chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number 58160-A15-43, expiry date 24th May 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 18th July 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th July 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: 19-Jul-2022 Reporter's comment: The reporter reported that the first dose of Twinrix was on June 2022. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received his second Shingrix vaccine yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 03 Sep 2022 of shingrix vaccine intramuscular in unknown arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 19-Jul-2022 Reporters comment: The reporter reported that the patient received his first Shingrix vaccine and did not received the 2nd dose of shingrix vaccine  The reporter did not consent to follow-up. The reporter not willing to shared any demographics except zip code and that was not correct Additional Supportive information:  The Patient did not received the 2nd dose of shingrix vaccine which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 10/3/2020 and 2nd on 4/12/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd October 2020).   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th 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: 19-JUL-2022 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of the vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion of menveo; received only the liquid portion of menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-Jul-2022 Reporter's comment: Healthcare professional reported the patient received only the liquid portion of Menveo. The consent to follow up was given. No other details available. Additional Supportive Information: The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administered boostrix that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 19th July 2022, the patient received Boostrix. On 19th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-Jul-2022 Reporter's Comments: A medical assistant administered expired dose of Boostrix. The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Boostrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022108788:duplicate case
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (received 2 doses back in 2009).   On 19th July 2022, the patient received the 3rd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th July 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, drug dose administration interval too long and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose, drug dose administration interval too long and inappropriate age at vaccine administration were 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: 19-Jul-2022 Reporter's comment: The 14 years old patient received an adult of Havrix which was also the patient's 3rd dose. The consent to follow-up was given via postal. Lot number and expiry date was not available at the time of the call.  Additional Supportive Information: The 14 year patient received Havrix 1440 adult as 3rd dose and got 2 doses back in 2009, which led to lengthening of the vaccine schedule, overdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: administered exposed vaccines, 52 Fahrenheit; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number 7P2PS, expiry date 2nd June 2023), (batch number 75B29, expiry date 24th August 2023) and (batch number 24LA3, expiry date 7th July 2023) for prophylaxis.   On 31st March 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The medical assistant called in to check stability of vaccines exposed on 29th March 2022, as Shingrix and Boostrix, 52 Fahrenheit for 3 months. The reporter reported that 20 patients were administered the exposed vaccines, 15 patients were administered the Shingrix and 5 patients were administered Boostrix. The reporter stated that Boostrix details were unknown. The reporter was unable to provide any additional details. The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Shingrix which was exposed at 52 Fahrenheit for 3 months, which led to incorrect storage of drug. This is 1 out of 20 linked cases, reported by same reporter. As it was not clear from which Lot which patient received the vaccine, therefore conservatively all the Lot details were coded in sub tab of product details.; Sender's Comments:  US-GSK-US2022AMR109267:same report, other patient US-GSK-US2022AMR109268:same report, other patient US-GSK-US2022AMR109269:same report, other patient US-GSK-US2022AMR109270:same report, other patient US-GSK-US2022AMR109271:same report, other patient US-GSK-US2022AMR109272:same report, other patient US-GSK-US2022AMR109273:same report, other patient US-GSK-US2022AMR109274:same report, other patient US-GSK-US2022AMR109275:same report, other patient US-GSK-US2022AMR109276:same report, other patient US-GSK-US2022AMR109265:same report, other patient US-GSK-US2022AMR109264:same report, other patient US-GSK-US2022AMR109263:same report, other patient US-GSK-US2022108790:same report, other patient US-GSK-US2022AMR109266:same report, other patient US-GSK-US2022AMR109278:same report, other patient US-GSK-US2022AMR109279:same report, other patient US-GSK-US2022AMR109280:same report, other patient US-GSK-US2022AMR109281:same report, other patient
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose 4 weeks after the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PEDIARIX for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of PEDIARIX. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 20-Jul-2022 Reporter's Comments: The patient received the Pediarix 3rd dose 4 weeks after the 2nd dose. No reactions reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive Information: The patient received the Pediarix 3rd dose before recommended interval, which leads to shortening of vaccination schedule.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: was administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 75M9B, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 20th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 20th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 20-JUL-2022 Reporter's Comment: The reporter was medical assistant, calling on behalf of the patient.  The reporter reported that the patient was administered expired Rotarix.  The reporter reported that, no adverse reactions had been observed. The reporter consented to follow up. Additional Supportive Information: The patient was administered expired Rotarix, which led to expired vaccine used.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Pertussis, Pneumonia
Clinical narrative: pneumonia; whooping cough; I was sick for 6 months.; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pneumonia (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pneumonia, whooping cough and sickness were recovered/resolved.   It was unknown if the reporter considered the pneumonia, whooping cough and sickness to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got whooping cough and pneumonia the last time when he/she got a flu shot. The patient was sick for 6 months. The reporter stated that no more flu shots for him/her. Follow-up would not possible as no contact details were available.
Age: 64.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site swelling
Clinical narrative: Slight swelling on the injection site. Patient did not take any medications for the swelling nor seek medical attention.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose given a week early ( 1st dose administered on 7/9/22)   There was no medical or any other adverse reaction. vaccine just administered to soon , Parents made a wear and will follow up with PCP on 7/25/22.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Metamorphopsia
Clinical narrative: This is patient's second shingrix shot. Patient had almost no symptopms after the first shot.  7/20/2022, got her first shot in the morning, no side effect that night  7/21/2022, woke up with distored vision, went to the ER 7/23/2022, stayed 2 days at the hospital, did numerous of tests and labs, and could not find anything. Discharged with Prednisone 100mg once daily for 2 days. Patient will see the opthamologist
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Anxiety, Cold sweat, Feeling cold, Heart rate increased
Clinical narrative: Patient reported c/o rapid heart rate while under observation. Pt's stated "I feel anxious" was cold clamny, skin cool.  initial V/S : HR 145 , RR 21 BP 130/80 Sat 99  Pt's anxious, ice pack applied to head, feet elevated, water provided Lungs CTA  no SOB no dizziness  VS before D/C : BP 128/88 HR 101 RR 20 sat 99%  NP cleared patient to go home,symptoms fully resolved prior to leaving event site and encourage patient to follow up if symtoms return.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was supposed to receive 0.3 ml of adult pfizer vaccine, instead received 0.3 ml of undiluted pediatric pfizer vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was supposed to receive 0.3 ml of adult pfizer vaccine, instead received 0.3 ml of unconstituted pediatric pfizer vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Patient was supposed to receive 0.3 ml of adult pfizer vaccine, instead received 0.3 ml of unconstituted pediatric pfizer vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient requested 4th dose of the COVID-19 Pfizer vaccine.   0.3ml COVID-19 Pfizer vaccine administered.  After the vaccine was give, old chart records revealed that the patient had already received their 4th dose three months ago.   Spoke with the patient about previous doses, she could not remember getting the 4th dose,  she found her COVID-19 Vaccine card, the 4th dose was written on the back, verifying she had received it.  Patient denies any adverse effects, no further action was taken.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, COVID-19, Dysphonia, Hyperaesthesia, Pain
Clinical narrative: According to patient a few days after she got the Shingrix, there is some sensitivity/ pain on her  (skin) arm that radiates to the back. It is very sensitive to touch, even to wearing of clothing. She also stated few days after she got her Shingrix vaccine, she contracted Covid. It has been about 2 weeks now that she has been experiencing the sensation. She also stated she observed some hoarseness of her voice.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin, Sensitive skin
Clinical narrative: According to patient a few days after she got the Shingrix, there is some sensitivity/ pain on her  (skin) arm that radiates to the back. It is very sensitive to touch, even to wearing of clothing. She also stated few days after she got her Shingrix vaccine, she contracted Covid. It has been about 2 weeks now that she has been experiencing the sensation. She also stated she observed some hoarseness of her voice.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: PT WAS GIVEN UNDILUTED PEDIATRIC PFIZER INSTEAD OF ADULT PFIZER
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: No adverse effects immediately after the vaccination. Very sore arm at night. The following morning and afternoon fatigue, muscle aches and mild headache. Arm continues to be mildly sore, but a large area at the injection site is red, swollen and bumpy, like a rash, with no itchiness. About a four inch irregular area. Still very tired with mild muscle aches at 7pm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: No adverse effects immediately after the vaccination. Very sore arm at night. The following morning and afternoon fatigue, muscle aches and mild headache. Arm continues to be mildly sore, but a large area at the injection site is red, swollen and bumpy, like a rash, with no itchiness. About a four inch irregular area. Still very tired with mild muscle aches at 7pm.
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase increased, Muscle spasms
Clinical narrative: Muscle spasms in entire right upper extremity, lasting for 10 days since onset
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Blood creatine phosphokinase, Blood magnesium, Differential white blood cell count, Full blood count, Headache
Clinical narrative: Muscle spasms in entire right upper extremity, lasting for 10 days since onset
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Metabolic function test, Muscle spasms, Myalgia
Clinical narrative: Muscle spasms in entire right upper extremity, lasting for 10 days since onset
Age: 41.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urine analysis, X-ray
Clinical narrative: Muscle spasms in entire right upper extremity, lasting for 10 days since onset
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Parosmia
Clinical narrative: I have developed Parosmia (self-diagnosed) in the last months and some mild fatigue. I did not immediately associate it with the COVID vaccine but have recently read some medical publications (I am a medical professional) reporting this as a rare side effect. I can't really pinpoint the exact date when this started but it has been within the last year or so and it is getting WORSE! There doesn't appear to be any other obvious cause because my medications and medical condition have been unchanged for several years. I have never contracted COVID and have had no minor illnesses for some long time (certainly none in more than a year or two).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: The patient's mother informed my team lead of an allergic reaction. The patient developed a rash on her left, lateral, lower leg. The rash was warm to touch with red, raised bumps. The child was not in distress, she had no pain and responded no when asked if it itched. After doing a head to toe exam, I found the patient was A/Ox3, PMS x3 and airway was open. The patient was administered (1) children's chewable benadryl. The mother was advised to follow up with a pediatrician and monitor her child for any other developing symptoms.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Vaginal ulceration
Clinical narrative: Developed vaginal ulcers 48 hours after Moderna booster (4th shot).   Had received Pfizer for 1st, 2nd and first booster. Had vaginal ulcers after 2nd pfizer shot as well.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of this report. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The patient received with elasomeran (Moderna) (dose number in series 3) (form of admin and route of admin were not reported, batch number: unknown expiry: unknown) dose was not reported, administered on an unspecified date for covid-19 prophylaxis.  On an unspecified date in JUN-2022 patient had COVID-19. The patient took unspecified drug from 22-JUN-2022 till 27-JUN-2022 for Coronavirus Disease (COVID 19). On 01-JUL-2022 the patient experienced rebound 4 days after completing treatment with an unspecified drug. Worse symptoms than originally reported (dose number in series 3). Treatment medications (dates unspecified) included: prednisone, Short Acting Beta Agonists (SABAs). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with unspecified drug was drug discontinued. The patient had not recovered from rebound 4 days after completing treatment. worse symptoms than originally reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 60 year old female. Initial information was processed along with the additional information on 15-JUL-2022. The patient's height and weight were not reported. The patient was not pregnant at the time of vaccination. The patient had no any drug allergies. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration were not reported, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). Age at time of vaccination 58 years old. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: Unknown) dose was not reported, 1 total administered on 04-JAN-2022 for covid-19 prophylaxis. Age at time of vaccination 59 years old. Concomitant medications included Wellbutrin (bupropion hydrochloride), Vitamin D (ergocalciferol), Valtrex (valaciclovir hydrochloride), Z stack vitamin, Probiotic (bifidobacterium lactis) and steroid dose pack. On an unspecified date in 2022, the patient experienced covid-19 captured as suspected covid-19 infection (dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number and expiry were not reported) dose was not reported, administered from 24-JUN-2022 to 29-JUN-2022 for treatment of COVID-19. The patient was received other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that on 04-JUL-2022, the symptoms returned which include fatigue and scratchy throat subsumed under suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was not reported. The patient was recovering from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000242437 and 90000242438.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other manufacturer Pfizer concerned a 58 year old male. Initial information was processed with the additional information received on 15-JUL-2022 and 18-JUL-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: hyperthyroidism, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date at 12:00 to left arm for covid-19 prophylaxis. Concomitant medications included bupropion hydrochloride (Wellbutrin), levothyroxine sodium (Synthroid) and sertraline hydrochloride (Zoloft) for drug used for unknown indication. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received non-company Moderna vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 048L21A, expiry: unknown) dose was not reported, administered on 02-APR-2022 at 12:00 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of Moderna vaccine (elasomeran) (Dose number in series 2). The patient received another non-company Pfizer biontech Covid-19 vaccine (Tozinameran) (Dose number in series 3) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 02-JUN-2022 at 12:00 to left arm for covid-19 prophylaxis. On an unspecified date in 2022, patient had covid-19 (Dose number in series 3). The patient received non company suspect Paxlovid (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on 21-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 25-JUN-2022.  On 04-JUL-2022 at 08:00, the patient experienced covid rebound after paxlovid five day treatment. (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and tozinameran was not applicable and action taken with Paxlovid was treatment discontinued. The patient had not recovered from covid rebound after paxlovid five day treatment. This report was non-serious. This report was associated with product quality complaint number: 90000242596. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via a Pfizer Inc, (other company) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, high blood pressure, Sjogren's syndrome, Raynaud's, migraines, and discoid lupus, and other pre-existing medical conditions included: The patient was not a pregnant at the time of report. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: Unknown) dose was not reported, dose 1, 1 in total, administered in left arm on 30-MAR-2021 for prophylactic vaccination. Age at time of vaccination 56 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series: 2) (form of admin and route of admin were not reported, batch number: 939905 and expiry: Unknown) dose was not reported, dose 2, administered in left arm on 02-NOV-2021 for prophylactic vaccination. Age at time of vaccination 57 years old. Concomitant medications included amitriptyline, amlodipine, calcium pantothenate/choline/cyanocobalamin/nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride, colecalciferol, folic acid, hydroxychloroquine, magnesium oxide, meloxicam, methotrexate, metoprolol succinate, riboflavin, and ubidecarenone. On an unspecified date, the patient experienced covid-19 which is coded as suspected covid-19 infection (Dose number in series: 2). On 28-JUN-2022, the patient received non-company suspect Paxlovid (form of admin, route of admin and batch number were not reported) dose was not reported, administered for an treatment of covid-19. On 30-JUN-2022, the patient experienced rash on left arm, rash was red raised bumps and described that there was no whiteheads or pustules, non-itchy and the bumps range in size from small (pinhead size) to a little less than a 1/4 (Dose number in series 2). On 01-JUL-2022, treatment medications included: diphenhydramine hydrochloride The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Moderna covid-19 vaccine) was not applicable, and with Paxlovid was withdrawn on 30-JUN-2022. The patient had not recovered from rash on left arm/rash was red raised bumps, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID- 19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 65 year old female. Initial information was processed along with additional information received on 19-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic kidney disease, hypothyroidism, high blood pressure, and drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of the report.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 10-MAR-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 64 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine, lisinopril and simvastatin.  On 18-JUN-2022, the patient was exposed to COVID which lead to confirmed clinical vaccination failure (dose number in series 1). The patient received additional two doses of Non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 27-OCT-2021 in left arm (dose 2), and dose was not reported, administered on 23-APR-2022 (dose 3) in left arm for covid-19 prophylaxis.  On 18-JUN-2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 2). On 22-JUN-2022, Laboratory data included: COVID-19 virus test Positive and received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 22-JUN-2022 to 27-JUN-2022 for covid-19 treatment. On 27-JUN-2022, 29-JUN-2022 and on 01-JUL-2022 patient tested negative. On 02-JUL-2022, at 11 hours, evening the patient experienced cold symptoms. On 03-JUL-2022, the patient tested positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable paxlovid was discontinued. The patient was recovering from confirmed covid- 19 infection, and the outcome of confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000242796.; Sender's Comments: V0:20220731131-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nausea, Vomiting
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: highly susceptable to nausea, and highly susceptable to motion sickness. The patient experienced drug allergy when treated with sumatriptan. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) first dose dose was not reported, 1 total, administered on 08-APR-2021 on left arm for covid-19 prophylaxis. On an unspecified date, the patient experienced covid-19 infection (dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (Pfizer) (dose number in series 2) (form of admin and route of admin was not reported, batch number: FE3690, and expiry: UNKNOWN) second dose, dose was not reported, administered on 30-OCT-2021 on left arm for covid-19 prophylaxis. Concomitant medications included desvenlafaxine succinate monohydrate, and gabapentin. The patient received non-company suspect drug included paxlovid (form of admin and route of admin, batch number, and expiry were not reported) dose was not reported, administered from 03-JUL-2022 for the treatment of covid 19 (coronavirus disease). On 03-JUL-2022, the patient experienced nausea, and vomiting (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and for paxlovid was treatment discontinued on 04-JUL-2022. The patient was recovering from nausea, and vomiting, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (initial dose) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown if the patient experienced any adverse events following administration of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received first booster dose of covid-19 vaccine ad26. cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown if the patient experienced any adverse events following administration of covid-19 vaccine ad26. cov2.s (dose number in series 2). The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was off label dosing frequency. The drug was associated with off label use (dose number in series 3). The batch number was not reported and has been requested. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total, administered on 28-APR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown expiry date: unknown) dose was not reported, 1 total, administered on unspecified dates in 2021 (either on OCT-2021 or NOV-2021) for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2022, the patient experienced contracted covid many months after the Janssen booster shot (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted covid many months after the Janssen booster shot was not reported. This report was non-serious. This report was associated with product quality complaint 90000242517.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Vaccination site vasculitis
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vasculitis after being inoculated. Laboratory data (dates unspecified) included: Blood test vasculitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vasculitis after being inoculated was not reported. This report was non-serious. This case, from the same reporter is linked to 20220732338.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Lethargy, Pain in extremity
Clinical narrative: COVID PNEUMONIA; LETHARGIC; SORE ARM; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total (dose 1) administered on 13-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 67 years old. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced little lethargic and sore arm (about as bad as a tetanus shot) after the shot but nothing major. On 13-JAN-2022, the patient experienced covid pneumonia, and was hospitalized (date unspecified). Duration and discharge information were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid pneumonia, lethargic, and sore arm. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000242584. This case, from the same reporter is linked to 20220733196.; Sender's Comments: V0: 20220733188 -COVID-19 VACCINE AD26.COV2.S- COVID PNEUMONIA. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: none. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. On 13-MAR-2021, the patient experienced a little lethargic. On 03-JAN-2022, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and a little lethargic. This report was non-serious. This case, from the same reporter is linked to 20220733188. This report was associated with a product quality complaint: 90000242587.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: RUNNY NOSE; SORENESS IN THE INJECTION SITE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2022 for covid-19 prophylaxis. No concomitant medications were reported. On JUL-2022, the patient experienced nausea. On 07-JUL-2022, the patient experienced runny nose, soreness in the injection site, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, soreness in the injection site, and fever on 10-JUL-2022, and had not recovered from nausea. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 in left arm for covid-19 prophylaxis. On an unspecified date in 2021, patient experienced upper left shoulder pain (minimal) that lasted one day (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-NOV-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 63 years old. No concomitant medications were reported.  On 31-DEC-2021, patient developed symptomatic covid (confirmed covid-19 infection) and he tested positive 2 days later with a rapid test (got the result within the hour) which resulted to confirmed clinical vaccination failure (dose number in series 2). Patient had quite the fever (lasted 4 days before it broke), had no thermometer, didn't know temperature. He felt his head was full, but there was no congestion. About a week later, he developed a cough and it lasted a month. He took 5 days off of work. He didn't see a doctor when he got covid, so his doctor was not aware. On 02-JAN-2022, Laboratory data included: COVID-19 rapid POC test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000242713 and 90000242714. This case, involving the same patient is linked to 20220737591 (dose number in series 1).; Sender's Comments: V0-20220735184-covid-19 vaccine ad26.cov2.s-Confirmed Clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.