chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Rash
Clinical narrative: rash around the shoulder area spread a little ways down towards belly and down the back; lot number FP7135; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 2-year-old female patient received BNT162b2 (BNT162B2), on 06Jul2022 at 14:30 as dose 1, single (Lot number: FP7135) at the age of 2 years, in left leg for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Jul2022 at 13:30, outcome "unknown", described as "lot number FP7135"; RASH (non-serious) with onset 06Jul2022 at 13:45, outcome "recovering", described as "rash around the shoulder area spread a little ways down towards belly and down the back". The events "rash around the shoulder area spread a little ways down towards belly and down the back" required emergency room visit. Therapeutic measures were taken as a result of rash.  Additional information: No other vaccine received in four weeks and no other medications in two weeks. Patient was not received covid prior vaccination and not tested covid post vaccination. It was reported that patient had a rash that wasn't a severe reaction couple of mins after the shot. Was around the shoulder area and under the neck both front and back and rash spread a little ways down towards belly and down the back. AE resulted in Emergency room/department or urgent care. Doctor checked and gave Benadryl.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: Fj1685), on 08Jan2021 as dose 2, single (Lot number: EL0142) and on 08Sep2021 as dose 3 (booster), single (Lot number: Er8732) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "Gluten" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; VITAMIN D3; OMEPRAZOLE; LOSARTAN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN B12 [CYANOCOBALAMIN]; TERAZOSIN; ROSUVASTATIN. Past drug history included: Lactose, reaction(s): "Known allergies: lactose"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: has not had a period since her shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 at 11:00 as dose 1, single (Lot number: FJ8762) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 05Jan2022, outcome "not recovered", described as "has not had a period since her shots". The event "has not had a period since her shots" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: There was no other vaccine in four weeks.  There was none other medication in two weeks. There was no covid prior vaccination and did not tested covid post vaccination. There was no known allergies. There was no other medical history.  Follow-Up (11Jul2022): Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test, Vaccination failure
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL3302), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma treated by inhaler PRN; "hayfever" (unspecified if ongoing); "Known Allergies: Tetracycline related medications (developed PIE)" (unspecified if ongoing); "Known Allergies: Soy (Anaphylaxis S2)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Macrodantin, reaction(s): "Known allergies: macrodantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (unspecified date) Negative, notes: when I tested on June 6 or 7, I was again negative; (19May2022) positive; (24May2022) Negative; (30May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had a sore throat and tested positive for COVID-19 on 19May2022. She was prescribed Paxlovid and was able to start the 5 day routine for the medication that same day (19May2022) and stopped on 23Jun2022. She was really never sick or fatigued. Her test result was light pink, not a bright pink as other positive tests she have seen. She tested negative on 24May2022. On 29May2022, she woke up with a mild sore throat. It was still sore on 30May so she tested again and was positive. She did not test for a week and when she tested on 6 or 7Jun2022, she was again negative. No S/S since then.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound COVID 3 days after finishing course of paxlovid.; Rebound COVID 3 days after finishing course of paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes; "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Rebound COVID 3 days after finishing course of paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (28Jun2022) Negative, notes: Tested negative for 2 days; (29Jun2022) Negative, notes: Tested negative for 2 days; (01Jul2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid, start date: 22Jun2022, stop date: 27Jun2022, Indication: Treatment of COVID-19.Other medication in 2 weeks includes Insulin and Levothyroxine. Adverse event: Rebound COVID 3 days after finishing course of Paxlovid. Tested negative for 2 days then positive with return of more severe symptoms. No hospitalization required. Other medical history: Type 1 diabetes, hypothyroidism. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: To first shot flu like response; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma, allergies" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulpher drugs" (unspecified if ongoing); "grasses" (unspecified if ongoing); "strawberries" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Allergy:Ceftin"; Avalox, reaction(s): "Allergy:avalox"; Forteo, reaction(s): "Allergy:forteo"; Tymlos, reaction(s): "allergy:tymlos"; Amoxicillin, reaction(s): "Allergies:amoxicillin". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "To first shot flu like response".  Additional information: Patient received other medication in 2 weeks includes Stelara, Claritan, Albuterol, DHL by pure botanicals with slippery elm and marshmallow. Known allergies: Ceftin, avalox, penicillin, forteo, tymlos, amoxicillin, sulpher drugs, strawberries, grasses, etc. Other medical history: Asthma, allergies. COVID 19 Treatment: Paxlovid, start date 18Jun2022, stop date 22Jun2022, Lot number: Nd#00069-1085-30. Patient received Pfizer second dose on 15Mar2021 in left arm with lot number: EN6199. Patient received Pfizer third dose on 12Oct2021 on left arm with lot number: FF2587. To first shot flu like response. Other 2 shots no symptons. Pcr Tested positive for covid 17Jun pm. Treatment on paxlovid began am 18Jun. On paxlovid just heavy head and chest cold symptons first 3 days and symptons began easing. Felt fine and tested negative on rapid test on 24Jun. Rebound with same cold symptons and positive rapid test 30Jun. Rebound with heavy head/chest cold symptoms 3 days. bwgan to ease up slowly as struggled to keep lungs clear of secondary infection with steam etc. Tested positive on homevtest day, 5, 6 though Felt milder cold symptons day 5 and 6. Day 7 Tested negative on rapid test though still heavy chest and coughing.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: has not had a period since her shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 at 11:00 as dose 2, single (Lot number: FL3209) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: FJ8762, Administration time: 11:00 AM, Vaccine location: Left arm), administration date: 05Jan2022, when the patient was 15-year-old, for Covid-19 Immunization, reaction(s): "has not had a period since her shots". The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "not recovered", described as "has not had a period since her shots". Therapeutic measures were not taken as a result of menstruation delayed.  Additional Information: Facility type vaccine was reported as Doctor's office/urgent care. Additional information: Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 19Mar2021 as dose 1, single (Lot number: EL9264), on 11Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 16Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) in 2 weeks included: TRIAMTERENE; LOSARTAN. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID; UNKNOWN RESULTS. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient completed her 5 day series of Paxlovid on 01Jul and was feeling much better. Stated that, on 6Jul, she woke up feeling sick again - fever, sore throat, congested, coughing, dizzy and tested positive for COVID. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 27Jun2022 and stopped on 01Jul2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Pain, SARS-CoV-2 test
Clinical narrative: pain that lasted over a year; joint swelling; inflammation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, 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: INFLAMMATION (non-serious) with onset May2021, outcome "recovering"; JOINT SWELLING (non-serious) with onset May2021, outcome "recovering"; PAIN (non-serious) with onset May2021, outcome "recovering", described as "pain that lasted over a year". The events "pain that lasted over a year", "joint swelling" and "inflammation" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, joint swelling, inflammation with medications, and physical therapy. Patient had covid prior vaccination was no, and covid tested post vaccination was yes. And other vaccine in four weeks was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin", notes: Known allergies: Vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After testing positive for covid and using Paxlovid; Negative, notes: I felt 100% better and tested negative; Positive, notes: Two days later I had rebound covid symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: After testing positive for COVID and using Paxlovid, I felt 100% better and tested negative. Two days later I had rebound COVID symptoms and tested positive. Symptoms were exactly the same as when I first had symptoms ten days before, including: sneezing, sore throat, congestion, cough, phlegm, trouble drawing a full breath in, chest pain/pressure, headache, dizziness. Treatment start date: 25Jun2022 and treatment stop date: 30Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
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) (Physician).  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertrophic obstructive cardiomyopathy" (unspecified if ongoing); "pulmonary hypertension" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Drug allergy:penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; TRULICITY; ROBITUSSIN EXPECTORANT [ACETYLCYSTEINE]; FLONASE [FLUTICASONE PROPIONATE]; GLIPIZIDE; METOPROLOL; PANTOPRAZOLE; VERAPAMIL. Past drug history included: Codeine, reaction(s): "Drug allergy"; Naproxen, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022 at 20:00, outcome "unknown" and all described as "COVID-19". The event "covid-19" required emergency room visit. 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FF8590) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: symptomatic and positive COVID Ag again; (06Jul2022) positive, notes: symptomatic and positive COVID Ag again. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: No other medication in 2weeks. The patient has no known drug allergy.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration, Vitiligo
Clinical narrative: a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening; Vitiligo; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. Vaccination history included: BNT162b2 (Dose Number: 1, single, Prev dose lot unknown reason=Unable to locate or read the details.), administration date: 13May2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: VITILIGO (non-serious) with onset 28Jun2021, outcome "not recovered"; SKIN DISCOLOURATION (non-serious) with onset 28Jun2021, outcome "not recovered", described as "a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening". The events "a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening" and "vitiligo" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin discolouration, vitiligo.  Additional Information: Patient also received BNT162B2 dose 3 (booster), single on 14Jan2022 for covid-19 immunization. It was reported by female (parent), that her 15-year-old daughter first noticed a darkening area of skin on her chin about 2 weeks after her 2nd covid vaccine. it became noticeably bigger around over the next few months.they thought it was melasma. They were able to see a dermatologist on 06Jul2022 and was told she had Vitiligo. She had very fair skin they weren't seeing darkening; it was the skin around the area lightening giving the appearance that skin was darkening. She(parent) believed this was related to the vaccine. AE treatment was reported as topical tacrolimus and triamcinolone. Wellbutrin was reported as other medications patient had in two weeks. Patient did not have covid Prior vaccination. patient did not have any other vaccine in four weeks. covid tested post vaccination was reported as Yes. Known allergies reported as None. there was no history of autoimmune disorders in her or the family. she had no other symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 48 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 included: "Brugada syndrome" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (07Jul2022) Unknown results, notes: Covid rebound 6 days after finishing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "vertigo" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA, start date: 01Mar2022, stop date: 30Jun2022; AMLODIPINE, start date: Jan2019, stop date: 07Jul2022; LISINOPRIL, start date: Jan2019, stop date: 07Jul2022; PRESERVISION, start date: Jan2020, stop date: 07Jul2022; VITAMIN D [VITAMIN D NOS], start date: Feb2022, stop date: 07Jul2022. Past drug history included: Maxzide, reaction(s): "Known allergies: Maxzide".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for Covid on an antigen test after completing the treatment; positive, notes: I began treatment after a positive pcr Covid test; positive, notes: A few days later I had symptoms of nasal congestion, sneezing, headache and tested positive on a PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was reporter and reported about covid treatment. Patient received vaccine and other medication in 2weeks.Patient received Paxlovid as antiviral therapy from 16Jun2022 to 20Jun2022 as treatment of COVID-19 she received BNT162B2 vaccine first dose on date Apr2021 and time 01:00 PM on right arm. Patient received BNT162B2 vaccine second dose on date Apr2021 and time 10:00 AM on right arm. And third dose on date Nov2021 and time 02:00 PM on right arm. Patient received BNT162B2 vaccine fourth dose on date 28Apr2022 and time 02:00 PM on right arm. It was reported that patient began treatment after a positive PCR Covid test and had a sore throat her symptoms went away and tested negative for Covid on an antigen test after completing the treatment. A few days later had symptoms of nasal congestion, sneezing, headache and tested positive on a PCR test. Adverse events start date was reported as 26Jun2022 and time 03:00 PM. Patient was recovered no treatment adverse event was reported. Patient had Known allergies with Maxzide and other medical history was Asthma, hypertension, vertigo.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/ tested positive for COVID on 24Jun2022; COVID 19 Treatment/ tested positive for COVID on 24Jun2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastric reflux" (unspecified if ongoing); "frequent headaches" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "unknown" and all described as "COVID 19 Treatment/ tested positive for COVID on 24Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jun2022) Positive; (30Jun2022) Negative; (01Jul2022) Negative; (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was exposed to COVID ON 20Jun2022 and tested positive for COVID on 24Jun2022 - rapid home test. Began treatment with Paxlovid later that day and completed treatment on 29Jun2022. Patient took all doses roughly 12 hours apart. Symptoms of body aches. Low grade fever, chest congestion and headache resolved before treatment ended and patient felt good. Some mild pluritic chest pain with non productive cough continued 1-2 more days and mild sinus drainage continued throughout 10 day quarantine. Patient tested negative on 30Jun and on 01Jul2022. On 03Jul2022 sinus drainage increased and on 05July I felt unwell with much more sinus congestion and pressure. She repeated home test and it was immediately positive. Restarted quarantine. Patient was still positive on 7Jul2022 but sinus congestion was improving. She was feeling better but she had a headache. Additional issue was she developed a macular hole with blurred vision in her right eye around 28Jun2023 physician said this was unrelated. Other medications included omeprazole, multivitamin, D-3 2000iu, ibuprofen, Docusate na100 mgx2 all started on 01May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19/nausea, extreme diarrhea with bleeding, rash, (bad taste), fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:  Maybe PEG" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jul2022, outcome "recovered" (06Jul2022), described as "Treatment of COVID-19"; SUSPECTED COVID-19 (medically significant) with onset 03Jul2022, outcome "recovered" (06Jul2022), described as "Treatment of COVID-19/nausea, extreme diarrhea with bleeding, rash, (bad taste), fainting". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid from 03Jul2022 to 05Jul2022 of Covid-19.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Nov2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Former smoker" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). Concomitant medication(s) included: PITAVASTATIN CALCIUM, start date: 01Oct2021, stop date: 07Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02Jul2022) Negative, notes: Tested negative on 02Jul2022; (05Jul2022) Positive, notes: Tested positive again on 05Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Anti-viral drug Paxlovid from 26Jun2022 to 30Jun2022 for COVID 19 Treatment.  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: Hypersensitivity, Skin lesion, Urticaria
Clinical narrative: hives/lesions all over her body; hives/lesions all over her body; severe allergic reaction to the second Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female patient received BNT162b2 (BNT162B2), 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; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), MANUFACTURER UNKNOWN; 1st booster), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), SKIN LESION (non-serious), outcome "not recovered" and all described as "hives/lesions all over her body"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "severe allergic reaction to the second Pfizer booster". The events "hives/lesions all over her body" and "severe allergic reaction to the second pfizer booster" required physician office visit.  Additional information: It was reported that she broke out in hives/lesions all over her body and continued to have the hives/lesions, which were not going away. She had seen a dermatologist who told her it was a reaction to the second booster. It's been 4-5 months. No sign of it going away. She continued to see the dermatologist. Wanted to know if there was anything that can be done.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 11:00 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 at 11:00 as dose 2, single (Lot number: EN6203), in left arm, on 04Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL, start date: 01Jan2018 and Novast. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2 weeks brand= Novast. Other medication in 2 weeks start date=01Jan2018.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (manufacture unknown, dose 1). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". No other medications/products within 2 weeks of starting COVID-19 treatment. Seriousness reported as no. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral drug Paxlovid which treatment started on 25Jun2022 and stopped on 29Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph in armpit breast- the very first occassion/ before booster vaccine for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 at 11:00 as dose 2, single (Lot number: EW0175) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (ongoing), notes: Migraines; "Mood disorder" (ongoing). Concomitant medication(s) included: BUPROPION oral taken for affective disorder, start date: 2018 (ongoing); SUMATRIPTAN oral taken for migraine, start date: 2016 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8737; Route of administration: Intramuscular; Anatomical site of injection: Left arm; Vaccine administration Time: 10:30), administration date: 02Apr2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph in armpit breast- the very first occassion/ before booster vaccine for covid".  Additional Information: Patient does not required the initiation of new medication/other treatment/procedure.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: My lips and outer mouth area were very numb for about an hour after  receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EW0161) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "Thyroid Medication" (unspecified if ongoing), notes: Verbatim:Thyroid Medication. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine.The following information was reported: HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "recovered", described as "My lips and outer mouth area were very numb for about an hour after receiving the vaccine". Therapeutic measures were not taken as a result of hypoaesthesia oral.  Additional information:Patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Other medications in two weeks included HRT [hormone replacement therapy] and thyroid medications.Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Neurological examination, SARS-CoV-2 test, Vaccination failure
Clinical narrative: single binax at home positive; single binax at home positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9266), in left deltoid, on 15Mar2021 as dose 2, single (Lot number: EN6204), in left deltoid and on 23Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 52 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Allergy Environmental" (unspecified if ongoing), notes: Allergy Environmental; "Late term food allergies", start date: 2012 (unspecified if ongoing), notes: Late term food allergies , onset date: 2012, 2013, 2015, increase in prednisone for food reactions(avoid); "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies; "Elhers danlos syndrome" (ongoing), notes: Ehlers-Danlos syndrome. Concomitant medication(s) included: SHINGRIX, on 21Jan2021 as unk, single; AIMOVIG intramuscular taken for migraine, start date: Oct2017 (ongoing); ALLEGRA oral taken for hypersensitivity, start date: 2008 (ongoing). Vaccination history included: shingrex (Shingrex, dose1), administration date: 23Nov2020; prevnar 13, administration date: 12Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "single binax at home positive". The patient underwent the following laboratory tests and procedures: Neurological examination: 70-140; SARS-CoV-2 test: Positive.  Clinical Course: Food allergies med allergen are avoided. Use of medications that suppress immune system: for allergies to food not taken. Food allergies med allergen are avoided. Cary epi-pen. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus. All negative except single binax at home positive 01Jan2022. Negative which tested by school.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Neurological examination, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: single binax at home positive; single binax at home positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9266), in left deltoid, on 15Mar2021 as dose 2, single (Lot number: EN6204), in left deltoid and on 23Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 52 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Allergy Environmental" (unspecified if ongoing), notes: Allergy Environmental; "Late term food allergies", start date: 2012 (unspecified if ongoing), notes: Late term food allergies , onset date: 2012, 2013, 2015, increase in prednisone for food reactions(avoid); "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies; "Elhers danlos syndrome" (ongoing), notes: Ehlers-Danlos syndrome. Concomitant medication(s) included: SHINGRIX, on 21Jan2021 as unk, single; AIMOVIG intramuscular taken for migraine, start date: Oct2017 (ongoing); ALLEGRA oral taken for hypersensitivity, start date: 2008 (ongoing). Vaccination history included: shingrex (Shingrex, dose1), administration date: 23Nov2020; prevnar 13, administration date: 12Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "single binax at home positive". The patient underwent the following laboratory tests and procedures: Neurological examination: 70-140; SARS-CoV-2 test: Positive.  Clinical Course: Food allergies med allergen are avoided. Use of medications that suppress immune system: for allergies to food not taken. Food allergies med allergen are avoided. Cary epi-pen. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus. All negative except single binax at home positive 01Jan2022. Negative which tested by school.