chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever (24 hours) Dizziness Nausea  Chills Body ache
Not sure whether received full dose; Vaccinated way too high; Bleeding a lot; Extreme pain in her arm; Can't lift her arm; A spontaneous report was received from a 39-year-old, female nurse, who was also a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced not sure if she received the full dose, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient experienced not sure if she received the full dose, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift arm.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, not sure if she received the full dose and vaccination site was too high next to her shoulder bone were resolved on 08 Jan 2021. The  outcomes of the events, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm, were unknown.; Reporter's Comments: This spontaneous report refers to a case a 39-year-old patient who experienced events of incorrect dose administration, vaccination site too high next to her shoulder bone, bleeding at injection site and extreme pain in her arm that she was not able to lift her arm for mRNA-127 (Lot number 012L20A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events of bleeding at injection site and extreme pain in her arm that she was not able to lift her arm and vaccine administration cannot be excluded. The other events of vaccinated way too high and incomplete dose administered are assessed as not applicable
when I was diagnosed I had nasal congestion and soon after I had severe sore throat, headache neck and back pain. I started coughing and experiencing shortness of breath. My daughter who is a doctor measured my oxygen drop to an 89 to a 88.  I still suffer from short of breath.  After two days she to me to get a infusion and it was regeneromes. In 36 hours after my oxygen went up and I felt better. The whole thing lasted about 4 days. I was a little fatigued.
Subsequent to receiving vax, pt developed an injection site reaction characterized by an area of redness, pain and swelling ranging in size from a half dollar to a softball.
Patient has severe (R) shoulder pain + limited mobility 1 day after injection treated with prednisone + VICODIN.
About 10 days after receiving vaccine had crusting in both eyes. That night had temor in both legs when lying down. Temors started progressing in body. About 14 days after vaccine had full body temor that night when lying still continues to have temors, most from waist down. Only occurring at night when lying down. Eyes continue to crust.
Our health department conducted a mass vaccination event on 4/3/21 where more than 1,000 people were vaccinated. Over the course of the 8 hr event there were 10 16&17 yo patients who received a first dose of Moderna vaccine. We have reported this to Moderna and they recommended we fill out a VAERS for each patient. We have spoken with the parents of each patient. There were no reported adverse effects and all of them are planning on getting their second shot of Moderna Vaccine.
Pt recvd MMR/HIB 7JAN92 & seen in clinic w/fever, vomiting, diarrhea 10JAN92; 13JAN92 was much improved; seen in clinic 6MAR92 w/ataxia, listlessness adm to hos 17MAR92 dx leukoencephalopathy
The 2nd day the valve on her heart was acting funny for 3 days and it was kinda scary; Her shoulder was barely sore at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in deltoid left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2003 (unspecified if ongoing), notes: lowered her medication because she changed her diet.; "Heart murmur" (unspecified if ongoing), notes: it was a slow heart and being young to keep a watch on it; "pregnancy" (unspecified if ongoing), notes: first kid at 15. The patient took concomitant medications. There were no additional vaccines administered on the same date of the suspect vaccine. There were no prior vaccinations (within 4 weeks) of the vaccine. There were no AE(s) following prior vaccinations. The following information was reported: CARDIAC VALVE DISEASE (medically significant) with onset Mar2021, outcome "recovered" (2021), described as "The 2nd day the valve on her heart was acting funny for 3 days and it was kinda scary"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Her shoulder was barely sore at all". The patient underwent the following laboratory tests and procedures: electrocardiogram: (2021) fine. Clinical course of events was further described as follows: On the 2nd day the valve on her heart was acting funny for 3 days. It was beneath her left breast and she could tell it was there and what is scary is that it didn't do it overnight, it was 3 days and subsided gradually. It started messing with her heart a little and it was not severe but she noticed it acting funny like sticking and it didn't feel normal and it was on and off. It did it for an hour straight and it would do it again. It was like a little tap on her heart and her doctor didn't force her to get the 2nd shot, it was up to her. The event did not require visit to Emergency Room or physician office. She waited and mentioned it to her doctor on 25Jun2021. Her heart suffered a little to help build immunity is how she is looking at it. Her symptoms have been gone since then and had to have been from the vaccine. She is scheduled to do one of the calcium tests.   The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.
Patient complained of chest pain within 15 minutes of vaccination, pain level 3/10.  Heavy breathing.  Called mgr/charge nurse.  Advised to call paramedics.  Pt did not appear to be in distress.  Paramedics arrived within 10 minutes.  Were not able to get BP because pt reportedly has low BP and difficult to measure.  HR=97  Bloodsugar=163 Paramedics took over.  Pt refused transport to ER.  (Pt is not alone, has 2 people living with her)
The pt experienced digestive system irregularities, malabsorption, diarrhea within weeks of vaccine. Loss of language, aloofness was also experienced within weeks of vaccine. 60 day follow-up states the pt has autism, leaky gut/gastrointestinal disorder.
Vomited Tuesday Sept 28; Nauseous; This is a spontaneous report from a contactable consumer. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Sep2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Sep2021 at 07:00, the patient vomited and was still nauseous at the time of report. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event vomited was resolved on 28Sep2021 and the event nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Administration of Pediarix with temperature excursion of 47.5 Fahrenheit/ 22 minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 01-AUG-2022 Reporter's Comments: The health Care Provider called and reported that 2 patients were vaccinated with vaccines that were exposed to a temperature excursion of 47.5 degree Fahrenheit for 22 minutes.  The patient reported on this AE Report by providing lot number and Expiry date of Pediarix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Pediarix which was went to temperature excursion of 47.5 degree Fahrenheit for 22 minutes, which led to incorrect storage of vaccine. This case was linked with US2022113810 reported by same reporter for different male patient received boostrix vaccine.; Sender's Comments:  US-GSK-US2022113810:Same reporter
Extreme Fatigue, Nausea, migratory joint pain, joint swelling, abnormal TSH,T3,T4, headaches
Serum sickness type reaction. 08/19/2003: Reporter now indicates there was no disability in this patient.
Diagnose with COVID after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnose with COVID after receiving the first dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced COVID-19 (Diagnose with COVID after receiving the first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnose with COVID after receiving the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information includes Blood Pressure Medication.
soreness of the shoulder; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient (wife) of unknown age that received bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at 09:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient had soreness of the shoulder after she received the vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
The Moderna COVID-19 booster shot (1st booster) was administered to the patient at around 2:15 PM on 5/5/22. Immediately after administration, the patient began to express feelings of dizziness and discomfort. Patient told me that he has had previous issues with vaccines, including dizziness and syncope. I sat with the patient and talked with him, asking questions to assess consciousness. The patient continued to express feelings of dizziness and discomfort, with no signs of allergic reaction, SOB, or anything concerning anaphylaxis. I offered the patient a bottle of water and he accepted the offer, so I had one of the pharmacy associates get the patient a water and notify store management. I continued to sit with the patient and monitor him for any changes of concern. After several minutes, the patient began to express concerns of itchiness in the facial area and chest area. At this point, I asked the patient if he was having any difficulty breathing and he said no. I asked a pharmacy associate to bring me a bottle of liquid Benadryl and asked the patient if he was willing to take Benadryl, as I suspected he was having a mild/moderate allergic reaction to the vaccine. Patient accepted and was given 25 mg of Benadryl (Diphenhydramine) PO and was monitored thereafter for roughly 30 minutes. Patient began to feel better after roughly 15 minutes of taking Benadryl, and did not want to be taken to the hospital for further evaluation. Patient was monitored and told that he is welcome to stay at the pharmacy for as long as he would like. After roughly 45 minutes, the patient said he was okay to leave and he left the pharmacy with his family member.
The adverse event undiluted Pfizer vaccine administered to client, at this time no reports of needed treats.
Extreme headache, body aches, nausea - unlike any I had ever experienced and that I can only describe as a chemical nausea meaning if I vomited, I don't think I would have felt any better.  Chills which I assume were from fever because I felt cold but I did not check my temperature as I felt too bad.  Injection site felt like someone had hit me in the arm with a baseball bat.  Totally uncontrollable shaking of entire body which I would describe as having an epileptic fit while being awake.
Mild sore arm; Severe back muscle spasms lasted about 36 hours also; This is a spontaneous report from a contactable consumer (patient).    A 56 years-old (non-pregnant) female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration at left arm on 17Mar2021 at 17.00 (at the age of 56 years) as dose 2, single for COVID-19 immunization. The patient medical history included asthma from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. The patient had seafood and environmental allergies. Prior to 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 4 weeks prior to the COVID vaccine. Concomitant medications included BUSPAR (buspirone hydrochloride) taken for unknown date, start and stop date were not reported, trazodone taken for unknown date, start and stop date were not reported, alprazolam taken for unknown date, start and stop date were not reported, PRISTIQ (desvenlafaxine succinate) taken for unknown date, start and stop date were not reported and losartan taken for unknown date, start and stop date were not reported (two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration at right arm on 24Feb2021 at 17.00 (at the age of 56 years) as dose 1, single for COVID-19 immunization and the patient experienced moderate sore arm, fatigue lasted for about 36 hours and chills for about 12 hours. On 17Mar2021, the patient experienced mild sore arm and severe back muscle spasms with lasted about 36 hours also. The patient called nurse and was advised to apply ice and take ibuprofen. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304436 same patient/drug, different dose/event
Low grade fever, blistering rash on arms, legs, chest, stomach, and back beginning 14 days after vaccination.
expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2021 at 1:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The vial  did not undergo any temperature excursions.  All vials were removed from freezer just prior to administration times.   This case was linked to MOD-2022-570980, MOD-2022-570985, MOD-2022-570968 (Patient Link).
Initially the area was sore for about two days after I got the shot, then the injection area began itching about 2 weeks after I got the shot,  then a big red  spot appeared in the area, it itched for about 2 days after I noticed it then slightly after that time....stopped itching and red spot left a week after I noticed it.
sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient is 81 year old with past medical history of CAD, A.Fib, CHF, Hypertension complicated by retinopathy, type 2 diabetes, obstructive sleep apnea, dyslipidemia, GERD, CVA in early and left carotid arterial stenosis, gout, calculus of kidney, Osteoarthritis of left knee joint, Hematuria, Degeneration of lumbar Intervertebral disc, memory lapses. Recent note said Patient passed away on 5.17 at hospital, heart complications. There were no other specific notes found. Patient received both doses of Pfizer COVID vaccine outside of the facility.
Chest pain and SOB Narrative: Patient received J&J COVID-19 vaccine on 4/1/21. About 6 days later, she developed a persistent headache, shortness of breath at rest, chest pain, and palpitations. Patient was sent to the local ED on day 13
Pt experienced malaise, sibjective fever, chills, headaches, and myalgias following vaccination then on 4/11 (3 days post vaccine) experienced sharp chest pains radiating up left side of neck and down bilateral arms. Pt presented to urgent care clinic where EMS was activated for transport to the Emergency Department. Pt was evaluated for STEMI by cardiologist in the ED, cath lab was not recommended and pt was admitted for ealuation of possible myocarditis.
Rach on (L) upper arm starting approximately 24 hrs after vaccine - treated for possible cellulitis w/clindamycin.
The patient developed a febrile seizure on 6/6/2021 just after midnight. The generalized seizure lasted 4-5 minutes. Temp was 39 degrees. He vomited shortly after that. I had him evaluated at Hospital E.R. and clinically looked good with Temp 38 degrees.
Child came in on 05/28/2002. Child came in with rash to body; mom denies fever. No changes in lifestyle. Rash started 1 day after MMR injection.
Extreme swelling, redness and itching of right arm. Swelling and redness extended to elbow and inside arm.
TITRES OF ANTIBODY RESULT IS LOW; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced titres of antibody result is low. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody levels low was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817934-covid-19 vaccine ad26.cov2.s- titres of antibody result is low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sore arm the day after the injection. Like, more than any other shot or vaccination I've ever gotten.
Painful, red, swelling in (R) posterior arm. Tender induration of soft tissue palpated in 3X4 inch in same region. No discharge, bleeding or signs of active infection noted. BENADRYL given and follow up appt 3/10/17. Advised cold compresses to site. LPN.
Redness,swelling, tenderness, bruising, cellulitis, warmth, itching at injection site
This spontaneous report as received from a nurse refers to a 19 year old patient of an unknown gender. On 06-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K005083 and expiry date: 04-NOV-2016). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.