chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 25Apr2022 COVID-19 test: Positive; 25Apr2022 COVID-19 test: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4396534-00 (AbbVie).  A 21-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for psoriatic arthropathy, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "25Apr2022 COVID-19 test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive. The action taken for adalimumab was unknown.  Clinical Course: Solicited report by a consumer of an adult female with events of non-serious COVID, hives at injection site and bump at injection site with Humira (Adalimumab). The patient was treated with Benadryl. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Daily Dose: 2) 1 in 1 once. Route of Admin: Intramuscular. Indications for Use: COVID19 Vaccination. On an unknown date patient experienced COVID, hives at injection site and bump at injection site Pfizer BioNTech COVID19 Vaccine (tozinameran) was also considered suspect. COVID-19 (COVID-19): Action(s) taken with drug: Unknown; Causality as per reporter (Drug/Vaccine): Probable; Dechallenge: N/A. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of hives at injection site and bump at injection site was not provided.  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: 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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8730), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: testing negative on Day 9 (13May2022); (17May2022) Positive, notes: I had recurring Covid symptoms on Day 13 (17May2022). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had recurring Covid symptoms on Day 13 (17May2022) - congestion and a sore throat and tested positive with an at home antigen test after testing negative on Day 9 (13May2022). No Known allergies.
Age: 48.0
Sex: F
Vaccine: COVID19, 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). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 48 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's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19. Reporter stating events as non serious. Patient did not have any known allergies.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 10:00 as dose 1, single (Lot number: EM9809), in left arm, on 23Feb2021 at 09:00 as dose 2, single (Lot number: EL9266), in left arm and on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial flutter" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Jan2019. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: still tested positive on day one after completing the paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient Anti-viral treatment for COVID 19 Treatment included Paxlovid (Lot number: GA6764) started on 11May2022 continued till 16May2022. The patient still tested positive on day one after completing the paxlovid. Severe body aches especially back and right shoulder blade. The patient had known allergy with cephalosporin. AE treatment included Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 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's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details stated product used for COVID 19 Treatment was Paxlovid and Treatment was start from 17May2022. Adverse events start date was 17May2022.The patient has not recovered. Experienced strong metallic taste in mouth about an hour after taking first dose. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:30 as dose 1, single (Lot number: EN6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: soy allergy" (unspecified if ongoing), notes: Known allergies: soy allergy. Concomitant medication(s) included: QVAR REDIHALER, start date: 06May2022, stop date: 15May2022. Past drug history included: Allergic to cipro antibiotic, reaction(s): "Allergy: Cipro", notes: Known allergies: Allergic to Cipro antibiotic. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: I tested still positive with Covid. Therapeutic measures were taken as a result of covid-19, vaccination failure.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Colonoscopy, Drug ineffective, Endoscopy, Illness
Clinical narrative: vaccinated and got sick; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), 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) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer of Colon", start date: 1997 (unspecified if ongoing), notes: Cancer of Colon Had his first surgery 20 years ago in 1997.; "high blood pressure" (unspecified if ongoing), notes: high blood pressure Controlled by bisoprolol. He was diagnosed when he was 25 years old.; "Anxiety" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "surgery on rotator cuff" (unspecified if ongoing), notes: He has had surgery on rotator cuff for a sports injury,. Concomitant medication(s) included: AMBIEN taken for insomnia; CLONAZEPAM taken for anxiety; BISOPROLOL FUMARATE taken for hypertension; ATORVASTATIN CALCIUM taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Covid-19"; ILLNESS (non-serious), outcome "unknown", described as "vaccinated and got sick". The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; Endoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; SARS-CoV-2 test: (Apr2022) Negative, notes: After taking Paxlovid for 5 days, he had two days of home test that were negative; (Apr2022) Positive, notes: Between 25Apr2022 and 27Apr2022 they were positive again; (22Apr2022) Positive, notes: He was positive for a 22 day span since the 22Apr2022; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, illness included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: vaccinated and got sick; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), 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) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer of Colon", start date: 1997 (unspecified if ongoing), notes: Cancer of Colon Had his first surgery 20 years ago in 1997.; "high blood pressure" (unspecified if ongoing), notes: high blood pressure Controlled by bisoprolol. He was diagnosed when he was 25 years old.; "Anxiety" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "surgery on rotator cuff" (unspecified if ongoing), notes: He has had surgery on rotator cuff for a sports injury,. Concomitant medication(s) included: AMBIEN taken for insomnia; CLONAZEPAM taken for anxiety; BISOPROLOL FUMARATE taken for hypertension; ATORVASTATIN CALCIUM taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Covid-19"; ILLNESS (non-serious), outcome "unknown", described as "vaccinated and got sick". The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; Endoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; SARS-CoV-2 test: (Apr2022) Negative, notes: After taking Paxlovid for 5 days, he had two days of home test that were negative; (Apr2022) Positive, notes: Between 25Apr2022 and 27Apr2022 they were positive again; (22Apr2022) Positive, notes: He was positive for a 22 day span since the 22Apr2022; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, illness included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 34 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 following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Symptoms came back about two weeks after last dose of paxlovid. Nothing major just runny nose and I decided to take a rapid test and it came up positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient did not received other medication in 2 weeks. Patient received treatment with paxlovid from 25Apr2022 to 30Apr2022.
Sex: F
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 73-year-old female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Mar2021 as dose 1, single (Lot number: 007M20A) and on 20Feb2021 as dose 2, single (Lot number: 011A21A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "hypothyroidism" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Dose3 Pfizer, Dose 2 an 1 Moderna. Concomitant medication(s) included: LEVOTHYROXINE (100MCG); VITAMIN C [ASCORBIC ACID] 1000; VITAMIN D3 (2000 IU); VITAMIN B12 [CYANOCOBALAMIN](5000mcg); ZINC (50mg); MAGNESIUM (250mg); CALCIUM CITRATE (600mg); SELENIUM (200mcg); PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; COLLAGEN + BIOTIN 6000mg.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Covid-19 treatment included Paxlovid from 04May2022 to 09May2022 of lot number GA1519 for the indication treatment of COVID-19.
Age: 52.0
Sex: F
Vaccine: 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Er8733), in left arm, as dose 2, single (Lot number: Er8735), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Costochrondritis" (unspecified if ongoing); "low blood pressure;" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (08May2022) Negative; (17May2022) Positive; (2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient had taken full course Paxlovid starting 01May2022 to 05May2022 after positive COVID test. Symptoms improved slowly but felt worse on 07May2022 and tested positive. Negative COVID test on 08May2022 as symptoms subsided. On 16May2022 COVID resurged. Tested positive on 17May2022 with sudden onset fatigue, chills, tiredness, congestion.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster) , single (Lot number: FF2593) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Aug2021 as dose 2 , single (Lot number: 025A21A), in left arm. The patient's relevant medical history included: "Charcot Marie Tooth disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Darvon, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1 manufacture unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "not recovered" and all described as "Paxlovid indication:Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 30Apr2022, treatment stop date 05May2022, indication Treatment of COVID-19. Covid positive April 30, Paxlovid regimen started April30 completed May 5, tested negative May 6 and continued to test negative through May 13. Symptomatic headache and cough May 14 and test positive. Urgent Care phone consult with nurse advised to treat manageable symptoms with over-the-counter meds, but go directly to ER if symptoms become severe
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic; Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 79 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. Concomitant medication(s) included: AZITHROMYCIN oral, start date: 05May2022, stop date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "unknown", ASYMPTOMATIC COVID-19 (medically significant) with onset 14May2022, outcome "recovering" and all described as "Pt. (patient) tested + for Covid-19. Pt (patient) asymptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, asymptomatic covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and Asymptomatic COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We both got the Pfizer vaccines and now we are both taking Paxlovid; We both got the Pfizer vaccines and now we are both taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086).  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 was not reported. Concomitant medication(s) included: LORAZEPAM; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]; ALKA-SELTZER FLU; TUMS [CALCIUM CARBONATE]; MOTRIN [IBUPROFEN]; CLARITIN [LORATADINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We both got the Pfizer vaccines and now we are both taking Paxlovid".  Clinical course included Reporter states that he is on his 2nd day of taking Paxlovid. Reporter states that his doctor told him to stop taking Lipitor while taking Paxlovid. Reporter states that his doctor told him to continue taking his blood pressure medicine Lisinopril and Hydrochlorathiazide. it was reported that Referred Reporter to follow up with his doctor for clarification and informed Reporter not to stop taking any medications before first consulting with his doctor.Reporter is a male consumer who is calling on behalf of his wife, withheld (female), who was prescribed Paxlovid today and just picked up her prescription from the pharmacy. Reporter states that both he and his wife have both been vaccinated with Pfizer Covid19 vaccines. Reporter states "it is 3pm here now and my wife would like to know if she should take her 1st dose of Paxlovid now or wait until this evening" Reporter also states "Reporter started my Paxlovid yesterday at 9:00 and then took my evening dose at 9pm and then my morning dose this morning at 9:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200726753 same reporter/drug/event, diff patients
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Eye pain, Headache, SARS-CoV-2 test
Clinical narrative: eyeball was also aching; bad headache/had the headache on the right side of her head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 1, single (Lot number: FK9895) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 03May2022, outcome "recovering", described as "bad headache/had the headache on the right side of her head"; EYE PAIN (non-serious) with onset 04May2022, outcome "recovering", described as "eyeball was also aching". The events "bad headache/had the headache on the right side of her head" and "eyeball was also aching" 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 headache, eye pain.  Additional information: The patient took Advil and Tylenol as treatment drug. The patient had a virtual appointment with the walk-in clinic because at this point the headache had lasted over a week. She went to the ER for a CT scan to rule out any dangerous stuff. She said her CAT scan came back normal. They gave her a steroid injection and an Ibuprofen injection that worked for like a day.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200730344 Pfizer
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Mar2022, outcome "recovered" (01Apr2022) and all described as "Paxlovid indication: Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events vaccination failure and covid19 cannot be totally excluded.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: 028L20A), in left leg, on 02Mar2021 as dose 2, single (Lot number: 002A21A), in right arm and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: 045521A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Jan2020; HYDROCHLOROTHIAZIDE, start date: 01Jan2020; ADVAIR, start date: 04Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Testing positive 14 days after starting Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures included Paxlovid 150mg/100mg, for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: I tested positive/ I have tested positive on 16May and 17May; I tested positive/ I have tested positive on 16May and 17May; sore throat; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tree nuts, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary immunization series complete. Manufacturer unknown), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 13May2022 at 14:00, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 13May2022 at 14:00, outcome "not recovered", described as "sore throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive/ I have tested positive on 16May and 17May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Negative, notes: testing negative on May 8th, and recovering from my symptoms I tested positive again on May 13th; (13May2022) Positive, notes: testing negative on May 8th, and recovering from my symptoms I tested positive again on May 13th; (16May2022) Positive, notes: Since then I have tested positive on May 16th and May 17th; (17May2022) Positive, notes: Since then I have tested positive on May 16th and May 17th. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of oropharyngeal pain, cough. Clinical information: Paxlovid treatment started on 02May2022 till 07May2022 for COVID-19. After taking the Paxlovid, testing negative on 8May, and recovering from her symptoms she tested positive again on 13May and started having a sore throat and cough again on 12May. On 14May she had almost no symptoms besides a minor cough. Since then she had tested positive on 16May and 17May. No other medication in 2 weeks.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster) , single (Lot number: FF2590) at the age of 48 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's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: AMPHETAMINE SALTS. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), all with latency 6 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.No known allergies. other medication in 2weeks product Amphetamine Salts 20 mg. Initially she began to feel 1000% better in about a day and a half. It took away my breathing issues and my coughing. After I finished the five days dosage, the next day I came down with fatigue, fever, chills/sweats, and headache form two days. She did not have any of these symptoms before. Then about 3 days after completing the meds I began to recover again. Treatment included Paxlovid from 19Apr2022 to 23Apr2022 for treatment of covid-19.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: taken COVID 19 Treatment; taken COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: CVS01477) at the age of 28 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's relevant medical history included: "Known allergies: Food - sweet potatoes" (unspecified if ongoing), notes: Known allergies: Food - sweet potatoes. No medication allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "recovering" and all described as "taken COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Now, 13 days after testing positive; (11May2022) faint positive, notes: a rapid at home test went from a faint positive line 2 days after ending Paxlovid to a bold; (13May2022) positive, notes: positive line 4 days after ending Paxlovid. Therapeutic measures were taken as a result of covid-19.  Adverse event: Consumer experienced a rebound of COVID symptoms in the week after he finished the Paxlovid course. Congestion and cough came back and were worse than while he was taking the Paxlovid. Additionally, a rapid at home test went from a faint positive line 2 days after ending Paxlovid to a bold, positive line 4 days after ending Paxlovid. Now, 13 days after testing positive and 8 days after finishing Paxlovid, his symptoms are the worst they've been so far. Antiviral details: Paxlovid started on 05May2022 for treatment of COVID-19 and stopped on 09May2022.
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as unk (unknown dose number), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "Thyroidectomy" (unspecified if ongoing); "Allergies: Sulfa" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative.
Age: 45.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single and on 27Oct2021 as dose 3 (booster), single at the age of 45 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TIROSINT, start date: 01Aug2021. 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 covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: 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) (Physician).  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 11Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies ibuprofen. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) positive, notes: tested positive 26Apr; (unspecified date) negative, notes: neg home antigen test; (15May2022) positive, notes: 15May developed symptoms and positive home antigen test. Therapeutic measures were not taken as a result of covid-19, drug ineffective.   Clinical course: It was reported that rebound covid, tested positive 26Apr2022 s/p 5 days Paxlovid and neg home antigen test and symptom resolution. 15May developed symptoms and positive home antigen test.  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 information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID test after previous negative test 6 days earlier; positive COVID test after previous negative test 6 days earlier; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 09:00 as dose 1, single (Lot number: EL0140), in left arm and on 06Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myocarditis" (unspecified if ongoing), notes: Myocarditis from 2nd dose of initial Pfizer vaccine. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "not recovered" and all described as "positive COVID test after previous negative test 6 days earlier". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive COVID test after previous negative test 6 days earlier; Positive, notes: positive COVID test after previous negative test 6 days earlier. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: GA1513) for treatment of COVID-19, the treatment start date was captured as 5May2022 and stop date was captured as 09May2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: also had a severe case of covid at the beginning of the year; also had a severe case of covid at the beginning of the year; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: (054550).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Grass-Pollen" (unspecified if ongoing); "Grass-Pollen" (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 "also had a severe case of covid at the beginning of the year".  Additional information: Medication: Pfizer COVID Vaccine. Drug Allergies Allergic To Grass-Pollen (Xeljanz XR). Event Description: I also had a severe case of COVID at the beginning of the year.  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 in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 26Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years oral, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR HCL oral; LEVOTHYROXINE SODIUM oral; ATORVASTATIN CALCIUM oral. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid cyst
Clinical narrative: I found out last month that I have a cyst in my thyroid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (002591). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am a former smoker" (unspecified if ongoing), notes: I am a former smoker. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, I go all the way to the PET scan and PET scan is the one that detects cancer), for COVID-19 immunization, reaction(s): "I go all the way to the PET scan and PET scan is the one that detects cancer", "I just now this February discovered that I have a lung nodule"; Bnt162b2 (DOSE: 2, I go all the way to the PET scan and PET scan is the one that detects cancer), for COVID-19 immunization, reaction(s): "I go all the way to the PET scan and PET scan is the one that detects cancer", "I just now this February discovered that I have a lung nodule"; Bnt162b2 (DOSE: 3, I go all the way to the PET scan and PET scan is the one that detects cancer), for COVID-19 immunization, reaction(s): "I go all the way to the PET scan and PET scan is the one that detects cancer", "I just now this February discovered that I have a lung nodule". The following information was reported: THYROID CYST (non-serious) with onset Apr2022, outcome "unknown", described as "I found out last month that I have a cyst in my thyroid".  Additional Information: It was reported that the patient found out last month (Apr2022) that she had a cyst in her thyroid that her arthritis doctor found, and she was going to endocrinologist tomorrow. The patient was shocked about her thyroid having a cyst.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (159558).  A 10-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 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: COVID-19 (non-serious) with onset 17May2022, outcome "unknown", described as "received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Product Description: Compound bnt162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 pediatric. NDC number, UPC number and Expiry Date of COVID-19 Vaccine were Unknown. The reporter, (name withheld) said that her 10-year-old grandson received the Pfizer covid-19 vaccine yesterday 16May2022 and he was tested positive today 17May2022. The reporter didn't specify if it's the first or the second dose of the Pfizer covid-19 vaccine. Description of Product Complaint: Transferring agent stated, "I have a caller on the other line. She said that her grandson 10 years of age received the vaccine, the Pfizer COVID-19 Vaccine yesterday and today her grandson tested positive to COVID-19."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.