chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 35 years, in left arm for Covid-19 immunization; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Gluten, reaction(s): "Known allergies: gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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. Clinical course: The patient was received vaccine and other medications with in 2 weeks as reported no. The patient tested positive for Covid again 6 weeks after initial infection. After taking 5-day course of Paxlovid as well. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient previously received the Pfizer COVID vaccine, and is now taking Paxlovid (COVID treatment); patient previously received the Pfizer COVID vaccine, and is now taking Paxlovid (COVID treatment); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm 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 included: "Elbow replacement" (unspecified if ongoing); "traumatic arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" (07May2022) and all described as "patient previously received the Pfizer COVID vaccine, and is now taking Paxlovid (COVID treatment)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Recovered quickly with neg retest. 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6198), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE5430), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hard blood pressure" (unspecified if ongoing), notes: successfully treated; "elevated cholesterol levels" (unspecified if ongoing), notes: successfully treated; "Two cardiac stents placed in 2007 with no issues since then.", start date: 2007 (unspecified if ongoing), notes: Two cardiac stents placed in 2007 with no issues since then. Concomitant medication(s) included: ATORVASTATIN; CANDESARTAN; METOPROLOL; GABAPENTIN; DULOXETINE; VITAMIN D 3. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: After his main symptoms (extensive coughing and some nasal congestion) seemed to diminish considerably, they returned, especially the congestion. Paxlovid for Covid-19 treatment started on 29Apr2022 and stopped on 04May2022.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysphonia, Feeling abnormal, Headache
Clinical narrative: 07May2022 AG test (Positive); 07May2022 AG test (Positive); sore throat; cough; headache; hoarse voice; squeezing; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247), on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovering" and all described as "07May2022 AG test (Positive)"; COUGH (non-serious) with onset 07May2022, outcome "recovering"; HEADACHE (non-serious) with onset 07May2022, outcome "recovering"; DYSPHONIA (non-serious) with onset 07May2022, outcome "recovering", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 07May2022, outcome "recovering", described as "sore throat"; FEELING ABNORMAL (non-serious) with onset 07May2022, outcome "recovering", described as "squeezing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: 07May2022 AG test (positive). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, cough, headache, dysphonia, feeling abnormal. Clinical course: Facility type vaccine reported as Workplace clinic. If other vaccine in four weeks reported as Unknown. If other vaccine in four weeks reported Unknown. If COVID tested post vaccination reported as Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 07May2022 AG test (Positive); 07May2022 AG test (Positive); sore throat; cough; headache; hoarse voice; squeezing; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247), on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "recovering" and all described as "07May2022 AG test (Positive)"; COUGH (non-serious) with onset 07May2022, outcome "recovering"; HEADACHE (non-serious) with onset 07May2022, outcome "recovering"; DYSPHONIA (non-serious) with onset 07May2022, outcome "recovering", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 07May2022, outcome "recovering", described as "sore throat"; FEELING ABNORMAL (non-serious) with onset 07May2022, outcome "recovering", described as "squeezing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: 07May2022 AG test (positive). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, oropharyngeal pain, cough, headache, dysphonia, feeling abnormal. Clinical course: Facility type vaccine reported as Workplace clinic. If other vaccine in four weeks reported as Unknown. If other vaccine in four weeks reported Unknown. If COVID tested post vaccination reported as Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Nasopharyngitis, Pyrexia
Clinical narrative: COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022; COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022; fever; chills; cold symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years 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 02May2022, outcome "unknown" and all described as "COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022"; CHILLS (non-serious) with onset 02May2022, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 02May2022, outcome "unknown", described as "cold symptoms"; PYREXIA (non-serious) with onset 02May2022, outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (09May2022) Positive; (02May2022) Unknown results; (07May2022) Unknown results. It was unknown if therapeutic measures were taken as a result of covid-19, pyrexia, chills, nasopharyngitis.  Clinical course:adverse event :COVID sx (symptoms) after travel, weekend of 29Apr2022 then 02May2022 fever chills and cold symptoms and rapid Ag 02May2022 and 07May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2  cannot be excluded for the reported events of Covid-19 and drug ineffective.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022; COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022; fever; chills; cold symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years 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 02May2022, outcome "unknown" and all described as "COVID sx (symptoms) after travel to (state-withheld) weekend of 29Apr2022"; CHILLS (non-serious) with onset 02May2022, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset 02May2022, outcome "unknown", described as "cold symptoms"; PYREXIA (non-serious) with onset 02May2022, outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (09May2022) Positive; (02May2022) Unknown results; (07May2022) Unknown results. It was unknown if therapeutic measures were taken as a result of covid-19, pyrexia, chills, nasopharyngitis.  Clinical course:adverse event :COVID sx (symptoms) after travel, weekend of 29Apr2022 then 02May2022 fever chills and cold symptoms and rapid Ag 02May2022 and 07May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2  cannot be excluded for the reported events of Covid-19 and drug ineffective.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: her husband tested and he was also positive; her husband tested and he was also positive; cold; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8731), on 04May2021 as dose 2, single (Lot number: EW0167) and on 11Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 Kidney Disease has had for years" (ongoing), notes: Continuing: True, Comments: Stage 4 Kidney Disease has had for years; "Diabetes has had for years" (ongoing), notes: Continuing: True, Comments: Diabetes has had for years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her husband tested and he was also positive"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive, notes: tested positive for Covid.  Clinical Course: Caller states that she and her husband are in their 80s, states they had Covid at the same time and they took the Paxlovid at the same time and after a couple weeks after that we both started getting severe muscle aches at the same time. Caller wants to know if this from the medication. Caller states the she thinks it is so odd that they both got the muscle aches at exactly the same time. Started Paxlovid on 09Apr2022, ended the treatment on 13Apr2022. States she documented the muscle aches began on 29Apr2022. States they started in the lower back and now they are down into her legs, states it even hurts to get out of bed and getting into the bed is severe and to stand and try to take the first step when she gets out of bed it is severe, states she did get a muscle relaxer prescribed by Dr. (Name withheld) called for a muscle relaxer, states that has not worked, manufacturer is unknown, product was dispensed in a pharmacy vial from pharmacy, NDC LOT and expiration date are unknown, dosage: 500mg tablets, 1 tablet by mouth every six hours as needed, has been trying this since 06May2022 until now and it has not worked. Caller states she has issues with her back, has had them for years and these muscle aches have exacerbated her back issues, this patient is confirmed a female, as documented correctly by the call handler. A clone case was filed for the husband.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Series of vaccination complete; Manufacturer Unknown.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "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, suspected covid-19.  Clinical course: Other medication in 2weeks was no. Patient received anti viral medicine (Pfizer band) for covid 19 treatment from 01May2022 to 05May2022.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from product quality group. A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 42 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Over Weight" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL taken for blood cholesterol increased, overweight. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome unknown, COVID-19 (medically significant) with onset 29Apr2022, outcome not recovered and all described as "he had three Pfizer vaccine (COVID Vaccine) and then he tested positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: he had three Pfizer vaccine (COVID Vaccine) and then he tested positive and then less than 12 hours had the Paxlovid; (04May2022) Negative; (05May2022) Negative; (06May2022) Negative; (07May2022) Negative; (08May2022) Negative; (09May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: It was reported that, he was started taking Paxlovid on 29Apr2022 at 10 am. He took at 29th to 30th the first the second and one two three four he stopped the last dose was night of 03May (03May2022). The reporter stated, "he started it and then finished his 5 day treatment. On day 5 he was feeling better he tested negative he didn't had any symptom but because he was in high risk they had him to stayed in isolation until today and he was tested for the past 5 days and then negative with no symptoms. Then later before he took his mask off around him and his children because they were high risk he tested one more time and he was positive and then within 30-45 minutes later all the symptoms came back. He had 100 degree fever, drainage came back, cough came back his oxygen levels went to 96 and so everything came back he had negative for 5 days and then later it was positive with all the symptoms which were all gone they all came back. So, he had the Pfizer Vaccine (COVID Vaccine) he had the booster (COVID Vaccine) so he had three Pfizer vaccine (COVID Vaccine) and then he tested positive and then less than 12 hours had the Paxlovid and did 5 days and then was symptom free and negative on rapid test and later was day 11 and he positive and symptoms back. He was not around anyone, he hadn't left house, he slept in the quarantine room. It was reported that, he was given 30 pills to take for 5 days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Hives rash beginning on arms; have more spots mostly on arms and wrist and other random areas; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 at 19:15 as dose 3 (booster), single (Lot number: FJ9943) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KIRKLAND SIGNATURE ALLERGY MEDICINE taken for hypersensitivity. Past drug history included: Known allergies : cephalexin, reaction(s): "Known allergies : Cephalexin". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FC3182, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 30Aug2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FF2588, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 20Sep2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 18Apr2022, outcome "not recovered", described as "Hives rash beginning on arms"; RASH MACULAR (non-serious) with onset 18Apr2022, outcome "not recovered", described as "have more spots mostly on arms and wrist and other random areas". The events "hives rash beginning on arms" and "have more spots mostly on arms and wrist and other random areas" required physician office visit. Therapeutic measures were taken as a result of rash, rash macular.  Additional information: Hives rash beginning on arms started two to three weeks after injection on 30Mar2022. Been almost six weeks since vaccine and have more spots mostly on arms and wrist and other random areas. Rash does not itch but gets spots get bigger if scratched. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives started on arms within a week of vaccination; hives itch; hives rash/spread to my leg/knee area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 18:45 as dose 3 (booster), single (Lot number: FJ9943) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Not that I'm aware of besides weeds" (unspecified if ongoing). Concomitant medication(s) included: ALLERGY MEDICINE. Past drug history included: Poison ivy, reaction(s): "known allergies". Vaccination history included: BNT162b2 (Dose 2, Product: COVID 19, Brand: COVID 12 yrs (Purple CAP Pfizer), Lot number: FF2588, Dose administration time: 07:45 PM, Vaccine location: Left arm), administration date: 20Sep2021, when the patient was 46-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Product: COVID 19, Brand: COVID 12 yrs (Purple CAP Pfizer), Lot number: FC3182, Dose administration time: 07:45 PM, Vaccine location: Left arm), administration date: 30Aug2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 06Apr2022, outcome "not recovered", described as "Hives started on arms within a week of vaccination"; PRURITUS (non-serious) with onset 06Apr2022, outcome "not recovered", described as "hives itch"; RASH (non-serious) with onset 06Apr2022, outcome "not recovered", described as "hives rash/spread to my leg/knee area". The events "hives started on arms within a week of vaccination", "hives itch" and "hives rash/spread to my leg/knee area" required physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus, rash.  Additional information: The patient had not other vaccine in four weeks. Patient had received other medications in two weeks with allergy medicine. Reporter stated, hives started on arms within a week of vaccination. The hives itch as well. Still have hives rash almost 6 weeks after vaccine shot, had for about 5 of those 6 weeks. It has now spread to my leg/knee area. Sought medical attention on 25Apr2022 for relief, was prescribed prednisone tablets and relieved itching, but still have hives. Sought additional medical attention from allergist on 05May2022 for further relief and prescribed Fluocinonide Ointment to put on rash. It relieves itching, but still have hives and appearing in other areas on body. Does not seem to be going away anytime soon. The patient was visited to doctor or other healthcare professional office/clinic visit for adverse event. Prednisone tablets and fluocinonide ointment as treatment was received for the events. The patient had not covid prior vaccination and had not covid tested post vaccination. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Menstrual disorder
Clinical narrative: After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; 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 62-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: Bnt162b2 (Dose 01), for Covid-19 immunization. The following information was reported: HAEMORRHAGE (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again."  Consumer was a 62-year-old female patient. She explained that she had 3 doses of the Pfizer-BioNTech COVID-19 Vaccine so far. Prior to vaccination, she had been in menopause for 16 or 17 years. After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again. She wanted to know if similar cases have been reported before.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Haemorrhage, Hysteroscopy, Postmenopausal haemorrhage
Clinical narrative: After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again.; 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 62-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: Bnt162b2 (Dose 01), for Covid-19 immunization. The following information was reported: HAEMORRHAGE (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again."  Consumer was a 62-year-old female patient. She explained that she had 3 doses of the Pfizer-BioNTech COVID-19 Vaccine so far. Prior to vaccination, she had been in menopause for 16 or 17 years. After the second dose of the vaccine, she developed a bleeding that turned into a menstrual period again. She wanted to know if similar cases have been reported before.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Tested positive for Covid 19 on 09May2022; Tested positive for Covid 19 on 09May2022; Fever; Body ache; Runny nose; Cough; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 31Mar2021 as dose 2, single (Lot number: 3248), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 09May2022, outcome "not recovered", described as "Body ache"; COUGH (non-serious) with onset 09May2022, outcome "not recovered"; PYREXIA (non-serious) with onset 09May2022, outcome "not recovered", described as "Fever"; RHINORRHOEA (non-serious) with onset 09May2022, outcome "not recovered", described as "Runny nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Tested positive for Covid 19 on 09May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, pain, rhinorrhoea, cough.  Clinical information:No other vaccine in four weeks.No other medications in two weeks. AE were treated with acetaminophen. No covid prior vaccination and no known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19 on 09May2022; Tested positive for Covid 19 on 09May2022; Fever; Body ache; Runny nose; Cough; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 31Mar2021 as dose 2, single (Lot number: 3248), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 09May2022, outcome "not recovered", described as "Body ache"; COUGH (non-serious) with onset 09May2022, outcome "not recovered"; PYREXIA (non-serious) with onset 09May2022, outcome "not recovered", described as "Fever"; RHINORRHOEA (non-serious) with onset 09May2022, outcome "not recovered", described as "Runny nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Tested positive for Covid 19 on 09May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, pain, rhinorrhoea, cough.  Clinical information:No other vaccine in four weeks.No other medications in two weeks. AE were treated with acetaminophen. No covid prior vaccination and no known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm pain which she is unable to move and that her arms keep hurting; left arm pain which she is unable to move and that her arms keep hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (COMIRNATY), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset May2021, outcome "not recovered" and all described as "left arm pain which she is unable to move and that her arms keep hurting". The events "left arm pain which she is unable to move and that her arms keep hurting" required physician office visit.  Additional information: The reporter is female and was 49 years when she received the vaccine and is now 50 years. she had her 1st dose of Comirnaty on 23Apr2021 and the 2nd dose on 14May2021. she said that starting around May2021, she experienced left arm pain she is unable to move and that her arms keep hurting. she asked if this should be lasting long as it's been a year now. she wanted information on that side effect. she took her first shot last year at the end of April and it is still aching from that long ago and it is hard to bend it and it won't go away. Her sister also has the same problem, and it was still hurting and she can't bend her left arm. Treatment: she stated her doctor sent her over to the hospital to get her arm checked out and they gave her a shot to help with the pain, but it didn't help at all. she didn't know what the name of the medication was. she doesn't think she was seen in the Emergency Room. she asked, should this be lasting this long. she states no one knows what is wrong with her arm. Her Sister's arm was hurting too, she has the same problem. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations.   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: Abdominal discomfort, Anaemia, Bone tuberculosis, Chest pain, Cough
Clinical narrative: sjogrens; POTS; SSP; anemic; I lost 50 pounds slowly; double vision; leg weakness pain; leg weakness pain; cough; bad back stomach; bad back stomach; chest pain; sick; 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 1, 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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "sjogrens"; BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "POTS"; SUBACUTE SCLEROSING PANENCEPHALITIS (medically significant), outcome "unknown", described as "SSP"; ANAEMIA (medically significant), outcome "unknown", described as "anemic"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "I lost 50 pounds slowly"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "leg weakness pain"; COUGH (non-serious), outcome "unknown"; MUSCULOSKELETAL DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "bad back stomach"; CHEST PAIN (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The events "sjogrens", "pots", "ssp", "anemic", "double vision" and "leg weakness pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 50 pounds. Clinical course: Patient was stated that, i am writing you today to find out how many people complained about (contracting or a flare) of getting sicker and sicker after each vaccine. I followed my paper trail with my primary and I got attacked by sjogrens after my first vaccine. Now I have POTS, SSP, anemic, double vision, leg weakness pain everywhere. Been to ER 5 times now, recent I have developed a cough and bad back stomach and chest pain. I lost 50 pounds slowly at first without trying as I became sick a Bd couldn't leave house.  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: Diplopia, Illness, Muscular weakness, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: sjogrens; POTS; SSP; anemic; I lost 50 pounds slowly; double vision; leg weakness pain; leg weakness pain; cough; bad back stomach; bad back stomach; chest pain; sick; 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 1, 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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "sjogrens"; BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "POTS"; SUBACUTE SCLEROSING PANENCEPHALITIS (medically significant), outcome "unknown", described as "SSP"; ANAEMIA (medically significant), outcome "unknown", described as "anemic"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "I lost 50 pounds slowly"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "leg weakness pain"; COUGH (non-serious), outcome "unknown"; MUSCULOSKELETAL DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "bad back stomach"; CHEST PAIN (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The events "sjogrens", "pots", "ssp", "anemic", "double vision" and "leg weakness pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 50 pounds. Clinical course: Patient was stated that, i am writing you today to find out how many people complained about (contracting or a flare) of getting sicker and sicker after each vaccine. I followed my paper trail with my primary and I got attacked by sjogrens after my first vaccine. Now I have POTS, SSP, anemic, double vision, leg weakness pain everywhere. Been to ER 5 times now, recent I have developed a cough and bad back stomach and chest pain. I lost 50 pounds slowly at first without trying as I became sick a Bd couldn't leave house.  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: Sjogren's syndrome, Subacute sclerosing panencephalitis, Weight, Weight decreased
Clinical narrative: sjogrens; POTS; SSP; anemic; I lost 50 pounds slowly; double vision; leg weakness pain; leg weakness pain; cough; bad back stomach; bad back stomach; chest pain; sick; 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 1, 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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "sjogrens"; BONE TUBERCULOSIS (medically significant), outcome "unknown", described as "POTS"; SUBACUTE SCLEROSING PANENCEPHALITIS (medically significant), outcome "unknown", described as "SSP"; ANAEMIA (medically significant), outcome "unknown", described as "anemic"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "I lost 50 pounds slowly"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision"; PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious), outcome "unknown" and all described as "leg weakness pain"; COUGH (non-serious), outcome "unknown"; MUSCULOSKELETAL DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "bad back stomach"; CHEST PAIN (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The events "sjogrens", "pots", "ssp", "anemic", "double vision" and "leg weakness pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 50 pounds. Clinical course: Patient was stated that, i am writing you today to find out how many people complained about (contracting or a flare) of getting sicker and sicker after each vaccine. I followed my paper trail with my primary and I got attacked by sjogrens after my first vaccine. Now I have POTS, SSP, anemic, double vision, leg weakness pain everywhere. Been to ER 5 times now, recent I have developed a cough and bad back stomach and chest pain. I lost 50 pounds slowly at first without trying as I became sick a Bd couldn't leave house.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, General physical health deterioration, Pain, Pneumonia bacterial, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis recurrent flare up; bacterial pneumonia; Worsening Health; Increased Pain; Felt a drop in support; Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4382680-00 (Abbvie).  A 54-year-old female 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis recurrent flare up"; PNEUMONIA BACTERIAL (medically significant), outcome "unknown", described as "bacterial pneumonia"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "Worsening Health"; PAIN (non-serious), outcome "unknown", described as "Increased Pain"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "Felt a drop in support"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was dosage permanently withdrawn. The event had not abated after stopping drug. Other relevant history was not reported.   The reporter's assessment of the causal relationship with the suspect product(s) BNT162b2 for "rheumatoid arthritis recurrent flare up", "increased pain" was possible, "bacterial pneumonia", "worsening health", "Felt a drop in support" and "drug effect decreased" was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of Worsening Health was not related, bacterial pneumonia, Rheumatoid arthritis recurrent flare up, Increased Pain, Felt a drop in support and Drug effect decreased from Humira was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: Rheumatoid arthritis recurrent flare up; bacterial pneumonia; Worsening Health; Increased Pain; Felt a drop in support; Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4382680-00 (Abbvie).  A 54-year-old female 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis recurrent flare up"; PNEUMONIA BACTERIAL (medically significant), outcome "unknown", described as "bacterial pneumonia"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "Worsening Health"; PAIN (non-serious), outcome "unknown", described as "Increased Pain"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "Felt a drop in support"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was dosage permanently withdrawn. The event had not abated after stopping drug. Other relevant history was not reported.   The reporter's assessment of the causal relationship with the suspect product(s) BNT162b2 for "rheumatoid arthritis recurrent flare up", "increased pain" was possible, "bacterial pneumonia", "worsening health", "Felt a drop in support" and "drug effect decreased" was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of Worsening Health was not related, bacterial pneumonia, Rheumatoid arthritis recurrent flare up, Increased Pain, Felt a drop in support and Drug effect decreased from Humira was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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