chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna /Pfizer / BioNTech; Reoccurrence of COVID symptoms and positive test; Reoccurrence of COVID symptoms and positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 2, single (Lot number: FF2593), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Lot number: 030A21A), in left arm and on 05Apr2022 as dose 3 (booster), single (Lot number: 025B21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Reoccurrence of COVID symptoms and positive test"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Moderna /Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Positive, notes: Reoccurrence of COVID symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2 weeks, treatment with Paxlovid (Treatment start date: 29Jul2022, Treatment stop date: 02Aug2022) Indication: Treatment of COVID-19, no known allergies.
Age: 25.0
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 a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249), on 01Feb2021 as dose 2, single (Lot number: EL9265) and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: camphor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2weeks: Unknown. patient took COVID 19 Treatment as Paxlovid, Treatment start date: 06Aug2022, Lot number: GF4424. Persistent strange/bad taste in mouth and back of throat that quickly returns after eating or drinking (does not disappear with other methods). Began 3 hours after first dose of Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported events VACCINATION FAILURE, COVID-19  are assessed as related to suspect drug .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 03Jun2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "Tested positive for Covid on 25Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I did another home Covid test. It was Positive; (unspecified date) Negative, notes: then finally had a negative test; (25Jul2022) Positive, notes: tested positive for Covid on 25Jul2022; (31Jul2022) Negative, notes: I tested negative on Sun 31Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient had two Pfizer Covid19 vaccines (03Mar2021 and 24Mar2021) and two Pfizer Covid19 boosters (dates listed on form, latest on 03Jun2022.) On 22Jul2022 I started w/ sore throat, added cough and runny nose on 23Jul2022, and tested positive for Covid on 25Jul2022. My PCP put me on Paxlovid. The metallic taste in mouth was very strong and constant until 29Jul2022 but I had a mild sore throat, congestion, with significant fatigue. I tested negative on Sun 31Jul and felt good with no symptoms. Ran some errands (masked.)On Mon. 01Aug the sore throat returned as well as some nasal congestion, so I did another home Covid test. It was Positive. I continued to be positive, with congestion and very, very tired until Sat. 06Aug, then finally had a negative test and felt good. Ran a bunch of errands (masked), then was fatigued. Today (Sun. 07Aug) continue w fatigue and sinus drain/slight sore throat, malaise, but still negative. Hooray! But when will this fatigue go away?? I am a normally very active 73-year-old. The patient has not taken Other medications in two weeks. The patient has no Known allergies and no other medical history. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 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 included: "DCIS", start date: 2009 (unspecified if ongoing), notes: HX of DCIS in 2009; "known allergies: PCN" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid orally from 03Aug2022 to 07Aug2022. It was unknown whether the patient had any other medications in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information in the case, an association between the reported events Drug ineffective and Covid-19 and the suspect product bnt162b2 cannot be ruled out.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Lot number: fk9895) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: Had Positive Antigen test and positive symptoms on 25Jul; (31Jul2022) Negative, notes: antigen test negative on 31Jul; (03Aug2022) Positive, notes: Super strong positive antigen test on 03Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received Anti-viral treatment of Paxlovid from 25Jul2022 to 30Jul2022 for COVID-19. Vaccine administration time: 09:00 AM.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GI issues" (unspecified if ongoing); "chronic sinus inflammation" (unspecified if ongoing); "prostatitis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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, notes: although continued to test positive off and on for the next 6 days; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were taken as a result of covid-19. Recovered 3 days after beginning Paxlovid, although continued to test positive off and on for the next 6 days. On day 9 (4 days after Paxlovid) all initial symptoms returned. Have been ill for 1 1/2 days now. The patient did not have any known allergies. Patient received Lisinopril on 13Apr2022 and Lamotrigine on 01Jun2022.  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: Computerised tomogram, Feeling abnormal, Headache, Magnetic resonance imaging
Clinical narrative: Headache; Feeling bad all days; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), on 09Apr2021 at 16:00 as dose 2, single (Lot number: ER8737) intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "Type 2 Diabetes", start date: 2005 (ongoing), notes: Pertinent Details: Only take medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Pfizer/BioNTech Covid-19 Vaccine Details:, Dose: 1st, Date: 19Mar2021, Time: 10:30, Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: ER2613), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "The vaccines only left me with arm pain". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad all days". Relevant laboratory tests and procedures are available in the appropriate section. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200038868 same patient, different dose/AE.; PFIZER INC-PV202200026969 same patient, different dose/AE.;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 68 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 included: "Renal disease" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Dec2020, stop date: 25Jul2022; VALSARTAN+HYDROCHLOROTHIAZIDE; VITAMIN B 12 [CYANOCOBALAMIN]; CRANBERRY; FISH OIL; TURMERIC [CURCUMA LONGA]; ASPIRIN [ACETYLSALICYLIC ACID]; ZINC; COQ10 [UBIDECARENONE], stop date: 25Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient received treatment Paxlovid from 25Jul2022 to 30Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Testing positive again due Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: el3246), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN9681), in left arm and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Jun2022 as dose 4 (booster), single (Lot number: 042121A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; ROSUVASTATIN; MAGNESIUM; VITAMIN D3; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on day 10; Negative, notes: an almost-negative test on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Patient started taking Paxlovid same day as positive test.; Patient started taking Paxlovid same day as positive test.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 24Feb2022 as dose 4 (booster), single (Lot number: FK9896) 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: "Crohn's" (unspecified if ongoing); "Previous DVT" (unspecified if ongoing); "Joint replacements" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: 12Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient started taking Paxlovid same day as positive test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive; (04Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient took other medication with in 2 weeks of vaccination. It was reported that patient received COVID-19 treatment from 24Jul2022 to 29Jul2022. It was also reported that patient started taking Paxlovid same day as positive test. Patient completed 5-day course without incident. Patient did not test negative until 04Aug2022 (approx 7 days after completion).   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy.; Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9942) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound two days after negative test.  New symptoms started the next day including cold like symptoms including runny nose and less energy". The patient received treatment Paxlovid from 25Jul2022 to 29Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID with home test; tested positive for COVID with home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: PJ4991) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 007M20A), on 26Feb2021 as dose 2, single (Lot number: 004M20A) and on 11Nov2021 as dose 3 (booster), single (Lot number: 939903) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "heart attack" (unspecified if ongoing); "kidney stone all resolved." (unspecified if ongoing), notes: Other medical history: Kidney stone all resolved. 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 "tested positive for COVID with home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid for Treatment of COVID-19 from 23Jul2022 to 03Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-Aug-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient received Shingles vaccine and caught shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR117006:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo administered after freezing exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comment: The reporter reported that, patient received Menveo that had been stored in the freezer. The reporter did not want MI to store information in MI database. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo that had been stored in the freezer, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115730:Same reporter. Patient 3 US-GSK-US2022115428:Same reporter. Patient 1
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Injection site induration, Injection site pain
Clinical narrative: Induration at the injection site; Arm tenderness; Half the dose ran down her arm; Half the dose ran down her arm; Needle became detached, half dose ran down the arm; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site induration (1st dose of Shingrix received on 6th May 2022, refer case US2022116391).   On 5th August 2022, the patient received the 2nd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced injection site induration, pain in arm, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site induration and pain in arm were not recovered/not resolved and the outcome of the exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown.  It was unknown if the reporter considered the injection site induration and pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022116391.  Additional Information: GSK Receipt Date: 08-Aug-2022. Reporter's Comments: This case was reported by the physician (MD) who was the patient herself. The patient received second dose of Shingrix on an unknown arm and again experienced arm tenderness and an induration at the injection site. The reporter reported that during the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm. Spoke per package insert and content. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter consented to follow up. Additional Supportive Information: During the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose.; Sender's Comments:  US-GSK-US2022116391:Same reporter.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Induration at the injection site; Arm tenderness; Half the dose ran down her arm; Half the dose ran down her arm; Needle became detached, half dose ran down the arm; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site induration (1st dose of Shingrix received on 6th May 2022, refer case US2022116391).   On 5th August 2022, the patient received the 2nd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced injection site induration, pain in arm, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site induration and pain in arm were not recovered/not resolved and the outcome of the exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown.  It was unknown if the reporter considered the injection site induration and pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022116391.  Additional Information: GSK Receipt Date: 08-Aug-2022. Reporter's Comments: This case was reported by the physician (MD) who was the patient herself. The patient received second dose of Shingrix on an unknown arm and again experienced arm tenderness and an induration at the injection site. The reporter reported that during the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm. Spoke per package insert and content. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter consented to follow up. Additional Supportive Information: During the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose.; Sender's Comments:  US-GSK-US2022116391:Same reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 002az1a), in left arm and on 13Jun2022 as dose 4 (booster), single (Lot number: 056m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". 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 with Plaxovid from 26Jul2022 to 30Jul2022.  Clinical course: Patient had no known allergies.
Age: 35.0
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 35-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: 30135ba) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation (corrected)" (unspecified if ongoing), notes: Other medical history: Atrial fibrillation (corrected), Asthma (childhood); "Asthma (childhood)" (unspecified if ongoing), notes: Other medical history: Atrial fibrillation (corrected), Asthma (childhood). Concomitant medication(s) included: ASPIRIN (E.C.); LISINOPRIL; XYZAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. The patient had taken Paxlovid from 27July2022 to 31July2022 for the treatment of covid-19. No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster),single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Feb2001, stop date: 08Aug2022; BUSPIRONE, start date: Mar2000, stop date: 08Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 and the patient was given Paxlovid, treatment start date 02Aug2022 and stop date 07Aug2022(lot number GD8784.Clinical course:The patient reported after 7th dose of BID Paxlovid she experienced novel panic attack upon awakening from overnight sleep. Pt. had never previously experienced this. Later, uncharacteristic restlessness.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 58.0
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). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 13Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "others are borderline: cholesterol" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "Known allergies: Cashews" (unspecified if ongoing). Concomitant medication(s) included: ALVESCO, start date: 03Aug2020; FLONASE ALLERGY RELIEF. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2022) Positive, notes: Positive antigen test on 07Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient received treatment of Paxlovid for COVID-19 from 29Jul2022 to 03Aug2022. Patient received other medications in two weeks one is haler which brand was Alvesco, and another one was nasal spray brand was Flonase.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201042070 Same patient, different product and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech 24Feb2022/ COVID-19 Treatment 24Jul2022; Pfizer / BioNTech 24Feb2022/ COVID-19 Treatment 24Jul2022; 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), on 24Feb2022 as dose 4 (booster), single (Lot number: FK9896) 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: "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech 24Feb2022/ COVID-19 Treatment 24Jul2022". The patient received treatment from 24Jul2022 to 29Jul2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive; (31Jul2022) Negative; (04Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Treatment for covid-19 test; (2022) Postive, notes: Treatment for covid-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment of paxlovid start date from 31Jul2022 to stop date 01Aug2022. It was reported that after 5 days of isolation, patient got a negative test. 5 days after that he tested positive. Patient took paxlovid for 1 day but stopped it because it made me feel too bad.  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: 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 (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CITALOPRAM, start date: 30Apr2014. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient received treatment from 30Jul2022 to 03Aug 2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Positive, notes: I test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 16:30 as dose 1, single (Lot number: EL9261), in left arm, on 09Mar2021 as dose 2, single (Lot number: EON9810), in left arm, on 11Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabeties" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 15Jul2017; EZETIMIBE, start date: 15Jul2017; LOSARTAN, start date: 15Jul2017; DILTIAZEM HCL, start date: 16Nov2021; ATORVASTATIN, start date: 15May2013; METFORMIN, start date: 15Jul2017; METOPROLOL TARTRATE, start date: 14Jul2012. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received nirmatrelvir/ ritonavir (PAXLOVID) for the event (refers to AER#202201045334).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound/ Treatment of COVID-19; Rebound/ Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Rebound/ Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Positive, notes: Adverse event: Rebound. Therapeutic measures were taken as a result of covid-19 with Paxlovid. The patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Autonomic nervous system imbalance, SARS-CoV-2 test
Clinical narrative: A-Fib; Dysautonomia (unspecified, in process of diagnosis); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 as dose 3 (booster), single (Lot number: FM7553) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) in 2 weeks included: METOPROLOL; ASPRIN. No other vaccine in four weeks. Vaccination history included: pfizer covid 19 vaccine (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 39-year-old, for covid-19 immunization; pfizer covid 19 vaccine (Dose Number: 1, Batch/Lot No: 6206, Location of injection: Arm Left), administration date: 14Mar2021, when the patient was 39-year-old, for covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, disability), outcome "not recovered", described as "A-Fib"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (hospitalization, disability), outcome "not recovered", described as "Dysautonomia (unspecified, in process of diagnosis)". The patient was hospitalized for atrial fibrillation, autonomic nervous system imbalance (hospitalization duration: 3 day(s)). The events "a-fib" and "dysautonomia (unspecified, in process of diagnosis)" required physician office visit and emergency room visit. No Covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination was nasal swab. Therapeutic measures for the events included Beta Blockers, Compression Socks, TBD.
Age: 75.0
Sex: M
Vaccine: 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 76-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: If vaccine received, Yes, Other medication in 2weeks Yes, product, COVID 19 Treatment, brand, Pfizer, treatment start date 29Jul2022 and treatment stop date 02Aug2022 for Treatment of COVID-19. other medication in 2 weeks product is Simvastatin started on 01Jul2022 and stopped on 28Jul2022. Patient not on blood thinners but when he was scratching his left he got a reaction like he was on blood thinners. After 5 days of Paxlovid he started feeling a little dizzy. He also have soreness in my muscles. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Significant hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Lot number: EL9265) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PNC" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose number=1,, prev dose vaccine location=Left arm, prev dose lot number=EJ1686,), administration date: 06Jan2021, when the patient was 49-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 01Feb2021, outcome "not recovered", described as "Significant hair loss". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia. Additional information: Patient received dose 3 vaccination on 01Oct2021 at left arm with unknown lot number. Patient did not receive any other vaccines within 4 weeks and other medications within 2 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination with unknown results.