chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 41 year old female with breast cancer and morphine allergy who on 30-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 in the left gluteus, and then presented with cellulitis on 02-FEB-2009. The patient was hospitalized for the cellulitis. Follow up information received on 13-APR-2009 stated that there was no other information available. No further information is available.
First Shingrix May 21, 2023. Second Shingrix July 22, 2023. August 12th, a few weeks after vaccination, patient developed a burning rash/red blisters on her lips that became swollen. A few days later her whole face was broken out in red, burning splotches. She went to the ER 8/14th and was given Prednisone. Follow up with PCP on 8/18th and required more prednisone. Even now (September), she has burning splotches under both eyes and her lips remain slightly swollen. She states that nothing else changed (no new moisturizer, sunscreen, makeup, detergent, etc.)
The subject's medical history included high blood pressure and high cholesterol. Previous and/or concurrent vaccination included inactivated IPOL; unknown given on 30 April 2008; MENACTRA; unknown given on 30 April 2008. Concurrent medications included Unknown. On 30 April 2008, the subject received 1st dose of HAVRIX 1440 (unknown, left arm), unspecified dose of VIVOTIF (oral). On 3 May 2008, 3 days after vaccination with HAVRIX 1440, at an unspecified time after vaccination with VIVOTIF, the subject experienced rash. The subject received HAVRIX alone with other vaccines on 30 April 2008 prior to a trip. Three days later a rash developed under his arms and groin area. The rash was circular, red and not extensive. The subject contacted the healthcare professional who recommended a topical cortisone product. The subject traveled starting the 24 May 2008 for one week. The subject reported that the cortisone cream helped for a little bit, but then the rash became more generalized. Upon return, the subject saw a dermatologist and one of the spots on his arms was biopsies. The dermatologist determined the rash was vial and advised the subject not to complete the HAVRIX. The dermatologist gave an injection of a corticosteroid, provided topical cortisone type cream and "heavy duty cram" that he advised the subject not to use for more than 10 days. The subject's rash resolved by mid-June 2008. The healthcare professional considered the event was possibly related to vaccination with HAVRIX 1440 and VIVOTIF.
1 week of raised, red, some with vesicles and some without vesicles on torso, arms, legs, face. Fever. Appear like flea bites.
Tired; COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), FATIGUE (Tired) and COVID-19 (COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Tired) outcome was unknown and COVID-19 (COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be possibly related. No further causality assessments were provided for DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Tired).    Concomitant medications include blood pressure pills (unspecified) and cholesterol pills (unspecified).  No treatment medications provided.  This is a Spontaneous case concerning a 72-year-old, male patient with medical history of taking medication for blood pressure and cholesterol (unknown exact indication),  who experienced the unexpected non serious (AESI) event of COVID 19 and Lack of efficacy, along with the non serious expected event of fatigue. The event occurred approximately 7 months after the first dose and 8 months after the second dose of Moderna COVID 19 vaccine, received with a correct latency between doses (28 days). The rechallenge is negative for the event Fatigue. The patient´s demographics and medical history of blood pressure and cholesterol pathology could be a confounder for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-375480 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 72-year-old, male patient with medical history of taking medication for blood pressure and cholesterol (unknown exact indication),  who experienced the unexpected non serious (AESI) event of COVID 19 and Lack of efficacy, along with the non serious expected event of fatigue. The event occurred approximately 7 months after the first dose and 8 months after the second dose of Moderna COVID 19 vaccine, received with a correct latency between doses (28 days). The rechallenge is negative for the event Fatigue. The patient´s demographics and medical history of blood pressure and cholesterol pathology could be a confounder for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Sore arm at injection site with 4 x 6 inch swollen a day after TDAP injection, one week later both knee joint sore & discomfort then left hand with same symptoms. Not able to do daily exercise: still has discomfort now.
Pain in ankle and hand, fatigue started after 1st shot of LYMErix and increased after third. Right foot and hand swelled and could not bend joints very painful and debilitating.  Diagnosed with gout. Also diagnosed with hypercholesteremia, HTN, obesity and arthritis
expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Boostrix. On 03-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-MAY-2023 The reporter reported that an expired dose of Boostrix was administered to a patient.  The reporter was consented to follow up. The patient received expired dose of Boostrix, which led to Expired vaccine used.
I had tightness in my chest, nasal congestion. I tested for COVID-19 with a home test that came back positive. I called my doctor, had a virtual visit and received a prescription for the Paxlovid. Once I started the Paxlovid, my stomach started to cramp, hurt, I got diarrhea. I'm not sure if I ever started feeling better. My nose started to run profusely and would not stop, I took another home COVID-19 test on seven says later and it was still very dark. My doctor said I had gotten rebound COVID-19. I started taking my supplements again, within fours days I tested negative.
Information has been received from a physician concerning a 13 year old female who "about 2 to 3 weeks ago" on approximately 25-SEP-2008, received the first dose of GARDASIL vaccine (lot# not provided). Subsequently the patient experienced joint pain in one of her knees. The patient sought medical attention and he Orthopedic doctor said it could be from the vaccine. The patient's joint pain in one of knees persisted. Additional information has been requested.
Aprroximate 1-2 hours after vaccination given: The vaccination was given roughly around 11:30 am on 10/4/08. Roughly around 2:00 I was driving to a car appointment and began to feel nausea, clammy feeling, dry mouthed, felt as if I was about to faint, little dizziness. I was driving at this time coming to a stop light. Within 3-4 minutes I didn't feel so much panic as if I were going to pass out, but i felt very worn out and somewhat achy. I got to my destination within 5 minutes and ate a little food and had some water. I then took a 1 hour nap. I woke up and felt better but took it easy the rest of the day as I felt weak, achy, and just overall run down.
Starting early morning of 3/18/2021 was awaken by severe muscle soreness/ache down both arms into my hands, across my back an into my jaw area. I had the same thing happen the following early morning 3/19. Then I experienced the same reactions while working out at the gym during the morning and or if not at the gym on a morning fast paced walk. I also had a rash near the site of the injection for three and a half weeks. I have been having this reaction for four weeks. On reporting this to my PCP he advised me to go to the ER and have myself checked out as it sounded like angina pain to him. I did this on 4/2/2021. No problem found.
Miscarriage. I am now a GTAP 2-1-1-1. I had no reaction other than this pregnancy loss.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not provided). Subsequently, the patient experienced muscle weakness, pulmonary embolism and arthritic pain. The patient was seen by the physician. At the time of the report, the patient was recovering. Upon internal review, pulmonary embolism was determined to be an other important medical event. Additional information has been requested.
Per patient report: He received 0.25ml Moderna booster shot around 10am on 11/4/2021. At 3am on 11/5/2021 (roughly 14 hours after booster injection) patient could not move both legs and was admitted to local hospital. About 24hours after after initial onsey of symptoms, symptoms started resolving and patient completely back to baseline/normal on 11/7/2021 when he was discharged from hospital.
Encounter Summary; 57 y.o. Female; Reason for Visit; Nasal Congestion; Other; possible covid exposure; 02/07/2021 Emergency Department; Suspected COVID-19 virus infection; Flu-like symptoms; Dx; Headache, Nasal Congestion, Covid-19 Screening, Generalized Body Aches, Chest Pain.
Headache, Myalgia, Arthralgia, Injection site pain, Anorexia, Fatigue, Aphthous Ulcer
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Was nursing child in bed about 3-4am. Child noted to be "shaking" and was not arousable. Was febrile at the time. Seizure lasted about a minute. Seen at ER. Exam ok. Has family history of seizure in in brother and sister. Has had 2-3 seizures since the first episode.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). This is subject's 1st pregnancy. On 14 April 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on 19 September 2013 and estimated date of delivery was on 26 June 2014. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 13 June 2014: Facility where vaccine was administered was provided. 15 September 2014 - No further information was provided; patient lost to follow-up. Additional information received on 01 October 2014: VAERS has been updated.
LEFT ARM SWELLING, NKO LYMPHADENOPATHY OR SIGNS OF CELLULITIS.  TREATED WITH ORAL ANTIINFLAMATORIES.
Tested positive for Covid-19 on Wednesday (04Aug2021); Lack of drug effect; Low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Low-grade fever). On 04-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received and lack of drug effect added as per latest guidelines and outcome of COVID-19  updated.; Sender's Comments: This case concerns a 48 year-old, male with no relevant medical history , who experienced the unexpected events of COVID19, DRUG INEFFECTIVE . The event occurred approximately 3 month and 23 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Always walked until he got the flu shot - now he can't walk at all - has to be after shot carried. Never walked again.
The vaccine was a Pfizer Covid-19 pediatric and WAS NOT diluted prior to administration off 0.2ml
Information has been received from a Licensed Vocational nurse referring to a 3 month old female patient. The patient had no relevant medical history, concomitant medications, or drug history. On 07-JUL-2016, the patient started ROTATEQ orally at a 2 ml dose at an unknown frequency. On 12-JUL-2016 the patient received ROTATEQ (lot # L029615, expiration date of 15-MAY-2017, 2 ml, oral) that was exposed to a temperature excursion. After receiving ROTATEQ, no adverse events had been reported thus far. The patient had not relevant laboratory data. As of 25-AUG-2016, it was unknown if the patient would continued to ROTATEQ and the outcome of the events was unknown. Additional information has been requested.
Shortness of breath, tightening of throat, near syncope.  PT had a Hx asthma and allergic reactions to antibiotics.  0.3 mg EPI via autoinjector left medical thigh.    8 doses of albuterol MDI  PT improved after treatment.  Evaluated, treated by EMS.  Transported to ED for further evaluation and treatment.
COVID-19 virus test positive; COVID-19 virus test positive; 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-163-4482235-00 (RA).  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19 virus test positive" related to BNT162b2.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Patient received the vaccines on 2/12/2020. She noticed some itching on 2/13/2020. There is a 30mm x 50mm area of induration on the back of the left upper arm. It itches her and is warm to the touch and hard. A thin layer of hydrocortisone was applied and ice pack suggested. Encouraged her to not scratch at it. The left arm is where the Varicella vaccine was administered. The MMR vaccine administration site has a small red area, approximately 15mm x 15mm, Not warm or hard. Not bothersome.
Sore throat in PM. Sore throat and warm temperature next AM (9/23/15).
injection site pain; muscle pain; chills; fever; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced injection site pain, muscle pain, chills and fever. The outcome was unknown for the reported events. The reporter also asked whether the patient could use the antipyretic.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Patient was given second Pfizer vaccine at 8:19. About 11 minutes after receiving the vaccine patient complained of chest pain. 911 was called, nasal 02 was administered. BP 150/90, P103. Patient was taken by ambulance to the ED. She stated her chest pain was an 8 out of 10.
Low grade fever, nauseous and headache. Took Tylenol. Didn?t really feel any better till 4/8/21.
effected my friends ability to breathe immensely; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (effected my friends ability to breathe immensely) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATION ABNORMAL (effected my friends ability to breathe immensely). At the time of the report, RESPIRATION ABNORMAL (effected my friends ability to breathe immensely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent. Other Case identifier(s): MOC20230210000073 (MODERNA).  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown manufacturer), for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant) with onset 2022, outcome "fatal". The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed.  Course of events: Caller called a few weeks ago and one of the things she had mentioned during that call was that her son died this past summer (2022), but she states it had nothing to do with the Moderna COVID-19 vaccine. In fact, her son had received the Pfizer vaccine and was living in another state at the time of vaccination. He was living with her when he had the cardiac arrest and she again claims that it had nothing at all to do with any vaccines. Now, she is getting emails with Moderna thinking that the cardiac arrest was caused by the Moderna vaccine when her son didn't even receive the Moderna COVID-19 vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The reporter considered "cardiac arrest" not related to BNT162b2, BNT162b2 omi ba.4-5. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known drug safety profile, the event cardia arrest is assessed as unrelated to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. This case will be reassessed should additional information become available.; Reported Cause(s) of Death: Cardiac arrest
Patient stated that she felt a "lump and tightness" after 15 minutes of injection in her throat after receiving her first Pfizer covid vaccine. Vital signs taken o2 97%, HR 102, temp 98.4 orally, BP 126/88. Patient seen by PA who stated no swelling in mouth seen, vitals normal. Patient waited an additional 15 minutes. Patient felt better when she left clinic.
Diffuse swelling of leg from upper thigh to knee. No redness. Painful with lump.
Eosinophils on 2013-01-03, clinician comment: Possible that elevated eosinophil count related to vaccine. No clinic sequelae.