chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild COPD" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Elevated PSA" (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 "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 24Jan2023 to 29Jan2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: loose bowel situation; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset Dec2022, outcome "not recovered", described as "loose bowel situation".  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: 76.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD w Stent", start date: 17Jan2023 (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: BRILINTA, start date: 17Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Feb2023) Positive, notes: Rapid test + again on 04Feb2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 72.0
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 contactable reporter(s) (Physician) from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (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 Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive, notes: Test-positive minimally symptomatic rebound following completion of five-day. PAXLOVID course. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 58.0
Sex: F
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) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 06Jan2021 as dose 2, single (Lot number: EL3246), in right arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Hypersomnia" (unspecified if ongoing); "Total Hysterectomy", start date: Oct2018 (unspecified if ongoing); "Tonsils" (unspecified if ongoing); "Adnoids", start date: 1967 (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 21Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Positive, notes: (home); (05Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 75 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), 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 included: "lumbar stenosis" (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 Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Feb2023) Negative; (04Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 27Jan2023 to 01Feb2023 (lot number GG0052) for COVID-19 treatment.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site rash
Clinical narrative: injection site is blotchy and has small bumps like a little bit of a rash right over where I had it; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Feb2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 07Feb2023, outcome "unknown", described as "injection site is blotchy and has small bumps like a little bit of a rash right over where I had it". Additional information: the patient received Prevnar 20 last Wednesday and did fine after that. The morning of this report she woke up and looked in the mirror, and the injection site was blotchy and has small bumps like a little bit of a rash right over where she had it. The area was probably like maybe it extends like 2 inches down from the injection site.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal, Drug ineffective, Ear infection, Upper respiratory tract infection
Clinical narrative: ear infections; ear infections; there was a less than 0.3 mcg/ml antibody level for serotypes 1, 2,3,5, 14, and 19F; upper respiratory infections; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 4-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), EAR INFECTION (medically significant), outcome "unknown" and all described as "ear infections"; ANTIBODY TEST ABNORMAL (medically significant), outcome "unknown", described as "there was a less than 0.3 mcg/ml antibody level for serotypes 1, 2,3,5, 14, and 19F"; UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "upper respiratory infections". The patient underwent the following laboratory tests and procedures: Antibody test abnormal: less than 0.3mcg/ml, notes: there was a less than 0.3mcg/ml antibody level for serotypes 1, 2, 3, 5, 14, and 19F.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the onset of ear infection/antibody levels low in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Sex: U
Vaccine: IPV
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: IPOL multidose vial vaccine. 11 doses from this vial had been administered from this 10-dose vial with no adverse event; Initial information received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients and other health professional reporters that poliomyelitis vaccine (inactivated) ipol multidose vial vaccine IPV (VERO) [IPOL], 11 doses from this vial had been administered from this 10-dose vial with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patients received a dose of suspect IPV (VERO) suspension for injection (lot: V1A024M) with unknown strength, dose, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patients received ipol multidose vial vaccine. 11 doses from  this vial had been administered from this 10-dose vial with no adverse event (incorrect dose administered) (unknown latency) following the administration of IPV (VERO).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: received YF-VAX via intramuscular route instead of subcutaneous route with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old female patient who experienced received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event after receiving vaccine yellow fever vaccine - [yf-vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch vi (typhim vi) for Immunisation.  On 06-Feb-2023, the patient received a 0.5 ml once of standard strength suspect yellow fever vaccine - Solution for injection lot UJ654AB, expiry 11-Oct-2023 via intramuscular route in the left deltoid for Immunization.  On 06-Feb-2023 the patient developed a non-serious received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event (incorrect route of product administration) (Latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome was Unknown for the event received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01479414:
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: received YF-VAX via intramuscular route instead of subcutaneous route with no reported Adverse event; Initial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old female patient who experienced received yellow fever vaccine -[YF-VAX] via intramuscular route instead of subcutaneous route with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (Typhim) for Immunisation.  On 06-Feb-2023, the patient received once a dose of suspect yellow fever vaccine - (strength: standard, lot number: UJ654AB, formulation: Unknown) via intramuscular route in the left deltoid instead of subcutaneous route with no reported adverse event (incorrect route of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01479362:
Age: 30.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect route of product administration, Medication error, Wrong product administered
Clinical narrative: IPOL 0.1mL was given to the patient instead of Tubersol with no reported adverse event; IPOL was administered intradermally with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA043808.  This case involves a 30 years old male patient and poliomyelitis vaccine (inactivated) (IPOL) 0.1ml was given to the patient instead of tubersol and ipol was administered intradermally with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 06-Feb-2023, the patient received an unknown dose of suspect poliomyelitis vaccine (inactivated) (ipol) suspension for injection(batch/lot number: W1A191M and expiry date: 16-Feb-2025; unknown strength; 0.1 mL 1X) via intradermal route (incorrect route of product administration) in the left forearm for immunization instead of tubersol (wrong product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01479461: 01479487:
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error
Clinical narrative: Td vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event; Initial information was received on 06-Feb-2023 regarding an unsolicited valid  non-serious case from an other health professional.  This case involves an unknown age/ gender patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expiry date: 22-Jan-2023) (lot number, batch number, dose, strength, formulation: Unknown) for prophylactic vaccination (Immunisation) this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event (expired product administered) (unknown latency)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event td vaccine this morning, but didn't check the expiration prior to putting it in the patient's arm with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, Poor quality product administered, Product preparation error
Clinical narrative: administered act-hib that was reconstituted with expired diluent with no reported adverse event; administered act-hib that was reconstituted with expired diluent with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who was administered Hib (Prp/T) Vaccine [Act-Hib] that was reconstituted with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ633AA, expiry date: 30-Jan-2023) [ACTHIB Diluent component (Expiry date: 30-Nov-2022, lot number: U7178AD) (with an unknown strength) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered Hib (Prp/T) Vaccine that was reconstituted with expired diluent with no reported adverse event (product preparation error) (poor quality product administered) (latency: unknown).  It was reported, reporter did a monthly count on the product ACTHIB and noticed that the lot numbers and expiration dates are different from the box and the vials. Reporter is not sure which information she should be logging when the products are administered and would like further guidance and clarification. Caller transferred  with question about ACTHIB expiration dates being different on the vials and on the box. Wanting to know which expiration dates they need to go by. Caller also stated that a patient was administered ACTHIB that was reconstituted with expired diluent. Caller does not have patients information or any further details of event.  Action taken: not applicable.  Outcome was Unknown for reported events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Month after COVID vaccine #3 (1rst booster), menstrual periods now 21 days instead of every 28 days. Also periods were lasting 5 days and are now 7 days.  Also intermittent vaginal spotting for days at a time  .
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: the day after I had a few bumps and itching on my left arm but not near the site so I didn?t think anything of it but as days went by I noticed the itching got worse and more bumps developed in my skin on the left arm. 5 days later bumps started appearing on my right arm as well, also itchy. a day later I started having a rash all over both arms and on the tops of my thighs. Then it spread to my calves. Starting on day 5 I also started a vacation in a warm, sunny climate, not sure if that effected the spread. The rash continues, I treated it with some topical creams, aloe. it may be subsiding. I don?t know that this is a reaction to the vaccine but I can?t identify any other unique factor that may have caused this.
Sex: F
Vaccine: PPV
Symptoms: Chemotherapy, Illness
Clinical narrative: Chemotherapy; This spontaneous report was received from a female patient of unspecified age and referring to herself. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On an unknown date in December 2021, the patient received vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T039322, expiration date was not reported, but upon internal validation established as 09-SEP-2022, administered for prophylaxis (strength, dose and route of administration were not provided).  On an unknown date, the patient received chemotherapy medication (chemotherapy). Consumer inquired about a lot number check for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), because she was about to go on a chemotherapy pill, she needed to know what kind of vaccine she received. Due to not knowing if the patient's illness causing the need for chemotherapy medication occurred prior to or after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), a precautionary adverse event was being filed. The outcome of chemotherapy was unknown. The causal relationship between chemotherapy and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   Upon internal review, the event chemotherapy was determined to be medically significant.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Fatigue, Injection site pain, Pyrexia, Therapeutic response unexpected
Clinical narrative: Left lower eyelid twitch; Fatigue; Soreness/pain at injection site; Fever; hives improved since receiving Shingrix; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bug bite (presumed bug bite). Concurrent medical conditions included hives (around one year ago she began having widespread hives on a daily basis due to a presumed bug bite). Concomitant products included cetirizine hydrochloride (Zirtec).   On 10th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2023, 12 hrs after receiving Shingrix, the patient experienced injection site pain, fever and fatigue. On 11th January 2023, the patient experienced eyelid twitching. In January 2023, the patient experienced unexpected therapeutic effect. On 11th January 2023, the outcome of the injection site pain was recovered/resolved. On 12th January 2023, the outcome of the fever and fatigue were recovered/resolved. On 21st January 2023, the outcome of the eyelid twitching was recovered/resolved. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the injection site pain, fever, eyelid twitching and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient reported that around one year ago she began to have widespread hives on a daily basis due to a presumed bug site and for that she had to take Zirtec approximately every 2 to 2.5 days since that time. The patient received first dose of Shingrix and reported that her hives dramatically improved since receiving Shingrix and that she not had to use a Zirtec since 11th January 2023. The patient also reported side effects of the vaccine such as fatigue, fever, soreness or pain at the injection site and an eye twitching began very shortly after injection within 12 hours. All symptoms lasted only one day, except the unexpected benefit, which was the true reason for her call and continued.   The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA747A, expiry date 1st October 2023) for prophylaxis.   In January 2023, the patient received Menveo. In January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The nurse called to report that last week before reporting, the patient received Menveo liquid portion without the powder.  A few days later according with Disease Control recommendations, the patient received a full dose of Menveo vaccine. The permission to create an account on sales force declined.  The reporter did not consent to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular, Scab
Clinical narrative: I have bumps and scabs on my whole entire back; Shortly after receiving the third vaccine, my back started to itch; I have bumps and scabs on my whole entire back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (I have bumps and scabs on my whole entire back), PRURITUS (Shortly after receiving the third vaccine, my back started to itch) and SCAB (I have bumps and scabs on my whole entire back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PAPULAR (I have bumps and scabs on my whole entire back), PRURITUS (Shortly after receiving the third vaccine, my back started to itch) and SCAB (I have bumps and scabs on my whole entire back). At the time of the report, RASH PAPULAR (I have bumps and scabs on my whole entire back) and SCAB (I have bumps and scabs on my whole entire back) outcome was unknown and PRURITUS (Shortly after receiving the third vaccine, my back started to itch) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: They have been seeing rashes more in patients; This spontaneous case was reported by a consumer and describes the occurrence of RASH (They have been seeing rashes more in patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza Vaccine. Past adverse reactions to the above products included No adverse event with Influenza Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (They have been seeing rashes more in patients). At the time of the report, RASH (They have been seeing rashes more in patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they had given two vaccines that was expired/2 patients were vaccinated with vaccines after manufacturing expiry date).    No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708315 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2023: Follow-up information included patient's date of birth, gender and vaccination date updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708315:same reporter
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  She stated that she had her last vaccine in October and caught pneumonia 4 weeks ago. Patient was not taking prednisone and worried about lacking immunity especially while going out of tow. Patient was recommended to get another vaccine by the provider but as per the pharmacist, due to cdc guidelines, they could not administer another vaccine to patient . Patient had already had both primary series and 3 boosters already. No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving a dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that the patient had received the primary series and 3 booster doses already with unspecified product. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    It was reported that 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose. No concomitant medication were reported. No treatment medication were reported.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Vaccinated and got COVID
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Cardiac flutter, Dizziness, Palpitations, Tendonitis
Clinical narrative: After HPV vaccine on dec 13 2022, developed progressive shoulder joint pain despite ibuprofen, found to have tendonitis. also experiencing intermittent dizziness, flutter/palpations.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Fatigue, Ischaemic stroke
Clinical narrative: On 9/11/2022 I experience an ischemic stroke after receiving my booster shot for covid-19. I received the Pfizer shot for all 3 doses. I was lucky enough to not suffer any long term deficits, however, I now have to live with extreme fatigue, anxiety and depression due to the stroke.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: I have been using Olmesartan (brand name Benicar) for controlling my hypertension since the mid-thirties. After generics became available, I switched to using them as my insurance did not cover the brand name medication. Over the years, I have tried different generic brands and have noticed that my hypertension has become less stable. Recently, I discovered that my blood pressure was consistently elevated while using the generic olmesartan made by Glennmark. I have also tried the generic version made by Alembic but it did not work well for me either. I found relief when I switched to the generic made by Accord, which I specifically request from my pharmacy. Another factor affecting my blood pressure control is that after receiving the COVID-19 vaccine (two initial shots and one booster, all made by Moderna), my blood pressure increased, requiring me to double my olmesartan dosage from 20mg to 40mg. I am now 55 years old and while my blood pressure is not fully controlled, it has improved and I have had readings under 120/80. I have noticed a difference in my blood pressure control when using different generic brands of olmesartan. The generic made by Accord works well for me, while others such as Glennmark and Alembic have not provided the same level of control. It is unclear why this difference exists, but I believe it may warrant further investigation.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Bradycardia, Chest pain, Electrocardiogram abnormal, Hypothyroidism
Clinical narrative: Received 2nd dose of Moderna Covid vaccination 9/21 and on Oct 12,2022 I started my menstrual cycle for the first time in a year. Then over the next month I noticed extreme lethargy, palpitations and chest pains. I endured this until April when I was admitted to the ER with abnormal EKG. In addition to tachycardia & bradycardia I've also subsequently been diagnosed with edema, gastroparesis, dysautonomia, and hypothyroidism
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Lethargy, Menstrual disorder, Oedema, Palpitations
Clinical narrative: Received 2nd dose of Moderna Covid vaccination 9/21 and on Oct 12,2022 I started my menstrual cycle for the first time in a year. Then over the next month I noticed extreme lethargy, palpitations and chest pains. I endured this until April when I was admitted to the ER with abnormal EKG. In addition to tachycardia & bradycardia I've also subsequently been diagnosed with edema, gastroparesis, dysautonomia, and hypothyroidism
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Received 2nd dose of Moderna Covid vaccination 9/21 and on Oct 12,2022 I started my menstrual cycle for the first time in a year. Then over the next month I noticed extreme lethargy, palpitations and chest pains. I endured this until April when I was admitted to the ER with abnormal EKG. In addition to tachycardia & bradycardia I've also subsequently been diagnosed with edema, gastroparesis, dysautonomia, and hypothyroidism
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: patient came in for a shingles booster shot and was given a covid booster shot instead. Patient already had a bivalent covid booster in September of 2020.
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Hyperthyroidism
Clinical narrative: After having Moderna Covid 19 vaccination initial 2 step dosing, I started to develop symptoms of hyperthyroid and was eventually diagnosed with Graves Disease.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Insomnia, Nausea
Clinical narrative: Received Shingrix (GSK) Series I, Lot 7KG39, exp 2/17/2024, NDC#058160082311 at the Hosp on 1/31/23. Six hours later - experienced nausea, abdominal pain, chills, fever. 12 hours later - insomnia, body aches. 24-hrs later- the beginning of itchy hives on thighs. 36 hrs later hives spread from thighs torso, arms, neck, scalp and body aches continues. I notified the facility of the reaction. They recommended to go to ER. I thought more prudent to just take a Benadryl. It's now a little more than 48 Hrs, the hives are still itching, the spread seems to have stopped. I do still have a headache.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Received Shingrix (GSK) Series I, Lot 7KG39, exp 2/17/2024, NDC#058160082311 at the Hosp on 1/31/23. Six hours later - experienced nausea, abdominal pain, chills, fever. 12 hours later - insomnia, body aches. 24-hrs later- the beginning of itchy hives on thighs. 36 hrs later hives spread from thighs torso, arms, neck, scalp and body aches continues. I notified the facility of the reaction. They recommended to go to ER. I thought more prudent to just take a Benadryl. It's now a little more than 48 Hrs, the hives are still itching, the spread seems to have stopped. I do still have a headache.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Pfizer Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Elevated AST to 400 and ALT 100 ~2 weeks after second dose
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chapped lips, Eye swelling, Lip swelling, Urticaria
Clinical narrative: Woke up the next morning with swollen and chapped lips, swollen eyes, and hives
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came to pharmacy for a COVID vaccine and the staff asked him for his COVID vaccine card. He did not have one and was therefore asked if this was his first dose of COVID vaccine - he said yes. Pharmacist checked and there was no record of COVID vaccination. Pharmacist also checked electronic record system and there was no record of COVID vaccination. The pharmacist then explained to patient that since this was his first dose, he would come back in about a month for a second dose. Patient voiced understanding. The pharmacist administered the vaccine (monovalent COVID vaccine 0.5 ml NDC 80777-0273-10). After patient left, it was brought to the pharmacist's attention that patient was found under a partial last name and was due for the bivalent booster, not the primary series. The record did not translate over to or because of the last name difference. Nurse spoke with patient regarding incident.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Pain
Clinical narrative: The second week after receiving the vaccine, I began feeling achy all over my body. I feel sore all over and I have mental fog. I have seen my doctor and they are not able to determine what is going on with me. As of today, these symptoms are still ongoing. At work, I have to really focus and be present at whatever is going on. I do not take a lot of medication, so these symptoms are really concerning.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Headache, Injection site rash, Pyrexia, Rash
Clinical narrative: I started to have running nose on 02/04, followed by headaches, dry cough, fever on 02/05 and 02/06, rashes on the injection site and back on 02/07 and is still going on. fever lasted for 2 days, so did headaches and dry cough. running nose was just one day. I used tylenol and steroid cream.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: I started to have running nose on 02/04, followed by headaches, dry cough, fever on 02/05 and 02/06, rashes on the injection site and back on 02/07 and is still going on. fever lasted for 2 days, so did headaches and dry cough. running nose was just one day. I used tylenol and steroid cream.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the clinic 2/2/23 with redness, swelling, and warmth around the injection site, Denied a fever. NP started patient on Bactrim DS 1 tab BID x 7 days. Patient came back on 2/6/23 for a recheck and arm looked a lot better with no swelling redness or warmth noted.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Pt was given an additional dose of Pfizer Bivalent vaccine. First was given on 10/06/2022 and another on 2/8/23. Pt made aware of this after it was discovered. She did not have any symptoms prior to leaving facility after waiting her 15 minutes.