chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    The case was reported for 51st patient out of 77 adult patients who had received the bivalent booster dose as reported by the reporter. No concomitant medication was provided. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient was administered diluent for ACT HIB vaccine only without reconstitution of HIB vaccine, but telephone call to mother to advise of error.  Mother noted child with no adverse reaction per reporter.
Product administered to patient of inappropriate age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Acne on 09-Nov-2020, Asthma on 25-Sep-2018 and ADHD on 10-May-2018. Concurrent medical conditions included Allergic reaction to antibiotics (Amoxicillin), Allergic reaction to antibiotics (Rocephin), Allergic rhinitis due to pollen on 17-May-2021 and Environmental allergy since 10-May-2018. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 17-May-2021 to an unknown date for Allergy, FLUTICASONE from 11-Oct-2017 to an unknown date for Allergy and Asthma.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine). On 15-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Medical history, Patient race information, Concomitant drugs and route of administration was provided.
fever; chills; slight nausea; ache; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, nausea, pain and headache. On an unknown date, the outcome of the fever, chills, nausea, pain and headache were unknown.   It was unknown if the reporter considered the fever, chills, nausea, pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix within a 5 month time frame. The patient experienced fever, chills, slight nausea, and ache and asked for what to take for headache.
No adverse event; Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date; his spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter.  Patients administered Moderna vaccine monovalent beyond the 30 day beyond use date. Batch number 053C21A (BUD- 01Jul2021). No treatment information was provided.
Woke the during the night on 07/04/2019-07/05/2019 with nightmares and a fever of 105.  Mother tried to give him Tylenol but he vomited right after taking it.  Called the Dr office the next morning, 07/05/2019, and they could see him at 3 pm.  Mother then called us at 10:35 am.  Stated he still had a fever at that time of 103 and vomited and unable to keep any medicine down.  Encouraged her to take him to the ER for an evaluation.  Was given Zofran and then able to keep Tylenol down.  Mother states by 6pm that evening he was better and didn't have any more fevers or vomiting.
Red swelling and soreness at the site of injection a few hours after injection. Swelling increasing to 2 inches in 24hrs. In 48 hrs redness and swelling is 3.5 inches at the time of reporting. Soreness at site of injection and warm. Fever 36 hours post injection subsequently subsided.  Took benadryl at 36 and 48 hrs post injection and ibuprofin 24 hrs post injection.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient asked was it normal for the whole arm to be sore. Additional supportive information:  Follow up would not possible, as no contact details were available.
pt recv vax 23JAN98 & 26JAN98 called c/o rt arm pain w/movement (no signs of infect) lasting few weeks;dec strength cont;slowly improving;pain @ deltoid, some pain & tingling in fingers earlier but not now;
Caller stated that some of the vaccines have been administered since the temperature excursion; No additional AE reported; This spontaneous report was received from a medical assisstant concerning an unknown number of patients of unknown age and gender.   The patients' concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, there was a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and hepatitis a vaccine, inactivated (VAQTA) vaccines (11 Celcius degrees for 1 hour and 27 minutes). On unknown dates, some of those vaccines were administered to an unknown number of patients (dose, route of administration, lot #, and expiration date were not reported for any of the reported vaccines) for prophylaxis (product storage error). The reporter was unsure of which vaccines were administered. It was reporter that there was no previous excursion. No aditional adverse events were reported.  This case was considered non-valid due to lack of patients' identifiers.
Bloodshot eyes, tearing, eyes felt like sand was in them, raspy voice, cough. Patient was treated in the ER, was given meds and sent home.
extreme tiredeness, headache, body aches, dizzy, brain fog. worst 2  and 3 days after second dose. First dose had very little side effects.
I felt like I was going to pass out faint my blood pressure was really low. My vision was tunnel like with no peripheral vision. My friends who are nurses could not get a reading for 15 minutes. I felt like I was in shock.
To ED c/o body aches, 101 fever, SOB; tx: Levaquin, Lovenox, Singulair, Zinc, CXR negative for pneumonia, did not qualify for remdesivir or steroid tx, no O2 required. Tx'd for CHF and then D/c home
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number unspecified patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB injection (lot number not provided) (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakness. It lasted about 4 hours, from 9am to 1:15pm.
Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; Night of 2nd dose: chest pain, muscle painSince then I've had paplitations and chest pain daily; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E23248) via intramuscular, administered in Arm Right on 21Jan2021 15:00 (at the age of 28-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, fluticasone, ibuprofen all these taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had no known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E10142) via intramuscular, administered in Arm Left on 31Dec2020 11:00 (at the age of 28-year-old) as DOSE 1, SINGLE for covid-19 immunisation. On 21Jan2021 22:00 the patient experienced night of 2nd dose: chest pain, muscle pain since then I've had palpitations and chest pain daily. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the resulted events. The clinical outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
She received her flu shot at the workplace clinic with her family. Upon returning to her house with her family, she was staring at the cupboards in their kitchen. Her dad asked her what she was doing and then she passed out. She was laid to the ground by her father. She was sweating and then awoke. She did have a 99.3 fever after this event. They called and talked to, the ARNP at the Clinic about this occurrence. She stated to just watch her. The next day she was back to her self again. She did pass out after her vaccination last year also and a VAERS was submitted for that incident also.
Gout flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown", described as "Gout flare up". Therapeutic measures were taken as a result of gout.  Additional information: The reporter stated that since he got his first dose of the Pfizer COIVD-19 vaccine he has been put on Prednisone for a Gout flare up and he is due to get his second dose of the Pfizer COVID-19 vaccine on 06Oct2021 but Thursday was his last day to be on the Prednisone. He was wondering if he should wait to be off the prednisone before getting his second dose. He spoke to 2-3 different pharmacies and he was given different answers.  The lot number for bnt162b2 was not provided and will be requested during follow up.
received 2 vaccines on July 24, 2021 / found out 2 weeks ago that  she is 6 weeks pregnant; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis.   On 24th July 2021, the patient received HPV vaccine and Tetanus vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received HPV vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving HPV vaccine and Tetanus vaccine, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.  Additional case details were reported as follows: The case was reported by the patient. The patient received 2 vaccines on 24th July 2021. She could not remember the names of the vaccines but stated one was for HPV and the other for tetanus.  She found out 2 weeks before the date of reporting that she was 6 weeks pregnant.
Pfizer 3/18/21, 5/6/21. Positive on 8/31
This case involves Adult and unknown gender patient who caught the flu few weeks after sick as a dog for 2 weeks after, while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event, "caught the flu few weeks after sick as a dog for 2 weeks after" (influenza) (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported, " I got a flu shot about 30 years ago, caught the flu few weeks after sick as a dog for 2 weeks after,,,, haven't had a flu shot since and haven't had the flu either." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (caught the flu few weeks after sick as a dog for 2 weeks afte, caught the flu few weeks after sick as a dog for 2 weeks after). At time of reporting, the outcome was Unknown for the event caught the flu few weeks after sick as a dog for 2 weeks afte and was Unknown for the event caught the flu few weeks after sick as a dog for 2 weeks after.
Pt got red sensitive rash with bumps (not open blisters). Site: Right Vastus lateralis. Size 30 mm diameter. Denied fever. Onset 10 days after vaccination.
pt recvd vax & p/2nd dose c/o bones hurting, achey feeling;
Fainting, ~5 minutes after getting out of bed in the morning. Collapsed to floor. Recovered after a few minutes in prone position. Minor injuries caused by fall.
Two nurses checked vaccine record and identified vaccines due. Initially planned to give IPV and PEDIARIX (charge), then realized PENTACEL indicated instead (VFC). IPV already planned and subsequently given. Client received PENTACEL and IPV.
Patient became distant and stopped responding to his name within days after receiving the MMR vaccination on 05/17/1999. He gradually became more and more withdrawn and stopped associating with parents and siblings.  We had his hearing tested in the fall of 1999 which came back normal. He was tested by the state and qualified for special education services.  He is currently special ed. under the label of autism, severe.  We believe that Patient was permanently disabled by the vaccine/s that were administered to him by his health care provider.  06/19/2007 MR received from diagnosing psychologist for OVs in Aug. and Sept. 2000.  Child meets criteria for a Pervasive Developmental disorder, most likely Autism. Child has significant delays in expressive language, difficulty in establishing and maintaining eye contact, displays impairment of social interaction, engages in repetitive motions, and inappropriate actions such as eating non-food items.  07/02/2007 MR received from PCP.  Normal growth and development noted until 9/21/1999 OV with concerns about speech/hearing noted. Autism ? Public school eval 11/11/1999. Next visit 2/21/2000 with note of no spontaneous speech although seems to hear-comprehend (?).  Refered to Pediatric and Medical Genetic Specialist with eval 2/23/2000 showing significant speech delay and mild dysmorphia.  Hand flapping noted as ? autistic behavior. MR also received from 2nd PCP with initial visit of 1/12/2001 for opinion on child's dx of Autism with F/Us until 3/2005. 02/02/2010 He is autistic- a life long disability we feel the MMR triggered.  Follow-up: We firmly believe that the MMR vaccination directly contributed to patient developing autism. The marked difference in him 24-48 hrs after the MMR was profound - not responding to his name, going off by himself and stimming were now patient. We stand by this assessment.
Dizziness, dry mouth, rapid heart  within 3-4 hours after injection Low grade headache on going
5ml syringes that had been provided by Oregon Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.3ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Pt became unresponsive 5-10 minutes after receiving both vaccines. Pt's breathing also stopped. Epipen 0.3 mg was administered and pt became responsive again and dizzy. Paramedics were called and arrived then pt began to vomit and was taken to ER by ambulance.
pt cried cont for 305PM to 730PM on 27SEP93 & the crying was high pitched;
Back pain; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and COVID-19 (Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain) and COVID-19 (Covid-19). At the time of the report, BACK PAIN (Back pain) had not resolved and COVID-19 (Covid-19) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Pain at injection site beginning immediately after receiving the vaccine..  Headache, fatigue, body aches, chills beginning overnight.  Took OTC Motrin at 7PM with improvement of symptoms.  Symptoms currently still occurring.
8 days after my injection I have a large red raised, warm circle on the same arm I received my injection. It hurts a little and itches sometimes.
On the January 24th, I started to tingle all over. I went to the doctors about it. They gave me a muscle relaxer. Then I went to another doctor, and he gave me Gabapentin. They did MRI, X-rays, and nerve condition. They told me that I have Tendonitis. But they are unsure what is causing the tingling feelings.
Patient came in to clinic the morning of July 18th 2014 with cc of redness on right thigh. Patient had dollar sized red raised rash on upper right thigh in the area where the vaccine was given. Child did c/o some itchy. No pain or tenderness, no fever noted per mother.
I went running one morning and called 911 after falling out and experiencing extremely fast heart beats. My heart was literally racing, and that's never happened before. The EMT came and took me the hospital and told me I had tachycardia. They ran cardiac enzymes to test and ensure I wasn't having a heart attack. The doctor then prescribed me beta blockers to continue monitoring me as I stayed overnight in the hospital. I had a follow-up appointment, they brought me back in to perform an echocardiogram, CT angiogram, and other tests to see how my heart was performing. All was well until months following when I received my booster dose in November, and following in January of this year 2022-- I experienced tachycardia and atrial fibrillation. I had a cardiology appointment coming soon to monitor the health of my heart.