chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine
Clinical narrative: migraine; Disease recurrence; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 (Lot number: EPG955) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: on occasion she will take something for her Migraines, like Excedrin Migraine. The patient took concomitant medications. Past drug history included: Excedrin migraine for Migraine. The following information was reported: MIGRAINE (non-serious), outcome "recovered", described as "migraine"; DISEASE RECURRENCE (non-serious), outcome "recovered", described as "Disease recurrence". Therapeutic measures were taken as a result of migraine, disease recurrence.  Additional Information: Caller stated that, she takes a multivitamin. Is report related to a study or programme: No. Other conditions: Yes  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 19Jun2021, outcome "not recovered", described as "Hives". The event "hives" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional Information: Hives began 11 weeks after second vaccine and have been happening since (9+ months). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 15Jan2021 (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: Comirnaty (Dose: 01), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph nodes". Additional information: Action taken with respect to the suspect medication (i.e., in direct response to the AE): No action taken.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Burning sensation, Flushing, Tinnitus
Clinical narrative: ringing in her ears; it's burning in her skin.; flushing face; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0153) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing), notes: The patient was only taking a blood pressure pill and vitamins when she got her vaccines and stopped them to see if it was and it wasn't. , The patient stopped taking her blood pressure pill about 2 weeks ago. The patient took concomitant medications. The following information was reported: FLUSHING (non-serious) with onset 08Apr2021, outcome "recovering", described as "flushing face"; TINNITUS (non-serious), outcome "recovering", described as "ringing in her ears"; BURNING SENSATION (non-serious), outcome "unknown", described as "it's burning in her skin.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, she has received 3 doses of the vaccine and she has been experiencing a flushing face, ringing in her ears and rashes all over her body; stating also to have hives and blotches in her back and torso. She mentioned that every time she puts her clothes on it feels like it's burning in her skin. She went to the dermatologist and she had a biopsy and they told her that this side effects might be due to a medication. She's taking Benadryl and a medication for her blood pressure but they verified if the manufacturer changed the formulation for this medicines and at the end they see most probable that the side effects are due to the vaccine. The caller got the first dose on 08Apr2021 and she immediately had flushing in her face. The patient stayed there for 15 -20 minutes until it subsided. Then the patient had ringing in her ears, mostly in her left ear but it went down until 29Apr2021 when she got the second dose, then it increased and she had more ringing. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Headache, Lethargy, SARS-CoV-2 test
Clinical narrative: Headache; loss of appetite; Lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Lot number: EWD172) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer COVID-19 vaccine 1st dose , Lot Number / Expiry Date: 1Aug2021/unknown, Route, Anatomical Location: Left arm, No. of Previous Doses: n/a, Date: 01Aug2021, Age at Immunization if date not available: 54), administration date: 01Aug2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Caller reports when she had COVID-19, she was diagnosed with pneumonia after the 2nd COVID-19 vaccine. so she had them give it in her left. Caller states she was extremely ill, lethargic, had loss of appetite, and a headache that was really bad even after Tylenol and Motrin. She reports usually she tries to avoid the Tylenol and Motrin because Tylenol and Motrin is not good for the liver. Caller states she drinks tons of water and tries to stay hydrated. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: Headache; loss of appetite; Lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Lot number: EWD172) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer COVID-19 vaccine 1st dose , Lot Number / Expiry Date: 1Aug2021/unknown, Route, Anatomical Location: Left arm, No. of Previous Doses: n/a, Date: 01Aug2021, Age at Immunization if date not available: 54), administration date: 01Aug2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Caller reports when she had COVID-19, she was diagnosed with pneumonia after the 2nd COVID-19 vaccine. so she had them give it in her left. Caller states she was extremely ill, lethargic, had loss of appetite, and a headache that was really bad even after Tylenol and Motrin. She reports usually she tries to avoid the Tylenol and Motrin because Tylenol and Motrin is not good for the liver. Caller states she drinks tons of water and tries to stay hydrated. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia oral, Pollakiuria
Clinical narrative: going to the bathroom quite a bit; stomach soreness/stomach pain; numbness in her tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2022 (Lot number: PJ9943) at the age of 78 years as dose number unknown (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 Unknown, Unknown manufacturer), for COVID-19 immunization. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "going to the bathroom quite a bit"; HYPOAESTHESIA ORAL (non-serious) with onset 24Mar2022 12:30, outcome "unknown", described as "numbness in her tongue"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach soreness/stomach pain".
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Endoscopy, Gastrooesophageal reflux disease, Myalgia
Clinical narrative: maybe with all the doses of the Covid I've got these muscle aches; maybe it's caused me more acid; joint pain at the top of my legs; 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 74 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gastritis" (unspecified if ongoing); "esophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "maybe with all the doses of the Covid I've got these muscle aches"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "maybe it's caused me more acid"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain at the top of my legs". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:   Experience lists "Gastrointestinal Disorders: fundic gland polyps".  No mention of 'muscle pain' but patient medication guide does discuss "Low magnesium and other mineral levels in your body can happen in people who have taken PROTONIX for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice."   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: maybe with all the doses of the Covid I've got these muscle aches; maybe it's caused me more acid; joint pain at the top of my legs; 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 74 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gastritis" (unspecified if ongoing); "esophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "maybe with all the doses of the Covid I've got these muscle aches"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "maybe it's caused me more acid"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain at the top of my legs". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:   Experience lists "Gastrointestinal Disorders: fundic gland polyps".  No mention of 'muscle pain' but patient medication guide does discuss "Low magnesium and other mineral levels in your body can happen in people who have taken PROTONIX for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice."   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6203) at the age of 65 years as dose 2, single and administration date 10Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Itchy". The event "itchy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus. The lot number for bnt162b2 was not provided and will be requested during follow up. Additional information: Patient states that she got the vaccine last February and got the second dose by 03Mar2021. She then got the booster dose in October. Patient says that she started being itchy from the moment she got the vaccine. States that with the second dose she was itchy, itchy, itchy. States that the booster dose really set it off and she got a rash. Patient states that she has been to her doctor, dermatologist, allergist, and rheumatologist. States they have nothing besides the vaccine that is different. Patient asks is there any hope on the horizon,Will it go away, Patient states that she looked it up and saw that it is an occurrence, chronic urticaria. States that a man at her gym and a lady who just left her apartment have the same problem. Patient states that the itchiness was ongoing and she went to a dermatologist in September. Patient states at that time there was nothing there, nothing to see, just itchy. States that now she has the little tiny red dots on her back, stomach, and top of her legs. Patient states that the man at her gym had the same thing. Patient says that she google searched it recently. Patient states that she was having side effects from the Prednisone.           The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474085 same product and event, different patient;US-PFIZER INC-202200474055 same product and event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: States that the booster dose really set it off and she got a rash/States that a man at her gym and a lady who just left her apartment have the same problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (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 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "States that the booster dose really set it off and she got a rash/States that a man at her gym and a lady who just left her apartment have the same problem".  Additional information: Caller states that she got the vaccine last February and got the second dose by 03Mar2021. She then got the booster dose in October. Caller says that she started being itchy from the moment she got the vaccine. States that with the second dose she was itchy, itchy, itchy. States that the booster dose really set it off and she got a rash. States that a man at her gym and a lady who just left her apartment have the same problem. This report is related to the man at the caller's gym. Caller states that she declines to provide further information on the man at her gym.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200473977 same product and event, different patient;US-PFIZER INC-202200474085 same product and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: left shoulder got frozen; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date Jan2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), administration date: Dec2021, for COVID-19 immunization, reaction(s): "taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working.", "she has gained 10 pounds". The following information was reported: MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "left shoulder got frozen"; MUSCLE SPASMS (medically significant), outcome "unknown", described as "muscle spasm". The events "left shoulder got frozen" and "muscle spasm" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Menstrual disorder
Clinical narrative: I have not had a period since Nov 5th 2021.; I have not had a period since Nov 5th 2021.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 12:00 (Lot number: FF8839) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CAMRESE LO. Vaccination history included: Bnt162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: FF2587, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 15Oct2021, for Covid-19 immunization. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 05Nov2021 07:00, outcome "not recovered" and all described as "I have not had a period since Nov 5th 2021.". Therapeutic measures were not taken as a result of amenorrhoea, menstrual disorder. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: change in taste metal like taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 14:00 (Lot number: FF2593) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date Sep2021; HYDROCODONE; TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 06Feb2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 16Jan2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset Dec2021, outcome "not recovered", described as "change in taste metal like taste". The event "change in taste metal like taste" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia. Additional information- It was reported that facility where the most recent COVID-19 vaccine was administered was hospital.Prior to vaccination,the patient was not diagnosed with COVID-19 Since the vaccination,  the patient  had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Diarrhea; Vomiting; Headache; Sore throat; 99.5 degree F/ 103.3 degree F on Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2022 03:45 (Lot number: FK5618) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 03:45 AM), administration date: 11Feb2022, when the patient was 5 years old, for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Sore throat"; PYREXIA (non-serious) with onset 25Mar2022, outcome "not recovered", described as "99.5 degree F/ 103.3 degree F on Sunday"; DIARRHOEA (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Vomiting"; HEADACHE (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Headache". The events "sore throat", "99.5 degree f/ 103.3 degree f on sunday", "diarrhea", "vomiting" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, pyrexia, diarrhoea, vomiting, headache.  Additional information: Started with sore throat 2 days after. 99.5 degree F. It evolved to diarrhea, vomiting, headache, 103.3 degree F on Sunday. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Vomiting; Headache; Sore throat; 99.5 degree F/ 103.3 degree F on Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2022 03:45 (Lot number: FK5618) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 03:45 AM), administration date: 11Feb2022, when the patient was 5 years old, for COVID-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2022, outcome "not recovered", described as "Sore throat"; PYREXIA (non-serious) with onset 25Mar2022, outcome "not recovered", described as "99.5 degree F/ 103.3 degree F on Sunday"; DIARRHOEA (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Vomiting"; HEADACHE (non-serious) with onset 27Mar2022, outcome "not recovered", described as "Headache". The events "sore throat", "99.5 degree f/ 103.3 degree f on sunday", "diarrhea", "vomiting" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, pyrexia, diarrhoea, vomiting, headache.  Additional information: Started with sore throat 2 days after. 99.5 degree F. It evolved to diarrhea, vomiting, headache, 103.3 degree F on Sunday. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Fast heart beats; High blood pressure; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Dose1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Fast heart beats"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient got the Pfizer second dose and medical bills are up to like 800 from fast heart beats and high blood pressure from the spike protein.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Nasopharyngitis, Off label use
Clinical narrative: General tiredness; cold like symptoms; Dose Number: 4; Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Mar2022 02:00 (Batch/Lot number: unknown) at the age of 49 years as dose 4 (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: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 24Mar2022 02:00, outcome "unknown" and all described as "Dose Number: 4"; FATIGUE (non-serious) with onset 25Mar2022 07:00, outcome "not recovered", described as "General tiredness"; NASOPHARYNGITIS (non-serious) with onset 25Mar2022 07:00, outcome "not recovered", described as "cold like symptoms". Therapeutic measures were not taken as a result of fatigue, nasopharyngitis.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I received my booster shot and afterwards I was experiencing the trouble with my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2022 (Lot number: FK9893, Expiration Date: May2022) at the age of 23 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE; DEXTROAMPHETAMINE [DEXAMFETAMINE SULFATE]; NIKKI taken for contraception. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 25Mar2022, outcome "unknown", described as "I received my booster shot and afterwards I was experiencing the trouble with my vision". Therapeutic measures were not taken as a result of visual impairment.  Additional Information: Other medication: Consumer stated, I also take a birth control and took actually before I went, I took like an allergy medicines. I took Vyvanse, Dextroamphetamine and the birth control daily and then today I took an allergy medication."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurriness/blurry vision; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A 23 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FK9893) 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: VISION BLURRED (non-serious), outcome "unknown", described as "blurriness/blurry vision".  Additional information: The reporter was the pharmacist and just happened was that she gave the vaccine and she said that patient experienced blurriness. So, that's why she was just called because as she wanted to know the best thing to do regarding this matter. pharmacist stated, patient just called and said she is having blurry vision and patient know dizziness was a thing because of vaccine but patient do not know if there was a (incomplete sentence). (Further clarification unknown. Hence, dizziness not captured as event.) Pharmacist stated, It expired October of last year but we just got it so it should frozen so it should be good for two weeks. So, it will 23May. (Further clarification unknown. Hence, not captured in tab.)   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dyspnoea, SARS-CoV-2 test, Wheezing
Clinical narrative: Around 1 am I began to feel shortness of breath/have difficulty breathing at night; cough; chest pain; wheezing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2022 20:00 (Lot number: FK9894) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 18Mar2022 01:00, outcome "not recovered", described as "Around 1 am I began to feel shortness of breath/have difficulty breathing at night"; COUGH (non-serious) with onset 18Mar2022 01:00, outcome "not recovered", described as "cough"; CHEST PAIN (non-serious) with onset 18Mar2022 01:00, outcome "recovered" (18Mar2022 04:00), described as "chest pain"; WHEEZING (non-serious) with onset 18Mar2022 01:00, outcome "not recovered", described as "wheezing". The events "around 1 am i began to feel shortness of breath/have difficulty breathing at night", "cough", "chest pain" and "wheezing" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, cough, chest pain, wheezing.  Additional information: Patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had tested for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine level, Histamine level increased, Hypersensitivity, Mechanical urticaria, SARS-CoV-2 test
Clinical narrative: Hives; Dermatographia; Increase in allergies/Increased allergy reactivity; High histamine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jul2021 12:00 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Hives"; MECHANICAL URTICARIA (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Dermatographia"; HYPERSENSITIVITY (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Increase in allergies/Increased allergy reactivity"; HISTAMINE LEVEL INCREASED (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "High histamine". The events "hives", "dermatographia", "increase in allergies/increased allergy reactivity" and "high histamine" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, mechanical urticaria, hypersensitivity, histamine level increased.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Dermatographia; Increase in allergies/Increased allergy reactivity; High histamine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jul2021 12:00 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Hives"; MECHANICAL URTICARIA (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Dermatographia"; HYPERSENSITIVITY (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Increase in allergies/Increased allergy reactivity"; HISTAMINE LEVEL INCREASED (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "High histamine". The events "hives", "dermatographia", "increase in allergies/increased allergy reactivity" and "high histamine" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, mechanical urticaria, hypersensitivity, histamine level increased.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch; Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch; 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 (BNT162B2), administered in arm left, administration date 25Mar2022 14:30 (Lot number: FK9894) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Seizure disorder" (unspecified if ongoing), notes: Seizure disorder; "congenital heart defect" (ongoing), notes: congenital heart defect; "hypothyroidism" (unspecified if ongoing); "Covid prior vaccination: Yes" (unspecified if ongoing), notes: Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left), administration date: 05May2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 25Mar2022 16:45, outcome "not recovered" and all described as "Severe swelling on lymph nodes around left arm/armpit with pain and tenderness to touch". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. If covid prior vaccination was reported as yes. If covid tested post vaccination was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Immunisation
Clinical narrative: chills all day; body aches; no appetite; extreme fatigued; No energy; Slept a good part of day/still groggy; Dose number= 4; Dose number= 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2022 02:30 (Batch/Lot number: unknown) at the age of 74 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "Bronchiectasis" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone", notes: Known allergies: Oxycodone. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 3 (BOOSTER), Anatomical location: Left Arm), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious) all with onset 19Mar2022 02:30, outcome "unknown" and all described as "Dose number= 4"; CHILLS (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "chills all day"; PAIN (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "body aches"; DECREASED APPETITE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "no appetite"; FATIGUE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "extreme fatigued"; ASTHENIA (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "No energy"; SOMNOLENCE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "Slept a good part of day/still groggy". Therapeutic measures were not taken as a result of chills, pain, decreased appetite, fatigue, asthenia, somnolence.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Somnolence
Clinical narrative: chills all day; body aches; no appetite; extreme fatigued; No energy; Slept a good part of day/still groggy; Dose number= 4; Dose number= 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2022 02:30 (Batch/Lot number: unknown) at the age of 74 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "Bronchiectasis" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "Known allergies: Oxycodone", notes: Known allergies: Oxycodone. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 2, Anatomical location: Left Arm), for COVID-19 Immunization; Bnt162b2 (Dose: 3 (BOOSTER), Anatomical location: Left Arm), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious) all with onset 19Mar2022 02:30, outcome "unknown" and all described as "Dose number= 4"; CHILLS (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "chills all day"; PAIN (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "body aches"; DECREASED APPETITE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "no appetite"; FATIGUE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "extreme fatigued"; ASTHENIA (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "No energy"; SOMNOLENCE (non-serious) with onset 20Mar2022 08:00, outcome "recovered" (Mar2022), described as "Slept a good part of day/still groggy". Therapeutic measures were not taken as a result of chills, pain, decreased appetite, fatigue, asthenia, somnolence.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: she has had health issues from the booster vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "cancer", start date: 2012 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer by- unknown, dose number - unknown, Primary immunization complete), for COVID-19 immunization.  The following information was reported: GENERAL SYMPTOM (non-serious), outcome "unknown", described as "she has had health issues from the booster vaccine".  Additional information: It was reported that, caller states she had the Pfizer COVID 19 Vaccine "shot" and her booster was in Oct. She states she has had health issues from the booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.