chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea 30 minutes following; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 51-year-old non-pregnant female received first dose of BNT16B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), solution for injection, via an unspecified route of administration in the left arm on 18Mar2021at 14:15 (at the age 51-year-old) as single dose for COVID-19 vaccination. Medical history included Autoimmune hepatitis. The patient did not have allergies to any medications, food or other product. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were numerous. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 15:00, the patient experienced diarrhea, sore arm. The patient did not receive any treatment for the adverse events.  The clinical outcome of diarrhea, sore arm was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Normal side effects of head ache, severe body aches, chills, nausea, fatigue.  Fatigue has continued for over a month now. My depression and anxiety have become worse than before. After my first vaccine fatigue lasted almost two weeks and depression/anxiety worsened for about a week. After 2nd shot it?s been a month and fatigue and anxiety and depression have been bad since then.   The reporting is concerning fatigue and depression/anxiety.
Approximately 5cm red raised lesion at the vaccination site, soreness occurring 10 days post vaccine.  Also tachycardia occurring within first 20 minutes of vaccine administration, 2 episodes, both lasting 15-30 seconds.
Information has been received from a lawyer from a case in litigation concerning a 43 year old patient who on 20-JUN-2003 was vaccinated with a first dose of RECOMBIVAX HB. Subsequently the patient developed myalgia and fibromyalgia, experienced itching on her arms and pain in her knees but did not report to her physician. On 28-JUL-2003 the patient had a second vaccination with RECOMBIVAX HB. The patient developed itching and "an odd tingling sensation" in her fingers. Then she developed more significant problems such as pain in her fingers which would travel up her left arm and shoulder to her posterior neck causing sharp pain. The treating physicians diagnosed the patient as having a degenerative disc disease from a review of an MRI. No further information available.
Per the patient, the rash started 3 days post vaccination (4/1/22) on her right arm, where the vaccine was given and moved to her left arm, her face, and her chest/  She stated  that the rash started out very itchy and had kept her up at night. She reported the event to the clinic on 4/19 when she request a nurse visit with myself. I had Dr. come take a look at the rash, which was still evident mostly on her left arm and left side of her face. Per  the patient she was putting an unknown cream on the rash and it was doing better. Dr. prescribed Triamcinolone 0.1% cream to use BID.
Would not eat, had trouble waking up, had rash all over body, high fever 102.9F, diarrhea X 8 and vomiting 3-4 times.
Client developed chest tightness and pain after vaccination.  Vital signs normal, and lungs clear to auscultation.  No other local or systemic allergic type signs or symptoms noted.  Client appeared anxious and admitted to same.  Responding well to reassurance.  She normally takes hydroxyzine PRN for anxiety, and we offered diphenhydramine which she accepted (50mg po x 1).  Feeling improved prior to discharge, this is NOT suspected to be a severe adverse reaction to the vaccine (suspect panic/anxiety).
By mother's report, about 2 hours after vaccines were given, pt developed diffuse swelling of both her lower extremities from her thighs to her feet and also involving the vaginal area.  Mother also states mild swelling of her face but no wheezing or tongue swelling.  An urticarial rash also developed over her extremities and abdomen.  The swelling and rash had improved by the time pt was seen in the clinic on 12/30/05.  No medications were given by mother except for Tylenol for pain.
muscle aches and pains starting the day after injection, severe for the first 2 days getting better on the 3rd day
Red rash spots on multiple locations of the body (arm, leg, chest, back), not raised and do not itch
Vomitting, loss of appetite, very tired and disoriented 3/21/2021. Very low appetite 3/21/2021 - 3/26/2021
Began to notice neck itching and flushing of face. Seen for care at 10:50 am. B/P 130/80, pulse 68 resp 16. Observed.  Took own Benadryl. Talked with patient next day took a total of 2 Bendaryl. Feeling fine on 10/14/10.
rt upper arm-sore w/movement (lifting up & back);rates pain a "6" on 1-10 scale;has discomfort at rest;
Achy, sharp shooting pain in rotator cuff area of shoulder. Started a day after the vaccine, not at vaccine site but up above in shoulder area. Pain worsened over 9 days gradually getting worse instead of better. Very painful at night sleeping/not sleeping.
pt recvd vax 5PM & on 12APR94 father states pt devel a red, swollen lt arm that started @ the inject site & raidated down past the elbow; pt also had a fever of 102 orally; father states they took the pt the to MD on 14PAR94 in the afternoo
Shakey hands, stiffening in arms, loss of speech. EMS arrived, took pt to hospital. Pt. Dr was notified by his mother.
Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with headache,  Felt extremely hot and Red rash appeared on my face on both cheeks and when I got up to leave I had weakness in my legs and was dizzy.  Was given benedryl by the pharmacist who stated it look liked I had a reaction.  Still had pain in left temple, headache, rash and dizzyness the next day along with scratchy throat. Headache and pain in temple mild after 3 days.  I am concerned about second dose only because of shooting pains in my left temple.
Narrative: Patient received one dose of J&J vaccine. No details recorded in chart as cause of death. Reporting per facility instructions.
Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Redness, warmth, swelling, pain. Advised to take NSAIDS, anti histamines and apply cool compresses.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Aug-2020 and the estimated date of delivery was 11-May-2021. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 18-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was given.
Fell due to slippery floor; Stomach swollen; Dehydrated; 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-163-4467672-00.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years and on 16Sep2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159933) at 40 mg (40 mg (citrate free (1 in 2 wk))), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (hospitalization) with onset 31May2022, outcome "unknown", described as "Fell due to slippery floor"; DEHYDRATION (non-serious) with onset 2022, outcome "unknown", described as "Dehydrated"; ABDOMINAL DISTENSION (non-serious), outcome "recovering", described as "Stomach swollen". The action taken for adalimumab was unknown.  The reporter considered "fell due to slippery floor" and "stomach swollen" related to BNT162b2. The reporter's assessment of the causal relationship of "dehydrated" with the suspect product(s) BNT162b2 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. 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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.
Both feet ache; can't stand, walk, or run without my feet aching afterward; they even ache when I am not on my feet; I usually walk or run many miles every day.  Perhaps this is unrelated to the vaccine but have never felt this before.  The first day the symptoms developed by feet felt bruised on the bottoms.  10 days later and my feet still ache if I do any activity on them.
Patient experienced muscle aches and headache about 3-4 hours after the injection, which last about 2 days, then on 10/3/09 (5 days later) experienced rash and hives. Went to MD who prescribed ATARAX which helped symptoms. Hive resolved after 5 days.
No adverse effects reported.; Medical assistant reporting that an "adult male patient" received one dose of PROQUAD on 5/8/2019; This spontaneous report was received from a medical assistant referring to a male adult patient of unknown age. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 08-MAY-2019, the patient received one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R013575 with expiration date 11-OCT-2019; strength and dose detail were not reported) subcutaneously for prophylaxis(adult use of a child product ). Concomitant therapy included sterile diluent(lot # R033667 with expiration date 14-JUN-2021). No adverse effects reported. The causality was not provided.
Pt experienced soreness in left arm for 10 days at injections site, numbness in arm and hand, mild seizures in body 4 times (like vibrations).
Within short time experienced 103.4 temp. (L) thigh red and hot 4" x 2" lasating 24 hr. Redness warmth lasted 48 hours.
September 1, 1999, woke at 2:00 AM with fever. Had diarrhea at 13:30 PM and threw up at 15:00 PM. Gave Tylenol for fever. Passed away during the night. Pronounced dead on September 2, 1999.
neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown.  Information on the lot/batch number has been requested.
The patient received an expired dose of VARIVAX on 4/26/2023.; Itching; Facial Swelling; This spontaneous report was received from a licensed vocational nurse concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U012222, expiration date: 16-APR-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered). In addition, on the same day (26-APR-2023), she also received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection as prophylaxis (dose, route of administration, lot#, and expired date were not provided), meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), hepatitis a vaccine inact (HAVRIX) (doses, formulation, routes of administration, lot#, expired date, and indication were not provided). The reporter informed that all of the vaccines administered were the second dose in their respective series except hepatitis a vaccine inact (HAVRIX).  On an unspecified day in April 2023, the patient experienced itching (pruritus) and facial swelling (swelling face). Therefore, her patients parent took her to the emergency department on 27-APR-2023 (approximately 24 hours after vaccination with multiple vaccines to include varicella virus vaccine live (oka/merck) [VARIVAX]) and it was suggested having the patient allergy tested. It was reported that the patient was administered a dose of an antihistamine and was subsequently sent home from the emergency department and was not admitted to the hospital. It was also stated that a Varicella Zoster Virus (VZVIP) packet being sent via email since the HCP was not available at that moment and would  be back until 26-MAY-2023. No additional information was reported. The outcome of the events was not provided.  The action taken and causal relationship between the events and the suspect vaccines were not reported.
go for a walk and had onset of shortness of breath; little soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot/NDC number and expiration date were not provided), via an unspecified route of administration on 26Jan2021 at about 10:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID-19 vaccine on 26Jan2021 about 10:30 AM at the hospital and he had no effects then. He had a little soreness in arm that night (26Jan2021), but woke up in the morning of the report date, on 27Jan2021 with no soreness in arm, and felt pretty good. Also, at the time of the report on 27Jan2021, he went out to go for a walk and had onset of shortness of breath. He waited a few minutes then continued to walk and still getting the shortness of breath. He called to ask if that was a normal side effect of the vaccine. The patient further indicated having "no problems," went for a walk and experienced shortness of breath. The patient recovered from the event "little soreness in arm" on 27Jan2021, while the outcome of the event "go for a walk and had onset of shortness of breath" was unknown.  Information on the batch/lot number has been requested.
Information has been received from a registered nurse concerning a 35 year old female who on 08/06/2001 was vaccinated with a dose of varicella vaccine. On 08/10/2001 the pt developed "itchy bumps on feet and spots all over her body, mumps had vesicule centers and she had slight sore throat." The reporter stated that the pt had recently been to the dentist and that "may be the reason for sore throat." The pt had a temperature of 98.9 deg. F. The pt did not seek medical attention. There was no other info provided. Additional info has been reqeusted.
HAD A REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s. (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration were not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration were not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient had a reaction to the vaccine and wanted to know how many hours between taking Tylenol extra strength (paracetamol) (treatment medication). The patient stated that it helped and took two doses of one each (vaccine) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had a reaction to the vaccine. This report was non-serious.
6 days p/vax pt devel an inj site rxn characterized by pain, redness, warmth, swelling which extended from shoulder to elbow;pt also devel induration the size of a golf ball @ inj site;pt recovered @ the date of this report;
This case was reported by a consumer and described the occurrence of diarrhea in a adult patient who received Shingrix for prophylaxis. On 1st October 2018, the patient received Shingrix. In October 2018, less than a week after receiving Shingrix, the patient experienced diarrhea and dizziness. On an unknown date, the outcome of the diarrhea and dizziness were not recovered/not resolved. It was unknown if the reporter considered the diarrhea and dizziness to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter asked how long will the side effects last. After vaccination with Shingrix, the patient had diarrhea and a little dizziness. The reporter asked whether events would worsen.
Client has large erythema with induction approximately 2 by 3 and half inches, wasn't to touch, no fever on left leg.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored (Merck) VARIVAX (lot # L006383 and expiration date 25-FEB-2017, dose and route of administration were not reported). Concomitant medications were not reported. The temperature of the excursion was 7 Celsius degrees and the time frame was 1 hour. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Other medical history: Htn; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Rebound Covid after Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid administrator route Oral. Treatment start date 10Jul2022, Treatment top date 14Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Vaccine administered beyond 12 hour usage time frame, approximately 8 hours beyond the use time frame. No reports of adverse symptoms, reaction, or associated symptoms.
On the 1st I had fever with pain when flexing my neck and pain when bending my legs [meningismus]. Lasted for 2 days.
rash at injection point, back pain, sore at injection point, tingling hot feeling at injection point, headache, disoreintation