chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: feel 1000% better for her bones; feel 1000% better for her bones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown,single for covid-19 immunisation. Relevant medical history included: "COVID shot made her feel 1000% better for her bones" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "feel 1000% better for her bones"   Additional Information:Attempted transfer from Withheld with Pfizer who reports that the other party just hung up.it helped her tremendously, better than another medication she said she was taking. Agent doesn't know what the other medication was. Agent reports caller said it was short and didn't last.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 04Dec2021, outcome "recovered" (04Dec2021), described as "Sore back". Additional information: Reporter stated that, my daughter (patient) received the Pfizer vaccine 5 to 11 year old yesterday and for the second shot. Patient was fine and reporter just want to report that side effect. Patient didn't have pain in her arm normal, no fever, nothing she was fine.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Foot pain; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US105763_OS.  A 76-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Foot pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine; Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "Get her period 20 days late each month; no flow but its heavy blood and this happen as soon as she got her 1st vaccine"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: The report was not related to a study or programme. Reporter seriousness for the events was unspecified. Expiry Date of Pfizer BioNTech COVID-19 Vaccine was unknown. The reporter thought the patient was probably in her 30s. The reporter had weird female/hormonal side effects she gets her period 20 days late each month she says no flow but its heavy blood and this happen as soon as she got her 1st vaccine. She wrote headache and she never had headache before. Lot number Pfizer employee stated, "no, asked her she couldn't share that since she would but she hasn't yet I know there was specific time under which she have to report it so she never got it so don't have it.  QR Comment: Further clarifications unknown hence, patient is reporter tab left unchecked. Reporter type not probed over call hence captured as consumer or other non-hcp by default.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 2 others and they had the same pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "2 others and they had the same pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: booster; got infected with covid19 two weeks after receiving the booster dose; got infected with covid19 two weeks after receiving the booster dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with covid19 two weeks after receiving the booster dose". The reporter stated that the patient chose to get the 3 doses of the vaccines but got infected with covid19 two weeks after receiving the booster dose and was feeling severely unwell. She stated that the vaccines may as well not be effective.  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
Symptoms: Heavy menstrual bleeding
Clinical narrative: period on 09Dec and it started to go away around 14Dec and around the 16th I started bleeding again and on the 18th 19th 20Dec I bled a lot like another period; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 15:45 (Lot number: Fe3594) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 18Dec2021, outcome "recovered" (20Dec2021), described as "period on 09Dec and it started to go away around 14Dec and around the 16th I started bleeding again and on the 18th 19th 20Dec I bled a lot like another period". Therapeutic measures were not taken as a result of heavy menstrual bleeding. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Myocarditis
Clinical narrative: his heart is inflamed; heart has been acting up; he is tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization.The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "his heart is inflamed"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart has been acting up"; FATIGUE (non-serious), outcome "unknown", described as "he is tired". it was explained that the patient got his 2nd dose like might be a couple of months ago and his heart has been acting up and he was tired. He works in close contact because he was in the hospital obviously. He was completely healthy person and now 3 different doctors have said that his heart was inflamed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Immunisation
Clinical narrative: Tested positive for covid-19; Tested positive for covid-19; Male patient received Pfizer/BioNTech booster in Dec2021; Sore throat; Cough; Chills; Fever; Fell ill; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An adult male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Covid-19 vaccine (Dose Number: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Dec2021) and all described as "Tested positive for covid-19"; IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "Male patient received Pfizer/BioNTech booster in Dec2021"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Sore throat"; COUGH (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Cough"; CHILLS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Chills"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fever"; MALAISE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fell ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: if Covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of covid-19, oropharyngeal pain, cough, chills, pyrexia, malaise.  Clinical course: Male patient received Pfizer/BioNTech booster in Dec2021. He attended a work Christmas party and fell ill (sore throat, cough, chills, fever) the next couple days. He tested positive for Covid-19. He has recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; Tested positive for covid-19; Male patient received Pfizer/BioNTech booster in Dec2021; Sore throat; Cough; Chills; Fever; Fell ill; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An adult male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure"; Covid-19 vaccine (Dose Number: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "Covid-19", "Vaccination failure". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Dec2021) and all described as "Tested positive for covid-19"; IMMUNISATION (medically significant) with onset Dec2021, outcome "unknown", described as "Male patient received Pfizer/BioNTech booster in Dec2021"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Sore throat"; COUGH (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Cough"; CHILLS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Chills"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fever"; MALAISE (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Fell ill". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: if Covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of covid-19, oropharyngeal pain, cough, chills, pyrexia, malaise.  Clinical course: Male patient received Pfizer/BioNTech booster in Dec2021. He attended a work Christmas party and fell ill (sore throat, cough, chills, fever) the next couple days. He tested positive for Covid-19. He has recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Covid". The patient has Covid. The reporter was unsure about vaccination status, but more than likely the patient has been vaccinated. The reporter was unsure what vaccine and dosage the patient received.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; Tested positive for COVID-19; mild symptoms of COVID-19 (scratchy throat and mild congestion); Tested positive for COVID-19; mild symptoms of COVID-19 (scratchy throat and mild congestion); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Household member contracted COVID-19 and was a close contact of the patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The patient was in good health. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19; mild symptoms of COVID-19 (scratchy throat and mild congestion)". Event took place after use of product, 25 days after receiving third dose (booster) of BNT162B2. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms; contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "contracted Covid-19 almost 3 weeks after his second dose of comirnaty/had mild cold like symptoms". The event took place after use of the prouduct. The patient contracted Covid-19 almost 3 weeks after his second dose of Comirnaty. The patient had mild cold like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Overweight, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; overweight; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovering" and all described as "tested positive for Covid-19"; OVERWEIGHT (non-serious) with onset 2021, outcome "unknown", described as "overweight". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. Clinical courses: Symptoms were moderate for approximately 3 days and are now subsiding. While the patient is considered overweight he is otherwise in good health.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: contracted Covid-19; contracted Covid-19; Mild cold- like symptoms; fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "mild (controlled) asthma." (unspecified if ongoing), notes: Patient has a history of mild (controlled) asthma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted Covid-19"; NASOPHARYNGITIS (non-serious), outcome "recovered", described as "Mild cold- like symptoms"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: the patient contracted Covid-19 approximately 7 months after second dose of bnt162b2. Mild cold- like symptoms noted along with fatigue. Symptoms lasted approximately 7 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: We got vaccinated and boosted; we recently tested positive for COVID; we recently tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "We got vaccinated and boosted"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we recently tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101874487 Same reporter/drug/event for different patients.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Change of bowel habit, Faeces soft, Flatulence
Clinical narrative: severe and frequent malodorous flatulence; change in bowel habits; bloating; cramping after eating; soft stools; Booster; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 63 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, lot number unknown, Anatomical Location: Arm Left), administration date: 25Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 1, lot number unknown, Anatomical Location: Arm Left), administration date: Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; FLATULENCE (non-serious) with onset 05Dec2021, outcome "not recovered", described as "severe and frequent malodorous flatulence"; CHANGE OF BOWEL HABIT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "change in bowel habits"; ABDOMINAL DISTENSION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "bloating"; ABDOMINAL PAIN (non-serious) with onset 05Dec2021, outcome "not recovered", described as "cramping after eating"; FAECES SOFT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "soft stools". Therapeutic measures were not taken as a result of flatulence, change of bowel habit, abdominal distension, abdominal pain, faeces soft.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation
Clinical narrative: severe and frequent malodorous flatulence; change in bowel habits; bloating; cramping after eating; soft stools; Booster; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 63 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, lot number unknown, Anatomical Location: Arm Left), administration date: 25Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 1, lot number unknown, Anatomical Location: Arm Left), administration date: Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; FLATULENCE (non-serious) with onset 05Dec2021, outcome "not recovered", described as "severe and frequent malodorous flatulence"; CHANGE OF BOWEL HABIT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "change in bowel habits"; ABDOMINAL DISTENSION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "bloating"; ABDOMINAL PAIN (non-serious) with onset 05Dec2021, outcome "not recovered", described as "cramping after eating"; FAECES SOFT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "soft stools". Therapeutic measures were not taken as a result of flatulence, change of bowel habit, abdominal distension, abdominal pain, faeces soft.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Antibody test, Appendicitis, SARS-CoV-2 test, Weight increased
Clinical narrative: I had acute appendicitis resulting in surgery; I had abdominal bloating; A weight gain of 6 lbs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 11Dec2021 13:30 (Lot number: FJ8757) at the age of 34 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIPLE MAGNESIUM COMPLEX. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EG3527, Left arm, at 10:45 AM), administration date: 20Nov2021, when the patient was 34 years old, for COVID-19 Immunization; Flu, administration date: 26Oct2021, for vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: APPENDICITIS (hospitalization, medically significant, life threatening) with onset 19Dec2021 09:00, outcome "recovering", described as "I had acute appendicitis resulting in surgery"; ABDOMINAL DISTENSION (hospitalization, life threatening) with onset 13Dec2021, outcome "recovering", described as "I had abdominal bloating"; WEIGHT INCREASED (hospitalization, life threatening) with onset 13Dec2021, outcome "recovering", described as "A weight gain of 6 lbs". The patient was hospitalized for appendicitis, abdominal distension, weight increased (hospitalization duration: 1 day(s)). The events "I had acute appendicitis resulting in surgery", "I had abdominal bloating" and "a weight gain of 6 lbs" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: antibody test: (Sep2021) positive; sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab; weight increased: (Dec2021) gain of 6 lbs. Therapeutic measures were taken as a result of appendicitis, abdominal distension, weight increased. Additional information: The day after the second dose, the patient had abdominal bloating and a weight gain of 6 lbs by 13Dec2021, which subsided. Then on 19Dec2021 (day 8 after 2nd dose), the patient had an acute appendicitis resulting in surgery by day 9. The patient was positive for antibodies in Sep2021 prior to vaccine. Treatment for the event appendicitis included laparoscopic appendectomy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeding disorder, SARS-CoV-2 test
Clinical narrative: breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough; breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough; she is not eating; This is a spontaneous report received from a contactable consumer (the child of the patient) from  group.  A 78 year-old female patient received BNT162b2, administration date 13Apr2021 (Lot number: ER8734, NDC number: 5926-1000-03) at the age of 78 years as dose 2, single and administration date 23Mar2021 (Batch/Lot number: unknown, NDC number: 59267-1000-03) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history (No other medical condition, she is very healthy). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough"; FEEDING DISORDER (non-serious), outcome "unknown", described as "she is not eating". The patient underwent SARS-COVID RNA test: positive. Clinical course: The reporting consumer (patient's child) and the patient came to visit from out of state for the holidays. They were fully vaccinated, the patient was vaccinated with Pfizer and the child's was Moderna and they both have breakthrough cases of COVID. The state only reports the breakthrough cases of the people who have died and who are either bedded or on ventilator in the hospital and that is not good enough for the patient and her child. They had no way to report their breakthrough cases, that was why the child was calling Pfizer directly. The child had signed the patient up for 'Monoclonal' anti body therapy (They did not call the patient back and then they called the patient on the seventh day and said too many fax order came on the top of "yours" and the child kept filing for the patient). The child knew there were other treatment, shots and because the patient is of (off) age, she did not get any help. The patient's weight was 120 pounds, probably a little less now, she is not eating. The patient was suffering from COVID symptoms that make sense right, malaise, cough.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. The reported cause of death was myocardial infarction. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101881803 Same reporter/ drug/ event, different patient;US-PFIZER INC-202101881804 Same reporter/ drug/ event, different patient; Reported Cause(s) of Death: Heart attack
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal," described as "heart attack." The patient date of death was unknown. The reported cause of death was myocardial infarction. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101881775 Same reporter/ drug/ event, different patient;US-PFIZER INC-202101881804 Same reporter/ drug/ event, different patient; Reported Cause(s) of Death: heart attack
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "a little soreness".  Additional information: The patient stated, she did not have a problem her call was about the timeline for her 2nd vaccine. They gave her 28 days instead of 21 and she was concerned. Aside from a little soreness no problems after either shot. Thank you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (09Mar2021): The initial was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 09Mar2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported in response to the Non-HCP letter sent which included that: Event little soreness and other additional information was added.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine, and mentioned that it wasn't until after the vaccination that she read about ibuprofen and NSAIDs with the vaccination. Patient mentioned she had some back issues and took pain relievers (Patient doesn't have the specific date or time of taking the Advil). Patient was asking if she had "ruined her vaccination". Patient had her 1st and 2nd dose and she recently read in an article that Ibuprofen should not be taken before taking the vaccine. She did not know about this information and she had taken Ibuprofen to relieve her pain in between the vaccine doses. She would like to inquire what will happen if she had taken the Ibuprofen with her Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Potentiating drug interaction
Clinical narrative: He said he will be taking methylprednisolone and Neo/Poly/Dex eye drops; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 52 -old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "He said he will be taking methylprednisolone and Neo/Poly/Dex eye drops".  Additional information: Patient states he is scheduled to receive his second shot 24Mar2021. Patient having an eye surgery on 22Mar2021 prior to the scheduled second vaccination date and he wants to ensure none of the medications from the surgery will effect the efficacy of the second vaccine. Patient doctor has told him the medications will not interfere but he wants to make sure.  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: Fatigue, Pain in extremity
Clinical narrative: sore arm; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 16:00 (Lot number: EN5318) at the age of 68 years as dose 1, single for covid-19 immunisation. Family history included: "Meniere's syndrome" (unspecified if ongoing); "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "recovered" (27Feb2021), described as "sore arm"; FATIGUE (non-serious) with onset 05Feb2021, outcome "recovered" (09Mar2021), described as "tiredness".  Additional information: The patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (First dose last 04Feb2021 and Second dose on 25Feb2021), reported to have various side effects: Dose 1: sore arm, tiredness & Dose 2: sore arm, tiredness, minor chills, headache, and vertigo. The patient mentioned she had no other medications. She was asking for her vertigo when its going to go away because she mentioned that 6 days after the second dose it was still there. The patient stated that she just got some side effects and is wondering if they will go away; they are not bad but and they seem to be going away. Adds they are just minor side effects. She received the first dose of the Pfizer COVID 19 vaccine on 04Feb2021 at 1600PM in the left arm. The next day she had a sore arm; and tiredness; these effects resolved after a day or so. She received the second dose of the Pfizer COVID 19 vaccine on 25Feb2021 at 16:00PM in the left arm. Again the next day she had a sore arm; and tiredness. Then she had minor chills and a slight headache that resolved in a day or so. Then she started to have episodes of vertigo on day six and that worried her. It did happened many times during the day whenever she would turn her head or get up or sit down. She has had the vertigo everyday since from 04Mar2021 to today although it seems to be getting less. Mentioned she is very healthy and does not take any medications. Pfizer COVID 19 vaccine; treatment first dose 4Feb2021/second dose 25Feb2021;Lot for second dose is EN6202. Time the Vaccination Was Given: 04Feb2021 at 16:00PM/25Feb2021 at 16:00PM. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The adverse events did not require a visit to physician or ER. The patient had no prior Vaccinations (within 4 weeks), no Medical History (including any illness at time of vaccination). She reported that her mother had vertigo in her 70's due to Meniere's syndrome of the inner ear.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Pain in extremity
Clinical narrative: experienced a sensation in the back of her throat, not a burning, but like a heated sensation; it was a weird sensation; her arm is hurting; tired; headache; burning/warm sensation in the back of her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Lot number: EN6205) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "headache"; THROAT IRRITATION (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "burning/warm sensation in the back of her throat"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "unknown", described as "her arm is hurting"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tired"; FEELING HOT (non-serious), outcome "unknown", described as "experienced a sensation in the back of her throat, not a burning, but like a heated sensation"; FEELING ABNORMAL (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "it was a weird sensation".  Additional information: Caller stated that she received the first dose of the pfizer covid 19 vaccine yesterday and within five seconds she got an instant headache and then a few seconds after that felt a burning/warm sensation in the back of her throat. Caller stated that it was completely gone in one-half hour. Caller stated that her arm was hurting and tired today. Caller wanted to know if this has been reported and was it safe to get the second shot. Caller states that she also experienced a sensation in the back of her throat, not a burning, but like a heated sensation, like people get if they go for a CAT scan or Magnetic resonance imaging (MRI), with the dye, but it happened within seconds of getting the vaccination. Caller was passionate about getting the vaccine because she takes care of her 92-Years-old mother who had Dementia and Parkinson's and the caller smokes, so she just had to get the vaccine. Caller states that it was a weird sensation and only lasted about 10 minutes and then it dissipated, but she did feel it for another two hours, but then it went away completely. Caller states that she was either 119 or 120 pounds.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: experienced a sensation in the back of her throat, not a burning, but like a heated sensation; it was a weird sensation; her arm is hurting; tired; headache; burning/warm sensation in the back of her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Lot number: EN6205) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "headache"; THROAT IRRITATION (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "burning/warm sensation in the back of her throat"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "unknown", described as "her arm is hurting"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tired"; FEELING HOT (non-serious), outcome "unknown", described as "experienced a sensation in the back of her throat, not a burning, but like a heated sensation"; FEELING ABNORMAL (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "it was a weird sensation".  Additional information: Caller stated that she received the first dose of the pfizer covid 19 vaccine yesterday and within five seconds she got an instant headache and then a few seconds after that felt a burning/warm sensation in the back of her throat. Caller stated that it was completely gone in one-half hour. Caller stated that her arm was hurting and tired today. Caller wanted to know if this has been reported and was it safe to get the second shot. Caller states that she also experienced a sensation in the back of her throat, not a burning, but like a heated sensation, like people get if they go for a CAT scan or Magnetic resonance imaging (MRI), with the dye, but it happened within seconds of getting the vaccination. Caller was passionate about getting the vaccine because she takes care of her 92-Years-old mother who had Dementia and Parkinson's and the caller smokes, so she just had to get the vaccine. Caller states that it was a weird sensation and only lasted about 10 minutes and then it dissipated, but she did feel it for another two hours, but then it went away completely. Caller states that she was either 119 or 120 pounds.  No follow-up attempts are possible. No further information is expected.