chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Rash, Vomiting
Clinical narrative: dizzy; I have a rash on the site; Just feeling very unwell; vomiting; Nauseated; I had the booster vaccine on Thursday; I had the booster vaccine on Thursday; This initial case was previously invalid due to no adverse event. Upon receipt of follow-up information on 11Oct2021, this case now contains all required information to be considered valid  This is a spontaneous report from a contactable Consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 30135BA), via an unspecified route of administration, administered in arm left on 07Oct2021 (at the age of 70 years old) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 01Oct2021 (Batch/Lot number was not reported) to 01Oct2021, at unspecified dose for an unspecified indication. Medical history included diabetes mellitus. Concomitant medications included metformin (METFORMIN), insulin glargine (BASAGLAR) and dulaglutide (TRULICITY) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for covid-19 immunisation. She had any vaccination 4 weeks prior to COVID 19 Vaccine (Booster), it was reported She received the Flu Shot (Unspecified flu shot) on 01Oct2021. On 07Oct2021, the patient had the booster vaccine on Thursday. On 10Oct2021, the patient experienced dizzy, had  a rash on the site, just feeling very unwell, vomiting and nauseated. the patient took I just took Advil and Tylenol, as treatment medication,it was reported 300 and 75mg, was a combination and  took 2, it's a dual action, took 4 pills, yeah but not all at once, took them earlier in the afternoon and then before bed. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 9.5 on 28Sep2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Fatigue, Immunisation, Night sweats
Clinical narrative: pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; fatigue; low fever; decreased appetite; night sweats; dose number=3; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female non-pregnant patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in Left Arm on 07Oct2021 10:00 (at the age of 68-years-old), as dose 3 (BOOSTER), single for covid-19 immunisation. The patient's medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. The patient' concomitant medications included diclofenac (DICLOFENAC) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), om taken for an unspecified indication, start and stop date were not reported with in two weeks. The patient did not take any other vaccine in four weeks. The patient had no covid prior vaccination. The patient not tested for covid post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Left Arm on 13Feb2021 (at the age of 67 years old) as dose 1, single for covid-19 immunisation and received second dose if of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Left Arm on 13Mar2021 ((at the age of 67 years old) as dose 2, single for covid-19 immunisation. On 07Oct2021, the patient received dose number=3, The patient experienced pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats on 07Oct2021 16:00. These symptoms lasted for about 4 days. The patient did not receive treatment. The outcome the events pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; pain, swelling and redness in my upper arm; fatigue; low fever; decreased appetite; night sweats; dose number=3; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old female non-pregnant patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in Left Arm on 07Oct2021 10:00 (at the age of 68-years-old), as dose 3 (BOOSTER), single for covid-19 immunisation. The patient's medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. The patient' concomitant medications included diclofenac (DICLOFENAC) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), om taken for an unspecified indication, start and stop date were not reported with in two weeks. The patient did not take any other vaccine in four weeks. The patient had no covid prior vaccination. The patient not tested for covid post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in Left Arm on 13Feb2021 (at the age of 67 years old) as dose 1, single for covid-19 immunisation and received second dose if of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Left Arm on 13Mar2021 ((at the age of 67 years old) as dose 2, single for covid-19 immunisation. On 07Oct2021, the patient received dose number=3, The patient experienced pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats on 07Oct2021 16:00. These symptoms lasted for about 4 days. The patient did not receive treatment. The outcome the events pain, swelling and redness in upper arm, fatigue, low fever, decreased appetite and night sweats was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This is a spontaneous report from a contactable other hcp (nurse) via medical information team. A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), dose 3 via an unspecified route of administration, administered in arm on 12Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received second dose of Covid-19 vaccine (manufacture unknown) dose 2 via unspecified route of administration on an unspecified date and received Covid-19 vaccine (manufacture unknown) dose 1 via unspecified route of administration on an unspecified date for Covid-19 immunisation. Nurse said they had undiluted vials of the Pfizer-BioNTech Covid-19 Vaccine that were already taken out and shipped to them. She said they were told to use the vaccines until 01Oct2021. However, the vaccines were stored inside the refrigerator for more than 31 days. She said 11 of these vaccines were given to patients. 1 was given as a first dose on 6Oct2021, and the rest were given as booster doses yesterday, 12Oct2021. HCP wants to know if they need to revaccinate the patients. Caller said she had information for the first six patients to provide, but she doesn't have full information for the rest and would have to look those up. Caller said she doesn't have patient's numbers, and doesn't have which arm was given for those last five patients. She says she does have the NDC/LOT/EXP and the date given for those, which for those patients the third dose booster dose was given 06Oct2021. Caller says she doesn't have provider information for the patients other than the for the first patient.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Linked Report(s): US-PFIZER INC-202101368445 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm is still painful and unbearable; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration in Right arm on 13Oct2021, as a Dose 3 (booster), Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received Dose 1 And Dose 2 of COVID-19 Vaccine (unknown manufacturer) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date in Oct2021, the patient arm was still painful and unbearable, and the patient queried if she could put ice or heat on the arm and was preparing to take ibuprofen. The patient also queried if she could be recommended for her painful arm with any treatment. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Immunisation, Peripheral swelling
Clinical narrative: right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; right upper arm swollen to half again its size, hot to tough and red.  7 days after vaccination; dose_number=3; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 68-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: fc3182 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 07Oct2021 at 01:30 PM, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization at Pharmacy or Drug Store (Age at vaccination: 68Years). The patient was not pregnant at the time of vaccination. The patient medical history included COPD and tendinitis. Concomitant medications included influenza vaccine (FLU), naproxen (NAPROXEN), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), salicylic acid (SALICYLIC ACID), albuterol (SALBUTAMOL), ipratropium (IPRATROPIUM). The patient received other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. Previously patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: en6201 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 17Feb2021 at 10:30 AM, as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: en6205 and expiry date was not reported), via an unspecified route of administration in Arm Right, on 09Mar2021 at 10:30 AM, as DOSE 2, SINGLE for covid-19 immunisation. On 07Oct2021 at 01:30 PM, the patient received third dose of BNT162B2 (Booster) and on 08Oct2021 experienced right upper arm swollen to half again its size, hot to tough and red 7 days after vaccination. The AE did not result in emergency room or physician office visit. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Musculoskeletal stiffness, Off label use, Pain
Clinical narrative: Off-label use; Booster; body stiffness; aches; arm soreness (a few days later); fatigue; This is a spontaneous report from a contactable consumer or other non hcp.   This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021124016), license party for etanercept (ENBREL).consumer from a commercial program (PSP00086). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 3 , SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis from an unknown date and unknown if ongoing Primary Immunization series complete but unknown manufacturer. Concomitant medication(s) included etanercept (ENBREL; 50 milligram, qwk).) taken for rheumatoid arthritis from an unspecified start date to Jul2021; etanercept (ENBREL; 50 milligram, qwk Lot number: 1127966; 1089818) taken for an unspecified indication from Jul2021 and ongoing. The patient experienced does not feel , injections site bruised slightly as well [injection site bruising], became puffy [injection site swelling .She experienced puffiness and swelling at the injection site twice. In 2021, the patient experienced body stiffness (musculoskeletal stiffness), aches (pain) (non-serious), arm soreness (a few days later) (pain in extremity), fatigue (fatigue). On 26Aug2021, the patient experienced off-label use (off label use) and booster (immunization). The clinical outcome for all the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Off-label use; Booster; body stiffness; aches; arm soreness (a few days later); fatigue; This is a spontaneous report from a contactable consumer or other non hcp.   This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021124016), license party for etanercept (ENBREL).consumer from a commercial program (PSP00086). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 3 , SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis from an unknown date and unknown if ongoing Primary Immunization series complete but unknown manufacturer. Concomitant medication(s) included etanercept (ENBREL; 50 milligram, qwk).) taken for rheumatoid arthritis from an unspecified start date to Jul2021; etanercept (ENBREL; 50 milligram, qwk Lot number: 1127966; 1089818) taken for an unspecified indication from Jul2021 and ongoing. The patient experienced does not feel , injections site bruised slightly as well [injection site bruising], became puffy [injection site swelling .She experienced puffiness and swelling at the injection site twice. In 2021, the patient experienced body stiffness (musculoskeletal stiffness), aches (pain) (non-serious), arm soreness (a few days later) (pain in extremity), fatigue (fatigue). On 26Aug2021, the patient experienced off-label use (off label use) and booster (immunization). The clinical outcome for all the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Off label use, Peripheral swelling
Clinical narrative: Swollen arm; underarm/lymph nodes; dose number=3; dose number=3; This is a spontaneous report from a non-contactable other hcp (patient). A 36-years-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0191) via an unspecified route of administration on an unspecified date (age at vaccination 36-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Jan2021 (age at vaccination 35-years-old) as dose 2, single for COVID-19 immunization. No COVID prior vaccination. No COVID tested post vaccination. Patient had no known allergies. On an unspecified date, the patient experienced Swollen arm, underarm/lymph nodes, and dose number=3. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Immunisation, Myalgia, Nausea
Clinical narrative: Chills.; Nausea; Diarrhea; muscle aches; Booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old male patient received bnt162b2 (Comirnaty, Solution for injection) via intramuscular, administered in arm left on 13Oct2021 12:30 (Lot Number: FF8839) (at the age of 35-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included known allergies: Sulfa Drugs from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient had previously received the second dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 04Feb2021 (Lot Number: FL3247) (at the age of 35-years-old) as dose 2, single and first dose of bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration, on 15Jan2021 (Lot Number: EL3247) (at the age of 35-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 13Oct2021 12:30, had administered booster. On 13Oct2021 16:30, the patient experienced nausea, diarrhea, muscle aches, chills. The patient did not received treatment for the events. The outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Abdominal discomfort, Blood test, Dizziness postural, Gait disturbance, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Oct2021 (at the age of 83-year-old) as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration administered in the right arm on 12Oct2021 (at the age of 83-year-old) (Batch/Lot number was not reported), at single for immunization. Medical history included Heart Surgery in 2003 (They told him he would only be good for 10 years but its been 18 years now and he was still good), Hernia Repair Surgery (He's an auto mechanic, He's had 4 in total. The last one was about 10 years ago.), Caller states that he needs to get his other glasses to see. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol (METOPROLOL), both taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm on 10Feb2021 (Lot number: EL9262) (at the age of 83-year-old) as a single dose and dose 2 via an unspecified route of administration in the left arm on 02Mar2021 (Lot number: EN6201) (at the age of 83-year-old) as a single dose for covid-19 immunization. The patient mentioned that he received his third shot on 12Oct2021 at the same time with his flu vaccine. He had concerns. He got the vaccine on Tuesday (12Oct2021), then on Wednesday (13Oct2021) and Thursday (14Oct2021) his stomach was upset. Upset stomach was very very little now, on Wednesday or Thursday it's like he was trying to throw up but nothing would come out, he laid down, and it went away, it is not as bad as before. Now today (15Oct2021) he was dizzy. He was just a little dizzy, when standing up, he feels a little bit off. Dizzy did not start in the morning, actually he went out and did his work, and around 3PM (15.00) today he got up and was woozy dizzy, he was still the same way, he was dizzy but can still walk, everything was not the same. He had a little trouble walking. He was not sure if that's part of what the vaccine was supposed to do. He got both shots of the Pfizer covid vaccine and the Flu shot. He wanted to know if this was a normal wide effect, could he get dizziness a couple days after. Patient asked if there could be delay in onset of symptoms or side effects of the vaccine. The patient had bloodwork done a couple months ago and his liver and kidney looked good. Outcome of the event dizzy was not recovered, upset stomach, trying to throw up but nothing would come out was recovering; other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Oct2021 (at the age of 83-year-old) as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration administered in the right arm on 12Oct2021 (at the age of 83-year-old) (Batch/Lot number was not reported), at single for immunization. Medical history included Heart Surgery in 2003 (They told him he would only be good for 10 years but its been 18 years now and he was still good), Hernia Repair Surgery (He's an auto mechanic, He's had 4 in total. The last one was about 10 years ago.), Caller states that he needs to get his other glasses to see. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol (METOPROLOL), both taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm on 10Feb2021 (Lot number: EL9262) (at the age of 83-year-old) as a single dose and dose 2 via an unspecified route of administration in the left arm on 02Mar2021 (Lot number: EN6201) (at the age of 83-year-old) as a single dose for covid-19 immunization. The patient mentioned that he received his third shot on 12Oct2021 at the same time with his flu vaccine. He had concerns. He got the vaccine on Tuesday (12Oct2021), then on Wednesday (13Oct2021) and Thursday (14Oct2021) his stomach was upset. Upset stomach was very very little now, on Wednesday or Thursday it's like he was trying to throw up but nothing would come out, he laid down, and it went away, it is not as bad as before. Now today (15Oct2021) he was dizzy. He was just a little dizzy, when standing up, he feels a little bit off. Dizzy did not start in the morning, actually he went out and did his work, and around 3PM (15.00) today he got up and was woozy dizzy, he was still the same way, he was dizzy but can still walk, everything was not the same. He had a little trouble walking. He was not sure if that's part of what the vaccine was supposed to do. He got both shots of the Pfizer covid vaccine and the Flu shot. He wanted to know if this was a normal wide effect, could he get dizziness a couple days after. Patient asked if there could be delay in onset of symptoms or side effects of the vaccine. The patient had bloodwork done a couple months ago and his liver and kidney looked good. Outcome of the event dizzy was not recovered, upset stomach, trying to throw up but nothing would come out was recovering; other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus
Clinical narrative: Lichen Planus; This is a spontaneous report from a contactable consumer (patient). This consumer reported in response to non-health care professional letter sent.  A 60-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 06Apr2021 at 14:30 (at the age of 60-years-old) as dose 2, single for covid-19 immunization. Patient medical history including any illness at time of vaccine was none. Concomitant medications included vitamin d3. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 13Mar2021 at 15:15 PM (at the age of 60-years-old) as dose 1, single for covid-19 immunization and had a feeling of lesion in the lower left area of mouth. On 07Apr2021, right after second shot the patient experienced lichen planus. Patient started feeling a lesion in the lower left area of mouth in front of the lower teeth. Reporter stated the day after the 2nd shot of the vaccine on 07Apr2021 went to dentist, they photographed it. Thought it was an allergic reaction to vitamin D3 that patient was taking, but stopped that and it got worse, went to dentist a few weeks later then lesion got larger and there were more. Dental hygienist said they never saw them in the mouth in the 6 years while cleaning teeth. Surgeon suggested a biopsy and they removed a portion from upper right side inside mouth near jaw in cheek area. (6 stitches). Confirmed Lichen Planus "Possibly due to vaccine". The patient underwent lab tests and procedures mouth lesion biopsy which included a result of non-cancer lichen planus on 28Jun2021. Reporter considered the event as non-serious. Therapeutic measures were taken as a result of the event. The clinical outcome of the event was not recovered at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Dizziness, Gait disturbance
Clinical narrative: I got my second Pfizer shot on 05Oct so it''s been about 16 days now since I got my second shot and my body still feels weird it still feels weak.; I am getting headaches every day.; I do have little blood pressure which sometimes make me dizzy.; I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot.; I was getting chest pain.; I have just been sleeping a lot.; I do have little blood pressure which sometimes make me dizzy.; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Oct2021 as dose 2, single for covid-19 immunisation. Medical history included hypotension: Low blood pressure, migraine, anxiety disorder. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid 19 immunization. It was reported that, Consumer stated, "I got my second Pfizer shot on 05 Oct, so it's been about 16 days now since I got my second shot, and my body still feels weird it still feels weak and I am getting headaches every day. Consumer stated, "I have just been sleeping a lot. I do have little blood pressure which sometimes make me dizzy but when I went to my cardiologist, he said my blood pressure has been perfect. The day that I got the shot my blood pressure was still perfect, but I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot or since I got the shot and it just doesn't seem to be letting up now and it starting to scare me because I got it on 5th and it's already been 19th.The event The events my body still feels weird it still feels weak and I am getting headaches every day, chest pain, sleeping a lot, weak and dizzy infect last night I could barely walk, low blood pressure .The outcome of the events was unknown on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: little blood pressure on blood pressure measurement: perfect on when I went to my cardiologist he said my blood pressure has been perfect , blood pressure measurement: still perfect  on 05Oct2021 The day that I got the shot my blood pressure was still perfect , laboratory test: negative on Lab Test performed recently: Consumer stated, "Nearly lab work they did was they took blood to make sure that it didn't get any blood clot from the Pfizer medication. I mean from the Pfizer shot because I was getting chest pain. But it came back negative. Thank-goodness." (Further not clarified hence tab left unchecked). The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of , i do have little blood pressure which sometimes make me dizzy. (hypotension).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Laboratory test, Somnolence
Clinical narrative: I got my second Pfizer shot on 05Oct so it''s been about 16 days now since I got my second shot and my body still feels weird it still feels weak.; I am getting headaches every day.; I do have little blood pressure which sometimes make me dizzy.; I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot.; I was getting chest pain.; I have just been sleeping a lot.; I do have little blood pressure which sometimes make me dizzy.; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 05Oct2021 as dose 2, single for covid-19 immunisation. Medical history included hypotension: Low blood pressure, migraine, anxiety disorder. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 for covid 19 immunization. It was reported that, Consumer stated, "I got my second Pfizer shot on 05 Oct, so it's been about 16 days now since I got my second shot, and my body still feels weird it still feels weak and I am getting headaches every day. Consumer stated, "I have just been sleeping a lot. I do have little blood pressure which sometimes make me dizzy but when I went to my cardiologist, he said my blood pressure has been perfect. The day that I got the shot my blood pressure was still perfect, but I have just been really weak and dizzy infect last night I could barely walk and this is 16 days after I got the shot or since I got the shot and it just doesn't seem to be letting up now and it starting to scare me because I got it on 5th and it's already been 19th.The event The events my body still feels weird it still feels weak and I am getting headaches every day, chest pain, sleeping a lot, weak and dizzy infect last night I could barely walk, low blood pressure .The outcome of the events was unknown on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: little blood pressure on blood pressure measurement: perfect on when I went to my cardiologist he said my blood pressure has been perfect , blood pressure measurement: still perfect  on 05Oct2021 The day that I got the shot my blood pressure was still perfect , laboratory test: negative on Lab Test performed recently: Consumer stated, "Nearly lab work they did was they took blood to make sure that it didn't get any blood clot from the Pfizer medication. I mean from the Pfizer shot because I was getting chest pain. But it came back negative. Thank-goodness." (Further not clarified hence tab left unchecked). The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of , i do have little blood pressure which sometimes make me dizzy. (hypotension).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation, Off label use
Clinical narrative: feels lousy today; Patient received third dose of bnt162b2 vaccine; Patient received third dose of bnt162b2 vaccine; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Oct2021 (age at vaccination was 52 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; palbociclib (IBRANCE, Film coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 02Oct2021 to an unspecified date, at 125 mg for malignant neoplasm of overlap sites of right female breast. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for covid-19 immunization. Patient wants to take ibuprofen and per facts and clinical pharm. On 23Oct2021 (1 day after vaccination), reported as today, the patient felt lousy. The outcome of the event was unknown. The action taken in response to the event for palbociclib was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperventilation, Nausea, Vertigo
Clinical narrative: severe vertigo; nausea; heavy breathing; dizzy; This is a spontaneous report from a contactable nurse (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (Lot Number: ER8733) as DOSE 2, SINGLE for COVID-19 immunization in an urgent care center at the age of 67 years old. Medical history included HBP (Blood pressure high), IBS (Irritable bowel syndrome), hypothyroid and sinus infection from an unknown date; and vertigo from 2013 to an unknown date. The patient was not pregnant at time of vaccination. The patient previously took BNT162B2 dose 1 on 14Mar2021 12:15 PM left arm  (Lot number: EN6208) at the age of 67 years old for COVID-19 immunization. Concomitant medication(s) included influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT) taken for immunisation from 28Sep2021 to 28Sep2021; nadolol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; aliskiren taken for an unspecified indication, start and stop date were not reported; asa (ASA) taken for an unspecified indication, start and stop date were not reported. On 12May2021 05:00 AM, the patient developed severe vertigo, dizzy, nausea and heavy breathing and required an ER visit. Developed several other vertigo events on 17Sep2021 and 20Sep2021 also requiring ER visits with similar symptoms. Treatment received for events such as IV Benadryl and Zofran. The patient had no COVID-19 or have not tested for COVID-19 prior to vaccination. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on temporal relationship. However, the patient's underlying medical history of vertigo may have contributed to the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Deafness unilateral, Myalgia, Nausea, Pyrexia
Clinical narrative: Unable to hear out of left hear due to severe tinnitus; Severe Tinnitus and mild vertigo; Severe Tinnitus and mild vertigo; severe muscle aches diffusely; fever (103.1); nausea; vomiting; This is a spontaneous report from a contactable Physician (patient). A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Oct2021 13:00 (Batch/Lot Number: FH8020) (at the age of 36 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 prior vaccination. There were no known allergies. There was no other vaccine in four weeks. The patient's concomitant medications were not reported. It was reported that 12 hours after vaccination (reported as on 23Oct2021 12:00 AM), there were severe muscle aches diffusely, fever (103.1), nausea, vomiting. These lasted for 3.5 days (also being reported as not recovered, pending clarification). Then 4 days after vaccination (26Oct2021), there was Severe Tinnitus and mild vertigo. Patient was unable to hear out of left ear due to severe tinnitus. The outcome of events was not recovered. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment was used for the events (primary care doctor - medication).  COVID was not tested post vaccination.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: Unable to hear out of left hear due to severe tinnitus; Severe Tinnitus and mild vertigo; Severe Tinnitus and mild vertigo; severe muscle aches diffusely; fever (103.1); nausea; vomiting; This is a spontaneous report from a contactable Physician (patient). A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Oct2021 13:00 (Batch/Lot Number: FH8020) (at the age of 36 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 prior vaccination. There were no known allergies. There was no other vaccine in four weeks. The patient's concomitant medications were not reported. It was reported that 12 hours after vaccination (reported as on 23Oct2021 12:00 AM), there were severe muscle aches diffusely, fever (103.1), nausea, vomiting. These lasted for 3.5 days (also being reported as not recovered, pending clarification). Then 4 days after vaccination (26Oct2021), there was Severe Tinnitus and mild vertigo. Patient was unable to hear out of left ear due to severe tinnitus. The outcome of events was not recovered. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment was used for the events (primary care doctor - medication).  COVID was not tested post vaccination.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge
Clinical narrative: vaginal discharge that was abnormal; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jun2021, the patient experienced vaginal discharge that was abnormal and it worried her so she didn't go back for the second dose. Patient was inquiring about additional information for receiving the second dose of the Pfizer Covid-19 vaccine outside of the recommended time frame. Outcome of the event was unknown at the time of reporting.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Essential thrombocythaemia, Gene mutation, Platelet count
Clinical narrative: genetic mutation; Essential Thrombocythemia; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Apr2021 13:00 (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history was reported none. The patient had no known allergies. Concomitant medication included ethinylestradiol, norethisterone acetate (FYAVOLV) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The vaccine was administered in a pharmacy or drug store. There were no other vaccine received in four weeks. The patient had no COVID-19 prior vaccination.  Historical vaccine included the first dose of BNT162B2  an unspecified route of administration, administered in the right arm on 24Mar2021 13:00 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunization. On 01Jul2021 12:00, the patient experienced essential thrombocythemia (medically significant). It was reported that approximately 2.5 months after receiving her second dose of Pfizer Covid-19, patient's blood results showed an alarmingly high platelet count and she had to see a hemotologist who ultimately diagnosed it as essential thrombocythemia, which could be caused by a genetic mutation (unspecified date). The timing made her concerned that possibly the vaccine had triggered this condition, which the patient now had to take medication for the rest of her life. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment, the patient was prescribed hydroxyurea medication. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovered with sequelae.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain is radiation down her arm into the left wrist on her pinky side; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Oct2021 (lot number and expiry date: unknown) as dose 3 (booster), single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first and second doses of bnt162b2 (COMIRNATY), for Covid-19 immunisation. Patient received Pfizer vaccine booster. Patient stated that she had an incident in the pharmacy. It was her first time to get hurt after she received it. She wanted to know if by any chance there might be an error that it hit her nerve. She was advised to report the event. She added that the nerve pain was radiating down her arm into the left wrist on her pinky side. Patient would like to know if she can take ibuprofen for her pain. The event was considered non-serious. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain lower, Constipation, Haematochezia, Product use issue
Clinical narrative: Blood present in stool at 5am; pain in lower abdomen; constipation; BNT162B2 on 26Oct2021, influenza vaccine on 26Oct2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via unspecified route in right arm on 26Oct2021 14:00 (Lot Number: FF2589) single dose for covid-19 immunization at 44-year-old; influenza vaccine via unspecified route in Left Arm on 26Oct2021 unspecified dose for immunisation. Medical history included diverticulum. No known allergies, no covid prior vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD); iron; vitamin D. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunisation, first dose on 28Mar2021 13:00 (lot number: ER2613) at 44-year-old, second dose on 16Apr2021 13:00 at 44-year-old; both had upset stomach and diarrhea. The patient experienced blood present in stool, pain in lower abdomen, constipation on 28Oct2021 05:00 with outcome of unknown. The third dose of vaccination was administered on 26Oct2021, patient woke up with pain in lower abdomen, constipation. Blood present in stool at 5am. The patient was keeping an eye on symptoms and would seek medical attention if it didn't improve. Outcome of the other event was unknown.  No follow-up attempts are needed. No further information is expected.