chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 82-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: "Diabetes" (unspecified if ongoing); "dementia" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ASPIRINE. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received Paxlovid orally from 17Aug2022 to 22Aug2022 for COVID 19 Treatment. Patient experienced acute kidney injury on 22Aug2022, after 5 day course of Paxlovid, Scr = 3.0 on presentation to hospital, treatment included treatment: IV fluids and bicarb, patient was resolving as of 24Aug2022 (AER 202201089918).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (22Aug2022) Positive, notes: Reoccurrence of COVID on 22Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: Paxlovid was given as anti-viral treatment for COVID 19 from 18Jul2022 to 22Jul2022. Reoccurrence of COVID on 22Aug2022. Reoccurrence of COVID on 22Aug2022 at 06:00 AM. The event was not recovered. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Rebound; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 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. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 24Aug2022 at 07:00, outcome "recovering", described as "Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. 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 information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: 103 degree fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 3-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), 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: PYREXIA (non-serious), outcome "unknown", described as "103-degree fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A 3-month-old baby received first dose of Prevnar 13 and developed 103 degree fever. Practitioner wanted to know if this should be treated as a precaution or not to give a second dose.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
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) (Other HCP).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (orally) from 11Aug2022 to 16Aug2022 for Covid-19 treatment. Patient had 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, covid-19 and suspect drug BNT162B2 cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; began feeling sick again and have been testing positive ever since; 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 05Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. There were no concomitant medications, reported as, no other medication received in 2 weeks. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 21Aug2022, outcome "not recovered", described as "began feeling sick again and have been testing positive ever since"; 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: (unspecified date) Positive; (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started from 14Aug2022 and stopped on 18Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Clinical course was reported as, the patient took Paxlovid as directed for 5 days and felt much better and tested negative. About 3 days after last dose, on 21Aug2022 she began feeling sick again and have been testing positive ever since. she have been so sick now for over 10 days.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable Consumer. The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: fc3184) at the age of 70 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (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. Patient received Paxlovid from 03Aug2022 to 08Aug2022 for COVID 19 Treatment.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022; Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2022 as dose number unknown, single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022". 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: Paxlovid for Treatment of COVID-19 and experienced Covid rebound.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster; He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster; 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 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), outcome "not recovered" and all described as "He states that this is day 8 for him (8 days after COVID started). 'He states he's had both Pfizer COVID vaccinations and one booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I continue to get positive home test results; (23Aug2022) Positive, notes: tested positive for COVID today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient came down with a mild case of COVID. His doctor put him on the 5-day Paxlovid treatment.  However, after taking it, he was continued to get positive home test results. Consumer clarified that he finished his course of Paxlovid yesterday and has tested positive for COVID today. He states that this was day 8 for him (8 days after COVID started). 'He states he had both Pfizer COVID vaccinations and one booster. He also stated: 'Friends have told him that they tested positive for 3-5 days and they were told that that was because they were vaccinated.' 'The primary efficacy endpoint was the proportion of subjects with COVID-19 related hospitalization or death from any cause through Day 28.' Viral RNA Rebound 'Post-treatment increases in SARS-CoV-2 RNA shedding levels (i.e., viral RNA rebound) in nasopharyngeal samples were observed on Day 10 and or Day 14 in a subset of PAXLOVID and placebo recipients, irrespective of COVID-19 symptoms.'  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: COVID/Caller also mentioned he has had 2 COVID vaccines from Pfizer, and probably one booster dose also from Pfizer.; COVID/Caller also mentioned he has had 2 COVID vaccines from Pfizer, and probably one booster dose also from Pfizer.; 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 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), outcome "unknown" and all described as "COVID/Caller also mentioned he has had 2 COVID vaccines from Pfizer, and probably one booster dose also from Pfizer.". 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 and taken Paxlovid  as a treatment.  Clinical Information; when consumer requested for further details; was reported that Paxlovid consists of Nirmatrelvir and Ritonavir. Working together, these medications prevent the viral replication. The medical objective of Paxlovid is to stop the progression of COVID-19 into a severe infection that would require hospitalization or major cares.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "PCOD" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, for Immunization, reaction(s): "Known allergies: Flu shot"; Allergy shot, for Immunization, reaction(s): "Known allergies: allergy shot". 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 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (24Aug2022) Positive, notes: Tested positive for covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received Paxlovid for treatment of COVID-19 on 11Aug2022 and stopped on 16Aug2022. The patient was tested positive for covid again on 24Aug2022. Brain fog started on 22Aug2022 and tiredness with some breathing impairment had continued. Adverse event start date: 22Aug2022. If vaccine received: Yes.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. 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; Negative, notes: after previously testing negative in two different days; Negative, notes: after previously testing negative in two different days; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Vaccine received: Yes, Other medication in 2weeks: Yes, Other medication details other medication in 2weeks product: Sertraline  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have COVID; have 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), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bad allergic reaction" (unspecified if ongoing), notes: I do have a lot of allergic reactions to a lot of stuff.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID". The event "have covid" required emergency room visit.  Clinical course: Caller stated: she have COVID, she had all my shots and everything, all Pfizer, the first two and 3 boosters, she was up to date, they gave me Paxlovid tablets standard dose. she took Pravastatin 40 mg for cholesterol, she took one at 7 am this morning and she wanted to know when can I start the Paxlovid". She also stated: "The pharmacist said she can't take any statin drugs, and she called because she wanted to make sure they are right, here the HCPs are not up to date and I don't want to take it and have something go wrong, they were strict on no statin drugs, she already took it at 7 am with the rest of my medicines, she don't know when can she start the Paxlovid. Her doctor doesn't know, he told me the pharmacist would tell me and she said no statins, that she can't take anything with statins, but didn't tell me when to start this. she don't want to take something that's going to kill me."She took the Pravastatin before she knew, before she went to the urgent care to be checked out for COVID and sure enough she have it, she don't want to take it too soon and have a bad allergic reaction, she do have a lot of allergic reactions to a lot of stuff. she waited 24 hours, it should be alright, she think". 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: Fatigue, Immunisation, Off label use, Pain in extremity
Clinical narrative: have COVID; have 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), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bad allergic reaction" (unspecified if ongoing), notes: I do have a lot of allergic reactions to a lot of stuff.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have COVID". The event "have covid" required emergency room visit.  Clinical course: Caller stated: she have COVID, she had all my shots and everything, all Pfizer, the first two and 3 boosters, she was up to date, they gave me Paxlovid tablets standard dose. she took Pravastatin 40 mg for cholesterol, she took one at 7 am this morning and she wanted to know when can I start the Paxlovid". She also stated: "The pharmacist said she can't take any statin drugs, and she called because she wanted to make sure they are right, here the HCPs are not up to date and I don't want to take it and have something go wrong, they were strict on no statin drugs, she already took it at 7 am with the rest of my medicines, she don't know when can she start the Paxlovid. Her doctor doesn't know, he told me the pharmacist would tell me and she said no statins, that she can't take anything with statins, but didn't tell me when to start this. she don't want to take something that's going to kill me."She took the Pravastatin before she knew, before she went to the urgent care to be checked out for COVID and sure enough she have it, she don't want to take it too soon and have a bad allergic reaction, she do have a lot of allergic reactions to a lot of stuff. she waited 24 hours, it should be alright, she think". 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: Inflammation, Injection site erythema, Injection site haemorrhage, Injection site pain, Myalgia
Clinical narrative: chronic pain at the injection site/ I have pain after 3 months; had a football shaped red welped area on my arm and the spot where it was injected; damaged nerve; inflammation; feel this pain in the deltoid muscle; 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 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2022 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: INJECTION SITE PAIN (non-serious) with onset Jun2022, outcome "not recovered", described as "chronic pain at the injection site/ I have pain after 3 months"; NERVE INJURY (non-serious) with onset 2022, outcome "unknown", described as "damaged nerve"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "feel this pain in the deltoid muscle"; INJECTION SITE ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "had a football shaped red welped area on my arm and the spot where it was injected"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown".  Additional information: Caller reports that 3 months ago he received the prevnar 20 vaccine, still having chronic pain at the injection site. He has seen his PCP and arm specialist they don't have any solution or know how to deal with this, seeking information if Pfizer has recommendations on what to do? Caller states one week after injection he had a football shaped red welped area on my arm and the spot where it was injected if I squeezed deltoid muscle blood would still come out. Caller also states that if he took a hot shower the blood in that football shaped area would travel to elbow to above my shoulder. Caller states he has remaining lingering pain but the physical stuff that you can see is gone. almost like a damaged nerve, inflammation, something affecting the nerve that comes and goes. Reports that at nighttime if its cold, if I move my arm outward lift it up feel this pain in the deltoid muscle. Caller states he is on day 90 of pain at the injection site. He is 61 years old with no previous history of pneumococcal vaccine. Caller asked how long people experienced injection site pain in the clinical trial? I have pain after 3 months. I would like to know what can I do for this cause I have gone to the doctor and nobody seems to know."So I am just trying to find out something that remedy the situation here. I am sure I am not the only one with this problem."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC20
Symptoms: Nerve injury
Clinical narrative: chronic pain at the injection site/ I have pain after 3 months; had a football shaped red welped area on my arm and the spot where it was injected; damaged nerve; inflammation; feel this pain in the deltoid muscle; 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 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2022 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: INJECTION SITE PAIN (non-serious) with onset Jun2022, outcome "not recovered", described as "chronic pain at the injection site/ I have pain after 3 months"; NERVE INJURY (non-serious) with onset 2022, outcome "unknown", described as "damaged nerve"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "feel this pain in the deltoid muscle"; INJECTION SITE ERYTHEMA (non-serious) with onset 2022, outcome "unknown", described as "had a football shaped red welped area on my arm and the spot where it was injected"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown".  Additional information: Caller reports that 3 months ago he received the prevnar 20 vaccine, still having chronic pain at the injection site. He has seen his PCP and arm specialist they don't have any solution or know how to deal with this, seeking information if Pfizer has recommendations on what to do? Caller states one week after injection he had a football shaped red welped area on my arm and the spot where it was injected if I squeezed deltoid muscle blood would still come out. Caller also states that if he took a hot shower the blood in that football shaped area would travel to elbow to above my shoulder. Caller states he has remaining lingering pain but the physical stuff that you can see is gone. almost like a damaged nerve, inflammation, something affecting the nerve that comes and goes. Reports that at nighttime if its cold, if I move my arm outward lift it up feel this pain in the deltoid muscle. Caller states he is on day 90 of pain at the injection site. He is 61 years old with no previous history of pneumococcal vaccine. Caller asked how long people experienced injection site pain in the clinical trial? I have pain after 3 months. I would like to know what can I do for this cause I have gone to the doctor and nobody seems to know."So I am just trying to find out something that remedy the situation here. I am sure I am not the only one with this problem."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: White blood cell disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "WBC are going into her fat cells". Additional information: Per caller she had the bone marrow test and computed tomography (CT). Per caller her dermatologist let her know that her WBC are going into her fat cells since receiving the Pfizer Covid 19 Vaccine. Caller reported that she knew a guy this was happeneing to since the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 2-year-old male patient received BNT162b2 (BNT162B2), on 13Aug2022 at 11:00 as dose 1, single (Lot number: FT9142) at the age of 2 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Face skin itching" (unspecified if ongoing), notes: Other medical history: Face skin itching since age 6 month. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 13Aug2022 at 11:00, outcome "unknown", described as "Vaccine site location Right leg  (site of vaccination)"; VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 15Aug2022 at 12:00, outcome "recovered with sequelae" and all described as "Itching rash of the right thigh (site of vaccination)". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site pruritus, product administered at inappropriate site. Additional information: Patient recovered with lasting effects. No treatment was given for adverse event. No covid prior and post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "High fever"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy all over". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain. Additional information: The reporter wanted to know some of the questions about that Pfizer vaccine for COVID and the Pfizer booster for COVID. And any side effects that may have had from shots or vaccine or booster. The reporter wanted to know if she should report that she has a very high fever temperature after each one. The reporter was informed that the adverse event can be reported here at Pfizer Drug Safety. The reporter experienced, "High fever, chills, achy all over for approximately 24 hours on each of those after 2 vaccines and the 2 boosters. When the patient got last booster, the CDC was monitoring me and sending a weekly, then monthly like how the patient was doing, has been been sick and got a questionnaire on Saturday and not heard anything. The patient wanted to make sure they have my like what happened maybe side effects. The patients age was 70 years (Not clarified as Age at time of Adverse Event hence not captured). The patient did not underwent any laboratory tests within 1 or 2 weeks. Therapeutic measures were taken as a result if the adverse events and included treatment with Tylenol 100 milligram. The patient received the first vaccine on 06Mar2021, the next one is 27Mar2021, the next one is 07Oct2021 and the last one is 21May2022. The reporter wanted to know some other side effects. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 1, single (Lot number: ER2613), on 17Mar2021 as dose 2, single (Lot number: EN6202), on 19Apr2022 as dose 3 (booster), single (Lot number: FJ4989) and on 09Nov2021 as dose 4 (booster), single (Lot number: FH330268D) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "heart issues" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METFORMIN; ADVAIR; MONTELUKAST; FLUTICASONE PROPIONATE; AZELASTINE HCL. Past drug history included: Aspirin, reaction(s): "Allergy"; Sulfites, reaction(s): "Allergy"; Levofloxan 750 mg, reaction(s): "Allergy". 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient received vaccine, other medication in 2 weeks. Patient received treatment for COVID 19 with Paxlovid, Treatment start date on 20Aug2022, Lot number: GE4259.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 14:15 as dose 1, single (Lot number: ER8737), in left arm, on 20Apr2021 at 14:45 as dose 2, single (Lot number: EW0162), in left arm, on 19Oct2021 at 15:30 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 27May2022 at 11:15 as dose 4 (booster), single (Lot number: FX9893) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE AND HYDROCHLOROTHIAZID; AMLODIPINE BESYLATE; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Covid-19 treatment as Paxlovid was started on 09Aug2022 till 13Aug2022.
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) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL0142), as dose 2, single (Lot number: EL9262) and as dose 3 (booster), single (Lot number: ER8729) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Iodine allergy" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive for COVID. Prescribed Paxlovid at ER; (Aug2022) Negative, notes: Tested negative 6 days later; (Aug2022) Positive, notes: Symptoms reoccurred on day 4 after last dose of Paxlovid. Retest is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Aug2022 to 20Aug2022.  Clinical information: Tested positive for COVID. Prescribed Plaxlovid at ER. Tested negative 6 days later. Symptoms reoccurred on day 4 after last dose of plaxlovid. Retest is positive. Increasing of symptoms.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association  of suspect drug cannot be excluded for reported  events ,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
Age: 66.0
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; Vaccine brand other= Moderna; vaccine administration date= 04Nov2021/vaccine brand= Pfizer/BioNTech; vaccine administration date=27Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Lot number: 066F21A), 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: "mild hypothyroid" (unspecified if ongoing); "mild hip arthritis" (unspecified if ongoing); "Known allergies: pineapple" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Apr2021, stop date: 24Aug2022; CYTOMEL, start date: 01Apr2021, stop date: 24Aug2022. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Apr2022, outcome "unknown", described as "Vaccine brand other= Moderna; vaccine administration date= 04Nov2021/vaccine brand= Pfizer/BioNTech; vaccine administration date=27Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: Treatment of COVID-19; (16Aug2022) Negative, notes: tested negative by antigen test day 6; (24Aug2022) Positive, notes: it's day 14 and I still have nasal congestion and test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on start date 12Aug2022 and stop date 16Aug2022.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7534), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 10Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MUCUS RELIEF DM, start date: 13Aug2022, stop date: 20Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment for covid-9 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: if vaccine received: Yes. other medication in 2weeks: Yes. anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 15Aug2022, treatment stop date: 19Aug2022, indication: Treatment of COVID-19. Adverse event: Tested positive again for COViD-19 after developing runny nose. known allergies: No. other medical history: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) 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); "fibromyalgia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "IV Contrast Dye" (unspecified if ongoing), notes: Known allergies: IV dye. The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Known allergies: NSAIDS.Other medication in 2weeks: Unknown. 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) Positive; (07Aug2022) Negative; (11Aug2022) Positive; (24Aug2022) Positive. COVID 19 Treatment with Paxlovid ,Treatment start date: 28Jul2022,Treatment stop date: 01Aug2022. Covid symptoms stopped 07Aug, negative test 11Aug, tested positive again 24Aug, husband tested positive 23Aug.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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 3 (booster), single (Lot number: EN5318) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ED140, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), RASH (non-serious) all with onset 04Feb2021, outcome "recovered with sequelae" and all described as "Swelling and painful rash for about a week around the area". The events "swelling and painful rash for about a week around the area" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of swelling, rash. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Dietary supplement within 2 weeks of vaccination. The patient experienced Swelling and painful rash for about a week. Around the area. The pain on my left arm never stopped and still going on worse than ever. Prior to vaccination, The patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. Patient has no other medical history.