Same reporter/patient, different drug, different AE;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Feb2021 at 09:30 as dose 1, single (Lot number: EM9810), in left arm, on 03Mar2021 at 12:45 as dose 2, single (Lot number: EN6199), in left arm, on 23Nov2021 at 09:30 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 27Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrosis" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis; "HTN" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis; "Dyslipidemia" (unspecified if ongoing), notes: Other medical history: HTN, Dyslipidemia, pulmonary fibrosis. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: Jun2017; SIMVASTATIN, start date: Jun1997, stop date: 03Sep2023; LISINOPRIL, start date: 28Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other vaccine and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 03Sep2023 to 08Sep2023
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Sep2023 to 09Sep2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302352 Same patient, different drug and event;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Lot number: EN6204), in left arm, on 09Apr2021 at 14:00 as dose 2, single (Lot number: ET8729), in left arm and on 29Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FE3592), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "CAD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 31Aug2023 to 05Sep2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5  in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 04Sep2023 to 08Sep2023.  No follow-up attempts are possible. No further information is expected.