chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/17/2022 late in the evening I started with a sore throat. 12/18 congestion got worse, sore throat persisted. 12/19 congestion got worse and all others consistent. 12/20 continued symptoms with nasal drainage. Tested positive with at home COVID-19 test. Telehealth with doctor who prescribed PAXLOVID and to treat symptomatically. By 12/21 evening of feeling better with symptoms slightly diminished. By the evening of 12/22 symptoms substantially diminished but fatigue remained. All symptoms but fatigue resolved by 12/24. Feeling recovered by 12/28/2022.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood creatine phosphokinase increased, Imaging procedure, Laboratory test, Liver function test increased, Pain
Clinical narrative: Patient seen for routine follow up on 9/28 and feeling/doing well and labs normal including LFTs.  on 10/14 had intradermal 0.1ML MPV vaccine (2nd dose) and some hours later developed burning jaw pain and presented to the ED and was found to have LFT elevation and CPK elevation. he left the ED against medical advice but returned on 10/15 and had full workup including labs/imaging that did not reveal cause for rhabdomyolysis
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pain in jaw, Rhabdomyolysis
Clinical narrative: Patient seen for routine follow up on 9/28 and feeling/doing well and labs normal including LFTs.  on 10/14 had intradermal 0.1ML MPV vaccine (2nd dose) and some hours later developed burning jaw pain and presented to the ED and was found to have LFT elevation and CPK elevation. he left the ED against medical advice but returned on 10/15 and had full workup including labs/imaging that did not reveal cause for rhabdomyolysis
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for primary series Infant Moderna 2nd dose. Patient was accidently given Infant Moderna Bivalent Booster.
Age: 1.42
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Stent placement, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Patient developed blood clots in left thigh. 1 removed- length of thigh.  1 removed length of belly button to left knee. A Stent was placed in groin area. There's now another one with limited blood flow. Xarelto is being used to help reduce clots.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertent administration past the 30-day Use by Date of the Moderna vaccine. No Symptoms to report as no adverse event was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, Pulmonary congestion
Clinical narrative: I had headache, slight fever, cough, nose, and lung congestion. I tested positive for COVID-19 at home. My brother was worried about my breathing getting too heavy, so I went to the emergency room. When I got there, they said everything was okay and sent me home. I still have a cough and congestion. The doctor prescribed me FLONASE and I was taking ADVIL.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiration abnormal, SARS-CoV-2 test positive
Clinical narrative: I had headache, slight fever, cough, nose, and lung congestion. I tested positive for COVID-19 at home. My brother was worried about my breathing getting too heavy, so I went to the emergency room. When I got there, they said everything was okay and sent me home. I still have a cough and congestion. The doctor prescribed me FLONASE and I was taking ADVIL.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Cough variant asthma, Feeling abnormal, SARS-CoV-2 test negative, Vomiting
Clinical narrative: I did not feel good 12/02/22, by 12/07/22 and 12/08/22 I was feeling even worse. I used two at home COVID-19 test from on 12/16/22 that came back negative. Work requested that I take another on 12/17/22 that also came back negative. I went to a clinic and saw the saw doctor that I had seen back in September when I had tested positive for COVID-19. He felt that I may have a cough variant of asthma and I needed to be using my albuterol inhaler more. I cough so hard that I have been throwing up. I started taking OZEMPIC. The coughing seems to come on at night, in the cold air. I have been taking TUMS to help keep my stomach calm, so I do not want to throw up. I will be following up with the doctor in January.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Gastrointestinal disorder, Headache, Influenza, Nausea
Clinical narrative: I received my Pfizer booster on 09/27/2022.  I came down with a Flu on 12/16/2022. I had intestinal stomach issue  and upper respiratory issue  at the same time. I had a severe headache, fever, chills,  nausea, and vomiting. .The next day 12/17/2022 I had all the same symptoms which continued till 1 week. On 12/19/2022 I did a telehealth with my doctor. He prescribed me with Albuterol 4-5 days  as per needed, Antibiotics ( Levofloxacin) , Prednisone for 5 days  and Ondansetron.  As of today 12/28/2022 I am still recovering.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pyrexia, Respiratory disorder, SARS-CoV-2 test negative, Vomiting
Clinical narrative: I received my Pfizer booster on 09/27/2022.  I came down with a Flu on 12/16/2022. I had intestinal stomach issue  and upper respiratory issue  at the same time. I had a severe headache, fever, chills,  nausea, and vomiting. .The next day 12/17/2022 I had all the same symptoms which continued till 1 week. On 12/19/2022 I did a telehealth with my doctor. He prescribed me with Albuterol 4-5 days  as per needed, Antibiotics ( Levofloxacin) , Prednisone for 5 days  and Ondansetron.  As of today 12/28/2022 I am still recovering.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I had symptoms of bad cold, post-nasal drip, coughing, sneezing, and tiredness. I consulted my doctor and because my symptoms was relatively minor she recommended over the counter medications. I took DAYQUIL for about a week.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing, Upper-airway cough syndrome
Clinical narrative: I had symptoms of bad cold, post-nasal drip, coughing, sneezing, and tiredness. I consulted my doctor and because my symptoms was relatively minor she recommended over the counter medications. I took DAYQUIL for about a week.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED BIVALENT VACCINE ON 12/2/22 AND AGAIN ON 12/22/22 IN ERROR.  WATCHING FOR ADVERSE EFFECTS BUT NONE NOTED TO DATE.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Exposure to SARS-CoV-2
Clinical narrative: I had got exposed to my COVID-19 positive wife. I was to have an appointment with my doctor and tested positive at home. I was prescribed PAXLOVID. I lost 95% of my taste and smell. I felt just as if I had a really bad cold. It was mild for the most part. I had a slight sore throat, running nose and a slight headache in the beginning. I had upper chest congestion and cough that latest a week. It was four days of sinus congestion; the rest was in my upper chest. I still have a chest cough, but other than that I feel fine.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I had got exposed to my COVID-19 positive wife. I was to have an appointment with my doctor and tested positive at home. I was prescribed PAXLOVID. I lost 95% of my taste and smell. I felt just as if I had a really bad cold. It was mild for the most part. I had a slight sore throat, running nose and a slight headache in the beginning. I had upper chest congestion and cough that latest a week. It was four days of sinus congestion; the rest was in my upper chest. I still have a chest cough, but other than that I feel fine.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I had got exposed to my COVID-19 positive wife. I was to have an appointment with my doctor and tested positive at home. I was prescribed PAXLOVID. I lost 95% of my taste and smell. I felt just as if I had a really bad cold. It was mild for the most part. I had a slight sore throat, running nose and a slight headache in the beginning. I had upper chest congestion and cough that latest a week. It was four days of sinus congestion; the rest was in my upper chest. I still have a chest cough, but other than that I feel fine.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient stated that they had never received a COVID vaccine, and a primary/monovalent Pfizer vaccination was given on 10/7/22. The patient came in for a second dose and the patient's daughter stated that the patient had received 3 previous vaccines. So, the patient should have received a Booster/Bivalent dose and not the first in the primary series.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: patient reports vaccine being given high on arm toward shoulder. Soon after the injection she experienced shoulder pain that did not resolve. Patient has since received one cortisone injection in shoulder and has been referred to physical therapy
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: I contracted COVID-19 with symptoms of fatigue, congestion, headache, diarrhea, vomiting, abdominal pain, insomnia, body aches, brain fog, and fatigue. I was prescribed PAXLOVID on 11/22/22. I was ill for 17 to 20 days before my symptoms began to resolve. I am still experiencing lingering fatigue and insomnia. I am not fully recovered yet.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Insomnia, Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I contracted COVID-19 with symptoms of fatigue, congestion, headache, diarrhea, vomiting, abdominal pain, insomnia, body aches, brain fog, and fatigue. I was prescribed PAXLOVID on 11/22/22. I was ill for 17 to 20 days before my symptoms began to resolve. I am still experiencing lingering fatigue and insomnia. I am not fully recovered yet.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: I contracted COVID-19 with symptoms of fatigue, congestion, headache, diarrhea, vomiting, abdominal pain, insomnia, body aches, brain fog, and fatigue. I was prescribed PAXLOVID on 11/22/22. I was ill for 17 to 20 days before my symptoms began to resolve. I am still experiencing lingering fatigue and insomnia. I am not fully recovered yet.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: I tested positive for Covid-19 on December 25, 2022. I experienced weakness, tiredness, fever of 99.0 chills, sneezing, coughing, headaches. No medications were taken.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I tested positive for Covid-19 on December 25, 2022. I experienced weakness, tiredness, fever of 99.0 chills, sneezing, coughing, headaches. No medications were taken.
Age: 40.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Respiratory tract congestion
Clinical narrative: About 2 weeks ago I started having a dry cough, congestion, some loss of taste and smell. I tested positive for COVID-19 today. I have an upcoming telehealth visit in order to get a prescription for PAXLOVID.
Age: 40.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: SARS-CoV-2 test positive
Clinical narrative: About 2 weeks ago I started having a dry cough, congestion, some loss of taste and smell. I tested positive for COVID-19 today. I have an upcoming telehealth visit in order to get a prescription for PAXLOVID.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient administered bivalent Pfizer-BioNTech in error for a primary series dose.   No adverse signs and symptom at time of administration or 15 minutes after while observed in the clinic
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 11/25/2022. On 12/24/2022 my throat was hurting and felt like I had a head cold. On 12/25/2022 I felt worse. On 12/26/2022 and the test was COVID-19 Negative. On 12/27/2022 I tested COVID-19 Positive and prescribed Paxlovid.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HBV (Engerix B) (batch number 2793Z, expiry date 5th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 16th December 2022, 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 Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 9th December 2022, unknown after receiving Havrix and Havrix 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-Dec-2022 Reporter's comment: The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: Adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Boostrix instead of Kinrix; A 5 years-old received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 397B5, expiry date 30th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered 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-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a Boostrix dose instead of Kinrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Havrix and Havrix 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-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Episodes of Syncope; This case was reported by a consumer via call center representative and described the occurrence of syncope in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of syncope (received 1st dose in October 2021, refer link case US2022AMR191767).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the syncope was not recovered/not resolved.   It was unknown if the reporter considered the syncope to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR191767   Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comments: The reporter was a patient.  The reporter stated that since receiving his first dose he was experienced episodes of syncope. No additional details were provided by the reporter. The reporter was consented to follow up. Note: Conservatively case was kept valid for 2nd dose as it was said since 1st dose but no outcome was provided, and it seems it was continued till 2nd dose.; Sender's Comments:  US-GSK-US2022AMR191767:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on April, 2nd on Octuber; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 24-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in April). Concurrent medical conditions included hiv infection (was HIV positive).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, 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: 14-Dec-2022 Reporter's comment: The patient received 1st dose of Menveo in April but he missed the 2nd dose in July, then 2nd dose was administered in October. The reporter asked that they should take the October dose as the first dose and start and complete (2 doses) immunization series or the patient was covered with April and October doses. Unfortunately they did not had any other data such as patient's identifiers or exact administration date. Did not had opportunity to consent to follow-up Additional supportive information: The patient received the 2nddose of Menveo later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Havrix and Havrix 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: 23-DEC-2022 Reporter's Comment: The medical assistant reported that the patient received an expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix dose, which was already expired on 9th August 2022, which led to expired vaccine used.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACKS; This spontaneous report received from a consumer via a company representative via social media concerned 5 decade old multiple (3) male patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patients previously 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, start therapy date were not reported 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patients additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 5 decade old. No concomitant medications were reported.  On an unspecified date, the patients died from heart attacks (Dose number in series 2). It was unspecified if an autopsy was performed. It was reported as "3 male friends in their 40s in a 3 week span got the booster and died days afterword from heart attacks. Coincidence". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221253631-Heart attacks. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART ATTACK
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: MILD COVID; This spontaneous report received from a consumer via a company representative through social media concerned multiple patients. Initial information was processed along with additional information on 27-DEC-2022. The patient's weight, height, and medical history were not reported. The patients 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, 1 total administrated on an unspecified date for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patients 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, 1 total administrated on an unspecified date 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 few patients experienced mild covid (dose number in series 2). The reporter stated "not everyone gets it! My family and friends got all vaccines and only a few got mild Covid".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild covid was not reported. This report was non-serious. This report was associated with a product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: ROUND 3 OF COVID; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (2 rounds of covid). The patient was previously treated with covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, 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 round 3 of covid (sicker) (Dose number in series 2). Reporter stated that, "I am on round 3 of covid. This time I am having a hard time getting well. I work in the medical field and we were forced to take it and the boosters. I am sicker now then before" The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of round 3 of covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: HAVE NEVER BEEN IN SO MUCH PAIN; 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 have never been in so much pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have never been in so much pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: COULD NOT WALK FOR 6 DAYS; 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 could not walk for 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 6 days. This report was non-serious. This case, involving the same patient is linked to 20221258571.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HAD IT BAD; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients did not have any of those factors (unspecified). 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 had it bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had it bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20221257371.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: INFLAMMATION; PAIN IN JOINTS; 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 was not reported, administered on APR-2021 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 2021, the patient experienced inflammation, and pain in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation, and pain in joints on 2022. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain
Clinical narrative: SEVERE BREAST PAIN; A BIT MORE JOINT PAIN; This spontaneous report received from a patient via social media  via a company representative 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: autoimmune disorder. The patient experienced joint pain when treated with influenza vaccine for prophylactic vaccination.  The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported administered for covid-19 prophylaxis. On an unspecified date, the patient experienced severe breast pain following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The outcome of severe breast pain was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported administered 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 severe breast pain, and a bit more joint pain (Dose number in series 2). It was reported that, "I did take the J and J vector vaccine and I do have autoimmune. I can say I did have a bit more joint pain but then it subsided. I also have the same reaction after the flu shot. I did report this as well to J and J along with sever breast pain that occurred after both J and J shots. Overall no other challenges. Will not mix J and J vector with Pfizer or Moderna MRNA. Hoping J and J gets approval for their booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a bit more joint pain, and the outcome of severe breast pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20221258086.
Sex: U
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: TROUBLE WITH VEINS IN LEGS; 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 trouble with veins in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of trouble with veins in legs was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HORRIBLE HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had any problems with his heart or health. 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 horrible heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible heart problems was not reported. This report was non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Rash
Clinical narrative: Rash (urgent care visit); Shingles diagnosis; Severe pain/pain in right side lower back; Discomfort right side lower back; This case was reported by a consumer and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix. On 13th December 2022, 12 days after receiving Shingrix, the patient experienced shingles (serious criteria clinically significant/intervention required), pain and discomfort. On 17th December 2022, the patient experienced rash. The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the discomfort and rash were unknown.   It was unknown if the reporter considered the shingles, pain, discomfort and rash to be related to Shingrix.     Additional Information: Receipt Date: 21-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that on a routine visit to general practitioner he was advised to receive Shingrix shingles vaccine and he received Shingrixvaccine. The patient stated that on 13th December 2022, 12 days after received Shingrix vaccine he experienced pain and discomfort at right side lower back. The patient reported that by on 17th December 2022, 16 days after received Shingrix vaccine he started to developed rash, so he went to urgent care facility where he was diagnosed as had shingles. The patient was now suffering from disease with severe pain. The reporter did requested to consent the follow up.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident, Heart rate increased
Clinical narrative: Stroke; Fast heart rate, elevated heart rate; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 49-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2G7K9, expiry date 12th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season .5 ml and Flulaval Tetra Pre-Filled Syringe Device. In October 2022, 3 weeks after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced heart rate increased (serious criteria clinically significant/intervention required). On 3rd December 2022, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the stroke and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the stroke and heart rate increased to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022191338   Additional Information: GSK Receipt Date: 21 DEC 2022 Reporter's comment: The reporter was the patient. The patient received a dose of Flulaval Quadrivalent. The patient stated that about three weeks later patient developed an elevated heart rate that was unresolved. The patient had fast heart rate from 2nd November 2022 and was ongoing till the time of reporting. The patient was in hospital for stroke. The reporter wanted to know if this was mRNA vaccine. Reporter consented to follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022).    Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-691560 (Linked Report).; Sender's Comments:  MOD-2022-691560:Original Case : MOD-2022-691256
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to 2 patients as their Primary dose on 21Dec2022).    No concomitant medication information was provided. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication were provided.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal
Clinical narrative: feeling a bit under the weather; feeling wiped out; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling a bit under the weather) and FATIGUE (feeling wiped out) in a 74-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced FEELING ABNORMAL (feeling a bit under the weather) and FATIGUE (feeling wiped out). In December 2022, FATIGUE (feeling wiped out) had resolved. At the time of the report, FEELING ABNORMAL (feeling a bit under the weather) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: His temperature is 96.8.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient explained that he was super fit and had done sports all his life. People won't believe him when he told them he was 74. It was reported that the patient felt wiped out for first few days after the bivalent booster dose.   No treatment drug information was provided.   This case was linked to MOD-2022-691929 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: have covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (have covid) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (have covid). At the time of the report, COVID-19 (have covid) outcome was unknown.            No concomitant medications were reported. Patient got product (Paxlovid) and a little worried because had two Moderna Booster shot (COVID-19 Vaccine). Patient just wanted to find out that (Paxlovid) safe to take over that (Moderna COVID-19 Vaccine). Did not take these tablets at all. Had the Medication (Paxlovid) besides but had not taken.