chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/03/2021- Starting feeling dizzy, like I was going to faint. Vomiting for 24 hours, tightness in chest, shortness of breath, lymph node was swollen, injection site pain, loss of voice, cough. Estimated date of delivery- 2/13/2022
Arm swelling and soreness/exhaustion /could not exercise- bike riding with heart rate at 110 was exhausting
PT COMES IN TODAY ON 6-13-07 C/O SMALL REACTION NOTED FROM SHOTS RT UPPER ARM RED AND WARM TO TOUCH DOESN'T HURT
I had COVID test 2 months ago and was negative and I went two times and both negative.  Then I got the vaccine 3 weeks ago.  Today I tested positive for COVID19 and believe the vaccine caused me to be positive. Asymptomatic as of now.   Wants the public to be made aware that you may test positive for COVID  after receiving the vaccine.
ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event; Initial information received on 22-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reported a product preparation error (received Act-Hib vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event ), for the vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength , ( lot: UJ522AA ; expiry date: 06-Aug-2022) for immunization.  The reporter stated that approximately 6 patients received the ACT-HIB vaccine but one of the doses was mixed with saline and not the approved 0.4% diluent with no reported adverse event (product preparation error) (latency: same day)  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache Myalgia, Fever, Diarrhea, NauseaVomiting, severe left arm pain radiating to left side of neck and down arm; nausea; fever; chills; diarrhea; stomach cramps; headache after 2nd dose
The employee says the next morning, the day after the injection, he found it difficult to extend his right arm away from the body. The employee reports performing push-up exercise to help the discomfort but it only made it worst. This nurse observed the injection site on 8/13/2020 and there was no redness or swelling but there was tenderness to touch.  There was still limited extension of the right arm but the employee reports extension progression from the day prior. The employee called the office on 8/20/2020 to report his arm was back at 100% per Staff. This nurse left several messages on the employee phone but has yet to speak with him since 8/13/2020
Information has been received from a medical assistant refers to an unspecified number of patients who on unknown dates were vaccinated with VARIVAX (dose, lot # and route not provided) that were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
May 10, 2021: heaviness on injected arm May 11,2021: left arm pain, back pain and body pain, left leg cramps and pain, numbness on both hands
Patient developed swelling of face and body with redness-had swelling at eyes.  10/30/06 Received medical records from reporter/provider which reveal patient seen for well child vs on day of vax.  Only finding on exam was nasal congestion & URI symptoms.  Patient then seen in ER for allergic reaction on 10/16/06.  Next office visit was 10/17/06 & patient was much improved but still had periorbital swelling.  Patient was to continue on steroids & zantac.  Next vs was 10/24 after completed steroid.  Now dx: dermatitis on face & oral thrush.   11/16/06 Received medical records from hospital which reveal patient seen in ER 10/16/06 early AM with swelling of face & lips w/rhonchorous breath sounds.  Received Epi per EMTs & IV solumedrol in ER.  Observed in ER for approx 8 hours & d/c to home on oral steroids. D/C DX: anaphylaxis/angioedema.
Cardiac arrest due to suspected myocardial infarction <36 hours after receiving Covid-19 booster shot.  Had previously recieved second dose of Moderna Covid vaccine on 2/24/21 without complication.
shingles; stomach disconfort; leg numb; could hardly walk/barely move; arm swollen; arm  hot; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 31st May 2019, 1 days after receiving Shingrix, the patient experienced swelling arm and extremities hot feeling of. On 1st June 2019, the patient experienced numbness in leg and movements reduced. On 4th June 2019, the patient experienced shingles and stomach discomfort. On an unknown date, the outcome of the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort were unknown.   It was unknown if the reporter considered the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient's arm was very swollen and hot. The patient said she could barely move and her leg was numb. The patient was feeling sick to her stomach and thoughts she may have shingles.
Large local reaction and hives + vesicular euphoria & fatigue @ local site. Day 7+ largely 2/2 Varicella
Instant swelling of deltoid. Decreased within 20 minutes. Pain at injection site and bruising after.
both arms were having red dots; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (both arms were having red dots) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     The patient's past medical history included Back injury NOS (Broken back). Concurrent medical conditions included Hypertension, Diabetic, Arthritis, Cataract and Drug allergy (Alopurinol). Concomitant products included TRAMADOL, PRAMIPEXOLE, TORSEMIDE, PANTOPRAZOLE, CICLOSPORIN (RESTASIS) and POTASSIUM for an unknown indication.    On 29-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (both arms were having red dots). At the time of the report, ERYTHEMA (both arms were having red dots) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Outcome of the event On 10-Jun-2021: F/U attached
headache, sore arm, is lightheaded and dizzy, also has some weakness; lightheaded and dizzy; headache, sore arm, is lightheaded and dizzy, also has some weakness; headache, sore arm, is lightheaded and dizzy, also has some weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (headache, sore arm, is lightheaded and dizzy, also has some weakness), DIZZINESS (lightheaded and dizzy), ASTHENIA (headache, sore arm, is lightheaded and dizzy, also has some weakness) and HEADACHE (headache, sore arm, is lightheaded and dizzy, also has some weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe
Moderna booster #2 was administered on 03/31/22 - posts with all the pertinent vaccine information, had it listed to give 0.5 ml of the red top Moderna vaccine for the #2 booster.  It was supposed to only be 0.25 ml.  This error was caught on 04/05/2022.  Patient was notified and no adverse effects were noted post vaccine.
Numbness; Tingling; swelling, right arm & leg; headache; fatigue; pain and soreness; swelling, right arm & leg; This is a spontaneous report from a contactable Other HCP (patient)  A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 02Feb2021 10:00 (age at the time of vaccination was 56-year-old) as dose 1, single for COVID-19 immunization. Medical history included type 2 diabetes mellitus, depression and anxiety from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing Known allergy: Sulfa, Sulfur. Concomitant medications included levothyroxine sodium (SYNTHROID); methylphenidate hydrochloride (CONCERTA); metformin, lisinopril, and alprazolam (XANAX) all concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that on an unspecified date patient experienced numbness, tingling, swelling, right arm & leg, headache, fatigue, pain and soreness. These symptoms were worse with vaccine and lasted longer. No treatment was received for the event. Outcome of the events was reported as not recovered at this time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting Information has been received from a registered nurse (RN) concerning a 6 month old male who on approximately 16-MAY-2006 was vaccinated PO with a dose a rotavirus G1 G2 G3 G4 P1 vaccine live (human-bovine). The RN reported that on approximately 16-MAY-2006 the patient experienced vomiting. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering. No further information is available.
Pt recvd 3 doses of Engerix-B 28FEB91, 11APR91 & 30AUG91 & 1MAR91 pt exp t99-99.6; pt exp temp p/2nd dose as well;It was also determined that p/3rd dose of Engerix-b pt did not respond to the series; 4th dose of Engerix-B was administered;
Sick; I did not want to take the second shot. Am I still eligible to receive the 2nd shot?; Extreme fatigue; Muscle pain; Body ache; Heart palpitations; It felt like the vaccine would kill her; Vomiting; Nausea; Fever (101)/ fever of 102.5 for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (I did not want to take the second shot. Am I still eligible to receive the 2nd shot?), MYALGIA (Body ache), ILLNESS (Sick), PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (It felt like the vaccine would kill her) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Body ache) and PYREXIA (Fever (101)/ fever of 102.5 for 3 days). 14-Jan-2021, the patient experienced PALPITATIONS (Heart palpitations), VACCINATION COMPLICATION (It felt like the vaccine would kill her), VOMITING (Vomiting), NAUSEA (Nausea) and MYALGIA (Muscle pain). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (I did not want to take the second shot. Am I still eligible to receive the 2nd shot?), ILLNESS (Sick) and FATIGUE (Extreme fatigue). On 16-Jan-2021, PYREXIA (Fever (101)/ fever of 102.5 for 3 days) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (I did not want to take the second shot. Am I still eligible to receive the 2nd shot?) had resolved and MYALGIA (Body ache), ILLNESS (Sick), PALPITATIONS (Heart palpitations), VACCINATION COMPLICATION (It felt like the vaccine would kill her), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Extreme fatigue) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 101 (High) 101 and 102.5 (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow- up included additional events (fatigue, muscle pain, nausea, vomiting, heart palpitations and vaccination adverse reaction)
On June 17th, 2022 I developed a sore throat, dry cough, nasal congestion, and low grade fever. I went to the clinic on June 19th and saw a doctor and tested positive for Covid. Followed isolation and mask procedures and took Paxlovid for 5 days. Felt back to normal in about a week and a half.
pt recv 3 doses of vax & pt mom was chronic carrier & was hep B positive, lab eval 9JAN96 indicated HBs antigen positive & anti-HBs negative, & anti-HBc positive on approx 18JAN96;
Admitted to hospital on 1/28/21 from nursing home with altered mental status and UTI. PMH of heart failure, CKD, afib, COPD. discharged on 2/2/21. COVID negative during this admission. Readmitted on 2/28/21 for AMS, family was unable to wake patient up for an hour prior to calling EMS. Upon admission, found COVID positive.
Pt received his vaccine and immediately slumped over and vasovagaled. Pt came to and told me he vasovagaled and that this has happened before, however usually it was when people take things out out of his body like when they draw blood. Pt states that he gets flushed, diaphoretic when this happens. He denies respiratory distress and pruritis. Pt was given juice and crackers. Shortly after, pt experienced another vasovagal episode. He became pale, diaphoretic, and vasovagaled.   Pt was brought on to a cot. He was given an ice pack. He stayed laying down for 15 minutes. Eventually pt was brought to sitting up position. He left and was comfortable to drive. A note was added into his chart for his second vaccine.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients might have been vaccinated with improperly stored doses of ZOSTAVAX lot # L012475, expiration date 10-JUL-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, flu like symptoms, temp of 100.5 over 24 hour period.  Fever finally broke.   Just feel weak  now.
non-allergic localized rxn to DT w/cellulitis to lt upper arm p/3 days
has a history of anxiety and felt anxious and warm. No signs of difficulty breathing.  directed to fan herself, drink fluids and deep breathing. Patient stated her throat felt tight and swallowing was 'lumpy'.  administered 10ml of benadryl. Assessed patient. Patient felt better with no difficulty breathing and throat felt better. Released from waiting room between 4:20 and 4:25pm.
60 minutes after vaccine was administered  recipient presented with Hives & Rash located on chest area and elevated blood pressure . Diphenhydramine  50mg  IM injection and  Solu-Medrol 40mg IM injection administered ,  patient monitored for extra time  within 30  minutes Hives & Rash disappeared , blood  Pressure gradually returned to  normal levels .
Headache, Fever, Chills, Sweats for 48 hours, Left arm extremely sore  for 72 hours
This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine; manufacturer unspecified; unknown; unknown given on 20 May 2014; MMR vaccine, strain not specified; manufacturer unspecified; unknown; unknown given on 20 May 2014; IPV (non-gsk); manufacturer unspecified; unknown; unknown given on 20 May 2014; varicella virus vaccine; manufacturer unspecified; unknown; unknown given on 20 May 2014. There were no concomitant medications or relevant medical history. There were no adverse reactions following previous vaccinations. On 20 May 2014 the subject received a dose of INFANRIX (1 dose, unknown route, right thigh) as the last dose in the DTaP series. In May 2014, within days after receiving INFANRIX, the patient experienced injection site cellulitis, injection site rash and incorrect storage of drug. Per the nurse, the INFANRIX that was administered was not viable as it was exposed to temperatures of 52.1 degrees Fahrenheit for 188 hours. The patient experienced a 3.5 centimeter sized rash on her right thigh and visited the emergency room. The patient was diagnosed with immunization reaction and cellulitis. The patient was treated with ZITHROMAX. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events of injection site cellulitis and injection site rash were related to vaccination with INFANRIX. Per the nurse, "the doctor thinks the cellulitis was caused by INFANRIX."
This spontaneous report as received from a consumer refers to a patient (the consumer's friend) of unknown age and gender. On an unknown date in 1991 (about 22 years ago), the patient was vaccinated with a dose of M-M-R II (dose, lot number and route of administration were not reported). On an unknown date the patient experienced seizures. The outcome of seizures was unknown. The relatedness between the seizures and M-M-R II was not reported. Upon internal review the seizures were considered to be medically significant. Additional information has been requested.
11 year old patient who received a dose of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th March 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 19th March 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were reported as follows: The patient was 11 years old and received the dose of Infanrix, which led to inappropriate age at vaccine administration. No adverse reaction reported. The reporter consented to follow up.
Arm soreness took Aleve. 09/06/2016 02:45 AM has 7 inflamed reddened swollen spots on left arm where Pneumo and Flu shot were given.  Will take Benadryl when off work and ice down.
Exposed to COVID 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (Herself and her partner). This is 2nd of two reports.  A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that he and his partner received their first dose of the Pfizer COVID vaccine on 28Jan2021. Caller states they are both scheduled to receive their second dose on 18Feb2021. Caller states on this past Saturday night her granddaughter was there with them and she left this morning and her daughter called her and told her that somebody at her office tested positive for COVID. Caller states that someone who had tested prior and was negative also tested positive for COVID. Caller states she was unsure if her granddaughter being present in the house has exposed them to the virus. Caller would like to know if she should receive the second dose of the vaccine on 18Feb2021 if she was exposed to COVID 19. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167420 Same Vaccine/event, different  patient