chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 7:00 pm on same day of injection, I felt fatigued and I began to feel chills (around 9 pm). I also had aching and soreness in my hips and legs around 9PM - 10PM as well. All of those symptoms continued through the next day until about 9 pm the next night. (So about 36 hours later.)  September 17, 2021 - estimated due date; Pregnancy history - I have had one miscarriage previously. This is my second pregnancy. Normal pregnancy at this time.
Severe body aches; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown), via an unspecified route of administration in the right arm on 23Mar2021 at 17:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, bleeding disorder and allergy (peroxide). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown), via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation and amoxicillin; clavulanate potassium (AUGMENTIN); on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced severe body aches. Therapeutic measures were taken as a result of severe body aches and included treatment with Tylenol heating pad. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event general body pain was recovering at the time of this report.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Felt achy and had a temp of 100.6 very weak. This happened the next afternoon from being given the shot. Injection site very sore also. Went to bed early at 7:00 p.m when I got up on Saturday the 20th. I was better.
Patient awoke at 3am on 9/29/19 and was observed by his parents to have a fever of 102 F with a headache, body aches, and chills. He was taken to a local emergency room where he was tested negative for strep throat and observed to have some redness in his throat and ears. The parent also mentioned he had pharyngitis at the ER as well. The patient was sent home and had been receiving ibuprofen and tylenol to help control his fever and instructed to provide supportive measures such as fluid intake as well. ER was unsure of what the cause of the symptoms were but have suggested vaccine may be the cause due to proximity and timing of the events. No site reaction or skin reaction such as hives had been observed at the time of reporting to the pharmacy at 4:45pm on 9/29/19. Patient advised to followup with their pediatrician Dr. as soon as able for reevaluation.
Developed flat rash 2/7/05 on neck, face, back, and chest, temp of 102. Resolved 2 days later.
A report has been received from a Health Professional concerning a 52 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The medical assistant reported that they did notice the patient's age that it was out of the window and inadvertently gave FLUMIST quadrivalent to a patient who was 52 years old on 06-Nov-2013 and were not reporting any symptoms. The outcome of the event of administered FLUMIST quadrivalent to a 52 year old is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 20-Nov-2013 from health professional: Narrative update.
A non-serious spontaneous report of positive flu test manifested with body aches has been received from a consumer concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 10-Sep-2011. On 19-Sep-2011, the patient tested positive for flu and then took oseltamivir and had symptoms of body aches. The outcome of event positive flu test was recovering.
Sore Arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient stated after the first dose of Shingrix had a sore arm. The patient enquired about 2nd dose.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107060:Same reporter/same patient
Patient started feeling dizzy, nauseous and feeling like she may faint.  She reported back after about 15 minutes after the shot.  I had her lay down and brought her some water.  I check her BP which was low and offered to call emergency services for her, but patient refused saying that she doesn't feel that bad, but still couldn't walk.  She was laying down for about 45 minutes before her BP returned to normal and with just rest and some water she felt better after about 30 -45 min.  After one hour patient was back to normal and she left home.
Administered 2nd COVID-19 vaccination on 06/28/2021 to patient. Vaccination had BUD of 06/26/2021, therefore, vaccine was given 2 days beyond BUD. Patient was called to make aware. At this time, unsure if patient has called facility back. We are waiting to hear back from Moderna regarding efficacy of vaccination administered.
Rash on face, neck, and arms for 1 week. Given steroid shot.
pt passed out 15min p/vax while driving home;pt remembers feeling nauseated just prior to losing consciousness;didn't feel had any injureis but contacted MD who felt either had med interaction or allerg rxn;
sorta sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sorta sick) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ILLNESS (sorta sick). At the time of the report, ILLNESS (sorta sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The consumer had  a very small suspicion that the husband possibly could have had covid back in February 2020
Patient received the flu vaccine on October 17th and said she still has muscle pain on the deltoid muscle where she received the vaccine over a month later. She reported seeing a physical therapist for the pain.
LARGE WELT ON ARM; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (LARGE WELT ON ARM) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (LARGE WELT ON ARM). At the time of the report, URTICARIA (LARGE WELT ON ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included hydrocortisone cream.
I experienced a fainting spell while sitting in a restaurant and was not responding to anyone. A Paramedic came to my rescue while awaiting the ambulance to arrive. The Paramedics took my vitals upon arrival and my bladder emptied once I came to and was given water which had a strange taste. They advised me to see my PCP since I did not want to go to the ER. I went to see my PCP who referred me to a Cardiologist that performed a stress test, MRI, CT Scan all test came back normal and he then referred me to another Cardiologist who performed a tilt table test that came back normal. I was then referred to a Neurologist who performed the MRI and said basically I had a stroke which she felt was an adverse event from the vaccine since I didn't have any risk factors. I still have the dizziness but not as frequent as the episode that I experienced.
PATIENT BROKE OUT IN RASH ALL OVER BODY 2 DAYS AFTER RECEIVING THE VACCINE. PATIENT SELF TREATED WITH  ORAL BENADRYL  AND HYDROCORTISONE CREAM. PATIENT HAS SEEN IMPROVEMENT.
sore throat; This is a spontaneous report via a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the call, the patient reported that she wanted to reschedule her 2nd dose due to sore throat. The patient's 2nd dose was due today, 01Mar2020. Outcome of the event was unknown.           Information on the lot/batch number has been requested.
Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination.   The outcome of the events was recovering. No treatment was given for the events.  No follow-up attempts are possible, information about batch number cannot be obtained.
This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's medical history was not reported. On unspecified date in 2006, the patient was vaccinated with the first dose of GARDASIL, .5 ml, intramuscular for "CDC guideline recommendations". No concomitant medications were reported. The reporter reported that the year GARDASIL come out in 2006 the patient had broken out in a rash all over her body after being given GARDASIL. The patient sought medical attention contacted the physician. On unknown date, the patient received treatment with BENADRYL. Lab diagnostic studies were not reported. The outcome of the patient had broken out in a rash all over her body was reported as recovered/resolved. Additional information is not expected.
Two days post vax, the pt had puffiness and redness occurred at the injection site.
Yellow Fever Vaccine which may have been reconstituted with 0.7mL sterile diluent provided by Merck and meant for Merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution with no reported adverse event; Administered IM in lieu of SQ as directed with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old female patient who experienced Yellow Fever Vaccine - [YF-VAX] which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution and administered IM in lieu of SQ as directed with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On 28-Feb-2023, the patient received a dose of suspect Yellow Fever Vaccine -solution for injection which may have been reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution (lot: UJ782AA) via intramuscular route in lieu of SQ as directed in unknown administration site for prophylactic vaccination with no reported adverse event (product preparation error) and (incorrect route of product administration) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
The night started with fever 101 (controlled with tylenol), followed by dizzy spells on Sunday, which are preceded by hot, tingly feeling in body and chest pressure, sometimes tingle is in arms, or face.
Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever.  COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.
Second dose- Fever of 102, headaches, fatigue. Tylenol does help but fever only goes to 99. Got covid 2 days after receiving first dose.
It turned out that I had contracted shingles. The pain started on the August 13th. I thought it was back pain but then started getting a rash. I was told to go to Urgent Care - 8/18/2021. They gave me an anti-viral med for shingles and Prescription Ibuprofen. After that it was several weeks of the progression of the shingles and getting rid of it. Several weeks.
Patient presented to the ED and was hospitalized for alcoholic intoxication with complication, hepatic encephalopathy within 6 weeks of receiving COVID vaccination. He was hospitalized for 7 days starting 3/19/2021 for alcoholic cirrhosis of liver without ascites. Patient had several more ED visits, and did receive second dose of covid vaccine on 6/11/2021.
After 7 days, on August 12th, I starting feeling pains around the shot area and it was severely itchy. When I finally took a look at it, it was a red, swollen and rash-like spot, measuring about 2 inches and round in shape.
Acute onset swelling, redness and warmth to left bicep area surrounding identified site of injection above in generalized distribution of bicep extending to shoulder approximately 5 cm area of induration centrally.
1st Covid Vaccine: Pfizer 8/9/21 Symptoms: dizziness, headache, extreme nausea + digestive upset, congestion, muscle + joint aches, tender breasts and painful injection site   -Day after vaccine: unable to function, feeling extremely ill, in bed   -Headache, dizziness, nausea + digestive upset, muscle aches, tender breasts continue until 8/18   -Nausea + digestive upset and tender breasts continue until today   Question: Great concern in regard to receiving 2nd vaccine.  If yes, when?  If no, letter of exemption?   If yes: optimal wait time until 2nd shot, supporting body with second shot, teaching until receiving second shot?   If no: Exemption from vaccine, recommendation for medical leave?  Teaching without second vaccine? Safety measures?
Knot feeling at injection site almost immediately after injections. Headache and felt cold, then hot then nauseous. Went to bed early, approximately 1am couldn't move legs and had a sever headache. Couldn't stand . Son had to carry her to the bathroom. Went back to bed. Woke up next morning approximately 7 am was able to move legs and still had a sever headache nausea temperature of 101 Remained in bed on 5/14/22. Symptoms began to easy morning of 5/15/22 and temperature broke.  Monday 5/16 feels great other than injections site is still hard, but there has been not signs of infection and is not hot to the touch.
Woke up and had really bad pain in right shoulder, couldn't lift arm, no swelling, and no red marks.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 29 months old female patient who received PENTACEL but already had received ACT-HIB and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE at her 20 month visit. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE and HEPATITIS A VACCINE (administration site: left thigh). On 05-Nov-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5530AA in Right Thigh. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether any adverse event occurred or not. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
given an expired IPOL with no adverse event; Initial information received on 19-Mar-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years old male patient who was given an expired 0.5 ml dose of IPV (VERO) [IPOL] (lot R1B251M and expiration date 13-Mar-2021) via intramuscular route in the right thigh for prophylactic vaccination on 10-Mar-2021 (expired product administered) and this was noticed when reporter was entering the information into the computer.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of actual medication error due to expired vaccine used (same day latency).  It was not reported whether the patient had any adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information on the batch number for this case.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, "like Purified Protein Derivative (PPD)", under the skin, not subcutaneously, for immunisation. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced injection site vesicles (little bubbles like after PPD injection, raised skin). The patient sought medical attention by speaking to the pharmacist. The outcome of the injection site vesicles was unknown. The relatedness between the event and both suspect therapies was not assessed by the reporter. Product quality complaint was not involved.
pt recv vax 26JUL95 & 4 days later 30JUL95 pt had t103 & was lethargic; pt was adm to hosp 1AUG95; dx w/aseptic meningitis; discharged p/3 days in hosp; pt recovered; pt had contact w/sibling who had resp infect & cold 1wk prior
each time after getting the shot I got a bladder, Urinary tract infection I was hospitalized once; each time after getting the shot I got a bladder, Urinary tract infection I was hospitalized once; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER2613, Expiration date not reported, NDC number: unknown), via an unspecified route of administration in an unspecified anatomical location on 23Mar2021 (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes, cholesterol, partially deaf and heat. Concomitant medication(s) included isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for heat and diabetes, once a day for 8 years, metformin (MANUFACTRURE UNKNOWN) taken for diabetes mellitus, insulin (MANUFACTRURE UNKNOWN) taken for diabetes, metoprolol (METOPROLOL); atorvastatin (LIPITOR) taken for cholesterol. Consumer Stated that in her whole life she never had a bladder or urinary tract infection and each time after getting the shot she got a bladder, Urinary tract infection and was hospitalized for three days after the first shot and went to the emergency room just an hour to the second shot and was not admitted and left with medication antibiotics on 28Mar2021. On 23Mar2021, she got some symptoms but the result was from a urinary track and bladder infection, the first one was E.coli and the second one they didn't tell her what kind of infection it was. The seriousness of event was reported as serious. The outcome of the events was unknown.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.