chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4062321-00) via a contactable consumer (patient). A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date was not reported) via intramuscular route of administration on 16Mar2021 (at the age of 43-years-old) as DOSE 1, SINGLE, second dose (Batch/Lot number was not reported, expiry date was not reported) via intramuscular route of administration on 08Apr2021 as DOSE 2, SINGLE for covid-19 immunisation and adalimumab (HUMIRA, formulation: solution for injection in pre-filled pen) via subcutaneous route from Apr2021 and ongoing, at unspecified dose for an unspecified indication. The patient's medical history and the concomitant medications were not reported. On 25Aug2021, the patient experienced covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: experienced covid-19 on 25Aug2021. The outcome for the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The reporter's assessment of the causal relationship of the events (vaccination failure & COVID-19) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Erythema and induration measuring 15 1/2cm x 15 1/2cm over right deltoid at Hep B injection site. pruritis and pain noted superficially.
Incontinent X 2 the night of vaccine (unusual). On 2/13/01, had sore throat and night sweats but no fever. On 2/14/01, talked in sleep, restless, sweaty and headache. On 2/15/01, pallor and decreased appetite. No pain.
A report has been received from a Study Investigator concerning a 15 year old, Female subject, Height: 65.0 inches; Weight: 173.0 Pounds, enrolled in study MA-VA-MEDI3250-1115; A Post Marketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age. No relevant history was reported. The patient did not receive any concomitant medications. The study therapy was started on an unknown date for influenza. The date of last menstrual period was 27-May-2013. The patient experienced undesired pregnancy which was started on 27-May-2013. The estimated date of delivery was unknown. The outcome of the pregnancy was reported to be elective abortion which occurred on 23-Oct-2013. The number of weeks at outcome of pregnancy was 21. The report was considered to be non-serious. The study investigator considered that there was no causal relationship between pregnancy and study therapy.
no adverse event; 3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator for the 3 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator for the 3 patients.) 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. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2023, 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 20-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator for the 3 patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator for the 3 patients.) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (3 doses of the bivalent booster were administered 32 days after being stored in the refrigerator for the 3 patients.).    No concomitant medications were reported. Beyond use date was reported as 18-Jan-2023. It was stated that there were no adverse events reported by the patient. No treatment information was provided. This case belongs to 2 of 3 patients described by the reporter.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of GARDASIL 9 Lot # L020015, expiry date 16-AUG-2017 (dose and administration route were not reported) that had been exposed a 34 degree F for less than 30 minutes, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Throat felt like it was closing - has asthma - pt took 2 puffs.
Brain fog, tiredness, sleeplessness, loss of appetite, lethargic, thirst, joint pain
11/9/19 Patient woke up with a very swollen and red right thigh. He had a hard nodule under his skin at the injection site. He proceeded to develop a rash on his leg as well as on his face on the right side. THe rash began to worsen and progress. Over the course of the weeken the rash spread to his abdomen, chest, neck, both sides of his face, head and feet and legs. He began having sever gi symptoms, repeated vomiting, diarhea which caused him to fail to gain weight appropriately as this progressed for several weeks. We brought patient to Dr. several times for the rash, gastrointstinal issues. He also had extreme head pain. We thought he had an ear infection as he woke up out of a sleep several times screaming uncontrollablu holding his head. The doctor ruled out ear infection. We were referred to a dermatologis which we saw. This was scheduled by the pediatricians office. The dermatologist confirmed the the rash was due to a vaccine reaction and said to hold off on further vaccinating at this time until he is older and can verbalize symptoms as well as has a stronger immune system. He said the next reaction could result in the need for prednisone and could be anaphalactic or worse. That some children are not able to handle the vaccines and that we should consider the benefits/reactions and decide if it is worth continuing especially considering a family history of vaccine reactions on both sides of our family. In addition to this patient developed a terrible cough, respiratory distress and congestion. THis began within a week of the vaccines. He was tested for RSV twice which was negative. He has continuously treated with saline, beudesonide and albuterol nebulizer treatments. The cough persists as well as the congestion. He has not fully recovered at this point but the pediatrician does not accept patients who do not vaccinate. We are reluctant to move forward as he is not recovered and shows signs of genetic inability to process vaccinations safely. Has developed heart murmur from increased respiratory distress according to cardiologist - 12/31/19
Information has been received from a registered nurse referring to some patients of unknown age and gender. On unknown dates the patients were vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route were unknown) which exposed to 8F. No adverse effects were reported. Additional information has been requested.
Moderna Monovalent COVID-19 vaccine administered to patients after from 09/01/2022 to 09/12/2022. Will include patient information with report.  No adverse reactions reported.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna Vaccines on 1/30/2021, 2/28/2021 and 9/16/2021. Presented to OSH tacypneic w/acute hypoxic resp failure  w/known diagnosis of COVID-19 and recent onset of sxs 48 hrs. prior. Req'd 100% O2 via NRB. Tachycardic to 150 transferred to Med Ctr for further management. Admitted to ICU profoundly hypoxic requiring NIPPV immediately followed by intubation. Developed PEA arrest at 7am while CPR was in progress he was transitioned to DNR/COT per family's wishes. Tx'd with solumedrol, ceftriaxone, and azithromycin. Expired on 6/23/22.
Client went out to lobby and became very dizzy and ran into the wall. Check heart, blood pressure and lungs, gave H2O and some food.
Hives on face, ear,and back as first took 2 benadryl didn't help at all spread to arms and chest took 2 more benadryl pills 4 hours later.  Didn't go away until the early am after taking a 3rd dose of benadryl.
During observation period patient reported tingling feeling in lips which progressed to her tongue.  She also was not sure if she had trouble breathing or if she was just feeling anxious.  Gave her 50mg of oral Benadryl, administered an Epipen and called 911.  Paramedics responded and took her to E.R. where she remained under observation for a few hours before being released with a prescription for Epipen.  When paramedics evaluated her they said her condition appeared to be normal.  Hospital instructed her to return if allergic symptoms returned.
Case number PHEH2012US010776 is an initial spontaneous report received from pharmacist on 23 May 2012: This case refers to 45 years old female patient. The patient received MENVEO (batch number: 024011) intramuscularly on 22 May 2012. No adverse reactions occurred since administration.
Tested positive after all; Tested positive after all; This is a spontaneous report received from a contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and cough and tested positive after all in 2021. He stated that it's been 3 months he never got the 2nd dose of the vaccine. Right now, he wanted to know if he can get the 2nd dose and is it safe after all. The outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021480462 Same patient and product, different dose
I lost some of my hearing after being vaccinated and now I'm constantly having ringing in my left ear.
Enlarged left supraclavicular lymph node. I noticed it 8 days post-vaccine. It remained very enlarged for about 6 weeks and then began to decrease in size. It is now still enlarged but much smaller than before.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT DID NOT DISCLOSE SHE HAS A BLOOD/NEEDLE PHOBIA AND USUALLY PASSES OUT AFTER A SHOT. BOYFRIEND WAS ALSO AWARE OF THIS CONDITION AND DID NOT DISCLOSE TO RPH OR TECHNICIAN
about 20 minutes after getting the shot patient got intense tingling of mouth, tongue, lips. Lasted about 30 minutes. No difficulty breathing, no swelling noted anywhere. No residual effects.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 33-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of a 33-year-old, female patient who was administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Patient reports that symptoms began around 6:00 pm after eating. States that her tongue and throat feel like they are tingling and feel numb. Does not report having trouble breathing or any noticeable change or swelling to her throat or tongue. Pt is currently being watched by husband and reports taking a Benadryl as recommended by the other pharmacist on duty tonight. Pt instructed to seek medical attention (go to ER) if symptoms worsen or breathing trouble occurs.
05/10/2022 fatigue, body aches; dizziness; headache. On 05/13/2022 I had severe headaches and my stomach started feeling upset at the point that I was unable to eat anything. I had diarrhea  from 05/14/2022- 05/22/2022.  I even took laxatives  over the counter to reduce stomach upset stomach issues . My diarrhea  stopped on 05/14/2022 but I  didn't go to the bathroom for  about 1 week. on 02/28/2022 I had severe pain in  my stomach  and it continued till 05/31/2022  and dispensed. I went to the hospital on 05/31/2022. They did CT scan  and found tumor in my abdomen and told me to contact my regular PCP.  I contact my doctor the next day and  visited him on 06/02/2022.  My doctor said that I will need surgery if my stomach pain continued.  I was still having pain so I went to the ER on 06/05/2022 I was feeling dizzy and   had severe pain. They did surgery on me on the 06/06/2022 and 06/07/2022 I got result from the pathologist and  it turned out to be mentalistic cancer.  I will be needing chemotherapy soon.
This spontaneous report was received from a physician assistant via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 milliliter (reported as standard) of ZOSTAVAX (lot number, expiry date and route unspecified).No concomitant medications were reported. Approximately on an unknown date in April 2013 (reported as approximately with the last month), the patient developed a rash after receiving ZOSTAVAX. The patient sought medical attention at a local urgent care. It was unspecified if any treatment was given or if any lab tests were performed. The outcome of rash was unknown. The relatedness for rash was unknown for ZOSTAVAX. Additional information is not expected.
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 14th of 24 patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Patient age was between 6 months to 5 years.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Adult was given Infanrix; Adult was given Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 21-SEP-2022 Reporter's Comment: The nurse practitioner reported that the patient accidentally received Infanrix instead of Boostrix. At the time of reporting, the health care professional did not had the date of birth or lot/expiry but did stated or confirmed it was an adult patient. The reporter did not want the information stored in GlaxoSmithKline database but agreed to follow up by safety.  The reporter consented to follow up by email. HCP's contact information emailed to safety. Additional Supportive Information: An adult patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Patient reported swelling, redness, and pain at injection site and large portion of upper left arm. Symptoms started 2 to 3 hours after receiving vaccination, and patient still has mild redness and swelling. She says she took BUFFERIN to treat. She came to pharmacy on 10/20 to report, had not previously called.
Triggered arthritic flareup.  .  It caused inflamed right hip enough to jam the nerves in the right leg.  Taking 2 anti-inflamatory drugs and treating for pain.
pt noted onset of itching about one day after vaccine and then developed hives which lasted 10 days
Migraine, nausea and vomiting, low grade fever and headache. That resulted in tachycardia because I could not keep my medications down. This was similar to the reaction I had to flu vaccine. Migraine was intractable and I couldn't get rid of with medications I had on hand. It started on the 4th and I went to ER on 12th. I ended up getting dehydrated. I had a heart rate of 170's. After lab work was done, my troponin - they said it doubled while I was in the ER - but it was never out of range. But because it doubled, they admitted me to hospital to keep it from going up. I was given 2 liters of normal saline to hydrate. was given multiple medications. I had continuing  saline IVs through admission. My troponins did not keep going up. The prolonged QT was due to anti-nausea meds I had been taking at home. My QT returned to normal after hydration and Oral Metoprolol 100 mg given in the ER. Myocardia ischemia - They consulted with cardiologist - he said that they would do a echo-cardiogram if the Troponin kept going higher. But since my symptoms resolved that I didn't have to have that done. Also was given in the Hospital, Ativan, Toradol; Dilatid; Benadryl and Reglan while in the hospital. Mild carditis - from COVID vaccination - I wasn't diagnosed with it - but it's a concern. Currently, I have normal Tachycardia that still happens with me. I have shortness of breath sometimes - but that correlated with low blood pressure while standing but that can go with the POTTS.
high fever/ranging from 100.4F-104.4F; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that the patient has had a high fever since the vaccine dose on 27Jan2021, ranging from 100.4F-104.4F. She stated she is taking Tylenol for it and wants to know what else to do. The outcome of the event was unknown. The event was reported as non-serious.  Information on the lot/Batch number has been requested.
Information has been received from a health professional concerning a 19 week old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq vaccine (human-bovine) (lot#"08475 or possibility 08475") on 14-NOV-2006 and 16-JAN-2007, respectively. Concomitant vaccinations administered on 16-JAN-2007 included a dose Pediarix vaccine, a dose of Hib conj vaccine, a dose of Prevnar. Concomitant medication included Axid. On 29-JAN-2007 the patient came into the office cranky and would not take a bottle. The patient was transferred to the hospital on the same day and was admitted for intussusception. At the time of the report the reporter did not have any details about the patient's hospital course or any treatments. No product quality complaint was involved. No other information was provided. Additional information has been requested.   2/9/07 Received info from CDC that patient had symptoms of intermittent pain and lethargy on 1/29/07 with subsequent currant jelly stool.  Barium enema was diagnostic and therapeutic.  Child was observed overnight and discharged.  No specimens available.