chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Pain at injection site. No other side effects.; Maternal exposure during pregnancy; This is a spontaneous report from a contactable Nurse (patient). This nurse reported information for both mother and fetus/baby. This is the maternal report. A 32-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 14:00 pm (age at vaccination was 32-year-old) at a single dose for COVID-19 immunization. Medical history included hypothyroidism, PCOS and Raynaud's. The patient had no known allergies. The other medications the patient received within 2 weeks of vaccination included levothyroxine sodium (LEVOTHYROXINE SODIUM) and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]). The patient was pregnant at the time of vaccination. Gestational period was 14 weeks. The patient's delivery due date was reported as 07Aug2021. On 05Feb2021 at 14:00 pm, the patient experienced maternal exposure during pregnancy. On 05Feb2021 at 18:00 pm, the patient experienced pain at injection site. No other side effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event vaccination site pain was recovered on an unknown date and outcome of event maternal exposure during pregnancy was unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239924 mother/fetus
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Fatigue, Pain in extremity
Clinical narrative: not showing any immunity; he tested negative for antibodies/not showing any immunity; His arm was a little sore and he was a little tired; His arm was a little sore and he was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 73-years-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL9262 and expiry date was not provided), via an unspecified route of administration, in left upper arm muscle on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included ongoing blood pressure abnormal, ongoing Gout, CLL ((Chronic lymphocytic leukaemia), It is a blood disorder. He is not on medication for it and is asymptomatic. He has been diagnosed about four or five years), ongoing thyroid disorder and He had a nodule years ago and it was removed. The concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, allopurinol taken for gout, atorvastatin, amlodipine besilate, acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), finasteride, irbesartan taken for blood pressure abnormal and tamsulosin. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL1284 and expiry date was not provided) via an unspecified route of administration, in left upper arm muscle on 15Jan2021 as SINGLE DOSE for Covid-19 Immunization. It was reported that the patient had both doses of Pfizer vaccine, tomorrow would be four weeks since his second dose. The patient reported that his arm was a little sore and he was a little tired for a day or two. Patient had the antibody test on 01Mar2021 (Monday), got the results on 03Mar2021 as negative and reported that it was not showing any immunity. The patient had no vaccines within 4 weeks of getting his COVID19 Vaccine. The outcome of the events reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: not showing any immunity; he tested negative for antibodies/not showing any immunity; His arm was a little sore and he was a little tired; His arm was a little sore and he was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 73-years-old male patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL9262 and expiry date was not provided), via an unspecified route of administration, in left upper arm muscle on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included ongoing blood pressure abnormal, ongoing Gout, CLL ((Chronic lymphocytic leukaemia), It is a blood disorder. He is not on medication for it and is asymptomatic. He has been diagnosed about four or five years), ongoing thyroid disorder and He had a nodule years ago and it was removed. The concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, allopurinol taken for gout, atorvastatin, amlodipine besilate, acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), colecalciferol (VITAMIN D), finasteride, irbesartan taken for blood pressure abnormal and tamsulosin. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; Lot Number: EL1284 and expiry date was not provided) via an unspecified route of administration, in left upper arm muscle on 15Jan2021 as SINGLE DOSE for Covid-19 Immunization. It was reported that the patient had both doses of Pfizer vaccine, tomorrow would be four weeks since his second dose. The patient reported that his arm was a little sore and he was a little tired for a day or two. Patient had the antibody test on 01Mar2021 (Monday), got the results on 03Mar2021 as negative and reported that it was not showing any immunity. The patient had no vaccines within 4 weeks of getting his COVID19 Vaccine. The outcome of the events reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for Covid-19; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A 35-years-old male patient (Son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: Not reported) via an un-specified route of administration on an unspecified date as single dose for COVID-19 immuniza-tion. The patient's medical history and concomitant medications were not reported. On an un-specified date, patient experienced tested positive for COVID-19. On an unspecified date, pa-tient underwent lab tests and procedures which included sars-cov-2 test positive: positive. Re-porter wanted to know if her son should still receive the 2nd dose after 21 days or wait until he has recovered before receiving it. Reporter also wanted to know if it would be safe for her pregnant daughter to receive the Pfizer-BioNTech Covid-19 Vaccine, if there are recommenda-tions on what time it would be best for her daughter to receive the vaccine and how her daugh-ter could sign up for the clinical trials for pregnant women and the Pfizer vaccine. Outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: mild sore muscle pain at the injection site; headache; This is a spontaneous report from a contactable consumer (patient). An unspecified aged gender patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were not provided), via an unspecified route of administration, on 16Feb2021, as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 26Jan2021, as a single dose for COVID-19 immunization. It was reported that patient had experienced with mild sore muscle pain at the injection site and a mild headache for a couple of days that could as easily be attributed to normal workday stress. Patient do construction work and If Pfizer begin trials to test the efficacy of a booster vaccine against the Covid19 variants, patient would be happy to participate. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: twisted his knee; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient twisted his knee. On 23Feb2021, treatment received for knee injury which included Cortizone shot in his knee. Reporter was asking if this will interfere with the vaccine 6 days prior. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtain.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: headache; muscle aches; pain; This is a spontaneous report received contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch /lot number not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced a headache and has muscle aches and pain. she wants to know if she can take tylenol. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unknown route on 09Feb2021 at 13:00 (at the age of 75-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included: For allergies the patient takes Loratadine unknown dosage started unknown date, did not think he took Loratadine on 09Feb2021 but he can take it daily if he wants to. The patient injects self every 2 weeks with Dupilumab (Dupixent)started around over a year ago for Chronic dermatitis-further dosage details unknown. The patient had flu shot unknown date, maybe 6-8 months ago. Family medical history included: The patient wife died of Lupus, his dad had heart problems and emphysema from smoking. His mother had leukemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unknown route on 19Jan2021 at 12:00 (at the age of 75-years-old) at single dose on the right arm. Concomitant medications was not provided. After the vaccination of first dose (19Jan2021), the patient had sore arm to lay on for that night. After second dose of vaccination (09Feb2021), the patient was laying in bed around. On 10Feb2021, (at 00:30-01:00), the patient had chills, shaking from being cold and body temperature was above normal. His bedroom was warm, like 80 degrees Fahrenheit. Body temperature above normal. Temperature recorded during this event include 100.3 degrees Fahrenheit about a half hour ago. His body temperature was normally like 97.8 degrees Fahrenheit this time of the day. Right now his body temperature was 100.4 degrees Fahrenheit. His body temperature was never high like that. It was rare if he had a day with a 99 degrees Fahrenheit body temperature. Chills and shaking from being cold lasted about a half an hour. The patient had some warm clothes on and turned the heat up a little bit. He recovered with possible lasting effect of being tired. But the patient always feels tired in the morning so not sure if it was from him not sleeping well last night. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was none. Adverse event following prior vaccinations was none. Physician office or emergency room visit was not required for any event. Outcome of the events While he was laying in bed around 00:30-01:00 10Feb2021 he got chills, shaking from being cold and cold was recovered with sequel. Outcome of the remaining events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unknown route on 09Feb2021 at 13:00 (at the age of 75-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included: For allergies the patient takes Loratadine unknown dosage started unknown date, did not think he took Loratadine on 09Feb2021 but he can take it daily if he wants to. The patient injects self every 2 weeks with Dupilumab (Dupixent)started around over a year ago for Chronic dermatitis-further dosage details unknown. The patient had flu shot unknown date, maybe 6-8 months ago. Family medical history included: The patient wife died of Lupus, his dad had heart problems and emphysema from smoking. His mother had leukemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unknown route on 19Jan2021 at 12:00 (at the age of 75-years-old) at single dose on the right arm. Concomitant medications was not provided. After the vaccination of first dose (19Jan2021), the patient had sore arm to lay on for that night. After second dose of vaccination (09Feb2021), the patient was laying in bed around. On 10Feb2021, (at 00:30-01:00), the patient had chills, shaking from being cold and body temperature was above normal. His bedroom was warm, like 80 degrees Fahrenheit. Body temperature above normal. Temperature recorded during this event include 100.3 degrees Fahrenheit about a half hour ago. His body temperature was normally like 97.8 degrees Fahrenheit this time of the day. Right now his body temperature was 100.4 degrees Fahrenheit. His body temperature was never high like that. It was rare if he had a day with a 99 degrees Fahrenheit body temperature. Chills and shaking from being cold lasted about a half an hour. The patient had some warm clothes on and turned the heat up a little bit. He recovered with possible lasting effect of being tired. But the patient always feels tired in the morning so not sure if it was from him not sleeping well last night. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was none. Adverse event following prior vaccinations was none. Physician office or emergency room visit was not required for any event. Outcome of the events While he was laying in bed around 00:30-01:00 10Feb2021 he got chills, shaking from being cold and cold was recovered with sequel. Outcome of the remaining events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: slight fever; This is a spontaneous report received contactable female patient via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot/batch number not reported), dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (dose 1) for COVID-19 immunisation. On an unknown date, after second shot of vaccination patient had slight fever of 98.8-degree F. It was reported that patient asked if she could take Tylenol for fever. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash; Hives; This is a spontaneous report from a contactable consumer. This consumer reported for a 62-year-old female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via unspecified route of administration in left arm on 4Feb2021 (age at vaccination 62-year-old) as single dose for COVID-19 immunisation. The patient medical history, concomitant medications and past drug history were not reported. On 14Feb2021, patient experienced rash and hives. Reporter states he was calling for his wife, states she received the first shot on 04Feb2021 and after the first one about a week and a half later, 10 days later, she had a rash and hives, states it went away in 2-3 days and they did not think anything of it. Patient started treating hives with calamine lotion late night 28Feb2021. Reporter confirms wife received the Pfizer Covid vaccine, does not have patient card with him to provide NDC, Lot or Expiration Dates for either dose. States she received both doses in her left arm. The outcome of the events were recovered on an unknown date in Feb2021.  No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain which doubles the pain he experienced on his first shot; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer-sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for COVID-19 immunization and experience injection site pain. It was reported that patient received his second dose today (27Feb2021) and he experienced injection site pain which doubles the pain he experienced on his first shot. He was asking if he can apply ice or compress to the injected site. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (huband). A 62-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number and Expiration date was not reported) via an unspecified route of administration in left arm on 25Feb2021 (at the age of 62 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine on first dose of BNT162B2 on 04Feb2021 for covid-19 immunisation. On 26Feb2021 the patient experienced, After her second dose last Thursday, the hives came back, they are causing her no discomfort, he just wanted to report it. Patient started treating hives with calamine lotion late night 28Feb2021. Caller states it is not serious. The patient received treatment for the event hives with calamine lotion. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Nausea
Clinical narrative: headache; Chills; tired; weak; nauseated; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 16Feb2021 as single dose for COVID-19 immunization. Patient was 29 years old at the time of vaccination. On 26Jan2021 at 08:00 am patient received first dose of Bnt162b2 (lot number- EN5318, vaccine location=right arm). The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not test positive for Covid prior to vaccination. Patient did not receive any other vaccine in four weeks. On 16Feb2021 17:00 the patient experienced headache, chills, tired, weak and nauseated. The outcome of the events was recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The caller stated she got the first vaccine on 15Feb2021 and tested positive for Covid on 20Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself via a medical information team. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via unspecified route of administration on 15Feb2021 at single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient had COVID-19. On 20Feb2021 patient tested positive for COVID-19 and now symptom free. She was scheduled for her second dose on 08Mar2021. She asked, if she has no symptoms but gets another test and tests positive can she still get the vaccine? The outcome of the event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Fatigue, Headache, Myalgia
Clinical narrative: tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 65 Years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route of administration in left arm on 28Feb2021 at 10:00 AM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: (ID) 9809), via an unspecified route of administration in left arm on 07Feb2021 at 10:00 AM at single dose for COVID-19 immunisation and experienced head rush immediately after injection, extremely sore arm from first dose. Medical history included COVID 19 and allergic to flagyl, ciprofloxacin. The patient did not received other vaccine in four weeks. The patient did not tested for covid tested post vaccination. Concomitant medications included amlodipine besilate at 2.5 mg, metformin hydrochloride (METFORMIN ER) at 500 mg. On 28Feb2021 at 10:15 PM, the patient experienced tingle in lips, dry mouth, swallowing differences, slight fever, headaches, tried, muscle aches. No treatment was received. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 65 Years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route of administration in left arm on 28Feb2021 at 10:00 AM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: (ID) 9809), via an unspecified route of administration in left arm on 07Feb2021 at 10:00 AM at single dose for COVID-19 immunisation and experienced head rush immediately after injection, extremely sore arm from first dose. Medical history included COVID 19 and allergic to flagyl, ciprofloxacin. The patient did not received other vaccine in four weeks. The patient did not tested for covid tested post vaccination. Concomitant medications included amlodipine besilate at 2.5 mg, metformin hydrochloride (METFORMIN ER) at 500 mg. On 28Feb2021 at 10:15 PM, the patient experienced tingle in lips, dry mouth, swallowing differences, slight fever, headaches, tried, muscle aches. No treatment was received. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive a week after his first dose; tested positive a week after his first dose; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive a week after first dose. The patient was scheduled on 07Mar2021 for his second dose and asked if what to do about it since he was tested positive. The patient underwent lab tests and procedures which included sars-cov-2: positive on an unknown date in 2021. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 same thing for my mom; tested positive for COVID-19 same thing for my mom; This is a spontaneous report from a contactable consumer (patient's child). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first dose and she tested positive after on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021252440 Same reporter/drug/event, different patient.;US-PFIZER INC-2021244030 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: female patient received the first dose of Pfizer's COVID vaccine in Dec and was diagnosed with COVID and was treated with monoclonal antibody infusion; female patient received the first dose of Pfizer's COVID vaccine in Dec and was diagnosed with COVID and was treated with monoclonal antibody infusion; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient was diagnosed with COVID and was treated with monoclonal antibody infusion. The reporter asked if a patient would she be able to get the second dose next week. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events COVID-19, drug ineffective and the suspect vaccine 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 product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021239747 Different patient, same product and events
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: I tested positive on 03Mar2021; I tested positive on 03Mar2021; I was unknowingly exposed close contact; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 12Feb2021 and second dose via an unspecified route of administration on 26Feb2021 both at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported that i received the first vaccine on 12Feb2021. I received the second vaccine on 26Feb2021. I was unknowingly exposed close contact on 26Feb2021. I tested positive on 03Mar2021. I am asymptomatic as of today. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took my first dose and I tested positive for COVID; I took my first dose and I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (Solution for injection), via unspecified route of administration on an unspecified date (Batch/Lot number was unknown) at singe dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included phenytoin (DILANTIN [PHENYTOIN]). The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. It was reported that the patient tested positive for COVID after the first dose of the vaccine. Patient also reported that his parents too tested positive for COVID after vaccination. The patient read vaccination don't give you, you can't get COVID from being vaccinated. The patient's dads doctor told him he don't need to be vaccinated no more cause his dad has cancer and he read that Pfizer did not test the drug on cancer patient. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My mom and my dad they were vaccinated and they caught COVID too; My mom and my dad they were vaccinated and they caught COVID too; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) at single dose for covid-19 immunisation (unspecified age at vaccination). The patient's medical history was not reported. Concomitant medication included phenytoin (DILANTIN [PHENYTOIN]) taken for an unspecified indication. Patient called in seeking assistance with the medication Dilantin. The patient was vaccinated with the Pfizer shot and took first dose and tested positive for COVID and her mom and dad they were vaccinated and they caught COVID too everything that I read it says the vaccination don't give you, you can't get COVID from being vaccinated. We were vaccinated the first time and we've all come down with COVID we all tested positive. Her father doctor told him he don't need to be vaccinated no more cause her dad has cancer and she read that Pfizer did not test the drug on cancer patient's, the vaccine. She heard from doctor's office that were not the only people that's getting vaccinated and then test for COVID. They told that she was probably was already exposed to it, and doing fine and then went to take shot take all of a sudden started feeling bad and went to take the test and was positive. She was looking forward to going back to work and had been off of work since the 15Feb. She could not go back to work until she tested Negative. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. Outcome of the events was unknown.     Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my mom and my dad they were vaccinated and they caught COVID too; my mom and my dad they were vaccinated and they caught COVID too; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included family history of neoplasm malignant (cancer) in father. The patient's concomitant medications were not reported. The patient called in seeking assistance with the medication Dilantin. During the call the patient stated that he was vaccinated with the Pfizer shot. He took his first dose and tested positive for COVID and his mom and dad were vaccinated and they caught COVID too. The patient stated that everything that he had read, it said the vaccination can't give you, you can't get COVID from being vaccinated. He stated that they were vaccinated the first time and they all came down with COVID, all tested positive. He stated that his dad's doctor told him he doesn't need to be vaccinated anymore because his dad has cancer, and he had read that Pfizer did not test the drug on cancer patient's, the vaccine. The patient stated that he heard from his doctor's office that they were not the only people that's getting vaccinated and then tested for COVID. They told him that they were probably already exposed to it, were doing fine and then went to take their shot and all of a sudden they started feeling bad and then they went to take the test and were positive. The patient stated that he was looking forward to going back to work as he had been off of work since the 15th of February. He couldn't go back to work until he tested Negative. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021  as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the covid-19 vaccine on and then tested positive for covid-19. Patient queried if he should receive the second vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test.; positive COVID-19 test.; This is a spontaneous report from a contactable pharmacist (patient).A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 16Dec2020 as single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported.Patient tested Positive for Covid on 29Dec2020. He received bamlanivimab on 05Jan2021 and had out of quarantine 07Jan2021. Patient received 2nd vaccination 08Jan2021. Patient inquired, was he protected, with 2nd shot being so close (at time no info on how long could wait for 2n shot), should he get booster, was there blood test for active protection. the outcome of the event was Unknown.    Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Drug ineffective, Dry mouth, Eye irritation, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; burning eyes; dry mouth; Pink eye; This is a spontaneous report from a contactable consumer (Patient sister).  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number was not reported) dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient after she got the second dose of the vaccine, she was tired she could not get out of bed, had fever, chills, headache and aches. She was long hauler who had COVID. Periodically she had a pink eye, burning eyes, joint pain or dry mouth. Her symptoms were on and off. Sometimes she feels very sick and other times she was okay. After receiving the vaccine, she felt like she had COVID like around three. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected. Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: mother had 1st vaccine on Jan28, she tested positive for Covid; mother had 1st vaccine on Jan28, she tested positive for Covid; This is a spontaneous report from a contactable consumer (Patient's daughter) . A female patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on 28Jan2021 via unspecified route of administration at single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unknown date in 2021, after receiving the vaccine, the patient tested positive for Covid. The patient was supposed to get second dose of Covid vaccine on 18Feb2021 while she was in quarantine. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Patient who received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28Dec2020. While waiting for the second dose, Patient contracted COVID-19; Patient who received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28Dec2020. While waiting for the second dose, Patient contracted COVID-19; had to recover first and it is now past the 6 weeks after the first dose; This is a spontaneous report via a Pfizer sponsored program CEP/PSP: 159558 (Pfiz-er COVID-19 Vaccine Call Center) from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 28Dec2020 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who received the pfizer-biontech covid-19 vaccine first dose on last 28Dec2020 while waiting for the second dose, patient contracted covid-19 on an unspecified date. The patient had to recover first and it was now past the 6 weeks after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of events was unknown.  Information about lot/batch number has been requested.; 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 events Drug ineffective and Covid-19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid positive after getting the 1st dose; got Covid positive after getting the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported similar events for 2 patients (husband and herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 15Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her 1st dose of vaccine BNT162B2 on 15Feb2021 and was tested COVID-19 positive on an unspecified date. The patient was scheduled for second dose of vaccine BNT162B2 on 15Mar2021. Outcome of events was unknown.  Information on lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268440 Differente patient, same drug and AE.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: both of them got positive after getting the 1stdose; both of them got positive after getting the 1stdose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients (husband and herself). This is a 2nd of 2 reports. An unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 15Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient asked that he can take the COVID-19 vaccine 2nd dose and is scheduled for 15Mar2021, and both of them got positive after getting the 1st dose scheduled last 15Feb2021. Outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268439 Differente patient, same drug and AE
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller states she received her first dose of the Pfizer Covid vaccine 04Mar2021. She received a positive Covid PCR test on 10Mar2021; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose of the Pfizer COVID vaccine on 04Mar2021 and on 10Mar2021 she received a positive COVID PCR test. The patient stated that she wanted to know if the positive COVID test could be from the vaccine and inquired about guidance for getting the second dose with having a positive COVID viral test. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test
Clinical narrative: Tested positive/sneeze, lost sense of taste and smell for ten days/felt dizziness, extreme fatigue, stomachache, really horrific headache on the frontal area, had diarrhea for two days,; This is a spontaneous report from a Pfizer-sponsored program from contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 25Jan2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that on 25Jan2021, she got the first dose at (hospital name). On 01Feb2021, she started to sneeze, lost sense of taste and smell for ten days. She tested positive and felt dizziness, extreme fatigue, stomach-ache, really horrific headache on the frontal area, had diarrhea for two days, had checked her temperature and oximeter (92, 91, 90) for ten days in 2021. Her appointment for her second dose was put off and she was told to not get the shot until symptoms subside. On 10Feb2021, all COVID-19 signs and symptoms went away except for constant loss of taste and smell. she was experiencing this until now. The outcome of event was not recovered.   Information about batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269115 Same patient, different dose
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Gotten both vaccines; tested positive/but I have shown no symptoms at all except for runny nose, some sneezing; Gotten both vaccines; tested positive/but I have shown no symptoms at all except for runny nose, some sneezing; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose on unknown date and second dose on 25Feb2021 both via unspecified route of administration as single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that consumer stated, "I received the Pfizer vaccine one and two at the (Hospital name withheld). I received the second shot on 25Feb2021, and that was on a Thursday. I went on the next day, on Tuesday and I tested positive on 02Mar2021, but I have shown no symptoms at all except for runny nose, some sneezing which has popped already. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Mar2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.