chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report described the occurrence of flu-like symptoms in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 7/8/99, 8/6/99, and 9/9/99 according to the client. This represents a 0, 1, and 2 month schedule rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered flu like symptoms, fatigue, back pain, knee, shoulder, hip pain, burning and tingling of his hands and arms. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 19Nov2021, outcome "fatal", described as "Starting the day after his 2nd shot, my husband was in the hospital many times for different things over the next ten months, eventually passing on November 19Nov2021.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The patient date of death was 19Nov2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Additional information: Starting the day after his 2nd shot, the patient was in the hospital many times for different things over the next ten months, eventually passing on 19Nov2021. The patient was in the reporter's health plan. The patient was in relatively good health before the shots. He was tested for Covid every time he was admitted, and the test was always negative. The reporter gave permission to examine all of the patient's medical records. The reporter mentioned that if there are statistics on 'death after shots' the reporter would be interested. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Starting the day after his 2nd shot, my husband, was in the hospital, many times for different things over the next ten months, eventually passing on 19Nov2021
FLU LIKE SIDE EFFECT; ARM HURT FOR OVER A WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced flu like side effect, and arm hurt for over a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt for over a week, and the outcome of flu like side effect was not reported. This report was non-serious.
This initial spontaneous case, was received from other non-health professional on 20-Oct-2017, concerns a 32-year-old, adult female patient. On 18-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch no: 179403, expiry date: Jun-2018, route of administration and anatomical location: not reported). On 18-Oct-2017, 32-year-old, adult female patient was administered with FLUAD (explicitly considered as inappropriate age at vaccine administration). The reporter assessed this report as non-serious.
Information has been received from a an office manager, concerning 2 to 3 female patients who on an unspecified date were vaccinated with a dose of GARDASIL, Lot number was not available. The office manager reported that there were 2 to 3 patients who had miscarriage around the time when they received GARDASIL. At the time of the report the patients' outcome was unknown. The patient sought medical attention, seen by the physician. Miscarriage was considered to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
11:05AM- pt stated that she has anxiety and that she was nervous about receiving shot today. I asked patient if she wanted to lay down on a cot and see if that helped calm her anxiety. She accepted and I sat with the patient in the first aide room.  She drank some water and talked to me with no active signs of distress. Patient talking normally and breathing normally (respiratory Rate 13 BPM). Patient refusing vital signs insisting this is related to her anxiety. Patient stayed in first aide room for 45 minutes (11:50AM) until she stated "I feel better". Patient checked out and I walked her to her car.
A physician reported that a female in her late 80's received an injection of Flu Shield ('01-'02). On 11/12/01, approx. 5 to 7 days post vax, she developed a severe, blistering, maculopapular rash on the front and back of her trunk. She was treated with valacyclovir and steroids. On 11/18/01, she died. No further information was available at the date of this report. Death certificate states cause of death as vasculitis with other significant condition of stroke.
Positive COVID test after vaccination; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID test after vaccination) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID test after vaccination). The patient was treated with REMDESIVIR for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Positive COVID test after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) After receiving the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-APR-2021 indicated, the patient did not have any reactions from the vaccine and did not have COVID-19 after receiving the vaccine.; Sender's Comments: The causality for this event is not applicable.
Ddifficulty breathing-pain with inpiration, chest tightness, acute congestion & cough, sore throat, bright red eyes, acute periorbital edema & headache.
Recipient of vaccine was observed for 15 minutes post vaccine administration.  2 hours later a coworker came to inform the clinic recipient " had an allergic reaction". She stated she develop a funny feeling in her throat was given Benadryl 50mg at the oncology office where she works and was transported by ambulance to hospital for treatment.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 24-FEB-2014, the patient was vaccinated with PROQUAD (Merck), subcutaneous injection, (lot # H015642, expiry date 06-JAN-2014), dose 0.5 ml, subcutaneous after the expiration date. Concomitant medication was unspecified. No adverse effects reported. No product quality complaint involved. Outcome of the events was unknown. No further information was provided. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pain down into forearm., pt is able to use arm but is still painful. Slight sweling the day after but has subsided.
Paralysis on Left side of Face. Was prescribed and took 5 days of prednisone, following orders from ER 02/23/2021 visit - diagnosed with Bells Palsy. Followed up with PCP Dr. and was prescribed to physical therapy but insurance would not cover so I followed online Bells Palsy exercises. I currently have about 50% of my movement back.
death I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Wheezing, low grade fever 4 hours after receiving vaccine. Generalized itchy red, maculopapular rash on trunk and limbs 48 hours after receiving vaccine.
Pt developed a 103 fever 8 days after getting a PROQUAD vaccine. Has no other symptoms per mom. Per doctor advised to give TYLENOL or MOTRIN and continue to monitor.
Breakthrough Covid positive case 5 weeks post vaccination.  Tested Covid positive with a Rapid Test in the Emergency Department at hospital.  Asymptomatic during entire 10 day quarantine.  Was in the ED for treatment of a broken arm and elbow.
Local swelling, induration about 5cm, hot to touch and erythema. Pt complaint of pain and pruritus locally L deltoid. TX: Tylenol, home antics; contrast hot/cold application; apnea; reassurant.
Patient called from home stating she felt her throat closing up. RPh asked her to go straight to ER and/or if she wanted us to call the ambulance. Patient refused both and RPh recommended that she still go. RPh called patient 2 hours later and still refused to go to the ER but stated she was feeling better. I called the patient on 4/28/16 at 3pm and she states that she feels fine.
No additional adverse events; A patient was administered an expired but properly stored PROQUAD vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reaction or allergies, and concomitant medications were not reported.   On 20-FEB-2020, the patient was vaccinated with an expired but properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot number R024020 had been verified to be a valid number; expiration date 19-FEB-2020) (strength, dose, frequency, route of administration, and anatomical location were not reported), the vaccine was reconstituted with a not expired sterile diluent (DILUENT MRK). No additional adverse events.
Patient received two doses of the Moderna vaccine at the Health Dept; the first vaccine was administered on 2/4/2021; the second on 3/4/2021 (lot numbers not available); no adverse events are known.  The patient was admitted to hospital on 6/2/2021 for an elective procedure. In anticipation of transfer to an  inpatient Rehab facility, the patient was C19 testeded 3 separate times on 6/7/2021.  The first RT-PCR test was positive and considered a possible false positive; the 2nd test was also positive.  A third test was negative.  The patient is being isolated, is asymptomatic  and is being reported as a breakthrough case.
on the 2nd and 3rd day of vaccine I had fever(100.4 and 100.2), chills and body ache.  took Tylenol and Motrin. Symptoms resolved on 4th day.
A rash, it itches. about the size of a baseball. The rest of the; nauseated; tired; kinda lost the appetite; didn't have any reaction, just hurt on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm), DECREASED APPETITE (kinda lost the appetite), RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the), NAUSEA (nauseated) and FATIGUE (tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm). On 26-Feb-2021, the patient experienced DECREASED APPETITE (kinda lost the appetite), NAUSEA (nauseated) and FATIGUE (tired). On 01-Mar-2021, the patient experienced RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (didn't have any reaction, just hurt on the arm), DECREASED APPETITE (kinda lost the appetite), RASH PRURITIC (A rash, it itches. about the size of a baseball. The rest of the), NAUSEA (nauseated) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUNE-2021 and does not contain any new information
Reportedly, in 1996, the vaccinee received his first 20mcg intramuscular dose of Engerix-B. Reportedly, several days later, his feet started to itch. Reportedly, the itching resolved. Reportedly, one month after receiving his first dose of Engerix-B, the vaccinee received his second 20mcg intramuscular dose of Engerix-B. Reportedly several days later, his hands started to itch; then the itch moved to his scalp, and then to his feet. Reportedly, all his body parts did not itch at one time; The itch would just keep changing locations. Reportedly, he was taking Cetirizine hydrochloride (Zyrtec) 10mg every other day and, reportedly, that did help. Reportedly, he has not received the third dose in the series. As of 10 OCT 2001, reportedly, the outcome of the adverse event was unresolved.
Pt received a bivalent Pfizer dose when the patient should have received 2nd Monovalent Pfizer dose.
Vertigo type Sx when on my feet. OK when seated. Tried eating, BP was 92/70 which is normal for me. Just the feeling like I was going to fall if I ambulated. Sitting again was OK. Lasted 24 hours, and was noticeable to 10% the next half day. No treatment. Not classic vertigo, just felt unstable.
10 y.o. white male who got Hep A and Varicella Vaccine on 8/8/07.  Pt returned 2 days later with reddness and induration about the size of an apricot over his varicella vaccine site.  No fever/chills.  Pt reported some mild discomfort.
Started feeling dizzy the afternoon of the 2nd shot - next day was bed ridden with sore bones, severe headache, nausea, weakness, shortness of breath - I still feel extremely tired and have shortness of breath and brain fog - it has been more than 2 weeks since the 2nd shot
2 weeks after 3rd dose of moderna vaccine- pt started severely hurting, flare up of arthritis symptoms. Pt had to start pain medication, symptoms lasted until recently, just now starting to go away. Patient has not been able to resume normal activity as was before receiving 3rd dose of vaccine.
oderna covid vaccine found to be out of date after administration on 8/4/21.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: follow-up received on 10-AUG-2021 , race updated, and no new information added
Dizziness, Headache, Myalgia & Fever Narrative: As reported by Employee 6/24/2021: ***************************************** "1/13/21 I received 2nd dose I had very bad headache, dizzy, fever, Body ache for 3dyas after that I was Ok"
ESCALATING PAIN IN THE LOWER BACK; PAIN IN LEG; BLOOD CLOT IN LEG; This spontaneous report received from a consumer (representative) concerned a 4 decade (early 30's) old adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On 16-APR-2021, the patient experienced escalating pain in the lower back and in leg. The patient also experienced blood clot in leg, and was hospitalized in an unknown date in APR-2021. The patient had improvement and scheduled to leave the hospital in a few days at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in leg, escalating pain in the lower back, and pain in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452829-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT IN LEG, ESCALATING PAIN IN THE LOWER BACK. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210452829-COVID-19 VACCINE AD26.COV2.S-PAIN IN LEG . This event(s) is labeled per RSI and is therefore considered potentially related.
I got dizzy after the shot, head felt odd, body odd, and stayed at the pharmacy, since they were not concerned I stay 15 mins and left. Shortly after that I got body aches, and a small headache. This progressed all day and night. Woke up feeling lots of body aches and headache. Drank lots of water before and after the immunization. Took nothing for it. At 3pm on the 22 I called and they said I could take aspirin, which I did. I will report when I feel better.
received an expired dose of Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number DJ247, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe (batch number Unk, expiry date unknown) for prophylaxis.   On 5th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 provided as follows: The patient received an expired dose of Flulaval QIV. The reporter consented to follow up. This case has been linked to US2021232171, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232171:same reporter
Breakthrough COVID infection in fully vaccinated patient. Positive date 06/28/2021.
Cyst type induration on the injection arm/not on the deltoid; This is a spontaneous case from, initially reported by pharmacist via Agency (reference number: SEQ19-05212) on 21-Oct-2019, concerning a 56-year-old, female patient.  The patient's relevant medical history and concomitant medications were not provided.    On 20-Sep-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 261201 and expiry date: 30-May-2020] for influenza prophylaxis.  On unspecified date, unknown period after vaccination, the patient developed cyst type induration on the injection arm. The reporter stated that the induration is on the arm but not on the deltoid like it is referred. Induration was distal to shoulder where vaccine was administered. The pharmacist confirmed the vaccine was given in the correct location, by checking the camera. Patient received no treatment for the event.  The outcome of the event was unknown.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV..  Follow up received on 31-Oct-2019 from pharmacist via Agency (reference number: SEQ19-05872): batch number and expiry date of vaccine provided, the outcome of the event updated. The narrative was amended accordingly.  Company comment: The patient experienced skin induration after vaccination with the suspect product, Flucelvax QIV. Chronology and anatomical description of the event is suggestive of causal role of vaccine. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced skin induration after vaccination with the suspect product, Flucelvax QIV. Chronology and anatomical description of  the event is suggestive of causal role of vaccine. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke.