chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "scallops allergy" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: May2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Positive rapid test for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details: product= COVID 19 Treatment, brand= Paxlovid treatment start date: 23Nov2022, treatment stop date: 27Nov2022, Indication: Treatment of COVID-19. Rebound starting 04Dec2022 mild symptoms (coryza),slight cough, mild headache Positive rapid test for COVID-19.
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested postive with home test kit; tested postive with home test kit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 09:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 55 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 18Mar2021 as dose 2, single (Lot number: EN6200), on 01Nov2021 as dose 3 (booster), single (Lot number: FF8839) and on 04Apr2022 as dose 4 (booster), single (Lot number: FL3197), all intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "cholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Dec2022, outcome "recovering" and all described as "tested postive with home test kit". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Positive, notes: tested postive with home test kit; (04Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies.; Sender's Comments: As per the available information the causality of the events vaccination failure and covid-19 with the suspects can not be ruled out completely.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FD0809), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "gluten intolerance" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "migraine" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: SERTRALINE; MONTELUKAST; LORATADINE; METFORMIN; VITAMIN D [COLECALCIFEROL]; VITAMIN B COMPLEX; PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS BREVIS;LACTOBACILLUS BULGARICUS;LACTOBACILLUS CASEI;LACTOBACILLUS PARACASEI;LACTOBACILLUS PLANTARUM;LACTOBACILLUS RHAMNOSUS;LACTOBACILLUS SALIVARIUS]; GUAIFENESIN; MUCINEX, start date: 22Nov2022, stop date: 04Dec2022; ACETAMINOPHEN, start date: 22Nov2022, stop date: 04Dec2022; IBUPROFEN, start date: 24Nov2022, stop date: 04Dec2022. The following information was reported: VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: 03Dec2022 relapse of Covid symptoms (HA, low grade fever, extreme fatigue, sore throat, cough and congestion) and positive antigen test 5 days after completing Paxlovid and 11 days after initial symptoms began 22Nov2022; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect products BNT162B2,BNT162b2 omi ba.4-5 (BNT162B2  cannot be fully excluded.
Age: 41.0
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) (Other HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 08:15 as dose 4 (booster), single (Lot number: GJ6665) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 at 10:00 as dose 1, single (Lot number: 029L20A), in left arm, on 07Mar2021 at 11:30 as dose 2, single (Lot number: 027A21A), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: 017B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) Negative; (03Dec2022) Positive. 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. Patient treated with Paxlovid from 24Nov2022 to 28Nov2022.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 45.0
Sex: M
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 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product= COVID 19 Treatment; brand= Paxlovid; Treatment start date=29Nov2022; Treatment stop date=04Dec2022; Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Bivalent; Moderna Bivalent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8735), on 06May2021 as dose 2, single (Lot number: EW0173) and on 06Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 29 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 01Nov2022 as dose 4 (booster), single (Lot number: AS7165B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had asthma as child" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; SUDAFED PE, start date: 26Nov2022, stop date: 26Nov2022; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 26Nov2022, stop date: 27Nov2022; IBUPROFEN, start date: 25Nov2022, stop date: 26Nov2022. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Nov2022, outcome "unknown" and all described as "Moderna Bivalent"; VACCINATION FAILURE (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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks product: Emergen-C Immune+ on 25Nov2022 & stopped on 30Nov2022. Paxlovid received treatment for Covid-19 on 25Nov2022 and stooped on 30Nov2022.
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: Gh9703) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "afib" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; AMLODIPINE. 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: (04Dec2022) Negative; (04Dec2022) Negative; (06Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: PNC20
Symptoms: Electrocardiogram, Female sex hormone level, Heart rate increased, Hypertension
Clinical narrative: pressure fullness on the chest; heart rate  speeding up; after hours it got better than couple of hours it did the same thing; blood pressure /it was really 'high'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious) with onset Nov2022, outcome "not recovered", described as "blood pressure /it was really 'high'"; HEART RATE INCREASED (non-serious) with onset Nov2022, outcome "not recovered", described as "heart rate  speeding up; after hours it got better than couple of hours it did the same thing". The events "heart rate  speeding up; after hours it got better than couple of hours it did the same thing" and "blood pressure /it was really 'high'" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Patient went through again EKG and then went and had hormone check. Patient asking if anybody else has this kind of side effect for the heart rate speeding up and had pressure fullness on the chest. It got better and didn't then patient went to emergency room and after hours it got better than couple of hours it did the same thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea; "CPAP machine" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results.  Clinical course: Reporter stated that (78 years old, female) has narcolepsy with cataplexy reported that she had two primary Pfizer shots, had 1st Pfizer booster shot while ago ( no exact date provided). Patient had no problems primary doses. Patient called FDA and they told her not to get a second booster told her to wait for bivalent vaccine. Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cataplexy, Head injury, Malaise, Narcolepsy, Pulmonary congestion
Clinical narrative: Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea; "CPAP machine" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results.  Clinical course: Reporter stated that (78 years old, female) has narcolepsy with cataplexy reported that she had two primary Pfizer shots, had 1st Pfizer booster shot while ago ( no exact date provided). Patient had no problems primary doses. Patient called FDA and they told her not to get a second booster told her to wait for bivalent vaccine. Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "first covid when she run a fever for 16-17 days" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea; "CPAP machine" (unspecified if ongoing), notes: Caller stated I use CPAP machine I have a sleep apnea. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results.  Clinical course: Reporter stated that (78 years old, female) has narcolepsy with cataplexy reported that she had two primary Pfizer shots, had 1st Pfizer booster shot while ago ( no exact date provided). Patient had no problems primary doses. Patient called FDA and they told her not to get a second booster told her to wait for bivalent vaccine. Had covid 04Jul it was just a cold symptom it was not like a first covid when she run a fever for 16-17 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: extremely high blood pressure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2022, outcome "recovering", described as "extremely high blood pressure". The event "extremely high blood pressure" required physician office visit. Therapeutic measures were taken as a result of hypertension. Additional information: Other vaccine in four weeks was unknown. COVID prior vaccination and COVID tested post vaccination were unknown  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: this is the first time she got COVID; this is the first time she got COVID; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "this is the first time she got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller explained that she had the Pfizer COVID vaccine and booster. She mentioned that this was the first time she got COVID and she decided to take Paxlovid as she was not sure if her body could take it as she just gotten over a pretty bad cold. She said that she was "progressing well and it's been mild". Caller agreed to be transferred but disconnected while on hold. Was able to provide contact information to the caller. First attempt to connect to Safety agent was unsuccessful as they could not hear the agent. Second attempt was successful.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 11:15 as dose 1, single (Lot number: EN6202), in right arm, on 17Mar2021 at 07:30 as dose 2, single (Lot number: EP7534), in right arm and on 12Oct2021 at 08:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LOSARTAN; OMEPRAZOL; STEGLUJAN. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical course: it was reported that patient received other medication in 2 weeks. Patient received treatment for COVID 19 with anti-viral details with brand name Paxlovid which started on 27Nov2022 till 01Dec2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: K9895) at the age of 73 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 as dose 5 (booster), single (Lot number: AS7149B), 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: "Hashimoto's Disease (thyroid)" (unspecified if ongoing); "minor COPD" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; CITALOPRAM, start date: Nov2015; CALCIUM + VITAMIN D [CALCIUM CARBONATE; COLECALCIFEROL], start date: Jan2010; STOOL SOFTENER, start date: Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), INTERCHANGE OF VACCINE PRODUCTS (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: though still tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound Covid after taking Paxlovid. Day 9 felt fine, though still tested positive. Day 10 woke up with bad sinus headache and then restarted the nonstop runny nose I had had the first two days.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; chills; whole left side of her body (vaccine side) on fire; headache; nausea; throwing up; aches and pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Manufacturer: Unknown), for COVID-19 immunization; Bnt162b2 (Dose: 1st booster), for COVID-19 immunization, reaction(s): "chills", "whole left side of her body (vaccine side) on fire", "headache", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "nausea", "throwing up".  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; PAIN (non-serious), outcome "unknown", described as "aches and pains".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen, she can't close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201359619 same patient/AE., different vaccine dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; chills; whole left side of her body (vaccine side) on fire; headache; nausea; throwing up; aches and pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Manufacturer: Unknown), for COVID-19 immunization; Bnt162b2 (Dose: 1st booster), for COVID-19 immunization, reaction(s): "chills", "whole left side of her body (vaccine side) on fire", "headache", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "nausea", "throwing up".  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; PAIN (non-serious), outcome "unknown", described as "aches and pains".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen, she can't close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201359619 same patient/AE., different vaccine dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains; chills; whole left side of her body (vaccine side) on fire; headache; nausea; throwing up; aches and pains; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Manufacturer: Unknown), for COVID-19 immunization; Bnt162b2 (Dose: 1st booster), for COVID-19 immunization, reaction(s): "chills", "whole left side of her body (vaccine side) on fire", "headache", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains", "nausea", "throwing up".  The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "reaction to 1st and 2nd booster where her lymph nodes were so swollen she  cant clsoe her arm for serveral days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; PAIN (non-serious), outcome "unknown", described as "aches and pains".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen, she can't close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201359619 same patient/AE., different vaccine dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Chills; Whole left side of her body (vaccine side) on fire; Headache; Nausea; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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:01 Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:02 Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "Whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "Throwing up".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen she cant close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  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-202201359229 same patient//AE., different vaccine dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Chills; Whole left side of her body (vaccine side) on fire; Headache; Nausea; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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:01 Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:02 Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "Whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "Throwing up".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen she cant close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  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-202201359229 same patient//AE., different vaccine dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains; Chills; Whole left side of her body (vaccine side) on fire; Headache; Nausea; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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:01 Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:02 Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Reaction to 1st and 2nd booster where her lymph nodes were so swollen she can't close her arm for several days, aches and pains"; CHILLS (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "Whole left side of her body (vaccine side) on fire"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "Throwing up".  Additional information: Caller seeking information for the Pfizer BioNTech COVID vaccine booster. Caller has received two boosters previously both Pfizer. She reports reaction to 1st and 2nd booster where her lymph nodes were so swollen she cant close her arm for several days, aches and pains, chills, whole left side of her body (vaccine side) on fire, headache nausea and throwing up. Are these side effects a reason not to get another booster in the future.  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-202201359229 same patient//AE., different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Spinal operation
Clinical narrative: Back surgery; 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 male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SPINAL OPERATION (medically significant), outcome "unknown", described as "Back surgery". Therapeutic measures were taken as a result of spinal operation. 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: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body Aches; Fatigue; This is a spontaneous report received from a 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 2, single (Lot number: EN6207) for 1 day, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREMPRO LOW DOSE oral. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6205; Anatomical location: Left arm), for COVID-19 Immunization, reaction(s): "Chills", "Fatigue", "Body Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; FATIGUE (non-serious), outcome "unknown".  Additional information: It was also reported that the patient received unknown (Influenza Vac quadrivalent Prsv free 3 years IM within 4 weeks on 16Nov202 in the left arm. Fever, Chills, Body Aches, Fatigue began approximately 12 hrs. Post dose and continued for 12-16 hrs. This has happened after each of the vaccination doses. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201358718 same patient/AE, different vaccine dose;US-PFIZER INC-202201359444 same patient/AE, different vaccine dose;US-PFIZER INC-202201359446 same patient/AE, different vaccine dose;
Sex: U
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: developed cellulitis from the vaccines; This is a spontaneous report received from a contactable reporter (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2022 as dose number unknown, single (Lot number: FW6029). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Nov2022, outcome "unknown", described as "developed cellulitis from the vaccines".; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of CELLULITIS cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202201346421 same reporter, drug and event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pericarditis
Clinical narrative: Inflammation around his heart; heart racing after his second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  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: PERICARDITIS (medically significant), outcome "unknown", described as "Inflammation around his heart"; PALPITATIONS (non-serious), outcome "unknown", described as "heart racing after his second dose". Therapeutic measures were taken as a result of pericarditis.  Clinical course: Reporter stated, my son, started having heart racing after his second dose. Now months later he had inflammation around his heart and was on medicine for this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.