chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Rash pruritic
Clinical narrative: The itchy rash got worse every time she had a vaccine; The itchy rash got worse every time she had a vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: PJ4989) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing), notes: Allergies to Penicillin. The patient's concomitant medications were not reported. Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine", notes: Allergies to Penicillin and Clonidine. Vaccination history included: BNT162b2 (First dose, Lot: EL9269), administration date: 06Feb2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Second dose:, Lot: EN6201), administration date: 01Mar2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "itchy rash all over her legs, arms and body", "COVID-19"; BNT162b2 (Third dose:, Lot: FE3590), administration date: 07Oct2021, when the patient was 83-year-old, for Covid-19 immunization, reaction(s): "itchy rash all over her legs, arms and body", "itchy rash gets worse", "COVID-19". The following information was reported: RASH PRURITIC (non-serious), outcome "not recovered", CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "The itchy rash got worse every time she had a vaccine".
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, SARS-CoV-2 test
Clinical narrative: Caller thought she had allergies two days before 16May2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "slightly elevated blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure increased. Vaccination history included: BNT162b2 (Dose number: 1), administration date: 01Apr2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 14May2021, outcome "unknown", described as "Caller thought she had allergies two days before 16May2021". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:She is a very healthy 70 years old and fully vaccinated with Pfizer. She is only on one pill for slightly elevated blood pressure and it is a small dose. Caller clarified that she is fully vaccinated with Pfizer Covid vaccine. She has had 4 shots total. She did have her two boosters. Pfizer Covid vaccine: caller unable to provide lot number for any of her Pfizer Covid vaccines as they are not on her card. First dose given on 01Apr2021. Second dose given on 04May2021. First booster given on 24Nov2021. Second booster given on 18Apr2022. All Pfizer Covid vaccines were given at (withheld). Caller thought she had allergies two days before 16May2021. Caller clarified that the self test kit was a test for Covid. She had positive Covid test on 16May2022, but had all the symptoms two days earlier.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FH8C20) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013L20A), in left arm and on 12Feb2021 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALTAVERA, start date: 01Jan2006. Past drug history included: Benzocaine, reaction(s): "Known allergies: Benzocaine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, and indication was treatment of COVID-19.
Age: 61.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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 had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: negative test; (08Aug2022) Positive, notes: Redeveloped COVID symptoms and tested positive for COVID 4 days after completing Paxlovid. 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.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FX9896) at the age of 67 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies". 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: Re-tested 5 days after completion and found to be positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2weeks.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Aug2022) Positive, notes: tested Postive for Covid on Wednesday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Patient received COVID 19 treatment with anti viral Paxlovid treatment start date was 30Jul2022 and treatment stop date was 04Aug2022.   Clinical course: The patient had no other medication in 2 weeks.Vaccine lot unknown reason was reported as not available/provided to reporter at the time of report completion. Patient had no known all allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, 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 62-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR; AMLODIPINE. Patient had no known allergies. 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: Positive; Negative, notes: tested negative after 7 days; Positive, notes: tested positive 6 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took other medication in 2weeks. Patient took paxlovid for Treatment of COVID 19. Treatment stop date was 29Jul2022. Adverse event was took Paxlovid, tested negative after 7 days, symptoms returned and tested positive 6 days later.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9267), on 12Mar2021 as dose 2, single (Lot number: EN6198) and on 10Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: On 06 Aug 2022 Paxlovid treatment was started. No known allergies.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back kind of hurt like back ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the parent.   A 13-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset Aug2022, outcome "recovering", described as "back kind of hurt like back ache". Therapeutic measures were not taken as a result of back pain.   Additional information: Other Medical Conditions was reported as No. Reason for no lot number of COVID-19 Vaccine was I do not know that I just know she got it from doctor's office. The reporter was calling on behalf of her daughter. The reporter mentions her daughter experience some side effect after taking COVID-19 Vaccine. So, said that her daughter experiencing back kind of hurt like back ache and that was the only information that she provided. When asked for any further help: Reporter stated, "So, I guess my question was is that a normal side effect from the vaccine, because have the vaccine." Reporter was informed about the Pfizer medical information and was provided with number as ((Phone number) option 3 working timings as 8 Am to 9 Pm Monday to Friday. When again asked for any further help: Consumer stated, "No, thank you." Age at the time of Adverse event was reported just about an hour ago. Patient not received Concomitant Medication she just took some Ibuprofen. Number of Vaccine administered was It's a third one. date Today 10Aug2022. No treatment was received she has been putting heat on it right now, like heat pad. Outcome of event was It has improved. I think it has got little bit better. Reporter stated, So, I guess my question was that a normal side effect from the vaccine, because have the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive rapid test for Covid 19 on 11Aug2022; Positive rapid test for Covid 19 on 11Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: FH8030), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 26Nov2021 as dose 3 (booster), single (Lot number: EL3247) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "Positive rapid test for Covid 19 on 11Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: Positive rapid test for Covid 19 on 11Aug2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19   Follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Fever; discomfort at site of injection; pain in the injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Raynaud disease" (unspecified if ongoing); "cancer" (unspecified if ongoing); "allergic to Gluten" (unspecified if ongoing). Concomitant medication(s) included: AROMASIN. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "discomfort at site of injection"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain in the injection area". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: 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) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), 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: "Urticaria chronic" (unspecified if ongoing), notes: Other medical history= Chronic urticarial. There were no concomitant medications. 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: (unspecified date) Negative, notes: Had multiple days of negative tests prior to rebound; (11Aug2022) Positive, notes: Tested positive on rapid COVID test on day 11 (6 days after completing paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine and did not had other medication in 2 weeks. The patient was treated with Paxlovid for COIVD-19 from 01Aug2022 to 05Aug2022. Tested positive on rapid COVID test on day 11 (6 days after completing paxlovid). Had multiple days of negative tests prior to rebound. No Known allergies.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood creatinine, Blood urea, COVID-19, Echocardiogram, Renal function test
Clinical narrative: Rebound case, tested positive for Covid; Rebound case, tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EZ3247), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years, in left arm for covid-19 immunisation; atorvastatin (ATORVASTATIN), (Lot number: 312269) at 10 mg daily (10 mg, daily [10mg per day]). The patient's relevant medical history included: "Underlying kidney conditions" (unspecified if ongoing); "Treated for kidney stones" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Very low folic acid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ASPIRINE taken for prophylaxis; FOLIC ACID GENERIC taken for folate deficiency. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "unknown" and all described as "Rebound case, tested positive for Covid". The patient underwent the following laboratory tests and procedures: Blood creatinine: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Blood urea: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Echocardiogram: (unspecified date) Showed leaky heart valve, notes: Did Echocardiogram about 3 weeks ago that showed leaky heart valve, nothing significant; Renal function test: (unspecified date) Unknown results, notes: Kidney functions has been monitored; SARS-CoV-2 test: (06Aug2022) Negative; (09Aug2022) Positive; Urine analysis: (unspecified date) Unknown results, notes: Also did 24 hour urine sample.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Urine analysis, Vaccination failure
Clinical narrative: Rebound case, tested positive for Covid; Rebound case, tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EZ3247), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years, in left arm for covid-19 immunisation; atorvastatin (ATORVASTATIN), (Lot number: 312269) at 10 mg daily (10 mg, daily [10mg per day]). The patient's relevant medical history included: "Underlying kidney conditions" (unspecified if ongoing); "Treated for kidney stones" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Very low folic acid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ASPIRINE taken for prophylaxis; FOLIC ACID GENERIC taken for folate deficiency. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "unknown" and all described as "Rebound case, tested positive for Covid". The patient underwent the following laboratory tests and procedures: Blood creatinine: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Blood urea: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Echocardiogram: (unspecified date) Showed leaky heart valve, notes: Did Echocardiogram about 3 weeks ago that showed leaky heart valve, nothing significant; Renal function test: (unspecified date) Unknown results, notes: Kidney functions has been monitored; SARS-CoV-2 test: (06Aug2022) Negative; (09Aug2022) Positive; Urine analysis: (unspecified date) Unknown results, notes: Also did 24 hour urine sample.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. 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: Testing positive after testing negative; Positive, notes: Testing positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: COVID 19 Treatment was given as Paxlovid from 01Aug2022 to 06Aug2022. Other medications in 2weeks included Cold Medicine, and Alko-Seltzer from 01Aug2021 to 07Aug2021. The patient was Tested positive after tested negative, post-nasal drop, congestion, cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 13:30 as dose 1, single (Lot number: EL3246), in left arm, on 09Feb2021 at 13:30 as dose 2, single (Lot number: EL9265), in left arm, on 27Sep2021 at 16:15 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 04Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK98933579) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "EBV" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hyperlipemmia" (unspecified if ongoing); "Diverticulosis with Bowel resection" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies"; Erythromycin, reaction(s): "known allergies"; Gabapentin, reaction(s): "known allergies"; Statins, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 9 days after the suspect product(s) administration, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Body temperature: (30Jul2022) 104 Centigrade, notes: Day 0 temp104degree, High; (31Jul2022) 103 Centigrade, notes: Day 1 Temp 103degree, High; (08Aug2022) 101.4 Centigrade, notes: Day 9 rebound temp101.4degree, High; SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Paxlovid was used from 30Jul2022 to 03Aug2022 for the treatment of COVID-19. Adverse event: Day 0 temp 104degree, chills, severe Headache, eye ache. Muscle and joint pain Bronchitis type cough mild SOB with exertion (Hx Asthma), phlegm clear the yellow malaise. Day 1 Temp 103degree. Afebrile with Tylenol. Continued cough, malaise, joint and muscle pain. Day2 slight improvement. No loss of taste/ smell continued cough some nausea with paxlovid. Symbicourt increased to 2 puffs bid, Albuterol q8degree. Day 9 rebound temp101.4degree severe HA, body/joint pain eye ache cold symptoms runny nose, sneezing loss taste/smell test Pos. Adverse event start date: 08Aug2022 12:00AM. Patient was not recovered and no treatment was received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201053725 Same patient, different product and event;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "IBD" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "sensitive to penicillan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (08Aug2022) Negative; (10Aug2022) Positive, notes: I went to Urgent Care and tested positive with a PCR test for COVID-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient  tested positive for Covid on 26Jul and started Paxlovid the evening of 27Jul2022 finishing it the morning of 01Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 74-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), 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), in Aug2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Waldenstrom's Macroglobulinemea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flexeril, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound 3 days after cleared initial symptoms and negative home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was Unknown. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: Mar2022, treatment stop date: Mar2022 indication: Preventative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Congenital musculoskeletal disorder of spine, Diarrhoea, Fall, Pyrexia
Clinical narrative: had surgery on his spine, he has screws and cannot bend; diarrhea; fever; she stated that she fell in bed along with her brother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Lot number: FL3209) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: CONGENITAL MUSCULOSKELETAL DISORDER OF SPINE (medically significant), outcome "unknown", described as "had surgery on his spine, he has screws and cannot bend"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FALL (non-serious), outcome "unknown", described as "she stated that she fell in bed along with her brother". Therapeutic measures were taken as a result of congenital musculoskeletal disorder of spine. Clinical course: The patient received the same booster dose as was given to reporter, on the same day in the same place, the same injection from the same nurse. Since patient was vaccinated, patient fell in bed. The patient was in bed for 4 days, woke up to go to the bathroom because patient had diarrhea, and had fever. The patient got up and continued to do his daily life, with his back condition, but he was able to get up. The patient had surgery on his spine, he was merged from L1 to sacral S1, S2, S3, S4, he has screws and cannot bend, and does not like to take medicines so the doctor gave him the option to use medical cannabis.
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Hypersensitivity, Oropharyngeal discomfort
Clinical narrative: She had scaly rash all over her neck for 4 or 5 months; Severe allergies; They were not sure if her throat would close; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TALWIN [PENTAZOCINE]. The following information was reported: EXFOLIATIVE RASH (non-serious), outcome "unknown", described as "She had scaly rash all over her neck for 4 or 5 months"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergies"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "They were not sure if her throat would close".  Additional information: This patient called for asking if any ingredient of the Pfizer COVID-19 Vaccine was left in the body that might interact with Talwin. Reporter stated that she had severe allergies with the first dose of the Pfizer COVID-19 Vaccine. Patient had 2 shots and 2 boosters. On her 1st shot, patient had to go to the allergy department for 4 hours because they were not sure if her throat would close up and also stated that she had scaly rash all over her neck for 4 or 5 months. Patient reported that the vaccine was new to her since her last vaccine was from when she was 8 years old. She threw her back out and in pain and wanted to know if she can take Talwin. She had seen 3 pharmacists who told her to call Pfizer. Patient wanted to speak to an allergy department to help her what to do and wanted to know how the Pfizer COVID-19 Vaccine works and if it can affect Talwin or related medications. Patient stated that she feels like everyone's in the dark about it and it happened so fast. Other Conditions and investigations reported as not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: had difficulty walking; had mild pain in his right knee, the pain was severe; 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 75-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Aug2022 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: ARTHRALGIA (non-serious) with onset 10Aug2022, outcome "unknown", described as "had mild pain in his right knee, the pain was severe"; GAIT DISTURBANCE (non-serious) with onset 11Aug2022, outcome "unknown", described as "had difficulty walking". Additional information: On 10Aug2022, the patient had mild pain in his right knee. But on 11Aug2022, the pain was severe and had difficulty walking at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just tested positive yesterday; I just tested positive yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I just tested positive yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: I took a home test and it came out positive; (10Aug2022) Positive, notes: I just tested positive yesterday.  Clinical course: Inquiry: The caller questioned if Paxlovid can be taken with Amiodarone and if there is a potential drug drug interaction. Per caller; healthcare provider is aware of the medications that I am taking it was my pharmacist who indicated the problem, pharmacist called the doctor and the doctor told him to quit taking amiodarone, for the 5 days of the treatment but one thing with amiodarone once it is in your system is there for weeks, if not months at the time, even if you quit it has residual effect, I can't risk having arrhythmia problem again with my heart, so I guess I will not be able to take a Paxlovid because I cannot risk having an arrhythmia problem again. I will call my cardiologist in the morning, to see if they had any experience with the interaction between those two, I see that it is contraindicated for quite a few medications. I just tested positive yesterday, I have been fully vaccinated fully boosted so I have a mild case, I thought it was a "head cold" initially till I took a home test and it came out positive, I had both Pfizer upon further clarification caller referring to initial vaccinations and boosters with Pfizer COVID 19 vaccine, I was hoping I was able to make it till October when you supposed to be releasing a modified vaccine that will cover Omicron BA.4 and BA.5 variant but I currently did not make it .   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID 19 after receiving vaccinations; Tested positive for COVID 19 after receiving vaccinations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: FL3246), on 11Feb2021 as dose 2, single (Lot number: FL3302), on 21Sep2021 as dose 3 (booster), single (Lot number: FC3189) and on 31Mar2022 as dose 4 (booster), single (Lot number: EK9896) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALIGN (ongoing); CITRACAL + D3 (ongoing); VITAMIN B12 AND FOLIC ACID (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Tested positive for COVID 19 after receiving vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID 19 after receiving vaccinations; Negative, notes: She clarified she is COVID negative now. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid for the treatment of COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 40 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: "Epilepsy" (unspecified if ongoing); "gout" (unspecified if ongoing); "skin cancer" (unspecified if ongoing). Concomitant medication(s) included: LACOSAMIDE; ZONISAMIDE; ALLOPURINOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Negative, notes: Tested negative on 6Aug2022; (11Aug2022) Positive, notes: on 11Aug2022 and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Rebound. Patient took paxlovid on 1Aug2022-5Aug2022. Tested negative on 6Aug2022, no symptoms 6Aug2022-10Aug2022, then started having symptoms again (runny nose & congestion) on 11Aug2022 and tested positive. Had bad diarrhea while on paxlovid from 1Aug2022-5Aug2022.The patient had no known allergies.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: had hives for another 4 months; severe allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "she had scaly rash all over her neck for 4 or 5 months", "severe allergies", "they were not sure if her throat would close". The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "had hives for another 4 months"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergies".  Additional information: With the second dose of the Pfizer COVID-19 Vaccine the caller stated that she had hives for another 4 months.  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, Hypertension, Rash
Clinical narrative: caller's high blood pressure shot up really high; rash all over her neck; severe allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TALWIN [PENTAZOCINE]. Vaccination history included: Bnt162b2 (Dose number: 1, Manufacturer: Pfizer), for COVID-19 Immunization, reaction(s): "she had scaly rash all over her neck for 4 or 5 months", "severe allergies", "they were not sure if her throat would close"; Bnt162b2 (Dose number: 2, Manufacturer: Pfizer), for COVID-19 Immunization, reaction(s): "severe allergies", "had hives for another 4 months". The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "caller's high blood pressure shot up really high"; RASH (non-serious), outcome "unknown", described as "rash all over her neck"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergies".  Additional Information: It was reported that the patient was calling about the Pfizer COVID-19 Vaccine and had questions about if it interacts with a medication that she takes called Talwin. The caller stated that she had severe allergies with the first dose of the Pfizer COVID-19 Vaccine.She went to the allergy department for four hours and they were not sure if her throat would close up. Then for 4-5 months after that she had a scaly rash all over her neck. With the second dose of the Pfizer COVID-19 Vaccine the caller stated that she had hives for another 4 months. With her first booster dose of the Pfizer COVID-19 Vaccine, the caller stated that her blood pressure shot up really high and she also had a rash all over her neck. With her second booster dose of the Pfizer COVID-19 Vaccine, the caller stated that she didn't have any of the other problems; but she felt very drugged for about a week and was completely out of it. The caller stated that this occurred three weeks ago. The caller also mentioned that this vaccine is very new to her since she has never had any other vaccines since she was 08 years old.  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: Feeling abnormal
Clinical narrative: felt very drugged; 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 68-year-old female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose 1:), for COVID-19 immunization, reaction(s): "she had scaly rash all over her neck for 4 or 5 months", "severe allergies", "they were not sure if her throat would close"; Bnt162b2 (Dose 2:), for COVID-19 immunization, reaction(s): "severe allergies", "had hives for another 4 months"; Bnt162b2 (Dose 3 (booster):), for COVID-19 immunization, reaction(s): "severe allergies", "caller's high blood pressure shot up really high", "rash all over her neck". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt very drugged".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.