chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Therapeutic response unexpected
Clinical narrative: GERD and acid reflux has disappeared after her COVID-19 vaccines; has GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: FM7553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Her asthma is not severe. She has had asthma for probably 10 years.; "GERD" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing), notes: Acid reflux. Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease. Past drug history included: Nexium for acid reflux, reaction(s): "didn't work"; Tums for acid reflux, reaction(s): "didn't work"; Rolaids for acid reflux, reaction(s): "didn't work". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 27Feb2021, outcome "unknown", described as "GERD and acid reflux has disappeared after her COVID-19 vaccines"; DISEASE RECURRENCE (non-serious) with onset 27Feb2021, outcome "unknown", described as "has GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot".  Additional information: Caller reported a positive reaction to the Pfizer COVID-19 Vaccine. She mentions that her gastric reflux is gone away. Caller would like to know if there's any information on what's in the vaccine that can cause this acid production to go down. The acid reflux and asthma together enhanced the breathing problems from the acid coming up her esophagus. Pantoprazole: She was unsuccessfully taking Pantoprazole at the time of her first COVID-19 Vaccine. This worked best of the medications she tried. Worked in the beginning and then stopped working. She need to report a positive reaction to the COVID-19 Vaccine. She had GERD and acid reflux and this disappeared 2 days after the first shot up to a couple days before her second shot and then 2 days after her second shot this went away. She thought there was something in the product that resolves acid reflux problems. She is not sure if she is cured but her symptoms are gone. She believed she was 74-year-old when the acid reflux and GERD went away the first time. She hesitated to even get the COVID-19 Vaccine and was afraid the vaccine wouldn't work with her stomach problems. No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient did not experience any AE(s) following prior vaccinations; she has never had any.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 22May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), 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: "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01May2022; CIALIS, start date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received other medication in two weeks included CRESTOR and CIALIS. Anti-viral details for COVID-19 treatment included PAXLOVID, treatment start date was on 31May2022 and treatment stop date was on 04Jun2022. Adverse event reported was relapse with adverse event start date/time on 09Jun2022 at 12:00 PM (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Illness, Systemic lupus erythematosus
Clinical narrative: lupus; daughter is sick; daughter's "life is flipped upside down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller's daughter received the first and second dose of the Pfizer COVID-19 vaccine. Caller's daughter received the vaccine "when she was 15" years old), when the patient was 15 years old, for COVID-19 immunisation, reaction(s): "Lupus". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; ILLNESS (non-serious), outcome "unknown", described as "daughter is sick".   Clinical course: Caller's daughter received the first and second dose of the Pfizer COVID-19 vaccine. Caller's daughter received the vaccine "when she was 15" years old. Caller mentioned that her daughter "now has lupus" and the vaccine "gave her Lupus".  Caller also added that "no one in her side or her husband's side of the family has that type of auto-immune disease". Caller also mentioned that she read from the website that the "Pfizer vaccine causes this type of auto-immune dis-ease". Caller was frustrated that her "daughter was sick" and that her daughter's "life is flipped up-side down". Caller added that her daughter's "dreams of her future, of what she wanted to do was totally gone because now she won't be medically fit for it". Caller was also concerned with the medical bills and her daughter's "life long treatment". Caller asked if it was possible to be given the first and second dose of the Pfizer COVID-19 vaccine with the same lot numbers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxin, reaction(s): "Drug Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No other medication was received in 2weeks. Anti-viral details: Brand was Paxlovid, Treatment start date was 08Jun2022, Treatment stop date was 11Jun2022, Indication for Treatment of COVID-19.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Feb2021 as dose 2, single (Lot number: En6201), in left arm, on 17Oct2021 at 12:30 as dose 3 (booster), single (Lot number: Te3590), in left arm and on 26Apr2022 at 14:00 as dose 4 (booster), single (Lot number: Fk9720) at the age of 78 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: Patient did not receive any other medication with in 2 weeks. The patient received Anti-viral of Pfizer for the treatment of COVID-19 from 03May2022 to 10May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "known allergies", notes: known allergies: codeine and all derivitives, tramadol; Codeine and all derivitives, reaction(s): "known allergies", notes: known allergies: codeine and all derivitives, tramadol. 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: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (04Jun2022) Positive, notes: testing positive still for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any other medication within 2 weeks of vaccination. Treatment includes Anti-viral COVID 19 Treatment, brand Paxlovid, treatment start date 30May2022 to 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Alpha-gal syndrome" (unspecified if ongoing), notes: Alpha-gal syndrome. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2022 at 16:00 as dose 3 (booster initial pfizer dose), single at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Feb2021 at 13:00 as dose 2, 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: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient did not received other medication in 2weeks. Patient received Paxlovid Indication (Treatment of Covid-19)treatment start date was 07Jun2022 and stop date was11Jun2022. Patient has no known allergies.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 5 days 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 was not reported. Concomitant medication(s) included: SINGULAIR; LOSARTAN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  clinical course: patient had no Known allergies, patient received Other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 at 09:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 09:00 as dose 2, single (Lot number: EL3302), in left arm, on 23Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "microscopic colitis" (unspecified if ongoing), notes: microscopic colitis (no meds since May2022). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose#1,2,3,4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient did not receive other medications in 2 weeks. Patient took paxlovid as COVID-19 treatment from 29May2022 to 03Jun2022 via orally. Adverse event reported as rebound symptoms onset 2-3 days after, sore throat, fever, headache (faint positive antigen test); then 7 days later fever/chills, congestion, malaise, positive antigen test on 06Jun2022 at 07:00 and patient was not taken any treatment for adverse events and events were not recovered. Known allergies reported as none known.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccinationfailure (LOE) and covid 19  cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a 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 18Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 07Apr2021 as dose 2, single (Lot number: EP7533), in right arm, on 04Nov2021 as dose 3 (booster) single (Lot number: FH8026), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "kidney stones" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: 10Jun2022, stop date: 31May2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2019.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of runny nose, sneezing and coughing. Positive COVID test and had been free of symptoms but had not tested during that time.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN202; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JAN-2022, temperature excursion occurred. The vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) exposed at a temperature of -14 degrees Celsius for 7 hours. On an unspecified date in 2022 (reported as after temperature excursion), the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, dose reported as 1 (units not reported) (strength, frequency, and route of administration were not provided); which lot # U020244 has been verified to be a valid lot number with expiration date: 28-JUN-2023, administered as prophylaxis (product storage error). It was unknown whether there was previous temperature excursion. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA005084:02167789 US-009507513-2205USA004997:02167739 US-009507513-2205USA005067:02167784 US-009507513-2205USA005023:02167763 US-009507513-2205USA004990:02167746 US-009507513-2205USA005071:02167774 US-009507513-2205USA005002:02167802 US-009507513-2205USA005130:02167643 US-009507513-2205USA005126:02167756 US-009507513-2205USA005002:02167797 US-009507513-2205USA005023:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Hypoglycaemia
Clinical narrative: HYPOGLYCEMIA; This 69-year-old male subject was enrolled in an study  to evaluate the immune response and safety of both Herpes Zoster subunit vaccine in healthy adults aged 50 years and older AND the influenza virus vaccine in healthy adults aged 18 years and older when administered sequentially or co-administered with mRNA-1273 booster vaccination. The subject received the 1st dose of COVID-19 Vaccine Moderna (intramuscular) on 15th November 2021 10:30, for prophylaxis. The subject received the 1st dose of Zoster VZV-gE-AS01B (intramuscular) on 29th November 2021 09:35, for prophylaxis.   The subject's past medical history included colon cancer, cataract, degenerative disc disease (SURGERY (DEGENERATIVE DISK DISEASE)), cataract extraction, cataract extraction, colon cancer (resection), knee arthroplasty (right) and knee arthroplasty (Left). Concurrent medical conditions included allergic rhinitis, degenerative disc disease, depression, type ii diabetes mellitus, diabetic peripheral neuropathy, diverticulitis, gastroesophageal reflux disease, glaucoma, hyperlipidemia, hypertension, insomnia, chronic kidney disease, osteoarthritis and sleep apnea. Concomitant products included INFLUENZA VACCINE, COVID-19 VACCINE (COVID 19 VACCINE), acetylsalicylic acid (Aspirin), atorvastatin, benazepril, carvedilol, escitalopram (Lexapro (Escitalopram)), famotidine, furosemide, gabapentin, glipizide, pantoprazole, timolol, vitamin D nos (Vitamin D) and glucose (Dextrose 50%).   On 2nd June 2022, 199 days after receiving COVID-19 Vaccine Moderna and 185 days after receiving Zoster VZV-gE-AS01B, the subject developed hypoglycemia. Serious criteria included clinically significant/intervention required. The outcome of hypoglycemia was recovered/resolved on 2nd June 2022.   The investigator considered that there was a reasonable possibility that the hypoglycemia may have been caused by COVID-19 Vaccine Moderna and Zoster VZV-gE-AS01B.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 2nd June 2022, Blood glucose result was bg was down to 27 .                                                                                                     GSK Receipt Date:08-JUN-2022, 09-JUN-2022  Investigator Text: subject was found unresponsive and taken to the emergency room via ambulance, it was determined that he was having a very serious hypoglycemic event and his bg was down to 27. no overnight stay was required however they did administer 1 amp of d50 and got him back to baseline.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of shingrix on 3/6/2021, 2nd on 4/13/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 44XX4, expiry date 27th May 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th March 2021).   On 13th April 2022, the patient received the 2nd dose of Shingrix. On 13th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: No reactions reported. The reporter consented to follow up by email. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patients received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comment: Regional director reported that they found a Menveo diluent left in the box.  The reporter assumed that some patients received Menveo doses reconstituted with sterile water but they need to check this information. There were probably 5 patients involved as reported. The reporter given consented to follow up. Additional Supportive Information: The patients were administered Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: Pharmacist reported, that a patient received expired dose of Twinrix. The reporter consented to follow up. Additional Supportive Information: On 9th June 2022, patient received dose of Twinrix that was already expired on 8th February 2022, which led to expired vaccine used.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administered a pediatric dose instead of the adult dose; administered a pediatric dose instead of the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Engerix B pediatric. On 9th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: Medical Assistant (MA) reported that a patient was administered a pediatric dose of Engerix-B-vaccine instead of the adult dose in the left deltoid. The reporter consented to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia, Nausea, Pyrexia
Clinical narrative: Chilling; lowgrade fever 100.9; Extreme nausea; body ache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (Chilling), PYREXIA (lowgrade fever 100.9), NAUSEA (Extreme nausea) and MYALGIA (body ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 prophylaxis.     The patient's past medical history included Stevens-Johnson syndrome and Breast cancer (removal and repair in 2013). Concurrent medical conditions included Penicillin allergy (Penicillin reaction: Stevens-Johnson syndrome), Drug allergy (Keflex reaction: Stevens-Johnson syndrome) and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Chilling), PYREXIA (lowgrade fever 100.9), NAUSEA (Extreme nausea) and MYALGIA (body ache). At the time of the report, FEELING COLD (Chilling), PYREXIA (lowgrade fever 100.9), NAUSEA (Extreme nausea) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 100.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient never had COVID test or diagnosis. Patient never had reaction to taking the Flu shot. Reporter reporting side effects after Moderna vaccine stated that side effects got worse with every vaccine. No treatment medications was provided.   This case was linked to MOD-2022-588873, MOD-2022-589013, MOD-2022-589045 (Patient Link).
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) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Selective IgA deficiency" (unspecified if ongoing), notes: Selective IgA deficiency; "Dairy and eggs allergy" (unspecified if ongoing), notes: Dairy and eggs allergy; "Dairy and eggs allergy" (unspecified if ongoing), notes: Dairy and eggs allergy. Concomitant medication(s) included: VALTREX; LEXAPRO; WELLBUTRIN. 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient received Covid treatment. COVID 19 Treatment start date was 08Jun2022. The patient received other medication in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 08Mar2021 as dose 1, single (Lot number: En6203), in left arm, on 29Mar2021 as dose 2, single (Lot number: En6207), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: Fk9729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: TYSABRI, start date: 31May2022, stop date: 31May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (07Jun2022) Negative; (11Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient took Paxlovid for Treatment of COVID-19 on 02Jun2022 to 07Jun2022. The patient took other medication in 2 weeks. The patient reported felt better after 5 days of paxlovid, tested negative, then 4 days later felt sick again and tested positive.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (11Jun2022) Positive, notes: Rebound Covid antigen test positivity (negative to positive conversion). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events COVID-19 and Drug ineffective cannot be completely excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 2, single (Lot number: 008B21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing), notes: POTS; "Ehlers Danlos syndrome" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (dose 1 014M20A), for covid-19 immnunization; Moderna covid-19 vaccine (dose 2 008B21-2A), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022 at 19:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date was reported as 01Jun2022 and treatment stop date was 05Jun2022.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Peripheral swelling, Pharyngeal swelling, Swelling
Clinical narrative: my face is swollen and my underarm, there is some balls under my arm that are swollen; my face is swollen and my underarm, there is some balls under my arm that are swollen; behind my ear kind of under my neck and underneath my throat swollen like balls; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), DYSPNOEA (non-serious), SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "I feel really sick like shortness of breath, this neck and arm swollen"; PHARYNGEAL SWELLING (non-serious) with onset 11Jun2022, outcome "unknown", described as "behind my ear kind of under my neck and underneath my throat swollen like balls"; SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "my face is swollen and my underarm, there is some balls under my arm that are swollen".  Additional information: Concern: Consumer Stated, So, Yesterday I got the COVID Vaccine (clarified as Pfizer Covid-19 vaccine) and today my face is swollen and my underarm, there is some balls under my arm that are swollen and then also like behind my ear kind of under my neck and underneath my throat swollen like balls. Last time I got sick and I thought like if I had COVID, this is my booster shot but this time I feel really sick like shortness of breath, this neck and arm swollen. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Height and Weight: 160 pounds, 5 foot 3 inches (Voice distortion, not clarified)  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: my face is swollen and my underarm, there is some balls under my arm that are swollen; my face is swollen and my underarm, there is some balls under my arm that are swollen; behind my ear kind of under my neck and underneath my throat swollen like balls; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), DYSPNOEA (non-serious), SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "I feel really sick like shortness of breath, this neck and arm swollen"; PHARYNGEAL SWELLING (non-serious) with onset 11Jun2022, outcome "unknown", described as "behind my ear kind of under my neck and underneath my throat swollen like balls"; SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "my face is swollen and my underarm, there is some balls under my arm that are swollen".  Additional information: Concern: Consumer Stated, So, Yesterday I got the COVID Vaccine (clarified as Pfizer Covid-19 vaccine) and today my face is swollen and my underarm, there is some balls under my arm that are swollen and then also like behind my ear kind of under my neck and underneath my throat swollen like balls. Last time I got sick and I thought like if I had COVID, this is my booster shot but this time I feel really sick like shortness of breath, this neck and arm swollen. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Height and Weight: 160 pounds, 5 foot 3 inches (Voice distortion, not clarified)  No follow-up attempts are possible. No further information is expected.
Age: 61.0
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) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 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: "Reactive airway disorder" (unspecified if ongoing); "deleterious BRCA2 mutation" (unspecified if ongoing); "breast cancer survivor" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: citrus, cantaloupe and honeydew melons, apricots. The patient's concomitant medications were not reported. Past drug history included: Septra, reaction(s): "drug allergy"; Doxycycline, reaction(s): "drug allergy"; Fosamax, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive, notes: Tested positive on Abbott rapid antigen test on Day 12; (Jun2022) Positive, notes: Original course was positive testing Day 1-Day 4; (Jun2022) negative, notes: with Day 5 testing negatively. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2weeks. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 01Jun2022, Treatment stop date: 05Jun2022. Adverse event: Tested positive on Abbott rapid antigen test on Day 12. Original course was positive testing Day 1-Day 4, with Day 5 testing negatively. The Known allergies: Septra, doxycycline, Fosamax; food. Allergies are citrus, cantaloupe and honeydew melons, apricots. The other medical history: Reactive airway disorder; deleterious BRCA2 mutation and breast cancer survivor.  No follow-up attempts possible. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 booster, single (Lot number: FF2589) at the age of 48 years, in left arm for Covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride], start date: 01Jan2020, stop date: 11Jun2022, also reported as other medication in 2 weeks. Past drug history included: Tetracycline, reaction(s): "drug allergy"; NSAIDS, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: Pfizer/BioNTech: Patient Drug Start date 07Oct2021; Proprietary medicinal product name: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid started from 06Jun2022 and stopped on 10Jun2022. Clinical course was reported as, Patient experienced symptoms of Blurry vision, Small amount of bleed in stools, Dizziness, Facial rashes and Limbs itchy on 07Jun2022, No treatment received as result of symptoms and outcome of symptoms was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: AMIODARONE. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovering", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "recovering", described as "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, suspected covid-19.  Clinical course: Treatment start date was 28May2022 and treatment stop date was 01Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Lot number: EL1284), on 24Jan2021 as dose 2, single (Lot number: EN5318) and on 27Aug2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 46 years 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), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (02Jun2022) positive, notes: COVID again. Therapeutic measures were taken as a result of covid-19. The patient did not received any other medications within 2 weeks. The patient did not reported any known allergies.