chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Acne, Erythema, Pruritus, Skin exfoliation, Urticaria
Clinical narrative: skin itching; skin hive; Red big pimple over my body; Skin peeled; Red big pimple over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: ACNE (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Red big pimple over my body"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "not recovered", described as "Skin peeled"; URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "skin hive"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "skin itching". The events "skin itching", "skin hive", "red big pimple over my body" and "skin peeled" required physician office visit. Therapeutic measures were taken as a result of pruritus, urticaria, acne, skin exfoliation, erythema.  Additional info: Reporter stated, I visited many doctors and they gave me many kind of drags none of them works and get worst now, also one of the problem I am having it's those doctors can't prove if it's because vaccine shot or not.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Lethargy
Clinical narrative: Chills; Fever; Body aches particularly in my back and hips; Body aches particularly in my back and hips; Headache; Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: METOPROLOL SUCCINATE; ESCITALOPRAM; ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 23Mar2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6203), administration date: 01Mar2021, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 21Apr2022, outcome "recovered" (2022) and all described as "Body aches particularly in my back and hips"; CHILLS (non-serious) with onset 21Apr2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 21Apr2022, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 21Apr2022, outcome "recovered" (2022); LETHARGY (non-serious) with onset 21Apr2022, outcome "recovered" (2022). Therapeutic measures were not taken as a result of chills, pyrexia, arthralgia, back pain, headache, lethargy.  Additional information: The patient did not receive any other vaccine with in 4 weeks of covid-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Body aches particularly in my back and hips; Body aches particularly in my back and hips; Headache; Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: METOPROLOL SUCCINATE; ESCITALOPRAM; ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6203), administration date: 23Mar2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6203), administration date: 01Mar2021, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 21Apr2022, outcome "recovered" (2022) and all described as "Body aches particularly in my back and hips"; CHILLS (non-serious) with onset 21Apr2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 21Apr2022, outcome "recovered" (2022), described as "Fever"; HEADACHE (non-serious) with onset 21Apr2022, outcome "recovered" (2022); LETHARGY (non-serious) with onset 21Apr2022, outcome "recovered" (2022). Therapeutic measures were not taken as a result of chills, pyrexia, arthralgia, back pain, headache, lethargy.  Additional information: The patient did not receive any other vaccine with in 4 weeks of covid-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Biopsy, Psoriasis, Rash erythematous
Clinical narrative: after getting the covid booster shot (4 days after getting the flu shot) I broke out in a red rash all over my body.; I have psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unkown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series , Manufacture unknown), for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "after getting the covid booster shot (4 days after getting the flu shot) I broke out in a red rash all over my body."; PSORIASIS (non-serious), outcome "unknown", described as "I have psoriasis". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that immediately after getting the covid booster shot (4 days after getting the flu shot) patient broke out in a red rash all over patient body. The treatment the doctor was prescribing was very expensive. was there any financial help available to cover this. The doctor did a biopsy and determined patient had psoriasis. There was no history of this in patient family and had no health issues until patient got the booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had Covid confirmed with a PCR test in late Dec2021; I had Covid confirmed with a PCR test in late Dec21; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "I had Covid confirmed with a PCR test in late Dec2021"; COVID-19 (medically significant) with onset Dec2021, outcome "unknown", described as "I had Covid confirmed with a PCR test in late Dec21". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: 'tested positive on 12Apr'; (21Apr2022) Negative, notes: '21Apr tested negative with a nasal rapid test'; (Dec2021) Positive, notes: 'I had Covid confirmed with a test in late Dec2021'; (25Apr2022) Positive, notes: 'tested positive on 25Apr with PCR'; (26Apr2022) Positive, notes: 'tested positive on 25Apr with PCR and again on 26Apr with rapid antigen test'; (18Apr2022) Negative, notes: 'On 18Apr I tested negative with salivary PCR'. Therapeutic measures were taken as a result of covid-19.   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-202200633295 Same patient diiferent drug
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent); program ID:. A child female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the  COVID-19 vaccine (primary immunization series completed; manufacturer unknown), for immunization. The patient experienced urticaria/reporter's daughter took Pfizer booster shot and ended up with hives, lip swelling and face swelling, with outcome of not recovered. The events required a physician office visit. Therapeutic measures were taken as a result of urticaria, lip swelling and face swelling. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I first tested positive on 16Apr2022; I first tested positive on 16Apr2022; This was a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter was the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing), notes: somewhat high cholesterol treated with simvastatin. The patient had no known allergies. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "I first tested positive on 16Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: I started Paxlovid the same day I first tested positive (on 16Apr2022); (23Apr2022) Negative; (24Apr2022) Positive, notes: tested again using two different brand test kits and both came back very quickly and brightly positive. That was on 24Apr2022; (24Apr2022) Positive, notes: tested again using two different brand test kits and both came back very quickly and brightly positive. That was on 24Apr2022. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; still cough and congestion; still cough and congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL; ESTRADIOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROGESTERONE; HYDROCHLOROTHIAZIDE; VITAMIN D [VITAMIN D NOS]; VITAMIN B COMPLEX; VITAMIN C [ASCORBIC ACID]; FISH OIL; ALBUTEROL [SALBUTAMOL]. Past drug history included: Codeine, reaction(s): "Known allergies"; Ibuprofen, reaction(s): "Known allergies"; Naproxen, reaction(s): "Known allergies"; Quinolone antibiotics, reaction(s): "Known allergies". The following information was reported: COUGH (medically significant), NASAL CONGESTION (non-serious) all with onset 20Apr2022, outcome "not recovered" and all described as "still cough and congestion"; VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" (27Apr2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative; (21Apr2022) Positive; (27Apr2022) Negative. Therapeutic measures were taken as a result of covid-19, cough, nasal congestion.  Clinical course: Finished course 16Apr2022; well by 17Apr2022; tested negative 18Apr2022; all symptoms returned 20Apr2022; tested positive 21Apr2022; sick until 26Apr2022 then felt better (still cough and congestion but no fever); tested negative again 27Apr2022. Events were treated with Albuterol in nebulizer from 12Apr2022 to 16Apr2022 for treatment of COVID-19. Additional Information: No fever was reported.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FD0810) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Past drug history included: Known allergies: codeine for Known allergies: Codeine. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 13Apr2022, outcome "recovered" (23Apr2022) and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Mar2022) Negative; (13Apr2022) Negative; (13Apr2022) Positive; (23Apr2022) Negative. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Began taking Paxlovid on 26Mar2022; took full course. Tested negative starting 29Mar. Continued to test negative until 13Apr2022. her husband became ill and tested positive on 12Apr2022. She became ill the next day and tested positive and self-isolated with cold-like symptoms - no fever, just nasal drip and cough. Symptoms resolved within 10 days. Tested negative 23Apr2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19; Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19; 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 93-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (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 "Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive from COVID 19.  Clinical information: Caller stated that she tested positive from COVID 19 yesterday. And she is very confused about the dosage of Paxlovid, she doesn´t know if she has to take it every 12 hours or for how many hours she needs to wait between doses. She wants a clarification on this. She also recommended to write this information as an instruction in the package of Paxlovid. She also stated that she has COPD (Chronic obstructive pulmonary disease), but she was told that it should be no problem for her to take Paxlovid. Caller stated that she was supposed to receive her second booster shot of the Pfizer-BioNTech Covid 19 Vaccine the day after she tested positive from Covid 19. she received her first booster shot on Nov2021 and she wants to know how long she needs to wait until she can receive her second booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Breakthrough covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 20Apr2021 as dose 2, single (Lot number: EL3247), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 320308D), in right arm, all intramuscular for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient's relevant medical history and concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. The following information was reported: COVID-19 (medically significant) with onset 16Apr2022, outcome "recovered with sequelae", described as "Breakthrough covid-19 infection"; VACCINATION FAILURE (medically significant) with onset 16Apr2022, outcome "recovered with sequelae". The events "vaccination failure" and "breakthrough covid-19 infection" required physician office visit.   Patient's clinical course was the following: Breakthrough COVID-19 infection. Mild headache, runny nose, cough, fever, chills, general fatigue and loss of taste and smell. Most symptoms lasted about 3 days. Cough, runny nose and loss of taste and smell persisted for over a week. Slight recovery of taste and smell about 1.5 weeks post infection.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, notes: Clinitest Rapid Ag test; (25Apr2022) Positive, notes: BinaxNOW Rapid Ag test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: The nurse reports she received the Pfizer COVID-19 vaccines, and she had reactions including breast lymph node; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): MOD22-012425 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST MASS (non-serious), outcome "unknown", described as "The nurse reports she received the Pfizer COVID-19 vaccines, and she had reactions including breast lymph node".  Additional information: Description of A nurse on behalf of her mother who received the Modema Covid-19 booster dose in Event or Problem Jan2022. Patient reports that her mom has been experiencing an itchy rash, and the itchiness still has not gone away. Reporter reports big purple rash, with urticaria.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: + PCR test/fatigue/HA/nasal congestion/cough/body ache/fever; + PCR test/fatigue/HA/nasal congestion/cough/body ache/fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "+ PCR test/fatigue/HA/nasal congestion/cough/body ache/fever". The event "+ pcr test/fatigue/ha/nasal congestion/cough/body ache/fever" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: covid test type post vaccination=Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information included as Location of injection for vaccine received within 4 weeks Prior: seqirus- Right deltoid. Did the adverse event result in any of the following? Doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient been tested for COVID-19?:Yes  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Allergy test, Pruritus, Rash
Clinical narrative: Within 2 months after the second COVID vaccine, I had intermittent itching around my neck, chin, insides of my elbows; hand rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Apr2021 at 10:00 as dose 2, single (Lot number: EW0170), in left deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, Time: 11:00, Anatomical site of injection: Left shoulder, Batch/lot number: ER2613), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Within 2 months after the second COVID vaccine, I had intermittent itching around my neck, chin, insides of my elbows"; RASH (non-serious) with onset 2021, outcome "unknown", described as "hand rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent the following laboratory tests and procedures: Allergy test: (08Mar2022) Negative, notes: No food allergies. 17Dec2021, the patient received the booster shot and within 2 weeks developed rash beginning on patient's wrists spreading to chest and upper back, then progressed to all areas of body. With the rash, came intense itching. 25Jan 2022 went to withheld for condition. The patient was given a cortisone shot and prescribed triamcinolone 1% ointment. The cortisone shot had no effect on the rash. The patient was then prescribed dupixent, which began on 30Mar.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4346048-00 (Agency).  A 16-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 1, single (Batch/Lot number: unknown), on 01Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 20Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen at unk (citrate free) and second regimen (ongoing) at unk (citrate free), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset Apr2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possible   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2019, stop date: 20Apr2022; PRALUENT, start date: 01Jul2020, stop date: 27Apr2022; TRUVADA, start date: 01Jan2016, stop date: 18Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.The patient took other medications/products within 2 weeks of starting COVID-19 treatment with brand name Paxlovid and dates include treatment start date19Apr2022, treatment stop date 24Apr2022, Indication is Treatment of COVID-19. The patient previously received a COVID-19 Vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.; After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 21:30 as dose 3 (booster), single (Lot number: 330308D) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: 01Oct2021, stop date: 27Apr2022. Past drug history included: Erythromycin, reaction(s): "Known allergy:Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "After 5 day course (Thursday evening to Tuesday morning) of Paxlovid, symptoms improved and home test was negative/Took another home test on Tuesday, 26Apr and it was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative; (26Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Jan2021 at 08:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna. Concomitant medication(s) included: SINGULAIR, start date: 01Mar2021, stop date: 01Mar2021; XYZAL, start date: 01Mar2021; LO LOESTRIN FE; ALLERGAN, start date: 25Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Almost negative, notes: had an almost negative rapid test on day 8 of COVID; (27Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Crohn's disease, Fibromyalgia
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1140349) at citrate free (1 in 1 week) and second regimen (Lot number: 1154832) at citrate free (1 in 1 week), all subcutaneous for hidradenitis. The patient's relevant medical history included: "Bladder issues" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Vaccination history included: BNT162b2 (Dose 1, Single, via Intramuscular route), administration date: 02Aug2021, when the patient was 42-year-old, for COVID-19 Immunization, reaction(s): "COVID pneumonia", "Lung scarring", "Bladder inflammation", "Inflammatory marker increased", "Joint pain"; BNT162b2 (Dose 2, Single, via Intramuscular route), administration date: 11Nov2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: FIBROMYALGIA (medically significant), outcome "recovering"; ARTHROPATHY (medically significant), outcome "unknown", described as "joint issues"; CROHN'S DISEASE (medically significant), outcome "recovering", described as "Crohn's aggravated". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "fibromyalgia", "joint issues" and "crohn's aggravated" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: She had issues in the morning with her Crohn's, she had to go to the bathroom 3 times before she could start her day. She also had bladder issues but had those before Humira. It was unknown if patient was enrolled in a COVID--19 vaccine trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on known disease pathophysiology, the event of "fibromyalgia", "joint issues" and "crohn's aggravated  is assessed as not related to Suspected vaccine, and more likely due to medical history of the same. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthroscopy, Drug ineffective, Feeling abnormal, Fracture, Intervertebral disc operation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 38 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic sinus" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Upper respiratory infections" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Exercise tachycardia" (unspecified if ongoing), notes: Exercise tachycardia; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE]. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine", notes: Known allergies: Epinephrine. The following information was reported: FRACTURE (medically significant), INTERVERTEBRAL DISC OPERATION (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Recent L4/5 microdiscectomy (Jan) and right ankle arthroscopy/micro fracture treatment (Apr)"; SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "head fog"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure". The patient underwent the following laboratory tests and procedures: Arthroscopy: (Apr2022) Unknown results, notes: Right ankle arthroscopy. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19, fracture. Clinical course: Patient received other medication in 2 weeks. Patient received Paxlovid for Covid-19 treatment. Return of symptoms on 24Apr after initial symptoms resolved on Paxlovid by 20Apr. Recurring symptoms include sinus pressure, head fog, congestion, dry cough, strong headache, and fatigue. He had a history of chronic sinus and upper respiratory infections. He was currently being treated with Augmentin and Methylprednisolone with improving symptoms within 24 hours.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 38 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic sinus" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Upper respiratory infections" (unspecified if ongoing), notes: Chronic sinus and upper respiratory infections; "Exercise tachycardia" (unspecified if ongoing), notes: Exercise tachycardia; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE]. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine", notes: Known allergies: Epinephrine. The following information was reported: FRACTURE (medically significant), INTERVERTEBRAL DISC OPERATION (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Recent L4/5 microdiscectomy (Jan) and right ankle arthroscopy/micro fracture treatment (Apr)"; SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "head fog"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown", described as "sinus pressure". The patient underwent the following laboratory tests and procedures: Arthroscopy: (Apr2022) Unknown results, notes: Right ankle arthroscopy. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19, fracture. Clinical course: Patient received other medication in 2 weeks. Patient received Paxlovid for Covid-19 treatment. Return of symptoms on 24Apr after initial symptoms resolved on Paxlovid by 20Apr. Recurring symptoms include sinus pressure, head fog, congestion, dry cough, strong headache, and fatigue. He had a history of chronic sinus and upper respiratory infections. He was currently being treated with Augmentin and Methylprednisolone with improving symptoms within 24 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash, Skin warm
Clinical narrative: Shingles; sharp pains; hot skin; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing); "Graves" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known allergies: mango" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; VITAMIN D3; VITAMIN B2; CALCIUM; ZINC; MAGNESIUM. Past drug history included: Epinephrine, reaction(s): "Known allergies: Epinephrine". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 28Jul2021, when the patient was 62-year-old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: Mar2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 19Apr2022 at 03:00, outcome "not recovered", described as "Shingles"; SKIN WARM (non-serious) with onset 19Apr2022 at 03:00, outcome "not recovered", described as "hot skin"; RASH (non-serious) with onset 19Apr2022 at 03:00, outcome "not recovered"; PAIN (non-serious) with onset 19Apr2022 at 03:00, outcome "not recovered", described as "sharp pains". The events "shingles", "sharp pains", "hot skin" and "rash" required physician office visit. Therapeutic measures were taken as a result of herpes zoster, pain, skin warm, rash. The patient treated with Valtrex antiviral.  Additional information: No Covid prior vaccination. No Covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: El9264), on 09Mar2021 as dose 2, single (Lot number: En6206), in left arm and on 17Oct2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Urothelial cancer immunotherapy treatment." (unspecified if ongoing), notes: Urothelial cancer immunotherapy treatment.; "Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LEVOTHYROXINE; NEBIVOLOL; OLMESARTAN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive again for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: patient took Paxlovid for 5 days. Felt good day 6 to day 10. Day 11 woke with stuffy nose and sinus congestion. felt achy. Tired. No fever. Tested positive again for COVID. Known allergies: Codeine and sulfa.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Sudden visual loss
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 91-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 91 years for Covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Colon Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (1st Booster), for Covid-19 immunization. The following information was reported: SUDDEN VISUAL LOSS (hospitalization, medically significant) with onset 25Apr2022 at 21:00, outcome "not recovered", described as "Sudden onset left side monocular visual loss"; OFF LABEL USE (hospitalization, medically significant), IMMUNISATION (hospitalization, medically significant), outcome "unknown" and all described as "4th Pfizer Booster". The patient was hospitalized for sudden visual loss (start date: Apr2022, hospitalization duration: 3 day(s)). The event "sudden onset left side monocular visual loss" required emergency room visit. Therapeutic measures were taken as a result of sudden visual loss. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented with sudden onset left side monocular visual loss that start within 24 hours after receiving a booster dose vaccine. Patient received High dose steroid x 3 days as a treatment medication. Since the vaccination, the patient was not been tested for COVID-19. 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: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Sudden visual loss, Off label use and Immunisation. 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.