chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID on 01Dec2022; COVID on 01Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Jan2021 at 10:00 as dose 1, single (Lot number: EL0142), in right arm, on 26Jan2021 at 14:00 as dose 2, single (Lot number: EL8a82), in right arm and on 20Aug2022 at 10:00 as dose 3 (booster), single (Lot number: EW0186), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Retinal vein occulusion", start date: 01Aug2018 (ongoing), notes: eyelea injection every 4 to 6 weeks; "Thyroid" (ongoing), notes: Levothyroxine sodium 25 mcg; "overweight" (unspecified if ongoing). The patient's family history included: "High blood pressure" (ongoing); "eye disease" (unspecified if ongoing); "Thyroid both are deceased" (ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension (ongoing); LEVOTHYROXINE SODIUM taken for thyroid disorder (ongoing); EYLEA taken for retinal vein occlusion (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2022, outcome "unknown" and all described as "COVID on 01Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) Positive; (26Dec2022) Positive, notes: still got covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: On February 2 of this year I went with my daughter to be administered the first dose for Covid, I scheduled the second appointment for her to obtain her second dose, but at the time that the staff of the The pharmacy told me that it was not going to be possible, because the person who administered the first dose made the mistake or could not explain it to me well because he did not the language, to give him the booster, that is when I contacted his primary doctor and they told me They indicate that I contact the number 211, after that, they communicate me to the County Health Department, they made several calls to me from different personnel and nurses. After that, the pharmacy contacted me to tell me that they already contacted the laboratory that manufactured the vaccines and that there was no problem in giving a second dose, since the one that was administered contained the same as the first dose. which should have been worn. The Health Department continued to communicate with me and a nurse explained to me that my daughter was given the Bivalent vaccine, when due to her age the first dose should have been Monovalemt, and they themselves told me that I had to make my report in this institution for some future that something could happen I would be more sure about the health of my daughter, in case there is any consequence, since days later she started with the flu, temperature and days later when she slept she had strange movements like chills when she had never presented this last symptom, there has been no subsequent treatment, only monitored by us in case we notice something strange. either in their health or their behavior.
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chills, Incorrect product formulation administered, Influenza
Clinical narrative: On February 2 of this year I went with my daughter to be administered the first dose for Covid, I scheduled the second appointment for her to obtain her second dose, but at the time that the staff of the The pharmacy told me that it was not going to be possible, because the person who administered the first dose made the mistake or could not explain it to me well because he did not the language, to give him the booster, that is when I contacted his primary doctor and they told me They indicate that I contact the number 211, after that, they communicate me to the County Health Department, they made several calls to me from different personnel and nurses. After that, the pharmacy contacted me to tell me that they already contacted the laboratory that manufactured the vaccines and that there was no problem in giving a second dose, since the one that was administered contained the same as the first dose. which should have been worn. The Health Department continued to communicate with me and a nurse explained to me that my daughter was given the Bivalent vaccine, when due to her age the first dose should have been Monovalemt, and they themselves told me that I had to make my report in this institution for some future that something could happen I would be more sure about the health of my daughter, in case there is any consequence, since days later she started with the flu, temperature and days later when she slept she had strange movements like chills when she had never presented this last symptom, there has been no subsequent treatment, only monitored by us in case we notice something strange. either in their health or their behavior.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Incomplete course of vaccination, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; Inbound call from HCP who stated a pregnant patient came in for their second dose of VARIVAX where it was determined she was pregnant and did not receive her second dose. Patient had stated she had an injection site reaction after her first dose whic; This spontaneous prospective pregnancy report was received from a nurse, and refers to a 24-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 13-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5ml, lot  U016064, expiration date 20-MAY-2023 (route of administration was not reported) as prophylaxis, which was diluted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown).  The patient stated that on 13-JAN-2023, after the first dose, she experienced an injection site reaction after her first dose which was red, warm, and itchy but spontaneously resolved on an unspecified date in 2023 (reported as "a few days after she received the injection"). The patient had an ultrasound on an unspecified date in 2023 (reported as "since the first dose") which determined "everything was fine".  On an unspecified date in 2023, the patient came in for their second dose of varicella virus vaccine live (oka/merck)(VARIVAX) where it was determined she was pregnant and did not receive her second dose. The patient became pregnant with last menstrual period of 15-AUG-2022. Estimated date of delivery was 22-MAY-2023. Initial exposure to varicella virus vaccine live (oka/merck)(VARIVAX) was at 21 weeks. The pregnancy outcome was outcome pending.   Causality assessment was not provided.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Ultrasound antenatal screen normal
Clinical narrative: injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; injection site reaction after her first dose which was red, warm, and itchy; Inbound call from HCP who stated a pregnant patient came in for their second dose of VARIVAX where it was determined she was pregnant and did not receive her second dose. Patient had stated she had an injection site reaction after her first dose whic; This spontaneous prospective pregnancy report was received from a nurse, and refers to a 24-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 13-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) at a dose of 0.5ml, lot  U016064, expiration date 20-MAY-2023 (route of administration was not reported) as prophylaxis, which was diluted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown).  The patient stated that on 13-JAN-2023, after the first dose, she experienced an injection site reaction after her first dose which was red, warm, and itchy but spontaneously resolved on an unspecified date in 2023 (reported as "a few days after she received the injection"). The patient had an ultrasound on an unspecified date in 2023 (reported as "since the first dose") which determined "everything was fine".  On an unspecified date in 2023, the patient came in for their second dose of varicella virus vaccine live (oka/merck)(VARIVAX) where it was determined she was pregnant and did not receive her second dose. The patient became pregnant with last menstrual period of 15-AUG-2022. Estimated date of delivery was 22-MAY-2023. Initial exposure to varicella virus vaccine live (oka/merck)(VARIVAX) was at 21 weeks. The pregnancy outcome was outcome pending.   Causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Speech disorder
Clinical narrative: Reporter states patient started talking "jibberish" right after receiving her first dose of GARDASIL 9.; This spontaneous report was received from the patient's grandmother and refers to a 12-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot number, expiration date, and route of administration were not provided).  On an unknown date, the patient started talking "jibberish" right after receiving her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (speech disorder). It was unknown is she completed the series. The outcome of the event was unknown.   The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This is one of several reports from the same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only received adjuvant portion; Only received adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9S25, expiry date 18th June 2024) for prophylaxis.   On 15th February 2023, the patient received the 1st dose of Shingrix. On 15th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comments: The pharmacist reported that they were 99.9 percent sure that the patient received the adjuvant portion only from Shingrix vaccine. No further information was available. The reporter consented to follow up. Additional supportive information: The patient received adjuvant portion only from Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2023, the patient received Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was unknown.   It was unknown if the reporter considered the limbs stiffness to be related to Shingrix.     Additional Information: GSK receipt date: 23-FEB-2023 Reporter's comment: The reporter was the patient's wife.  The reporter stated that the patient received a dose of Shingrix and experienced a stiff arm. The reporter did not consent to follow up. Additional Supportive Information: The case had been linked with US2023030460 reported by same reporter.; Sender's Comments:  US-GSK-US2023030460:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: EL3246) for covid-19 immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: Congestive heart failure; "Stroke" (unspecified if ongoing), notes: Stroke; "comorbidities" (unspecified if ongoing), notes: Had stroke and everything. Because of his comorbidities, they were careful and got the vaccines. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "Heart attack". The patient date of death was unknown. Reported cause of death: "Heart attack".; Reported Cause(s) of Death: Heart attack
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Fatigue, Gingival bleeding, Gingival pain, Inflammation
Clinical narrative: mental fatigue; inflammation; severe pain; fatigue; gum sores; gum bleeding; soft lumps in right abdomen; Lymphodema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: other medical history: overweight; "work stress" (unspecified if ongoing), notes: other medical history: work stress; "previous surgery sites" (unspecified if ongoing), notes: Inflammation & Severe PAIN at ALL of the previous surgery sites. Mostly last 20 years; "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER and expiry date were not reported, vaccine location: Upper left arm, vaccine administration date: 04Jan2022, vaccine administration time: 09:00 AM,), administration date: 04Jan2022, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "First does extreme mental fatigue", "minor soreness". The following information was reported: LYMPHOEDEMA (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "Lymphedema"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GINGIVAL BLEEDING (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum bleeding"; GINGIVAL PAIN (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum sores"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered"; PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "severe pain"; ABDOMINAL DISTENSION (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "soft lumps in right abdomen"; MENTAL FATIGUE (non-serious) with onset Mar2022, outcome "not recovered". Therapeutic measures were not taken as a result of inflammation, pain, fatigue, gingival pain, gingival bleeding, abdominal distension, lymphoedema, mental fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema, Mental fatigue, Pain
Clinical narrative: mental fatigue; inflammation; severe pain; fatigue; gum sores; gum bleeding; soft lumps in right abdomen; Lymphodema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2022 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing), notes: other medical history: overweight; "work stress" (unspecified if ongoing), notes: other medical history: work stress; "previous surgery sites" (unspecified if ongoing), notes: Inflammation & Severe PAIN at ALL of the previous surgery sites. Mostly last 20 years; "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER and expiry date were not reported, vaccine location: Upper left arm, vaccine administration date: 04Jan2022, vaccine administration time: 09:00 AM,), administration date: 04Jan2022, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "First does extreme mental fatigue", "minor soreness". The following information was reported: LYMPHOEDEMA (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "Lymphedema"; FATIGUE (non-serious) with onset Jan2022, outcome "not recovered"; GINGIVAL BLEEDING (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum bleeding"; GINGIVAL PAIN (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "gum sores"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered"; PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "severe pain"; ABDOMINAL DISTENSION (non-serious) with onset Jan2022, outcome "recovered" (Mar2022), described as "soft lumps in right abdomen"; MENTAL FATIGUE (non-serious) with onset Mar2022, outcome "not recovered". Therapeutic measures were not taken as a result of inflammation, pain, fatigue, gingival pain, gingival bleeding, abdominal distension, lymphoedema, mental fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Bad headache; Dizzy; just ached all over; is is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 2, single (Lot number: EL9265) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic/ type 2 diabetic" (ongoing), notes: took Rybelsus and Jardiance; "osteoporosis" (ongoing), notes: takes supplements due to her osteoporosis; "Blood pressure abnormal" (ongoing), notes: Takes blood pressure medication; "Knows that she has a lot of sensitivities to medications" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Rybelsus for type 2 diabetic; Jardiance for type 2 diabetic. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EL3246, Anatomical location: left arm), administration date: 21Jan2021, for COVID-19 immunisation, reaction(s): "Bad headache", "Dizzy", "bone pain". The following information was reported: HEADACHE (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "Bad headache"; DIZZINESS (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "Dizzy"; PAIN (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "just ached all over". Therapeutic measures were taken as a result of headache, dizziness, pain.  Additional information: Additional information: Regarding Covid vaccines, caller states she felt very protected. Knows that she had a lot of sensitivities to mediations. Was pretty worried there would be some reaction. It was pretty strong so, she just blocked out a couple of days each time to get over it. Caller was very pleased with the vaccine. Knew there was going to be side effects. She was so sensitive to medications. Had a lot of allergic reactions, blocks out a couple of days each time for it. She had someone drive her to get it, because of the last reaction. Told them she had reaction and instead of waiting 20 minutes, like usual, they had her wait more, like an hour. Treatment given was just Tylenol. Patient takes medication for diabetes and blood pressure.  Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077890 Same patient/product, different dose/events;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hypokinesia, Malaise, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 75-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "Knows that she has a lot of sensitivities to mediations." (unspecified if ongoing), notes: Knows that she has a lot of sensitivities to mediations.; "Has a lot of allergic reactions" (unspecified if ongoing), notes: Has a lot of allergic reactions; "Takes blood pressure medication" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL3246, Dosage text: Left arm), administration date: 21Jan2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "bone pain", "Bad headache", "Dizzy"; BNT162b2 (DOSE 2, SINGLE, LOT: EL9265, NDC, EXP: Unknown), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "just ached all over", "Bad headache", "Dizzy". The following information was reported: HEADACHE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "Headache was awful"; DECREASED APPETITE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "hardly eat"; PAIN (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "pain was terrible."; HYPOKINESIA (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "she could hardly move"; MALAISE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "sick". Additional Context: Had booster, 08Oct2021, which was a Friday. That Friday when she had her booster, caller was so sick, she could hardly move. Headache was awful, pain was terrible. Started almost right away that Friday. Saturday was just really bad, could hardly eat. Was in such pain, could hardly move. Sunday did finally fall asleep. When she got up, husband asked her how she was feeling, caller stating, she just needed one more nap and should be fine. With this booster, it took a little longer to feel better. By Sunday, was kind of getting a little bit better. Everything was ok by Sunday evening. By 10Oct2021, she was okay. Just took longer to get over it. Sender's Comments: Linked Report(s): US-PFIZER INC-202300077890 same product, patient, different AEs, different dose;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), on 12Jan2021 as dose 2, single (Lot number: EL1283), on 02Oct2021 as dose 3 (booster), single (Lot number: 30135BA) and on 29Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 70 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2022 as dose 5 (booster), single (Lot number: C52D22S) for covid-19 immunisation. The patient's relevant medical history included: "Benign Hypertension" (unspecified if ongoing), notes: Benign Hypertension. Concomitant medication(s) included: BYSTOLIC, start date: 01Dec2020; ROSUVASTIN, start date: 01Dec2020, stop date: 10Feb2023; LISINOPRIL, start date: 01Dec2020. The patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown", described as "Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 10Feb2023 to 14Feb2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received 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; 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. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 07Feb2023 to 11Feb2023. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles in the same body region four times with normal immune system otherwise:  Sep2021, Dec2021, May2022, and Dec2022.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Doxycycline" (unspecified if ongoing); "Known allergies: Avelox" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown., Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM, Route of Administration: Intramuscular), administration date: 01Jan2021, when the patient was 59-year-old, for COVID-19 immunization; shingrix, administration date: 23Oct2020, when the patient was 59-year-old, for Immunization. The following information was reported: HERPES ZOSTER (medically significant) with onset Sep2021 12:00, outcome "not recovered", described as "Shingles in the same body region four times with normal immune system otherwise:  Sep2021, Dec2021, May2022, and Dec2022.". The events "shingles in the same body region four times with normal immune system otherwise:  sep2021, dec2021, may2022, and dec2022." required physician office visit. Therapeutic measures were taken as a result of herpes zoster. Facility type vaccine  was pharmacy or drug store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed as COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The patient received valaciclovir hydrochloride (VALTREX), steroid injections, steroid cream for adverse event treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and product safety profile, the reported event Hepes zoster is more likely due to intercurrent medical condition and unrelated to BNT162b2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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-202300078592 Same patient/vaccine, different dose and events;US-PFIZER INC-202300078593 Same patient/vaccine, different dose and events;
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive; Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 24 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; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 25Oct2022 as dose number unknown, single (Lot number: 942381) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Feb2023, outcome "recovering" and all described as "Sore Throat started 17Feb2023 then _ AG on 18Feb + rhinorrhea/Covid-19 Ag Test: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient was diagnosed as COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: still get sharp pain at the vaccination sites/in both arms at different times, not continuous; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:   A male patient received BNT162b2 (BNT162B2), 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: Flu vaccine (had a flu vaccine which was heavy/sore arm for about week and then it went away), reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still get sharp pain at the vaccination sites/in both arms at different times, not continuous"; VERTIGO (non-serious), outcome "unknown". Therapeutic measures were taken as a result of vertigo.  Additional information: the patient looked into the list and had seen there were many that were also getting pain at the injection site. He stated with all the many vaccinations he had over many years, this was the only one that had done this. The pain was like a dull pain and it started after a couple of weeks after the vaccinations and has been continuing on since then and had not gone away which was disturbing for him. After he discovered what was going on with the vaccines he decided to go against it, he was not pleased with the results of this vaccine. He had vertigo and he was treated like he was a hypochondriac. He did the alpine maneuver, which was little crystals in the ears. It was horrible but it was little crystals in your ear canals they start to form and then it falls and it all your hairs, ears, and it made you feel like you were spinning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079920 Same reporter/patient/drug/event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: still get sharp pain at the vaccination sites/in both arms at different times, not continuous; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:   A male patient received BNT162b2 (BNT162B2), 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: Flu vaccine (had a flu vaccine which was heavy/sore arm for about week and then it went away), reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still get sharp pain at the vaccination sites/in both arms at different times, not continuous"; VERTIGO (non-serious), outcome "unknown". Therapeutic measures were taken as a result of vertigo.  Additional information: the patient looked into the list and had seen there were many that were also getting pain at the injection site. He stated with all the many vaccinations he had over many years, this was the only one that had done this. The pain was like a dull pain and it started after a couple of weeks after the vaccinations and has been continuing on since then and had not gone away which was disturbing for him. After he discovered what was going on with the vaccines he decided to go against it, he was not pleased with the results of this vaccine. He had vertigo and he was treated like he was a hypochondriac. He did the alpine maneuver, which was little crystals in the ears. It was horrible but it was little crystals in your ear canals they start to form and then it falls and it all your hairs, ears, and it made you feel like you were spinning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079920 Same reporter/patient/drug/event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: we both had breakthrough covid cases; we both had breakthrough covid cases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 04May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (I have had a flu vaccine), for Immunization, reaction(s): "sore arm". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we both had breakthrough covid cases".  Clinical information: Caller confirmed inquiry in that original and linked interaction. He confirmed that he got the Pfizer covid vaccine for his first two doses to complete the primary series and shares his experience. The pain is sort of like a dull pain and it started a couple of weeks after the vaccinations it had been continuing on since then and it hasn't gone away which was rather disturbing. I have had a flu vaccine which was heavy, I had a sore arm for about week and then it went away. After we (presumably he and his wife) discovered what was going on with the vaccines we both decided to go against it, both of us caught at the same time we both had breakthrough covid cases we were not pleased with the results of this vaccine. Patient had no HCP, had vertigo and the guy treated me like I was a hypochondriac, they threw all of this at me which costs money and did nothing. They got patient to do the apline maneuver, it was little crystals in ears it was horrible but its little crystals in your ear canals they start to form and then it falls and it all your hairs in you ears and it make you feel just like your are spinning. According to the agent who handled the call: I went and relistened to the conversation I had with him because I was afraid to miss some AEs and I noticed that he was actually reporting about two persons. Now because I relistened to the call I wasn't able to confirm who the other person the caller was reporting for. Thus, reporter was reporting on himself and another person but may not have specifically been his wife. It was an assumption.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081533 Same reporter/drug/event for different patients.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we both had breakthrough covid cases; we both had breakthrough covid cases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 04May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (I have had a flu vaccine), for Immunization, reaction(s): "sore arm". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we both had breakthrough covid cases".  Clinical information: Caller confirmed inquiry in that original and linked interaction. He confirmed that he got the Pfizer covid vaccine for his first two doses to complete the primary series and shares his experience. The pain is sort of like a dull pain and it started a couple of weeks after the vaccinations it had been continuing on since then and it hasn't gone away which was rather disturbing. I have had a flu vaccine which was heavy, I had a sore arm for about week and then it went away. After we (presumably he and his wife) discovered what was going on with the vaccines we both decided to go against it, both of us caught at the same time we both had breakthrough covid cases we were not pleased with the results of this vaccine. Patient had no HCP, had vertigo and the guy treated me like I was a hypochondriac, they threw all of this at me which costs money and did nothing. They got patient to do the apline maneuver, it was little crystals in ears it was horrible but its little crystals in your ear canals they start to form and then it falls and it all your hairs in you ears and it make you feel just like your are spinning. According to the agent who handled the call: I went and relistened to the conversation I had with him because I was afraid to miss some AEs and I noticed that he was actually reporting about two persons. Now because I relistened to the call I wasn't able to confirm who the other person the caller was reporting for. Thus, reporter was reporting on himself and another person but may not have specifically been his wife. It was an assumption.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081533 Same reporter/drug/event for different patients.;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: His daughter had a rash after receiving the vaccine. Not a diffuse rash.; This is a spontaneous report received from contactable reporter(s) (Physician).  A female 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered", described as "His daughter had a rash after receiving the vaccine. Not a diffuse rash.". It was unknown if therapeutic measures were taken as a result of rash.  Additional information: It was unknown if patient received other vaccine in four weeks or other medications in two weeks. It was unknown if patient had any allergies. Other medical history was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: Rash on the elbow; shoulder/arm pain; shoulder/arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Feb2023 at 14:45 as dose 4 (booster), single (Lot number: GL0447) at the age of 59 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ROSUVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [COLECALCIFEROL]; ZINC. Vaccination history included: Covid-19 vaccine (DOSE: 1, SINGLE; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE:2, SINGLE; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE:3, SINGLE; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 15Feb2023 at 15:45, outcome "recovered with sequelae", described as "Rash on the elbow"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Feb2023 at 15:45, outcome "recovered with sequelae" and all described as "shoulder/arm pain". It was unknown if therapeutic measures were taken as a result of rash, arthralgia, pain in extremity. Additional information: Patient had no covid prior to vaccination, not tested for covid post vaccination, no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Prescribed Paxlovid; Prescribed Paxlovid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported that she was prescribed Paxlovid and completed the five-day treatment. After testing negative, she had a rebound of COVID. The patient has had all vaccinations and boosters up to date and all Pfizer vaccines.  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.