chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna,Vaccine administration date: 19Aug2022; Vaccine brand: Pfizer / BioNTech, Vaccine administration date: 27Oct2021; 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 58-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Aug2022 as dose 4 (booster), single (Lot number: 053B22A), 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: "Celiac disease" (unspecified if ongoing), notes: other medical history: Celiac Sprue. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Aug2022, outcome "not recovered", described as "Vaccine brand other: Moderna,Vaccine administration date: 19Aug2022; Vaccine brand: Pfizer / BioNTech, Vaccine administration date: 27Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2022) Negative; (01Nov2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, other medication in 2weeks was No. It was reported that, the patient was tested positive again 01Nov2022 after negative test 26Oct2022. Symptoms worse-sinus and chest infection. No known allergies.
Sex: F
Vaccine: PNC13
Symptoms: Neoplasm malignant
Clinical narrative: I did not clarify if cancer developed before or after Prevnar 13 shot; 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 76-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2020 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I did not clarify if cancer developed before or after Prevnar 13 shot". The patient got the Prevnar13 in 2020 and she was going 77 years old two weeks. The patient was not sure if this is a forever shot or not. She stated she only ever got Prevnar 13, not a Pneumovax23. Her oncologist is telling her its okay and then the pharmacist says she should get a forever shot. The action taken for pneumococcal 13-val conj vac (dipht CRM197 protein) was unknown. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Heart rate increased, Off label use, Palpitations, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:45 as dose 1, single (Lot number: GJ375) at the age of 25 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 14Oct2022 as dose 1, single (Lot number: UT7741 LA), in left arm. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]; ADDERALL; XOPENEX; LORYNA. Past drug history included: Aspirin, reaction(s): "Known allergies". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "Other vaccine same date product: Fluzone"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2022 at 14:45, outcome "unknown", described as "Dose received: 1/ Is bivalent=True"; FATIGUE (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering", described as "Extreme fatigue"; HEART RATE INCREASED (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering", described as "Fast heart rate"; PALPITATIONS (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering". The events "fast heart rate", "palpitations" and "extreme fatigue" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of heart rate increased, palpitations, fatigue.  Additional information: Patient did not receive any other vaccines within 4 week prior vaccination and had not been tested for COVID-19 since vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Wrong product administered
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:45 as dose 1, single (Lot number: GJ375) at the age of 25 years, in left arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 14Oct2022 as dose 1, single (Lot number: UT7741 LA), in left arm. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: dairy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]; ADDERALL; XOPENEX; LORYNA. Past drug history included: Aspirin, reaction(s): "Known allergies". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "Other vaccine same date product: Fluzone"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 14Oct2022 at 14:45, outcome "unknown", described as "Dose received: 1/ Is bivalent=True"; FATIGUE (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering", described as "Extreme fatigue"; HEART RATE INCREASED (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering", described as "Fast heart rate"; PALPITATIONS (non-serious) with onset 17Oct2022 at 07:15, outcome "recovering". The events "fast heart rate", "palpitations" and "extreme fatigue" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of heart rate increased, palpitations, fatigue.  Additional information: Patient did not receive any other vaccines within 4 week prior vaccination and had not been tested for COVID-19 since vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 08Feb2021 as dose 2, single (Lot number: EI9769), in left arm, on 11Jan2022 as dose 4 (booster), single (Lot number: FJ1620), in left arm and on 31May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Jul2021 as dose 3 (booster), single (Lot number: FC378) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 05Oct2022; SULFASALAZINE, start date: 05Oct2022; HYDROXYCHLOROQUINE, start date: 05Oct2022; CYMBALTA, start date: 05Oct2022; ROSUVASTATIN, start date: 05Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID Rebound 7 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 covid-19 which was Paxlovid (Lot number: 149136) from 19Oct2022 to 23Oct2022. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 and EL3247 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507; lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Vaccination date: 14Oct2022; COVID 19 Treatment start date: 18Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Oct2022, outcome "unknown", described as "Vaccination date: 14Oct2022; COVID 19 Treatment start date: 18Oct2022". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient was treated with Paxlovid from 18Oct2022 to 22Oct2022. She was not taking other medications or products within two weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Device Date : 01Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Peripheral swelling, Rash, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: coviD-19 vaccine (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Aug2021, when the patient was 27-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 01Aug2021, when the patient was 27-year-old, reaction(s): "COVID-19 immunization". The following information was reported: GAIT DISTURBANCE (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "I barely can walk on"; PERIPHERAL SWELLING (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "My fingers swallow"; FATIGUE (non-serious) with onset 27Oct2022 at 12:00, outcome "not recovered", described as "My leg so fatigue"; RASH (non-serious), URTICARIA (non-serious) all with onset 27Oct2022 at 12:00, outcome "not recovered" and all described as "Rashes and hives through my body". Therapeutic measures were taken as a result of rash, urticaria, peripheral swelling, fatigue, gait disturbance.  Additional Information: It was reported that, patient developed rashes and hives through her body on the 2nd day of the shot. still having rashes which comes and goes since the shot also her fingers swallow and her ring doesn't fit any more. Patient's leg so fatigue, she barely can walk on. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; headaches; chills; nausea; loss of appetite; arm pain; not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: G10446) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer in remission" (unspecified if ongoing); "IBS" (unspecified if ongoing); "several surgeries" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LOSARTAN; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "arm pain"; CHILLS (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; HEADACHE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "headaches"; DECREASED APPETITE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "loss of appetite"; NAUSEA (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; MALAISE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "not feeling well". Therapeutic measures were not taken as a result of fatigue, headache, chills, nausea, decreased appetite, pain in extremity, malaise.  Additional information: Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient has an unspecified vitamin as a concomitant medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Tiredness; headaches; chills; nausea; loss of appetite; arm pain; not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: G10446) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer in remission" (unspecified if ongoing); "IBS" (unspecified if ongoing); "several surgeries" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; LOSARTAN; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "arm pain"; CHILLS (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; HEADACHE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "headaches"; DECREASED APPETITE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "loss of appetite"; NAUSEA (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering"; MALAISE (non-serious) with onset 01Nov2022 at 10:30, outcome "recovering", described as "not feeling well". Therapeutic measures were not taken as a result of fatigue, headache, chills, nausea, decreased appetite, pain in extremity, malaise.  Additional information: Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient has an unspecified vitamin as a concomitant medication.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team,   A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vertigo" (unspecified if ongoing), notes: I suffer from vertigo pre covid and it got worse during early 2020; "it got worse", start date: 2020 (unspecified if ongoing), notes: it got worse during early 2020. Concomitant medication(s) included: MECLIZINE [MECLOZINE] taken for vertigo. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "vertigo pre covid/every time I have gotten the vaccine I finally feel clear headed and not having a serious case of vertigo as I previously had".  Additional information: He had a general question about the Pfizer vaccine and impact of curing vertigo. Again curing it not causing it, if there was any links to case studies or general information about it. He suffer from vertigo pre COVID and it got worse during early 2020. He noticed every time he have gotten the vaccine he finally feel clear headed and not having a serious case of vertigo as he previously had. Meclizine 25mg has had no impact anymore it feels like, he had 5 shots already of.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling, Vaccination site induration
Clinical narrative: swelling; redness; hotness; itchiness; hardness at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Autoimmune gastritis" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 12Oct2022; LEVOTHYROXINE; ROSUVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE INDURATION (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "hardness at injection site"; FEELING HOT (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "hotness"; PRURITUS (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "itchiness"; ERYTHEMA (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered", described as "redness"; SWELLING (non-serious) with onset 31Oct2022 at 18:00, outcome "not recovered". Therapeutic measures were not taken as a result of swelling, erythema, feeling hot, pruritus, vaccination site induration.
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis
Clinical narrative: Costochondritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 2022, outcome "not recovered".  Additional information: It was reported that after the third dose of the Pfizer Covid 19 Vaccine she was diagnosed with costochondritis. That had been going on since 3rd vaccine dose. It's been such a long time, but she came such a long way. Transfer agent provided information to her that it's uncertain if vaccine caused this diagnosis. Caller noted she had been battling since then (after 3rd dose), "such a long time hate to get it and here we go again, but if it's unrelated" then she stated she would want to get it. Caller noted that was where she had concerns about getting the booster dose as she noted she had come a long way from then, it's been a long time, patient did not want to get the vaccine if that was what triggered it. Never been prone to anything in the past and that was where HCP was not sure.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 30Dec2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: fragrances" (unspecified if ongoing); "known allergies: dust" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 01Jan2022. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 22Oct2022 to 26Oct2022 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201273468 Same reporter/patient, same drug/different dose, different AE;
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes T1" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, treatment start date 24Oct2022, treatment stop date= 29Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 19-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE : 3 (1st BOOSTER), UNKNOWN MANUFACTURER.), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Temperature is 103.7"; CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain in both arms and in his chest"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes on the side of the vaccine are swollen". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had feels much sicker after this than before. He had pain in both arms and in his chest. His lymph nodes on the side of the vaccine are swollen of course. Temperature is 103.7 which was not usual. Stated he had nothing relevant, he doesn't have medical conditions and doesn't take medications. Just had usual reactions to prior vaccines. Caller stated these side effects are a lot more serious than in the past noting that he only had a slight fever and sore arm. Caller stated she was aware of the chance of heart involvement with the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "obesity" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment with Paxlovid from 23Oct2022 to 27Oct2022. Other medication in 2weeks was reported as unknown.  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: Insomnia, Tinnitus
Clinical narrative: Tinnitus ringing in ears; Sleeping difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0168), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number : EW0153 ; anatomical location: Left arm), administration date: 09Apr2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), 5 days after the suspect product(s) administration, outcome "recovered", described as "Tinnitus ringing in ears"; INSOMNIA (non-serious), 5 days after the suspect product(s) administration, outcome "recovered", described as "Sleeping difficult".   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tinnitus ringing in ears; Sleeping difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EW0168), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number : EW0153 ; anatomical location: Left arm), administration date: 09Apr2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), 5 days after the suspect product(s) administration, outcome "recovered", described as "Tinnitus ringing in ears"; INSOMNIA (non-serious), 5 days after the suspect product(s) administration, outcome "recovered", described as "Sleeping difficult".   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on an unknown date at 03:00 PM as dose 2, single (Lot number: EW0168), in right arm and on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "COVID test date=19Apr2022, COVID test result=Positive; COVID test date=16Jun2022, COVID test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (16Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No other vaccine in four weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on an unknown date at 03:00 PM as dose 2, single (Lot number: EW0168), in right arm and on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "COVID test date=19Apr2022, COVID test result=Positive; COVID test date=16Jun2022, COVID test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (16Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No other vaccine in four weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna - Dose Number: 2 ... Pfizer / BioNTech - Dose Number: 3; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 28Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOFEN, start date: 20Oct2022, stop date: 24Oct2022; BENZONATATE, start date: 20Oct2022, stop date: 02Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2022, outcome "unknown", described as "Moderna - Dose Number: 2 ... Pfizer / BioNTech - Dose Number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: She stated with the first Pfizer COVID vaccine, she only had a headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's diagnosed many years ago and prior to receiving any of the Pfizer COVID vaccines.; "allergies to medicine" (unspecified if ongoing), notes: She has many allergies to medicine. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "She stated with the first Pfizer COVID vaccine, she only had a headache".  Additional information: The patient also received BNT162b2 on 06Mar2021 as dose 2, on 12Nov2021 as dose 3, on 08Apr2022 as dose 4, in left arm for covid-19 immunisation. The patient also received diphtheria and tetanus vaccine on 28Sep2022. She had Hashimoto's which was diagnosed many years ago and prior to receiving any of the Pfizer COVID vaccines. She had many allergies to medicine and needs to know when they change something. She had a lot of medicines she was allergic to. She did not wish to provide details about those medications because she stated it was lengthy. No other conditions and investigations reported. Family medical history relevant to adverse events were none. She stated with the first Pfizer COVID vaccine, she only had a headache. She did not have the lot or expiration for that one.   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: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A male patient 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: BELL'S PALSY (medically significant), outcome "unknown". Clinical course: Physician reported there was an adverse event with patient that was already reported with the initial version of the vaccine. The physician said it's a well-documented case of Bell's Palsy and in his mind it's related to the vaccine. Physician believed the patient's employer was requiring him to get the current vaccine. Physician didn't want to do it because of the prior adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event Bell's palsy is related to  BNT162b2 administration cannot be excluded. This case will be reassessed should additional information become 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: recovering from COVID; recovering from COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID: (003110). The reporter was patient wife.  A 70-year-old male 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "recovering from COVID". Patient was at home and had sniffles, a bit of a cough, and get to take extra naps. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200095748 Same reporter/event, different patient;
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Erythema, Feeling hot, Flushing, Pruritus
Clinical narrative: 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; 24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck.; she may have trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 09:00 as dose 3 (booster), single (Lot number: GK1657) at the age of 7 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 18Oct2022 as dose number unknown, single; MIRALAX; GAS RELIEF & PREVENTION. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FK5127), administration date: 01Dec2021, when the patient was 6-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Lot number: FL8094), administration date: 29Jan2022, when the patient was 6-year-old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: FLUSHING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 28Oct2022 at 09:15, outcome "recovered" (2022) and all described as "24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck."; PRURITUS (non-serious) with onset 28Oct2022 at 09:15, outcome "not recovered", described as "24 hours after the vaccine she experienced flushed, bright red, warm, and itchy skin all over her head and neck."; DYSPNOEA (non-serious) with onset 28Oct2022 at 09:15, outcome "recovered" (2022), described as "she may have trouble breathing". Therapeutic measures were not taken as a result of flushing, erythema, feeling hot, pruritus, dyspnoea.  Additional information: The patient had no known allergies. It was reported that 24 hours after the vaccine the patient experienced flushed, bright red, warm, and itchy skin all over her head and neck. This happened at school and her teacher was extremely concerned she may have trouble breathing. The school nurse had her ice it and symptoms resolved. Itchy skin has remained. The adverse events did not resulted in hospital prolongation. Since the vaccination, the patient had not been tested for COVID-19. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH0937) 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was Paxlovid which received from 28Oct2022 to 01Nov2022.