chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported in a literature article and described the occurrence of polydactyly in a infant. The mother received Flu Seasonal QIV Dresden. The infant was exposed to Flu Seasonal QIV Dresden during the third trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with polydactyly. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of polydactyly was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the polydactyly may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of polydactyly in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during the third trimester of pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVS) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero during the 3rd trimester of pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed polydactyly. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between polydactyly and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
After receiving 2nd dose client reported feeling anxious and that he was having difficulty breathing, and feeling faint. Then he loss consciousness and found himself on the ground not knowing how he got there.  He also reported having tingling and weakness in his legs. His left leg was on brace due to a surfing injury
new onset atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 31Mar2021 at 13:00 (Batch/Lot Number: en6208) (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. The vaccination facility type was hospital. Medical history included supraventricular tachycardia (SVT), and stroke in 2013. The patient has no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient took other medications in two weeks which included Aspirin 81mg, and One-a-day multivitamin. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient experienced a new onset atrial fibrillation on 14Apr2021 and was hospitalized on 14Apr2021 (for one day). The adverse event (AE) resulted in Emergency room/department or urgent care/hospitalization. The patient received treatment which included a medication to convert to sinus rhythm. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist. He stated he had unspecified number of doses of ZOSTAVAX which had been exposed to 70F for 18 hours. The pharmacist declined to provide lot numbers and expiration dates for doses to be evaluated. It was unclear as to whether or not doses were administered to patients after exposure. This is one of several reports from the same source. Additional information is not expected.
Symptoms started during bedtime and woke me up. Began with severe full body chills and full body muscle shaking and weakness during the night of 1/5 and early morning of 1/6, around 1000 to 0200. Slight headache began during that time as well.   Upon waking at 0900 on 1/6, chills and shaking decreased to mild severity, muscles still felt moderately weak and shaky, headache had increased in severity to a severe throbbing pain that worsened upon standing and walking, and moderate visual photosensitivity began. The headache persisted until I took 2 tablets of ibuprofen 200 mg, which is when the severity decreased to moderate after a few hours and then mild by bedtime. The photosensitivity persisted through the day and did not decrease much by bedtime.   Upon waking 1/7, there was only a mild headache and mild photosensitivity that faded completely within a few hours, no medication required. No more symptoms in the afternoon.
Rheumatoid arthritis flare up; Injection site bleeding; Pain during injection; Arthralgia aggravated; Pain aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4463646-00.  A 71-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Injection site bleeding"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain during injection"; ARTHRALGIA (non-serious), outcome "recovering", described as "Arthralgia aggravated"; PAIN (non-serious), outcome "recovering", described as "Pain aggravated". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "injection site bleeding", "pain during injection", "arthralgia aggravated" and "pain aggravated" related to BNT162b2.  Additional information: The reporter's causality for the event(s) of sometimes there was a drop of blood at the injection site/had more than a drop of blood/had bleeding more than before and rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of sharp pain/pain during injection, having more pain to knee and hand than normally right after an injection/increased symptoms compared to normal post injection days unknown onset and having more pain to knee and hand than normally right after an injection/increased symptoms compared to normal post injection days unknown onset was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient given pfizer covid vaccine formulation for 12 and up when they should have been given the 5 to 11 formulation.  Patient is aware of the error. Weight in within adult weight range. Parent has been advised to call if patient has any symptoms. As of 5/26/22, parent has called to inform us that patient just felts fatigued and worn out but nothing unexpected of typical vaccination side effects.
Stroke; Passed out; Was flailing like a fish; Could not walk; lost motor skills and had to be fed; Could not speak; Did not understand where he was; was in La La land; A spontaneous report was received from a consumer concerning his father a 83 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke, passed out, was flailing like a fish, was in la la land for many day, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound.  The patient's medical history, as provided by the reporter, included blindness in one and lost some hearing. Concomitant medications reported included diazepam, bisacodyl and oxycodone.  On 12 Feb 2021, approximately three days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (batch 013m20a) via unknown route for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. No tests were done, and it was previously agreed that he would not go to the hospital if anything should happen to him. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, he lost his motor skills and had to be fed, was considered resolving. The outcome of the events, stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he could not speak, did not understand where he was and he was wheelchair bound were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
88 year old vaccinated male resident was admitted for a fib with RVR. He also tested (+) for Covid-19. He was treated with Remdesivir. Rate became controlled. D dimer is elevated but he is already on NOAC. He will be transferred back to the nursing home today.
same side effects as the first dose came back; developed a skin rash that was swollen; developed a skin rash that was swollen; fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees). At the time of the report, VACCINATION COMPLICATION (same side effects as the first dose came back), SKIN SWELLING (developed a skin rash that was swollen), RASH (developed a skin rash that was swollen) and PYREXIA (fever of 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 99 f (High) had a fever of 99 degrees.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Vaccine error - asymptomatic 48 hours after. Immunization for flu shot (unknown type/brand) was given at PCP office 10/13/23 and a 2nd (SECOND) flu shot (fluzone quadrivalent) was given at pharmacy. Individual was present for Covid 2023 series shot.  No clinical symptoms presentation at this time, assessed by RN Case manager on evening of 10/30/23,  provider notified via phone, did not request office visit as individual asymptomatic will continue to monitor.
Left deltoid swelling and redness 4cm x 8cm area. blanchable. Will have f/u.
After receiving the vaccine the patient applied pressure to the injection site and the vaccine expelled from the wheel. The dose was repeated and was successful. No physical adverse events occurred.
When giving the injection, patient immediately felt pain which she stated spread down her arm to her hand and felt tingly. She was still able to move her hand, but the pain/tingly feeling persisted for about 20 minutes or so while in the store.  I called her back to follow up about 3 and a half hour later and she said her arm is feeling much better from before.  She still has some pain/tingly feeling remaining, but much less than a few hours prior.
Anaphylactic reaction; This is a serious spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Merck) on 14-Feb-2019, concerning a female patient of unspecified age.  On an unspecified date (reported as about 10 years ago), the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced an anaphylactic reaction.  At the time of the report, the outcome of the event was not reported.; Reporter's Comments: A female patient of unspecified age experienced anaphylactic reaction, unspecified period of time after receipt of INN Flu vaccine seasonal. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Despite the lack of temporal relationship, considering the plausible biological mechanism and acute presentation of the event, the causal role of suspect vaccine cannot be ruled out. Hence, causality of anaphylactic reaction assessed as related to suspect vaccine. The company assessed the event (anaphylactic reaction) as serious (medically significant).
PATIENT GIVEN EXPIRED PRIVATE PAY HEPATITIS A (PED) VACCINE TODAY; VACCINE EXPIRED ON 2/3/23, BUT WAS NOT TAKEN OUT OF THE FRIDGE WHEN EXPIRED;  TOLD PARENT THAT CHILD RECEIVED EXPIRED HEP A VACCINE.  PER IMMUNIZE, PATIENT OK TO RECEIVE ANOTHER DOSE OF HEP A VACCINE TODAY.  PARENT CONSENTED TO ANOTHER DOSE OF HEP A VACCINE.  CHECKED HEP A VACCINE LOT AND EXP DATE; PATIENT GIVEN NEW DOSE OF HEP A VACCINE.  PATIENT AND PARENT HAVING NO COMPLAINTS; PATIENT ORIENTED AND WALKED OUT OF CLINIC WITH STEADY GAIT;
within a few days my aunts parkinsons symptoms became so much worse. we contacted her neuro dr who said that if she had exp a fever or muscle pains after vaccination this was a temp issue. she is now at a month past first vaccine and still exp parkinsons symptoms that are far worse than before vaccination. such as "off times" meaning her parkinsons med will not stop the tremors and as of this past week she is exp parkinsons induced hallucinations. her general parkinsons health has gone down hill in last month. she was diag over 6 years ago and has maintained the same level of health since then.  she decided to not take the second vaccine bc she couldnt handle worse parkinsons symptoms.
The patient's mother reports that "vaccine appeared to be leaking out of the site"; The patient's mother reports that "vaccine appeared to be leaking out of the site"; The patient's mother reports that "vaccine appeared to be leaking out of the site"; blood coming out of the vaccination site; This is a spontaneous report from a contactable pharmacist reported for a 12-year-old female patient (NCSP: 159558). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, Batch/Lot Number: Not provided, Expiration Date: Not provided) via an unspecified route of administration on 02Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient's mother reports that vaccine appeared to be leaking out of the site, reporter stated that mother saw blood coming out of the vaccination site and she felt that all of the vaccine oozed out of the injection site and hours later brought it to our attention that patient mother was concerned that the patient was not adequately vaccinated. The vaccinator believes the dose to be adequate. Mother had a couple daughters receive their COVID-19 Vaccine. After administration, mother called back regarding one of her daughters stating the vaccine is coming out of the site, it is leaking out. Mother is concerned the daughter may not have received the full dose. Confirmed only one of the daughters experienced the vaccine leaking out of the site. Clarified there is only one patient, a 12-year-old female. Person who administered the vaccine is completely trustworthy. The administrator had the perception that there was a bubble to start with, then it bled. Reporter was thinking the mother is confusing serous fluid at the injection site with the vaccine contents. Mother claims the daughter's injection site did not bleed. Reporter stated they had the tissue from this patient showing there was blood. However, reporter also said, "when you vaccinate 20 people a day, how do you know who the tissue belongs to." Reporter doesn't see this as a safety concern and declines report. The reporter would like to know how to proceed: re-administer the entire series, or continue with the second dose? Response from Pfizer included pfizer cannot make individual treatment recommendations. The clinical outcome of all the events were unknown.  Follow-up attempts are completed. No further information is expected.
received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting.  EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE.  I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.
This spontaneous report was received from a certified medical assistant refers to an 68-year-old female patient. Current conditions included asthma, hyperlipidemia, gastric carcinoma, type 2 diabetes, allergy to MACRODANTIN, sulfacetamide sodium, SULFA GLUCOPHAGE and ASPIRIN. On 29-OCT-2012 the patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot # reported as H016230, expiration date 20-NOV-2013) subcutaneously. Concomitant medications included SEREVENT, FLOVENT, FLONASE, vitamins (unspecified), ALLEGRA and ALBUTEROL. Medical assistant reported that a patient who received ZOSTAVAX had developed pain on the right side of her body. She had pain near her breast area and rib area. Sometimes the pain was sharp and sometimes the pain was dull. The patient said the pain was a "10" on a scale of one to ten when the pain was sharp. The [patient said the pain is a "1" on a scale of one to ten when the pain was dull. Movement and coughing sometimes increased the pain. The physician then got on the phone to report that the patient seemed to have pain and neuropathy that goes from the breast and rib area and wraps around towards the patient's back. The pain did not cross the midsection. There was no rash. No other details. No treatment was given for the events. No lab studies were performed. The events did not resolve at the time of this report. The patient sought medical attention, the patient was in the office at the time of this report. The medical assistant had also mentioned that the patient experienced a fever when she received PNEUMOVAX23 on 11-NOV-2005 (MARRS # 1211USA006088). Additional information has been requested.
Immediately after receiving HPV 9 vaccine in right bicep patient became unconscious. He had already received MENACTRA and Hep A about 5 minutes earlier without incident.
I had a chemical sensitivity & an allergy to mold.; I had a chemical sensitivity & an allergy to mold.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220127000915 (Sanofi).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Cough" (unspecified if ongoing); "chest tightness" (unspecified if ongoing); "SOB" (unspecified if ongoing), notes: SOB. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: ALLERGY TO CHEMICALS (non-serious), MYCOTIC ALLERGY (non-serious) all with onset 15May2021, outcome "unknown" and all described as "I had a chemical sensitivity & an allergy to mold.".  Additional information: The patient had been taking DPXT since Jun2021 for asthma , reported over last month having cough, chest tightness and SOB and using my recue INH more than 2X/WK over the last month, its usually been better or about the same since taking DPXT but it has not got worse. The patient got the Pfizer Covid vaccine for 1st two doss and the Moderna vaccine for the booster in Dec2021 and it temporarily made him asthma symptoms worse. Ten days after 2nd Covid vaccine dose on 05May2021 the patient had chemical sensitivity and an allergy to mold  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (14Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.