chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: chills; headache; tiredness; cold like this; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on 06May2022 this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), 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: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold like this".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: tested positive for Covid-19 on 04May2022; tested positive for Covid-19 on 04May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 1, single (Lot number: ER8735), in right arm, on 28May2021 as dose 2, single (Lot number: EW0173), in right arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 48 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "history of Triple Negative Breast Cancer (diagnosed 11Dec2012)", start date: 11Dec2012 (unspecified if ongoing). No Covid prior vaccination. Patient tested for Covid post vaccination. Concomitant medication(s) included: FLU VACCINE VII taken for influenza, on 18Nov2021; FOLIC ACID; ESCITALOPRAM OXALATE; CALCIUM; VITAMIN E [TOCOPHEROL]; VITAMIN D [COLECALCIFEROL]; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovering" and all described as "tested positive for Covid-19 on 04May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (04May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Hair loss". The event "hair loss" required physician office visit.  Additional information: Caller states that she had her first dose of the Pfizer-BioNTech COVID-19 Vaccine back in Sep2021 or Oct2021 but she hasn't received the second booster dose because after getting the first dose of the primary series she began experiencing some hair loss. she got COVID in July. she went to see dermatologist to treat her hair loss and her dermatologist said that COVID and pneumonia are stressors that may cause hair loss too. She said the hair loss started around the first time with the first vaccine and she said she did have COVID. She said dermatologist told her there are a lot of people with that happening and she said was around 3 months after and from Jul and then she got pneumonia. She said lasted for 11 weeks. She said the hair loss stopped and is now coming back and she is due for a booster and asking should she be reluctant or should she wait. She is not sure if the vaccine could cause hair loss or could COVID cause hair loss. She is going through menopause. She said hair loss is the only thing that happened and she is not sure if from that. The dermatologist though the hair loss was from COVID. She said was around the 3 months timeframe. Caller declined to complete report since on her lunch hour. Unable to obtain full details. Caller confirmed Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: has been exposed several times in the last week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  An 81-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (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: EXPOSURE TO SARS-COV-2 (non-serious) with onset 09May2022, outcome "unknown", described as "has been exposed several times in the last week".  Additional information: Reporter stated that she has had four Pfizer shots and hasn't had COVID. Also, stated she was not sure if it was Pfizer shots and she has been exposed several times in the last week.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 13:00 as dose 2 (booster), single (Lot number: Fg3527) at the age of 49 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 at 12:00 as dose 1, single (Lot number: 043a21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Dose:1 Jnj, Dose: 2 Pfizer. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant) with onset 25Apr2021, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) positive; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was stated that patient experienced rebound COVID. Tested positive 25Apr2022, got better. Got sick again 08May2022. Tested positive again 09May2022. There was no other medication in 2 weeks. There were no known allergies. Treatment details to COVID was anti-viral product, Paxlovid, start date was 25Apr2022 and stop date was 29Apr2022. There was no other medical history.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 13:00 as dose 2 (booster), single (Lot number: Fg3527) at the age of 49 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05Apr2021 at 12:00 as dose 1, single (Lot number: 043a21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Dose:1 Jnj, Dose: 2 Pfizer. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant) with onset 25Apr2021, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) positive; (09May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was stated that patient experienced rebound COVID. Tested positive 25Apr2022, got better. Got sick again 08May2022. Tested positive again 09May2022. There was no other medication in 2 weeks. There were no known allergies. Treatment details to COVID was anti-viral product, Paxlovid, start date was 25Apr2022 and stop date was 29Apr2022. There was no other medical history.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Day 11 tested positive; Day 11 tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 at 09:30 as dose 1, single (Lot number: EN5318), in left arm, on 11Mar2021 at 09:45 as dose 2, single (Lot number: EN6208), in left arm and on 15Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "high cholesterol" (unspecified if ongoing); "borderline high blood pressure" (unspecified if ongoing), notes: borderline high blood pressure. Concomitant medication(s) included: BUPROPION, start date: Jan2008; CETIRIZIN, start date: Jan2008; ACETAMINOPHEN, start date: 21Apr2022, stop date: 24Apr2022; ALEVE, start date: 21Apr2022, stop date: 24Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Day 11 tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: day 11 tested Positive; (2022) Negative, notes: day 16 tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid (lot number:FY5657) form 22Apr2022 to 26Apr2022 for the treatment of COVID-19. Patient was also taking other medications within 2 weeks of starting COVID-19 treatment. Patient had previously received a COVID-19 Vaccine  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at Covid-19 vaccine injection site; big patch of swelling at the injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4615746.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "ground glass opacities in lungs" (unspecified if ongoing), notes: ground glass opacities in lungs; "Hashimoto's disease" (ongoing); "overactive bladder" (ongoing). Concomitant medication(s) included: SYNTHROID; HYDROXYCHLOROQUINE; OXYBUTYNIN; VITAMIN D [COLECALCIFEROL]; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]; BENADRYL. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at Covid-19 vaccine injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "big patch of swelling at the injection site".  Additional information: Patient's concomitant medication included: SYNTHROID, HYDROXYCHLOROQUINE, OXYBUTYNIN, VITAMIN D, CENTRUM SILVER, PROBIOTIC, BENADRYL. On unknown date, it was reported that patient experienced: soreness at Covid-19 vaccine injection site, big patch of swelling at the injection site. The outcome of the reported event(s) was Unknown. We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with company policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Petechiae, Skin discolouration
Clinical narrative: bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3, BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CONTUSION (non-serious) with onset 2022, outcome "recovering", PETECHIAE (non-serious), SKIN DISCOLOURATION (non-serious) all with onset 2022, outcome "unknown" and all described as "bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin". The events "bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin" required physician office visit.  Additional information: Patient states she is calling about the Pfizer Covid vaccine, booster number 2, and she is also taking Ibrance. she states that she had the bruising evaluated at her health center at (withheld) and states that the vaccine did not bother her, and she did not have any side effects. she had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin. she got her vaccine on 28Apr2022. she states it is getting better, and she took a picture of it. Patient states she is on an Ibrance trial, through the patient assistance program, and she just happened to mention it to agent, who calls and checks on her. she states that other people who were not healthcare professionals told her it was nothing to worry about and states she had health care professionals look at it as well.  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: Cough, Drug ineffective, Headache, Nasal congestion, Pyrexia
Clinical narrative: his wife has been testing positive for over a week now; his wife has been testing positive for over a week now; fever; coughing; congestions; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset May2022, outcome "unknown", described as "congestions"; COUGH (non-serious) with onset May2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "his wife has been testing positive for over a week now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: testing positive for over a week now. Clinical course: Caller, 38 year old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer COVID vaccine, then he tested positive for COVID infection on the Friday before reporting, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he was just wondering why the vaccine shots didn't work.  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: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: his wife has been testing positive for over a week now; his wife has been testing positive for over a week now; fever; coughing; congestions; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset May2022, outcome "unknown", described as "congestions"; COUGH (non-serious) with onset May2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "his wife has been testing positive for over a week now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: testing positive for over a week now. Clinical course: Caller, 38 year old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer COVID vaccine, then he tested positive for COVID infection on the Friday before reporting, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he was just wondering why the vaccine shots didn't work.  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: Vaccination site pain
Clinical narrative: My daughter and I went together for all thress of our shots/she had soreness a few days but then it went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FL3198) 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, Anatomical site of injection: Upper arm, Route of administration: Intramuscular, Batch/lot number: FC3180), administration date: 09Aug2021, for Covid-19 Immunization; BNT162b2 (Dose: 1, Anatomical site of injection: Upper arm, Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 19Jul2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Feb2022, outcome "recovered" (2022), described as "My daughter and I went together for all thress of our shots/she had soreness a few days but then it went away".  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). No prior vaccinations and no specific relevant tests. No treatment. I received the COVID booster on 09Feb2022. There was soreness in my arm at the injection site following the injection, which was normal. I noticed the next week that I still had Soreness at the injection site. My daughter and I went together for all three of our shots. I asked her if she noticed any thing and she told me she had soreness a few days but then it went away. It is going on three months since had the booster and there is still soreness in my arm where I was injected. More noticeable soreness /slight pain when actively using my arms manual labour, working on some-thing over head. Sometimes just have an achiness in my arm for no reason. Asked pharmacist if anything had been put out regarding this negative reply. Emailed Pfizer about it was instructed to call. Have not seen any medical professionals about issue.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic salty taste; Metallic salty taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "No appetite". The following information was reported: DYSGEUSIA (non-serious), DYSGEUSIA (non-serious), outcome "unknown" and all described as "Metallic salty taste".  Additional information: Patient had received two initial and then the booster dose. Patient have been left with a metallic salty taste in mouth after booster dose. Patient had no appetite since the second dose.  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid; Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 included: "IBD" (unspecified if ongoing); "Autoimmune" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; STELARA; IRON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Vaccine brand=Pfizer / BioNTech/product=COVID-19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took treatment for covid-19, brand= Paxlovid, treatment start date: 30Apr2022, treatment stop date: 05May2022, the patient took other medication/products within 2 weeks of starting covid-19 treatment, Previously patient took covid-19 vaccine.   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: Cardiac arrest
Clinical narrative: A sudden cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male 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: CARDIAC ARREST (medically significant), outcome "unknown", described as "A sudden cardiac arrest".  Clinical information: Reporter states that her husband had a sudden cardiac arrest a few days after getting his second Pfizer vaccine. He lived but 90 percent of people who have these do not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, 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). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right 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) for covid-19 immunization. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's 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 "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.Proprietary medicinal product name: Paxlovid. Indication for use in the case: Treatment of COVID-19. Date of start of drug: 07Apr2022. Date of last administration: 05Apr2022. 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: Antinuclear antibody, Antinuclear antibody positive, Erythema, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: My legs are in pain/My pain in feet has spread to legs; My feet and toes red; Walking painful especially when warm after walking; Fluttering in all parts of legs and muscle weakness in thighs; It is impacting my daily work at this point; Postive ANA; 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), on 30Jan2022 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, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "Fluttering in all parts of legs and muscle weakness in thighs"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "It is impacting my daily work at this point"; ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "My feet and toes red"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "My legs are in pain/My pain in feet has spread to legs"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 2022, outcome "unknown", described as "Postive ANA"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Walking painful especially when warm after walking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Forwarded as an Adverse Event on 09May2022. Reporter provided verification of contact address on 06May2022. Received booster shot 30Jan and patient feet and toes red, pain in feet had spread to legs when walking painful especially when warm after walking patient have fluttering in all parts of legs and muscle weakness in thighs, after some test Dr had only found a new case of postive ANA. This came on after patient booster and was progressing and they can not treat patient. How long was this in patient system what help patient can get, t was impacting patient daily work at this point and night patients legs are in pain.  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-202200695356 Pfizer
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: My legs are in pain/My pain in feet has spread to legs; My feet and toes red; Walking painful especially when warm after walking; Fluttering in all parts of legs and muscle weakness in thighs; It is impacting my daily work at this point; Postive ANA; 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), on 30Jan2022 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, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "Fluttering in all parts of legs and muscle weakness in thighs"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "It is impacting my daily work at this point"; ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "My feet and toes red"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "My legs are in pain/My pain in feet has spread to legs"; ANTINUCLEAR ANTIBODY POSITIVE (non-serious) with onset 2022, outcome "unknown", described as "Postive ANA"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Walking painful especially when warm after walking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Forwarded as an Adverse Event on 09May2022. Reporter provided verification of contact address on 06May2022. Received booster shot 30Jan and patient feet and toes red, pain in feet had spread to legs when walking painful especially when warm after walking patient have fluttering in all parts of legs and muscle weakness in thighs, after some test Dr had only found a new case of postive ANA. This came on after patient booster and was progressing and they can not treat patient. How long was this in patient system what help patient can get, t was impacting patient daily work at this point and night patients legs are in pain.  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-202200695356 Pfizer
Age: 57.0
Sex: F
Vaccine: COVID19, 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) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 13:30 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 at 13:30 as dose 2, single (Lot number: EN5318), in left arm and on 05Oct2021 at 14:30 as dose 3 (booster), single (Lot number: EW0186) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Well controlled hypertension" (unspecified if ongoing), notes: Well controlled hypertension. Concomitant medication(s) included: NORVASC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive.   Clinical course: COVID related heart attack on 18Apr2022 after testing positive for COVID on 08Apr2022 with cardiac arrest x2 stent occlusion 2 hours after placement CCU stay with intubation, defribillation and temporary pacemaker. Treatment received for events Cardiac arrest and Heart attack included Catherization, stent, defribillation, intubation.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure, Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 13:30 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 at 13:30 as dose 2, single (Lot number: EN5318), in left arm and on 05Oct2021 at 14:30 as dose 3 (booster), single (Lot number: EW0186) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Well controlled hypertension" (unspecified if ongoing), notes: Well controlled hypertension. Concomitant medication(s) included: NORVASC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive.   Clinical course: COVID related heart attack on 18Apr2022 after testing positive for COVID on 08Apr2022 with cardiac arrest x2 stent occlusion 2 hours after placement CCU stay with intubation, defribillation and temporary pacemaker. Treatment received for events Cardiac arrest and Heart attack included Catherization, stent, defribillation, intubation.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination failure, Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mitral valve disease, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: Heart surgery in Nov to repair a mitral valve; My fever is not as high as before; Congested like a bad cold; Congested like a bad cold; 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 59-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2020, stop date: Nov2020, notes: I had COVID in November (confirmed 2020); "I take cholesterol medicine" (unspecified if ongoing), notes: I take cholesterol medicine. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: MITRAL VALVE DISEASE (medically significant), outcome "unknown", described as "Heart surgery in Nov to repair a mitral valve"; PYREXIA (non-serious), outcome "unknown", described as "My fever is not as high as before"; NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "Congested like a bad cold". Therapeutic measures were taken as a result of mitral valve disease.  Clinical course: Patient had the Pfizer Covid 19 vaccine back in Apr2021 of last year (confirmed 2021) and I had my second dose 5 weeks later. I got my booster in Nov2021 (confirmed 2021). I have COVID now. I have read time and time again. I had COVID in Nov2020 (confirmed 2020) before vaccines were available. Is having the booster in Nov led to a lesser degree of Covid? I had it really bad last year. I think it was congenital but I had to have open heart surgery in Nov to repair a mitral valve. I am 59-year-old. I am not dying over here. I called my doctor and they were going to put me on Paxlovid which I am hesitant to take with the side effects and my history. I take cholesterol medicine. I made it through ok last time. My fever is not as high as before, I am just really congested like a bad cold. It doesn't seem as bad. I don't want to take that pill. Is it going to be shorter lived. Is COVID shorter lived after 3 doses.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Heart surgery in Nov to repair a mitral valve; My fever is not as high as before; Congested like a bad cold; Congested like a bad cold; 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 59-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2020, stop date: Nov2020, notes: I had COVID in November (confirmed 2020); "I take cholesterol medicine" (unspecified if ongoing), notes: I take cholesterol medicine. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: MITRAL VALVE DISEASE (medically significant), outcome "unknown", described as "Heart surgery in Nov to repair a mitral valve"; PYREXIA (non-serious), outcome "unknown", described as "My fever is not as high as before"; NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "Congested like a bad cold". Therapeutic measures were taken as a result of mitral valve disease.  Clinical course: Patient had the Pfizer Covid 19 vaccine back in Apr2021 of last year (confirmed 2021) and I had my second dose 5 weeks later. I got my booster in Nov2021 (confirmed 2021). I have COVID now. I have read time and time again. I had COVID in Nov2020 (confirmed 2020) before vaccines were available. Is having the booster in Nov led to a lesser degree of Covid? I had it really bad last year. I think it was congenital but I had to have open heart surgery in Nov to repair a mitral valve. I am 59-year-old. I am not dying over here. I called my doctor and they were going to put me on Paxlovid which I am hesitant to take with the side effects and my history. I take cholesterol medicine. I made it through ok last time. My fever is not as high as before, I am just really congested like a bad cold. It doesn't seem as bad. I don't want to take that pill. Is it going to be shorter lived. Is COVID shorter lived after 3 doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 74-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 03Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Brain tumor" (unspecified if ongoing); "poor balance" (unspecified if ongoing), notes: poor balance. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "recovered" (07May2022) and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (26Apr2022) Negative; (04May2022) Positive; (07May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive for COVID 19Apr2022. Started Paxlovid 21Apr2022. Tested negative 26Apr2022 & symptoms gone. On 29Apr2022 flew back home. On 03May2022 symptoms returned & on 04May2022 tested positive again. On 04May2022 started second course of Paxlovid (lot: 641513). On 07May2022 symptoms gone and tested negative. On 09May2022, treatment with Paxlovid was stopped. Adverse event is that COVID returned after taking Poxlovtd. No known allergies. Other medication in 2 weeks product included Atorvastatin.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: 1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.; 1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), in right arm and on 01May2021 as dose 2, single (Lot number: EW0172), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight but not obese" (unspecified if ongoing), notes: Overweight but not obese; "Depression" (unspecified if ongoing), notes: treated with bupropion.; "ADHD" (unspecified if ongoing), notes: not treated. Concomitant medication(s) included: BUPROPION. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "1st day of COVID symptoms, and positive rapid antigen test, was 26Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of sars-cov-2 test positive, vaccination failure.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IgA deficiency" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) apparent much high viral load, notes: apparent much high viral load as indicated by a much deeper, thicker t line; (09May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years 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 "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had re-infection of covid after completing series (Pavloxid for COVID-19). Tested negative and then tested positive 5 days later. Patient previously received covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.