chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLUC3, PNC15, RV5, COVID19, DTPPVHBHPB, FLUC3, PNC15, RV5
Symptoms: Nausea, Overdose, Pyrexia
Clinical narrative: Fever; Nausea; Was given 0.5 ml when it needed to be 0.25 ml; This spontaneous case was reported by a medical assistant and describes the occurrence of OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml), PYREXIA (Fever) and NAUSEA (Nausea) in a 6-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.    Co-suspect products included non-company products INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication, VAXELIS for an unknown indication, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for an unknown indication and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for an unknown indication.    No Medical History information was reported.   On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter and third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form. On 26-Dec-2023, the patient received first dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form, third dose of VAXELIS (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (Oral use) 1 dosage form. On 26-Oct-2023, the patient experienced OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml). In December 2023, the patient experienced PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) had resolved and PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessments were provided for PYREXIA (Fever) and NAUSEA (Nausea).    This case is reported for patient 25 out of 29 patients. After vaccination had fever for 2 days. Patient did not have any chronic or long-standing health condition. Patient did not experience any side effects. No treatment and concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: We went to a walk in clinic ... and we were tested and we were both positive for COVID/Had a little  productive cough, my joint hurt a little but not incredibly; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (We went to a walk in clinic ... and we were tested and we were both positive for COVID/Had a little  productive cough, my joint hurt a little but not incredibly) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (We went to a walk in clinic ... and we were tested and we were both positive for COVID/Had a little  productive cough, my joint hurt a little but not incredibly). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (We went to a walk in clinic .. and we were tested and we were both positive for COVID/Had a little  productive cough, my joint hurt a little but not incredibly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medications provided by the reporter. Patient did not have any real problem. It has been reported that 4 to 5 days as of Monday, yesterday the patient had all the vaccination including booster dose. Patient experienced symptom of bad clod on and off. Patient symptom was not severe.  It has been informed to patient that treatment medication should only be taken twice a day for 5 consecutive days.   This case was linked to US-MODERNATX, INC.-MOD-2024-757193 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757193:Same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: I also have intermittent ringing in my ears also; I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13; I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13), TINNITUS (I also have intermittent ringing in my ears also) and DIZZINESS (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057413) for COVID-19 prophylaxis.     hypertension, type 2 diabetes, hypothyroidism, GERD. Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 05-Jan-2022. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hypothyroidism and GERD.    On 13-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 13-Jan-2024, the patient experienced VERTIGO (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13) and DIZZINESS (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13). On an unknown date, the patient experienced TINNITUS (I also have intermittent ringing in my ears also). At the time of the report, VERTIGO (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13), TINNITUS (I also have intermittent ringing in my ears also) and DIZZINESS (I started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that, patient started having dizziness and vertigo- the world spinning around me within 3 hrs of the vaccine on Sat Jan 13. This last about an hour or two and then subsides. On Jan 17, it was reported that she was 4 days out from the vaccine and these symptoms continue. She also had intermittent ringing in her ears also.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Have no taken any medication nor treatments for these symptoms The patient did not have any additional medical history, concomitant disease or risk factor. There were no lab data/results available  No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Electrocardiogram
Clinical narrative: 2 days post vaccination patient had an atrial fibrillation episode. He was exercising with a heart monitor and noticed, He followed up with cardiologist and they confirmed a.fib, he was placed on blood thinner and then issue resolved within 2 weeks
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: patient stated that after few month of  vaccination  she had shingles breakout !!! and got  nerve pain
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence, Vaccination site hypoaesthesia, Vision blurred, Vital signs measurement
Clinical narrative: not feeling ok "feeling weird"; right arm kind of numb; blurry vision for a while; became a little sleepy; This is a spontaneous report received from a Nurse.  A 12-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Jan2024 at 13:15 as dose 1, single (Lot number: HM7006) at the age of 12 years intramuscular, in right arm for covid-19 immunisation, Device Lot Number: HM7006. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN LISPRO. The following information was reported: SOMNOLENCE (non-serious) with onset 04Jan2024 at 13:15, outcome "recovered" (Jan2024), described as "became a little sleepy"; VISION BLURRED (non-serious) with onset 04Jan2024 at 13:15, outcome "recovered" (Jan2024), described as "blurry vision for a while"; FEELING ABNORMAL (non-serious) with onset 04Jan2024 at 13:15, outcome "recovered" (Jan2024), described as "not feeling ok "feeling weird""; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 04Jan2024 at 13:15, outcome "recovered" (Jan2024), described as "right arm kind of numb". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, vaccination site hypoaesthesia, vision blurred, somnolence.  Additional information: The nurse reported that the patient complained of not feeling ok ''feeling weird'', right arm kind of numb, expressed he had blurry vision for a while and then became a little sleepy, no fainting. The nurse had to lay the patient in exam table and took vital signs after he felt better. Vital signs were normal and the patient became ok. The patient didn't have COVID prior vaccination. The patient wasn't tested for COVID post vaccination. The patient had no known allergy.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: redness near the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An elderly female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Thimerosal, reaction(s): "allergic". Vaccination history included: Pneumococcus shot, for Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness near the injection site". Additional information: The caller would like to know about Prevnar 13 preservatives ingredients that's in the second shot. She said that there was something in vaccinations that caused her terrible reactions. She mentioned that they used to put Marisol and their products and had bad reactions for that. But she thought that they took it all out and so she was trying to  get a shingles vaccine. She her pneumococcus shot and got Prevnar and two Promenade came in two shots. The first shot did not bother her but the second shot did. She was trying to speak with a nurse so she can start comparing what is causing the problem. She stated that she had Prevnar 13 4 years ago. The patient is currently 72 years old now (Jan2024) and she was supposed to get Prevnar 13 at 65 years old and so she stated it may have been more than 4 years ago when she got Prevnar 13. She got two shots of Prevnar 13 and they were 6 months apart and so did her husband. She said that the first shot didn't bother her and just had redness near the injection site.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Jan2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Jan2024, outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) negative, notes: tested negative 6 days later; (Jan2024) positive, notes: tested positive again. Therapeutic measures were taken as a result of covid-19. Clinical course: Paxlovid, treatment from 01Jan2024 to 05Jan2024. Rebound Covid. Was feeling all better and tested negative 6 days later. 3 days after that relapsed, symptoms returned, and tested positive again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: got COVID twice; got COVID twice; got COVID twice; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "got COVID twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: still got COVID twice. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Additional information: Caller stated that she had all her vaccines and had the booster and the booster COMIRNATY 2023-2024. Caller stated that she received all the vaccines that she needs but still got COVID twice. She took Paxlovid for 5 consecutive days.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm  was a little sore; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (dose 1, LOT: EN6199 or EN6/99 EXP: Jun2021), administration date: 11Mar2021, for COVID-19 immunization; comirnaty (dose 2 in Arm Right, LOT: ER8734 EXP Jul2021), administration date: 01Apr2021, for COVID-19 immunization, reaction(s): "tired"; Comirnaty (dose 2 in Arm Right, LOT: ER8734 EXP Jul2021), for COVID-19 immunization, reaction(s): "no energy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his arm  was a little sore". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Additional information: Patient was retired, worked in medical field, for basically a day care program. Height: About 5, 7 and a half Weight: About 183 (as reported). This booster he got, they call it a booster, he guessed, for this year, for 23-24. Patient thought he had all vaccines in right arm. He was left handed. After last Pfizer Covid shot, Oct2023, patient noticed arm was a little sore but, not for long. No investigations. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011820 same patient, different vaccine doses/events;
Age: 59.0
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 Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Dec2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "diabetes 2" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR, start date: Dec2023. Vaccination history included: Covid-19 vaccine (DOSE 1 , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2 , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 , Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Jan2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2023) Positive, notes: Tested positive on antigen test still at this point; (Jan2024) Negative, notes: All symptoms gone and negative antigen test a few days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 22Dec2023 to 26Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: M
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 an Other HCP.  A 49-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient was treated with PAXLOVID from 03Jan2024 to 08Jan2024. The patient had a positive test 3 days after finishing course of PAXLOVID.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for the event vaccination failure. Case will be reassessed upon receipt of additional information.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility female
Clinical narrative: got the vaccine; got my birth control; I stopped that birth control pill (Estarylla) in August of 2022; I cannot get pregnant; This is a spontaneous report received from a Consumer or other non HCP.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Sep2021 as dose 2, single (Lot number: FC3182) at the age of 22 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "do not smoke" (unspecified if ongoing); "do not drink" (unspecified if ongoing); "Normal BMI" (unspecified if ongoing). Concomitant medication(s) included: ESTARYLLA, stop date: Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Deltoid (shoulder) left, Lot no: FC3180), administration date: 13Aug2021, for COVID-19 immunization. The following information was reported: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "got the vaccine; got my birth control; I stopped that birth control pill (Estarylla) in August of 2022; I cannot get pregnant".  Additional information: Patient stopped her birth control pill Estarylla in Aug2022 and until 2024 she still cannot get pregnant. Patient reported she is a fully healthy female with normal BMI, does not smoke and drink. She reported she is certain that it is the vaccine, reported this could be a side effect of infertility.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope; This is a spontaneous report received from a Physician from a sales representative.  A male patient in his 30's received BNT162b2 (COMIRNATY), as dose 1, 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: SYNCOPE (medically significant), outcome "recovered". The patient was treated and back to the baseline. Therapeutic measures were taken as a result of syncope.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: A possible contribution of suspect drug BNT162b2 (COMIRNATY) cannot be totally excluded for reported event. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202400013875 Same reporter and patient, different dose and event;US-PFIZER INC-202400013874 Same reporter and patient, different dose and event;US-PFIZER INC-202400013875 Same reporter and patient, different dose and event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Bone pain, Headache, Insomnia
Clinical narrative: Insomnia; temperature swings; headache; bones aching (migrating pain); bones aching (migrating pain); This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jan2024 as dose 1, single (Lot number: HM7006) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer bivalent (Dose Number: 4, Batch/Lot No: GJ3274, Location of injection: Arm Left), administration date: 22Dec2022, for COVID-19 immunization; pfizer (Dose Number: 3, Batch/Lot No: 33130BA, Location of injection: Arm Left), administration date: 10Dec2021, for COVID-19 immunization; pfizer (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 30Apr2021, for COVID-19 immunization; pfizer (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 13Jan2024, outcome "recovering"; BONE PAIN (non-serious), PAIN (non-serious) all with onset 13Jan2024, outcome "recovering" and all described as "bones aching (migrating pain)"; HEADACHE (non-serious) with onset 13Jan2024, outcome "recovering"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 13Jan2024, outcome "recovering", described as "temperature swings". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, body temperature abnormal, headache, bone pain, pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Insomnia; temperature swings; headache; bones aching (migrating pain); bones aching (migrating pain); This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Jan2024 as dose 1, single (Lot number: HM7006) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer bivalent (Dose Number: 4, Batch/Lot No: GJ3274, Location of injection: Arm Left), administration date: 22Dec2022, for COVID-19 immunization; pfizer (Dose Number: 3, Batch/Lot No: 33130BA, Location of injection: Arm Left), administration date: 10Dec2021, for COVID-19 immunization; pfizer (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 30Apr2021, for COVID-19 immunization; pfizer (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 13Jan2024, outcome "recovering"; BONE PAIN (non-serious), PAIN (non-serious) all with onset 13Jan2024, outcome "recovering" and all described as "bones aching (migrating pain)"; HEADACHE (non-serious) with onset 13Jan2024, outcome "recovering"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 13Jan2024, outcome "recovering", described as "temperature swings". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, body temperature abnormal, headache, bone pain, pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: made her sick for 6 weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, 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: ILLNESS (non-serious), outcome "unknown", described as "made her sick for 6 weeks".  Additional information: Caller stated she was given paxlovid, because she came down with Covid. She was nervous about taking it because she had so much trouble back in 2020 with her first Pfizer covid 19 vaccine, it made her sick for 6 weeks. The second shot she was really sick for a week, and it gave her a stroke. She already took Paxlovid and it gave her thrush in her throat and she had to take medication for that to get rid of it. When it first came on, it was a really bad sore throat, and she couldn't swallow. It was in the area where her windpipe was, when the ENT doctor did the exam he found it in the back of her throat. He gave her Nystatin swish and swallow.  When she was reading everything, there were problems with the throat or something in the possible side effects.  She would like to provide her experience so that she can help Pfizer and other people. Caller does not have a question for PMI.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400013602 Same patient, different drug/ event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single at the age of 63 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER: UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19.
Age: 38.0
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 Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 09:00 as dose 1, single at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Allergies: Ceclor"; Bactrim, reaction(s): "Allergies: Bactrim". Vaccination history included: BNT162b2 (Dose 1, Single, Vaccine administration date: 09Feb2021,, Vaccine administration time: 09:00 AM,, Vaccine location: Left arm), administration date: 09Feb2021, when the patient was 36-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, Single, Vaccine administration date: 09Mar2021,, Vaccine administration time: 09:00 AM, Vaccine location: Left arm), administration date: 09Mar2021, when the patient was 36-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Vaccine administration date: 15Oct2021,, Vaccine administration time: 09:00 AM,, Vaccine location: Left arm), administration date: 15Oct2021, when the patient was 36-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), Single, Vaccine administration date: 13Sep2022,, Vaccine administration time: 09:00 AM,, Vaccine location: Left arm), administration date: 13Sep2022, when the patient was 37-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Experienced COVID rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 03Jan2024 to 07Jan2024.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/symptoms 30Dec2023; Treatment of COVID-19/symptoms 30Dec2023; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 09:00 as dose 1, single (Lot number: HG4675) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing), notes: known allergies: Dairy. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose 6, single, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 03May2023, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 5, single, Batch/Lot No: GJ2524, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 05Sep2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose 4, single, Batch/Lot No: FJ4989, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18May2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, single, Batch/Lot No: FF8839, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 07Oct2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, Batch/Lot No: FL8982, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 15Jan2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "recovered" (05Jan2024) and all described as "Treatment of COVID-19/symptoms 30Dec2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Positive, notes: day 1; (02Jan2024) Positive, notes: day 3; (05Jan2024) Negative, notes: day 6; (06Jan2024) Negative, notes: day 7; (07Jan2024) Negative, notes: day 8; (08Jan2024) Negative, notes: day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: Symptoms 30Dec2023 (day 0); tested positive on 31Dec2023 (day 1); tested positive on 02Jan2024 (day 3); Tested negative on 05Jan2024, on 06Jan2024, on 07Jan2024, on 08Jan2024 (Day 6, 7, 8, 9). Patient received treatment with Paxlovid from 31Dec2023 to 04Jan2024 (lot:GL3641) for COVID-19.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 97-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single at the age of 97 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfur" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 31Dec2023 to 04Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
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 Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) 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 "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: negative antigen tests; (Jan2024) Negative; (Jan2024) Negative; (Jan2024) Positive, notes: 4th test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment from 29Dec2023 to 03Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 (administration time reported as 12:00 AM) as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient did not have other medical history and known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures including Paxlovid from 03Jan2024 to 07Jan2024 were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid as treatment from 31Dec2023 to 04Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension (controlled)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 BOOSTER, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 BOOSTER, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 BOOSTER, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 01Jan2024 to 06Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's 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-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 04Jan2024 to 09Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HG2282) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS (nonprogressive)" (unspecified if ongoing), notes: patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (lot number: GJ7122) from 02Jan2024 to 07Jan2024, for the treatment of COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HG4628) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Wet AMD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 6 (BOOSTER), SINGLE , Vaccine lot number- GJ6743, Vaccine location- Left arm), administration date: 18May2023, when the patient was 70-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE , Batch/Lot No: GH9694, Vaccine location- Left arm), administration date: 23Sep2022, when the patient was 70-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. 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: (11Jan2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 05Jan2024 to 09Jan2024.
Age: 29.0
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 an Other HCP.  A 29-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; VITAMIN C [ASCORBIC ACID]; HAILEY 24 FE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 5 days after testing negative for COVID); (12Jan2024) Positive, notes: Started testing COVID+ again 12Jan2024 (six days after finishing Paxlovid,. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 02Jan2024 to 06Jan2024; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HG4680) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible.