chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Pain in extremity, Thirst
Clinical narrative: excessive thirst; experienced some arm soreness like all the previous doses; diarrhea; lost of appetite; 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 47-year-old female patient received BNT162b2 (BNT162B2), on 23May2022 at 14:15 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "experienced some arm soreness like all the previous doses". The following information was reported: DIARRHOEA (non-serious) with onset 24May2022, outcome "unknown", described as "diarrhea"; THIRST (non-serious) with onset 24May2022, outcome "unknown", described as "excessive thirst"; PAIN IN EXTREMITY (non-serious) with onset 24May2022, outcome "unknown", described as "experienced some arm soreness like all the previous doses"; DECREASED APPETITE (non-serious) with onset 24May2022, outcome "unknown", described as "lost of appetite".  Additional Information: Question: Call was transferred from another Dept. Caller states that she received the second booster dose Pfizer BioNtech covid vaccine on monday around 4:15 and experienced some arm soreness like all the previous doses. However she has also been experiencing other side effects such as excessive thirst, diarrhea and lost of appetite (she did not have these side effects with previous doses) and would like to know if its normal and if it was how she can treat it. Question: Caller would like to know how she can treat the diarrhea. Reporter related to a study or programme was reported as no. Other Conditions was Not Provided. Investigations was Not Provided. Other Products was Not Provided. Additional Context: Caller stated that she received the Covid 19 Pfizer booster second one on Monday afternoon. Stated that she was not sure that some of the side effects of getting diarrhea. Stated that she did not get this before and wanted to know how long does it last. Wanted to know if this was a normal side effect, how long it lasts and how to treat it. Stated that she had major loss of appetite. Stated that she had the vaccine at 14:15 on Monday and had no side effects until last night. Stated that she had all other Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Lymphadenopathy, Pain in extremity
Clinical narrative: lymph nodes in my armpit were swollen; inflammation extended to my left breast.; Following day after I got the vaccine I had arm pain that became stronger at night.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 at 16:45 as dose 4 (booster), single (Lot number: FM0173) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INDERAL; LANSOPRAZOL; ROSUVASTATIN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 03Sep2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EL1284, Location of injection: Arm Left), administration date: 08Jan2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 16Dec2020, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "little discomfort".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2022 at 10:00, outcome "recovered" (May2022), described as "Following day after I got the vaccine I had arm pain that became stronger at night."; BREAST INFLAMMATION (non-serious) with onset 22May2022 at 10:00, outcome "recovered" (May2022), described as "inflammation extended to my left breast."; LYMPHADENOPATHY (non-serious) with onset 22May2022 at 10:00, outcome "recovered" (May2022), described as "lymph nodes in my armpit were swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, breast inflammation.  Additional information: The patient had not received other vaccine in 4 weeks. Reporter stated, following day after I got the vaccine, I had arm pain that became stronger at night. By morning noticed the lymph nodes in my armpit were swollen. Following day, the inflammation extended to my left breast. This was the first time that I got this side effects, the first three were great, just a little discomfort. The patient had not covid prior vaccination and covid tested post vaccination. 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-202200765075 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: Ff8839), 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: "Endometriosis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: CT contrast" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single Vaccine administration time=12:00 AM (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Other medications in two weeks: No. Known allergies: No. Other medical history: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Adverse event start date: 09May2022 at 12:00 AM. Adverse event: Patient did great while on paxlovid. felt like patient was not sick at all. on day 7 from positive test, 2 days after finishing paxlovid. Patient got incredibly sick with covid. elevated heart rate and congestion. Patient was now day 24 and patient still have nasal congestion and elevated heart rate. Anti-viral details: Product= Covid-19 treatment Brand= Pfizer Treatment start date= 02May2022 Treatment stop date=06May2022 Indication= Treatment of Covid-19. Adverse event stop date: May2022. No treatment for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: En6201), on 09Mar2021 as dose 2, single (Lot number: En6206), on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A) and on 18Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 68 years, in left arm 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: she had fatigue; a little problem with breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: Jun2021) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN; MUCINEX; REPATHA taken for blood cholesterol increased. Past drug history included: Biaxin, reaction(s): "a horrible taste". Vaccination history included: BNT162b2 (Dose 1, Lot: could be EM9809 or GM9809, NDC: unknown , Expiry: Jun2021, Route: unknown), administration date: 16Feb2021, for Covid-19 immunization; Flu shot (Every year), for Immunization; Shingles shots (does just fine with those), for Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "a little problem with breathing"; FATIGUE (non-serious) with onset 09Mar2021, outcome "unknown", described as "she had fatigue".  Additional information: The reporter reported that she received the first 2 where it was in a large tent outside. She did not receive any other vaccines on the same date. The patient did not visit to emergency room nor physician office, she tried to go to her doctor but wasn't successful. The office was having computer glitches, that is what she was told. The patient did not have prior vaccination within 4 weeks. The patient did not have any medical or family history. She does have asthma but it doesn't bother her too much. She also gets the flu shot every year and had the shingles shots and does just fine with those, confirms she has nothing to report with those products. She adds the only problem she has ever had is with the covid vaccine. The first shot she was fine. The second shot she had fatigue, a little problem with breathing but states it was not bad she was fine the next day. The third shot she was fine.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200762127
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: flu; cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The action taken for adalimumab was unknown.  Additional information: This report was non-serious. Janssen covid-19 vaccine: Causality for events flu (flu, influenza) causality as per reporter was possible; Cold (cold, nasopharyngitis) causality as per reporter was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 2 of which made him ill for 2/3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male 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: ILLNESS (non-serious), outcome "unknown", described as "2 of which made him ill for 2/3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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: "Asthma" (unspecified if ongoing). Patient had no Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 / given COVID 19 Treatment; COVID-19 / given COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 at 17:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left 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 had no relevant medical history. There were no concomitant medications. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 / given COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective and included treatment with paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22; Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jan2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "idiopathic urticaria" (unspecified if ongoing); "depression" (unspecified if ongoing), notes: other medical history :Asthma, idiopathic urticaria,, depression; "known allergies: Clams" (unspecified if ongoing); "adhesive" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01May2022; NYQUIL, start date: 11May2022, stop date: 14May2022; LEXAPRO, start date: 01May2022. Past drug history included: Amoxicillin, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 22:00, outcome "not recovered" and all described as "Rebound Covid. Positive home test on 5/26/22. Return of symptoms on 5/24/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that other medication was given in 2 weeks. Paxlovid was given as treatment for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Rebound COVID-19 infection; Rebound COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21May2022 at 15:00, outcome "not recovered" and all described as "Rebound COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected 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: As there is limited information in the case provided, the causal association between the Reported eventS and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; fever; 1 inch below injection site a red bump that is warm, tender, and hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 23May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "No reactions"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "No reactions". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "unknown", described as "1 inch below injection site a red bump that is warm, tender, and hard"; PYREXIA (non-serious) with onset May2022, outcome "recovered" (May2022), described as "fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 23May2022, outcome "unknown" and all described as "Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed".  Additional information: The patient was reporter's mother. The patient received her booster shot on 23May2022. On 23May2022 (4 days before 27May2022), she had approximately 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she had a big red bump that was hot to touch and sort of hard to touch as well like compressed and was not sure if that was a normal reaction. She had 'normal' symptoms and fever for about 2 days. There were no reactions before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed; fever; 1 inch below injection site a red bump that is warm, tender, and hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 23May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "No reactions"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "No reactions". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "unknown", described as "1 inch below injection site a red bump that is warm, tender, and hard"; PYREXIA (non-serious) with onset May2022, outcome "recovered" (May2022), described as "fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 23May2022, outcome "unknown" and all described as "Approx. 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she has a big red bump that is hot to touch and sort of hard to touch as well like yeah compressed".  Additional information: The patient was reporter's mother. The patient received her booster shot on 23May2022. On 23May2022 (4 days before 27May2022), she had approximately 1 inch under where she got her vaccine (COVID-19 Vaccine), her booster shot, she had a big red bump that was hot to touch and sort of hard to touch as well like compressed and was not sure if that was a normal reaction. She had 'normal' symptoms and fever for about 2 days. There were no reactions before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear infection
Clinical narrative: hearing loss; infection on the left ear; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization. Patient had no known allergies. The following information was reported: DEAFNESS (disability, medically significant) with onset 11May2022, outcome "recovered" (2022), described as "hearing loss"; EAR INFECTION (disability) with onset 11May2022, outcome "recovered" (2022), described as "infection on the left ear". Therapeutic measures were taken as a result of deafness. It was unknown if therapeutic measures were taken as a result of ear infection.  The clinical course was reported as: The patient had received other medications in 2 weeks. Patient received other vaccine in four weeks was unknown. Patient developed hearing loss and infection on the left ear about a week after receiving the vaccine. Patient recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Sinus congestion
Clinical narrative: I've now tested COVID positive again; I've now tested COVID positive again; Sinus congestion; 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 45-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years 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 had no relevant medical history. Concomitant medication(s) included: FINASTERIDE. Past drug history included: None. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "I've now tested COVID positive again"; SINUS CONGESTION (non-serious) with onset 28May2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: COVID-19: (23May2022) Negative; (27May2022) Negative; (28May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, sinus congestion.  Clinical information : Other medication in 2 weeks of vaccination : Finasteride. There were no Known allergies. It was reported that after taking Paxlovid for 5 days, I started to test Covid negative on Mon 23May22 (my fifth day) and my symptoms mostly stopped. I then tested negative every day through Fri 27May. But today I started to develop a cough and some sinus congestion, and I've now tested Covid positive again.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old male patient received BNT162b2 (BNT162B2), as dose 1, 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Panic attack
Clinical narrative: Elevated blood pressure; Panic anxiety attacks; Panic anxiety attacks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2022 as dose 3 (booster), single (Lot number: FJ639) at the age of 63 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT. Vaccination history included: BNT162b2 (Dose 1, Lot number: EW0178, Anatomical location: Right arm), administration date: 04Aug2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EW0178, Anatomical location: Right arm), administration date: 25Aug2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 09Mar2022, outcome "not recovered", described as "Elevated blood pressure"; ANXIETY (non-serious), PANIC ATTACK (non-serious) all with onset 09Mar2022, outcome "not recovered" and all described as "Panic anxiety attacks". The events "elevated blood pressure" and "panic anxiety attacks" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased, anxiety, panic attack.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that he was calling about the Pfizer COVID vaccine, adult, booster shot. He did fine with all his previous COVID vaccines. He took his booster shot when he was eligible. About a week or two after getting his booster, he experienced an elevated blood pressure and panic anxiety attacks. He had taken Zoloft 50mg a day for twenty years and he had been very steady and the medication worked well. After his panic anxiety attack he was prescribed generic Xanax, Alprazolam 0.25mg and it was working well. The patient experienced adverse event after the booster shot. The patient went on a trip and experienced elevated blood pressure. He went to an emergency room and he was evaluated. The patient stated that nothing wrong could be found. He was given the generic Xanax and a blood pressure medication called Enalapril. He stated that both medications were effective. He stated that it still occurs every now and then. Panic anxiety attacks, he stated he had another one happen on 25Mar2022. He had only had one booster. The outcome of the events was persisting.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had symptoms on 16May2022; tested positive on 18May2022; had symptoms on 16May2022; tested positive on 18May2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 06Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unknown if ongoing); "AFib" (unknown if ongoing). Concomitant medication(s) included: METOPROLOL MYLAN [METOPROLOL SUCCINATE]; XARELTO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "had symptoms on 16May2022; tested positive on 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive, notes: he patient did a self test of the COVID test on 18May; (23May2022) positive, notes: done by a laboratory on 23May of this year. Clinical information: The patient had COVID booster on 30Apr2022, received a message from (Pharmacy name) 21May2022 that booster was ineffective. She left for a cruise to the (Place) on 12May2022 and had symptoms on 16May2022, tested positive on 18May2022. Had she not received the booster, she would have been ineligible to board the ship as (Country) Cruise Lines requires vaccine no more than 270 days. Passport was confiscated in the (Country). It was asked what was Pfizer's explanation for ineffective booster. The patient like to know how this happened and what Pfizer has do about it because the patient got COVID, while she was on ship. The patient did a self test of the COVID test on 18May and it was positive and it was done by a laboratory on 23May of this year (Date not clarified) and it was positive COVID so the only test I have recently.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Drug ineffective and Covid 19, cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: just got Covid for the first time; just got Covid for the first time; 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, 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), COVID-19 (medically significant), outcome "unknown" and all described as "just got Covid for the first time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: just got Covid for the first time.  Clinical course: The reporter stated that "symptoms were mild and the whole time just felt so grateful that  didn't have to worried about going to the hospital or putting my older family at risk of dying, and that's all because of your miraculous work to create a vaccine so fast and save so many of our lives.  The information on the batch/lot number for BNT162b2 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: COVID 19 positive on 29May; COVID 19 positive on 29May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 16:00 as dose 4 (booster), single (Lot number: FK9729), 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 had no relevant medical history. There were no known allergies. The patient did not take any other vaccine in four weeks. Patient did not have covid prior vaccination. Patient tested for covid post vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022 at 12:00, outcome "recovering" and all described as "COVID 19 positive on 29May". The event "covid 19 positive on 29may" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive, notes: Nasal Swab, 12:00. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 44.0
Sex: M
Vaccine: 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 contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 at 10:00 as dose 1, single (Lot number: EJ1685), in left arm, on 25Jan2021 at 10:00 as dose 2, single (Lot number: FL1283), in left arm and on 04Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Test positive for COVID19 via binaxx2 and confirmatory PCR x1 Monday May 16th. Mild symptoms of sore throat, cough and rhinorhea; (20May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (22May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (24May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (30May2022) Positive, notes: Monday May 30th, COVID19 tests via binax x2 were again positive with PCR comformatoty positive in the settings of mild symptoms (sore throat, cough, rhinorrhea). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Mild symptoms of sore throat, cough and rhinorrhea. Started Paxlovid same evening (Monday 16May) and completed series Saturday 21May. Test was negative Binax beginning Friday 20May, Saturday 22May and Tuesday 24May. Monday 30May, COVID19 tests via Binax x2 were again positive with PCR conformity positive in the settings of mild symptoms (sore throat, cough, rhinorrhea). Monday 30May is 9 days post last date of Paxlovid dose. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: MENB
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; 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 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: SWELLING (non-serious), outcome "unknown". Therapeutic measures were taken as a result of swelling.  Additional Information: Caller stated that ever since she took the shot (no specific formulation was provided) , she has had this swelling and she has never had this before, and the treatment and stuff she was getting, she was not happy. She said she had Contacted Pfizer a year ago for the same  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid; had Covid; 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 female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: she and her husband had Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Caller was prescribed with Paxlovid. Caller states before she realizes, she and her husband had Covid, they got their second booster dose on Sunday. Caller states that she is getting her first dose of Paxlovid. Caller wants to know any information if it (Paxlovid) will reduce the effect of the Pfizer Covid-19 booster.Efficacy in Subjects at High Risk of Progressing to Severe COVID-19 Illnes.The clinical study excluded individuals with a history of vaccination.  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-202200786507 Same reporter/product/event, different patient