chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication, Vaccination site pain
Clinical narrative: expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine (ex: sore arm, etc.); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ), EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm). In November 2021, the patient experienced VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) and VACCINATION SITE PAIN (Sore arm) had resolved. In November 2021, VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Vaccination complication
Clinical narrative: term expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine (ex: sore arm, etc.); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) and EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (term expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.) ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions. On 11/5 all vaccines were administered within 3 hours   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received,  Secondary reporter Information was added; Sender's Comments: Non-serious case.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter Treatment information was not provided  vaccine expiration date was 11-OCT-2021.  No vial went any temperature excursions. vaccine  was administered within 2 hrs.   No adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: non significant follow up-Added Secondary reporter
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were Reported. No Treatments were Reported. Patient did not have migraines after years, experienced some after the first and second vaccination whit the Moderna vaccine in Jan 2021 as well as recently in late Oct 2021 after a flue shot.   This case was linked to MOD-2021-395791 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Interchange of vaccine products, Pain
Clinical narrative: First 2 shots were Pfizer. Pharmacy I went to only had Moderna for booster.  Since it has been stated it's OK to mix and match I decided to move forward with Moderna booster.  I was fine for first 12 hours after the booster.  Was out and about all day.  Late that evening I started to get a headache and chills.  Then it got progressively worse over next 24 hours.  Developed low-grade fever.  Body was very achy.   Injection site was sore for 2+ days.  Developed a wet cough day after getting booster.  Chills, fever, body ache when away on 11/25 but still have the cough.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia
Clinical narrative: First 2 shots were Pfizer. Pharmacy I went to only had Moderna for booster.  Since it has been stated it's OK to mix and match I decided to move forward with Moderna booster.  I was fine for first 12 hours after the booster.  Was out and about all day.  Late that evening I started to get a headache and chills.  Then it got progressively worse over next 24 hours.  Developed low-grade fever.  Body was very achy.   Injection site was sore for 2+ days.  Developed a wet cough day after getting booster.  Chills, fever, body ache when away on 11/25 but still have the cough.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: High fever of 102.5 on the day after shot, muscle aches, chills. Second day after shot, high fever of 101.2, muscle aches , chills. Third day normal temperature, felt better.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Severe unrelenting  underarm pain (7 out of 10) on same arm as Pfizer booster; Very tired, cold, somewhat dizzy, listless, overall aches.
Age: 70.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Paralysis
Clinical narrative: Paralyzed  toes to waist.5 days after vacine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Heart rate increased, Hypertension, Myocardial necrosis marker, Stress echocardiogram
Clinical narrative: Severe facial and neck swelling, extremely high blood pressure and extremely high heart rate
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Troponin
Clinical narrative: Severe facial and neck swelling, extremely high blood pressure and extremely high heart rate
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: On 11/14, started as bumps and redness from the middle of my back to my glutes, had a presence of shingles like. Bumps went down with Benadryl cream. Then every day since then, I have had a rash that welts up appearing on my back, legs, arms, chest, and face (basically all over my body). It welts and sometimes itches. It typically comes and goes throughout the day.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Got the booster in left arm, not sure if its in the muscle but my arm is HOT, you can feel the warmth through clothes and its red. The heat is bothering me...I iced it when I got home, tuesday and wednesday and took motrin.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: No initial adverse effects, rash appeared 3 days after injection.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Magnetic resonance imaging, Sudden hearing loss, Tinnitus, Vertigo
Clinical narrative: Sudden Hearing Loss Severe Tinnitus Vertigo
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: TWO AFTER I RECEIVED THE FIRST DOSE, I GOT SEVERE PAIN IN BOTH SHOULDERS WITHOUT ANY CAUSE OR INJURY. I WENT TO EMERGENCY ROOM, WHERE THE DOCTOR TOLD ME I HAD TENDINITIS OF BOTH SHOULDERS. I RECIEVED PHYSICAL THERAPY WITH MODEST RELIEF.  I RECEIVED BOOSTER DOSE ON OCTOBER 28, 2021. FEW DAYS LATER, I GOT SEVERE PAIN IN BOTH ANKLES AND KNEES. I AM GETTING PHYSICAL THERAPY.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Vaccine positive rechallenge
Clinical narrative: Dry eyes.  About two weeks after  my second Pfizer shot (3/2021), I had a sudden onset dry eye condition (right eye very dry upon waking). This has persisted since that time, though early in Nov 2021, I would have occasional days when I would wake and it would be normal. Then I got my booster on 11/11/21.  Now, about 2 weeks later, I am waking with both eyes dry, and done dryness during daytime. It?s not clear to me if the vaccine caused dry eye as a side effect or if it tipped off some auto immune process, but after the increased effect post-booster, with essentially the same timing as the onset relative to shot #2, I have virtually no doubt this is causally related to the vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Rapid heart beat, shortness of breath, chest pain
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cold sweat, Costochondritis, Dyspepsia, Electrocardiogram
Clinical narrative: Cold sweats, fever, indigestion, nausea [T+24 hours] costochondritis (T+48hours)   After being diagnosed with costochondritis, patient began regimen of 600mg ibuprofen q8h. Symptoms started to subside after for dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Troponin
Clinical narrative: Cold sweats, fever, indigestion, nausea [T+24 hours] costochondritis (T+48hours)   After being diagnosed with costochondritis, patient began regimen of 600mg ibuprofen q8h. Symptoms started to subside after for dose.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node under left collar bone swelling and pain. Began hours after injection.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Nervous system disorder, Visual impairment
Clinical narrative: herpes zoster; neurological eye disorder; vision problems; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) vaccine (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live(ZOSTAVAX) vaccine, the patient suffered herpes zoster, neurological eye disorder and vision problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), this patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her/his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, patient suffered serious, progressive permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality between the events and suspect vaccine was related.   The events of herpes zoster, neurological eye disorder and vision problems were considered to be disabled by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Vaccine positive rechallenge
Clinical narrative: soreness at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site pain (received first dose on an unknown date and had soreness at the injection site for a few days. For tolerance refer case US2021AMR241040).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient reported that he/she got the shots. All he/she had was soreness at the injection site for a few days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241040:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: on the right side of my face and iI had the shingle shot/suspected vaccination failure; it does as it is on the right side of my face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingle shot and stated that yes it did as it (shingles) was on the right side of his/her face. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine did not work. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Near death experience
Clinical narrative: Near death experience; she can no longer work; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and inability to work. On an unknown date, the outcome of the near death experience was not recovered/not resolved and the outcome of the inability to work was unknown.   It was unknown if the reporter considered the near death experience and inability to work to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's cousin. The age at vaccination was not reported. The reporter stated that the patient nearly died when she had a Shingles vaccine and it happened, initially and every month since, she had nearly died and would for the rest of her life. The reporter stated that the patient needed to get medical treatments, that was financially impossible for her to pay for and she could no longer work. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: second dose about 3-4 years ago / last week / Shingles/suspected vaccination failure; Shingles; Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix. In November 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were reported as follows; The patient self-reported this case. The age at vaccination was not reported. The patient stated that he received the second dose of Shingrix in deltoid about 3 to 4 years ago from reporting date and sometime last week, he came down with Shingles.  The patient had the nerve pain but no rash.  The patient stated that this had not resolved, and he continues to experience the shingles and nerve pain. The reporter consented to follow-up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccinated with an 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 patient who received HBV (Engerix B) (batch number unknown, expiry date 12th November 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 22nd November 2021, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The age at vaccination was not reported. Manager called to report a patient vaccinated yesterday (from the day of reporting) with an expired dose of Engerix-B. The HCP had no information about the patient and stated that he/she would call back with patient's demographics data. Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up by fax.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: received Rotarix second dose IM; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number AB3BR, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd November 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 23rd November 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were reported as follows: A nurse reported that, the patient received Rotarix 2nd dose intramuscular route by error, which led to inappropriate route of vaccination. The reporter also said that please call health care professional before sending the form to confirm address. The reporter consented to follow up. The case had been linked with US2021241785 (twins) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241785:same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received an expired 1st dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number H2HM2, expiry date 29th August 2021) for prophylaxis.   On 22nd November 2021, the patient received the 1st dose of Shingrix. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Office manager reported the case. The patient received a dose of an expired Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Coagulopathy, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: CEREBROVASCULAR ACCIDENT; SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; COAGULOPATHY; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS reference number 1779560] concerned a 50 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 07-APR-2021 to left arm for an unspecified indication. No concomitant medications were reported. On 21-SEP-2021, the patient experienced cerebrovascular accident, suspected clinical vaccination failure, confirmed covid-19 infection, coagulopathy and sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 11-Oct-2021 date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, cerebrovascular accident, coagulopathy, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with product quality complaint number: 90000199058. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Regulatory Authority department on 24-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result was added.; Sender's Comments: V1: Additional information in this version is regarding:  Product quality complaint investigation results. This does not alter company causality of previously reported events 20211046077-Covid-19 vaccine ad26.cov2.s-Cerebrovascular accident, Confirmed covid-19 infection, coagulopathy, sars-cov-2 test positive. This event(s) is considered unassessable. 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). 20211046077-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. 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
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: CEREBROVASCULAR ACCIDENT; SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; COAGULOPATHY; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS reference number 1779560] concerned a 50 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 07-APR-2021 to left arm for an unspecified indication. No concomitant medications were reported. On 21-SEP-2021, the patient experienced cerebrovascular accident, suspected clinical vaccination failure, confirmed covid-19 infection, coagulopathy and sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 11-Oct-2021 date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, cerebrovascular accident, coagulopathy, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with product quality complaint number: 90000199058. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Regulatory Authority department on 24-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result was added.; Sender's Comments: V1: Additional information in this version is regarding:  Product quality complaint investigation results. This does not alter company causality of previously reported events 20211046077-Covid-19 vaccine ad26.cov2.s-Cerebrovascular accident, Confirmed covid-19 infection, coagulopathy, sars-cov-2 test positive. This event(s) is considered unassessable. 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). 20211046077-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. 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
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-like symptoms). At the time of the report, VACCINATION COMPLICATION (COVID-like symptoms) outcome was unknown.            No concomitant and treatment information were reported by the reporter.  Caller mentioned she received 2nd dose of the Moderna COVID-19 vaccine on the 17th Nov 2021 and was experiencing COVID-like symptoms on the 18thNov 2021.  Company comment- This case concerns a female patient, unknown age, with no relevant medical history, who experienced the non-serious, unexpected event of vaccination complication. The event occurred  one day after second dose of mRNA 1273 vaccine. The patient felt COVID-like symptoms after her vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up received on 18-NOV-2021 and contains NNI.; Sender's Comments: This case concerns a female patient, unknown age, with no relevant medical history, who experienced the non-serious, unexpected event of vaccination complication. The event occurred  one day after second dose of mRNA 1273 vaccine. The patient felt Covid-like symptoms after her vaccine. The rechallenge is not applicable as there is no information regarding a third dose.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 025B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-390237 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Headache; Experiencing a swollen lymph node in the armpit; Fever; Chills; body ache; experiencing pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body ache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (LOT: first dose ER8730) on 22-Mar-2021 and Pfizer (LOT: second dose ER8737) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included OLMESARTAN for an unknown indication.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) had not resolved and LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22-Mar-2021, patient received first dose of Pfizer (batch no. ER8730). On 12-APR-2021, received the second dose of Pfizer (batch no. ER8737). Patient got both doses of Pfizer on left dominant arm.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Experiencing a swollen lymph node in the armpit; Fever; Chills; body ache; experiencing pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body ache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (LOT: first dose ER8730) on 22-Mar-2021 and Pfizer (LOT: second dose ER8737) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included OLMESARTAN for an unknown indication.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) had not resolved and LYMPHADENOPATHY (Experiencing a swollen lymph node in the armpit), PYREXIA (Fever), CHILLS (Chills), MYALGIA (body ache) and INJECTION SITE PAIN (experiencing pain at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22-Mar-2021, patient received first dose of Pfizer (batch no. ER8730). On 12-APR-2021, received the second dose of Pfizer (batch no. ER8737). Patient got both doses of Pfizer on left dominant arm.
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Vaginal infection/Yeast Infection; This spontaneous case was reported by a health care professional and describes the occurrence of VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection). The patient was treated with FLUCONAZOLE ongoing since an unknown date for Vaginal yeast infection, at an unspecified dose and frequency. At the time of the report, VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) to be possibly related.    Concomitant product use was not provided by the reporter. This spontaneous case concerns a female patient, of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious event of vulvovaginal mycotic infection. The event occurred on an unspecified date in Nov2021 after administration of the second dose of the Moderna mRNA-1273. The patient is being treated with Fluconazole. The event outcome was unknown at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious event of vulvovaginal mycotic infection. The event occurred on an unspecified date in Nov2021 after administration of the second dose of the Moderna mRNA-1273. The patient is being treated with Fluconazole. The event outcome was unknown at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Strange reaction to 2nd jab of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna). At the time of the report, VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick 4 days with the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick 4 days with the first one) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick 4 days with the first one). At the time of the report, ILLNESS (Sick 4 days with the first one) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-390750 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Gingival pain, Oral pain
Clinical narrative: Mouth pain; Sore gums; I am having oral pain; This spontaneous case was reported by a nurse and describes the occurrence of ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain). At the time of the report, ORAL PAIN (Mouth pain), GINGIVAL PAIN (Sore gums) and ORAL PAIN (I am having oral pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Faeces discoloured, Feeding disorder
Clinical narrative: Feelings of weakness; Nausea; Chills; Sickness; Flu like symptoms; Black stool; Diarrhea/still had a little diarrhea; Unable to eat; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea) and FEEDING DISORDER (Unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034P21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced HEADACHE (Headache). On 16-Nov-2021, the patient experienced ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), NAUSEA (Nausea) and CHILLS (Chills). On 18-Nov-2021, the patient experienced ASTHENIA (Feelings of weakness). At the time of the report, ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), ASTHENIA (Feelings of weakness), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            The patient experienced her intestinal did a number on her, and she still has a little diarrhea. No concomitant medication was reported. No treatment medication was reported.