chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN 6205), in left arm, on 20Mar2021 at 15:00 as dose 2, single (Lot number: EP 7534), in right arm and on 20Oct2021 at 12:00 as dose 3 (booster), single (Lot number: EWD173) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Axial Spondylarthritis" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "latex" (unspecified if ongoing); "gluten" (unspecified if ongoing); "capers/mango" (unspecified if ongoing); "pistachios/cashews" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Formaldehyde, reaction(s): "Known allergies: formaldehyde"; Beta interferon (avonex), reaction(s): "Known allergies: beta interferon (avonex)". The following information was reported: COVID-19 (medically significant) with onset 18May2022 at 16:00, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13May2022) Negative; SARS-CoV-2 test positive: (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Erythema, Feeling hot, Heart rate
Clinical narrative: in her previous doses she experienced redness in her arm and it felt hot; in her previous doses she experienced redness in her arm and it felt hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "First heart rate" (unspecified if ongoing), notes: Fast heart rate She has a fast heart rate that she takes medication for, the issue is that her her heart rate is around134 beats per minute but she did not have that problem last night.; "High cholesterol" (unspecified if ongoing), notes: High cholesterol The High Cholesterol is under control with medication; "Allergy" (unspecified if ongoing), notes: Allergy Her Nose runs quite a bit this time of year, it is environmental or happens when she goes outside, but this happens to a lot of people. Concomitant medication(s) included: PLAVIX. Vaccination history included: BNT162b2 (DOSE 2, SINGLE , Lot: EN6199), administration date: 06Mar2021, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE , Lot: EN6201), administration date: 12Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: FEELING HOT (non-serious), outcome "unknown", ERYTHEMA (non-serious), outcome "recovered" and all described as "in her previous doses she experienced redness in her arm and it felt hot". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1 , single (Lot number: EN6206), in left arm, on 07Apr2021 at 01:00 as dose 2 , single (Lot number: EW10151), in left arm and on 10Nov2021 at 01:00 as dose 3 (booster) , single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hight cholesterol" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown Result; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course Completed Paxlovid on 08May2022. On 14May2022, developed runny nose, low grade fever, cough, congestion. Went to the ER on 15May2022 to rule out pneumonia. Negative for that. Negative for flu. Prescribed antibiotics. Fever gone within 48 hrs. Was still testing positive for Covid throughout. dr wasn't convinced my symptoms were Covid related. the patient was not so sure. The patient's husband tested positive on May2021, 17 days after the patient originally tested positive. It's baffling. The patient believed that patient may have experienced rebound symptoms after taking Paxlovid. The patient was still experiencing some nasal congestion and cough.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 20Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Mitral Valve Prolapse" (unspecified if ongoing); "Sulfer Drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow up attempts are needed. No Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: still testing positive; still testing positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that rebound with new symptoms on day 10, so far 6 days into rebound, still testing positive.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN, start date: 02Nov2015, stop date: 19May2022. Past drug history included: Cipro, reaction(s): "known allergies: Cipro"; Acyclivir, reaction(s): "known allergies: Acyclivir". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Diarrhea started on fourth day Bitter taste in mouth after taking medication which lasted approx. 6-8 hrs after taking. Treatment start date was 19May2022 and treatment stop date was 23May2022. Indication: Treatment of COVID-19. Patient received other medication in 2 weeks was simvastatin 20 mg daily.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 05Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: Rebound COVID today, symptomatic and testing positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Other medication in two week was reported as unknown. Patient started Paxlovid on 11May2022 and stopped on 15May2022for the treatment of COVID-19. Vaccine lot no was not available/ provided to the reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment with anti-viral product, treatment start date 21May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy
Clinical narrative: Armpit swollen; Armpit swollen and pain; lump under armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 21May2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2; lot number: FK5127, administrator route: Intramuscular, administration time: 01:00 PM, vaccine location: Left arm), administration date: 19Dec2021, when the patient was 10-year-old, for Covid-19 immunization; BNT162b2 (Dose 1; lot number: FK5127, administrator route: Intramuscular, administration time: 01:00 PM, vaccine location: Left arm), administration date: 28Nov2021, when the patient was 10-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22May2022 at 07:00, outcome "not recovered", described as "Armpit swollen"; AXILLARY PAIN (non-serious) with onset 22May2022 at 07:00, outcome "not recovered", described as "Armpit swollen and pain"; AXILLARY MASS (non-serious) with onset 22May2022 at 07:00, outcome "not recovered", described as "lump under armpit". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain, axillary mass.  Additional Information: The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Other medications in two weeks: No; other medical history: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 Vaccine; COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Lot number: ER8132), in left arm, on 06Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 10:00 as dose 3 (booster), single (Lot number: FD7218), in left arm for covid-19 immunisation; tamsulosin (TAMSULOSIN), from 01Mar2022 (Batch/Lot number: unknown) to 09May2022. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive for covid and started Paxlovid May 10; (17May2022) Positive, notes: Re-tested positive for covid on May 17 and again May 20; (20May2022) Positive, notes: Re-tested positive for covid on May 17 and again May 20.  Clinical Course: Tested positive for COVID and started Paxlovid 10May2022, extremely mild symptoms throughout the 5 days of treatment (stopped taking on 15May2022). Re-tested positive for COVID on 17May2022 and again 20May2022. Cold symptoms (headache, sinus congestion, coughing got worse starting 18May2022. Today, on 22May2022, the patient was still coughing and congested: unwell enough to cause me to stay home from work for at least the next 5 days. The patient plan to retest for COVID on 25May2022 to confirm if he still showing positive or not. Antiviral details: Product: COVID 19 Treatment, Paxlovid treatment started on 10May2022 to 14May2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The Caller finished taking Paxlovid 4 weeks ago, he wants to know when he can get a booster vaccine. He was frustrated because everyone had a different recommendation on what to do, or how long to wait until someone can get their booster after Paxlovid- one pharmacy said 4 weeks, one said 3 months, its overwhelming as a consumer. Recognized AE after call, previous vaccines were inefficacious if patient received Paxlovid and then was interested in getting a booster- implies he and his mother had previous vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200754536 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash, Rash macular
Clinical narrative: itchiness all over my skin; red spots all over my skin and it itches; spongiotic dermatitis; a full rash all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Mar2022, outcome "unknown", described as "a full rash all over my body"; ECZEMA (non-serious) with onset Mar2022, outcome "unknown", described as "spongiotic dermatitis"; PRURITUS (non-serious), outcome "unknown", described as "itchiness all over my skin"; RASH MACULAR (non-serious), outcome "unknown", described as "red spots all over my skin and it itches". Therapeutic measures were taken as a result of eczema, pruritus, rash, rash macular.  Additional information: Patient took the Pfizer booster shot in early Dec2021 and then started to experience itchiness all over skin, especially when they would do any exercise. In Mar, got a massage and developed a full rash all over body. The dermatologist confirmed it as spongiotic dermatitis, the patient was treated with topical corticosteroids for eczema, pruritus, rash, rash macular. The reporter informed that but the spots move from one place to another and inquired that have you heard of such a side effect of the vaccine and what is the treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil (SP)", notes: Verbatim: Known allergies: Cefzil (SP). The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: There was no other medications in two weeks. Treatment was from 11May2022 to 15May2022. Rebound on 21May. Felt fine for a week and woke up with headache, cough and stuffy head. No fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Rebound or may have caught covid again; Rebound or may have caught covid again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Lot number: ER2613) and on 15Apr2021 at 12:00 as dose 2, single (Lot number: ER8729) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Nov2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 20May2022 at 18:00, outcome "recovering" and all described as "Rebound or may have caught covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Information: Patient had no other medications in two weeks. Treatment was started on 05May2022 and was stopped on 09May2022 for Covid-19. Rebound or may have caught covid again. No Known allergies. No Other medical history was reported.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 Treatment; Covid-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Crohn(s) Disease (mild)" (unspecified if ongoing); "Low HDL" (unspecified if ongoing). Concomitant medication(s) included: EDARBYCLOR; CRESTOR; REPATHA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Multiple negative RATs; Positive, notes: On day 11, mild Covid symptoms (sneezing, congestion) returned. RAT showed distinct positive; Positive, notes: Continue to be positive and symptomatic on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course-Facility where the most recent COVID-19 vaccine was administered was Other. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Migraine, Neck pain, Pyrexia
Clinical narrative: Numb arm from shoulder to elbow; Migraine; Fever; Neck pain; Anxiety; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 at 15:45 as dose 3 (booster), single (Lot number: FL8095) at the age of 11 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FK5127, Location of injection: Left arm, Vaccine Administration Time: 11:00), administration date: 11Dec2021, when the patient was 10-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FK5127, Location of injection: Left arm, Vaccine Administration Time: 10:30), administration date: 20Nov2021, when the patient was 10-year-old, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 23May2022 at 12:30, outcome "not recovered"; PYREXIA (non-serious) with onset 23May2022 at 12:30, outcome "not recovered", described as "Fever"; MIGRAINE (non-serious) with onset 23May2022 at 12:30, outcome "not recovered"; NECK PAIN (non-serious) with onset 23May2022 at 12:30, outcome "not recovered"; HYPOAESTHESIA (non-serious) with onset 23May2022 at 12:30, outcome "not recovered", described as "Numb arm from shoulder to elbow". Therapeutic measures were taken as a result of hypoaesthesia, migraine, pyrexia, neck pain, anxiety. Additional information: The patient received at home symptom care. The patient had no COVID prior vaccination and no COVID testing was done post vaccination. The patient had no known allergies.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 11:15 as dose 1, single (Lot number: EN6201), in right arm, on 19Mar2021 at 11:45 as dose 2, single (Lot number: EN6208), in right arm and on 27Aug2021 at 14:30 as dose 3 (booster), single (Lot number: EW0187), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 30Mar2022 at 14:45 as dose 4 (booster), single (Lot number: 016J21-2A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "N/A" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022 at 11:00, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.Clinical course: Known allergies was reported as no.Other medication in 2weeks was reported as Unknown. Anti viral details: Product COVID 19 Treatment, Treatment stop date 17May2022, Indication Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Madarosis
Clinical narrative: hair has been falling; eyebrows thinned; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair has been falling"; MADAROSIS (non-serious), outcome "unknown", described as "eyebrows thinned".  Additional information: Caller states that her hair has been falling ever since she got the second shot of the Pfizer Vaccine. Caller would like to know what to do and when it will be out of her system. Caller reports that her hair has been falling out all day long since the covid vaccine. She reports her eyebrows thinned out first. States she didn't' think it was the shot, her eyebrows almost disappeared. Proceeds to state after the second shot is when it started.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (the patient). A 63-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FH8030), at the age of 62, in left arm, Nov 16, 2021, at 18:45, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown) for immunization. No medical history or concomitant medications. The patient experienced COVID-19 (medically significant), onset 2022, with outcome of not recovered; and ineffective drug/vaccine brand: Pfizer BioNTech/product: COVID-19 treatment (medically significant), onset 2022, with outcome of unknown. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. Additional information: No other medication in 2 weeks.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21May2022 at 16:00, outcome "recovered" (22May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid 19 on 08May2022; (18May2022) Negative, notes: Tested negative on 18May2022 and 19May2022; (19May2022) Negative, notes: Tested negative on 18May2022 and 19May2022; (21May2022) Positive, notes: tested positive again on 21May2022; (22May2022) Negative, notes: Tested negative again on 22May2022. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course of the events: Other medications in two weeks: No. Anti-viral details: Paxlovid. Treatment start date: 11May2022. Treatment stop date: 15May2022. Indication: treatment of Covid-19. Administrator route: oral. Adverse event: Tested positive for Covid 19 on 08May2022. Started taking Paxlovid on day 3. Took full course of treatment. Tested negative on 18May2022 and 19May2022, but then tested positive again on 21May2022 and had mild symptoms. Tested negative again on 22May2022. Adverse event start date: 21May2022. Adverse event start time: 04:00 PM. If patient recovered: Recovered. Adverse event stop date: 22May2022 . If treatment ae: No. Known allergies: unsure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and drug ineffective.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Papule
Clinical narrative: normally have migraines and this has triggered one; feels like a full on flu; Plus a bump on my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization, reaction(s): "The first dose had side effects"; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "the second dose gave me covid arm". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "normally have migraines and this has triggered one"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feels like a full on flu"; PAPULE (non-serious), outcome "unknown", described as "Plus a bump on my arm".  Additional information: The third was giving patient what feels like a really bad flu plus triggered a migraine requiring medication. Patient was really happy that patient was not going to die of Covid-19.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lovastatin (LOVASTATIN), (Batch/Lot number: unknown) at 40 mg 1x/day (40 mg, 1x/day, (at bedtime)). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "Tested positive for COVID"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 2022, outcome "unknown", described as "He tested positive for COVID on 17May2022 after being exposed to someone who had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive. The action taken for lovastatin was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: the second dose gave me covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I normally have migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 immunization, reaction(s): "The first dose had side effects". The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "the second dose gave me covid arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate abnormal, Vomiting
Clinical narrative: vomiting; headache; Concerned about her son's heart rate and asking if they need to bring him to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), on 20May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 21May2022, outcome "unknown"; VOMITING (non-serious) with onset 21May2022, outcome "unknown"; HEART RATE ABNORMAL (non-serious) with onset May2022, outcome "unknown", described as "Concerned about her son's heart rate and asking if they need to bring him to the hospital". Therapeutic measures were taken as a result of vomiting, headache.  Additional information: A Caller reported that her son received the Pfizer covid-19 vaccine on Friday 20May2022 and her son started vomiting and had a headache on 21May and gave her son Tylenol. The caller was also concerned about her son's heart rate and asking if they need to bring him to the hospital.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (program ID: 005570). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Thepatient experienced ineffective drug (medically significant) and suspected COVID-19/rebound COVID-19 case (medically significant), with outcome of unknown. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Return of Covid symptoms and a positive antigen test seven days after completing Paxlovid course. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment; vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6208), on 12Apr2021 as dose 2, single (Lot number: EW0150) and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cinnamon, reaction(s): "Known allergies: Cinnamon", notes: Known allergies: Cinnamon. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (18May2022) Negative; (18May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included no other medication in 2weeks. Treatment for covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jun2021 as dose 2, single (Lot number: EW0191) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Eye pruritus, Myalgia
Clinical narrative: cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; sneezing; itchy eyes; itchy throat; cough developed with some myalgias so I prepared the test in the evening and it was positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant), COUGH (non-serious), MYALGIA (non-serious) all with onset 22May2022, outcome "unknown" and all described as "cough developed with some myalgias so I prepared the test in the evening and it was positive."; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "not recovered", described as "itchy throat"; EYE PRURITUS (non-serious) with onset 21May2022, outcome "unknown", described as "itchy eyes"; SNEEZING (non-serious) with onset 21May2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Negative, notes: I did a COVID home test that same morning which was negative; (22May2022) Positive, notes: On Sunday 22May, cough developed with some myalgias so I prepared the test in the evening and it was positive.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing, Throat irritation
Clinical narrative: cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; cough developed with some myalgias so I prepared the test in the evening and it was positive.; sneezing; itchy eyes; itchy throat; cough developed with some myalgias so I prepared the test in the evening and it was positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant), COUGH (non-serious), MYALGIA (non-serious) all with onset 22May2022, outcome "unknown" and all described as "cough developed with some myalgias so I prepared the test in the evening and it was positive."; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "not recovered", described as "itchy throat"; EYE PRURITUS (non-serious) with onset 21May2022, outcome "unknown", described as "itchy eyes"; SNEEZING (non-serious) with onset 21May2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Negative, notes: I did a COVID home test that same morning which was negative; (22May2022) Positive, notes: On Sunday 22May, cough developed with some myalgias so I prepared the test in the evening and it was positive.