chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Soreness at injection site; Tenderness at the injection site; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, soreness at injection site, tenderness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011L20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced fever, soreness at injection site, tenderness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.
Fever 100.4; Heart Palpitations; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old non-pregnant female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via unspecified route of administration on left arm on 12Feb2021 12:00 PM (at the age of 55-year-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included quetiapine fumarate (SEROQUEL), alprazolam (XANAX) atorvastatin (LIPITOR [ATORVASTATIN]), acetylsalicylic acid (BABY ASPIRIN) and lamotrigine (LAMICTAL). On 16Feb2021 14:00, the patient experienced fever 100.4, heart palpitations and headache. No treatment medications were received for the adverse events. Outcome of the events was not recovered.
Achy body; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 at 09:00 am on the right arm as unknown, single for COVID-19 immunization. Patient's medical history included Stroke, Allergy to Lisinopril and Latex allergy at an unspecified date. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications include Aspirin (325mg), Atorvistatin, Flomax and Famotadine at an unspecified start and stop date. On 27Jan2021 at 10:00 pm, the patient experienced Soreness at injection site after 36 hours of vaccination and 48 hours post injection experienced achy body. Patient confirmed that he had no fever. Treatment was received with Tylenol. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Began to have weakness rt hand & leg; fatigue 23DEC93 weakness progressed; hospitalized 27DEC93; dx w/GBS 28DEC; recovery is slow involving physical therapy & rest & chronic diarrhea on 12DEC93;
Patient reported to PCP office on 4/27/22 as an ER follow up. Was seen at free-standing ER on Monday 4/25/22 for an itchy rash. Diagnosed with urticaria. Instructed to add benadryl q 6 hours x 1 day, then OTC claritin /zyrtec/allergra daily x 5 days. Was given RX for prednisone 10MG qd x 3 days. Flare up of "itchy rash" on 4/27/22 prompting PCP visit. Had taken zyrtec earlier in the day at rash onset and symptoms resolved.Final dx of Urticaria. Continue with zyrtec daily 10MG x 2-3 weeks ; ok for benadryl at bedtime for breakthrough hives. Recommend evaluation with allergist - as patient just has first dose of Menveo vaccine. (Tolerated all previous doses of DTaP containing vaccines throughout childhood)
Discussed flu and Tdap vaccines. Client decided just Tdap at this visit. I administered flu vaccine instead. Noticed my mistake when client had already left the building. I phoned her and she plans to receive her Tdap when fiance also comes to health dept for Tdap next week.
shingles; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program, COVAX US Support. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician stated that the patient contracted shingles after first covax vaccine. The patient has second dose scheduled for 20Feb2021; physician advised patient not to get second covax vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
i have been having a pain in my left arm where the shot was given. i didn't have any pain right after the shot. it has all started in april
Woke up at 3 so cold, I rolled my shoulders in to keep warm.  So my chest is really hurting.  I took my temp and it was 100.  I was so cold I thought it was 102. I drank water and took nyquil.  I was able to sleep better. I still have a fever of 100, however not feeling as bad.  However my chest is very tight.
12/20/2021 Covid symptoms started. I felt very exhausted and fatigued. On the 21st I woke up very sick with runny nose, sneezing, horrible sinus pressure, facial pain, teeth pain, chills with no fever, a little tickle in my throat but it wasn't persistent, and drainage and congestion. The facial pain was the worst face pain I've ever experienced. It hit all at once and I slept for 2 days, and on the 23rd I felt better.
This spontaneous report was received from a female patient of unknown age. Information about concomitant medications and drug reactions was not provided. The patient's medical history included shingles. On an unspecified date in 2017, the patient was vaccinated with a dose of ZOSTAVAX (route reported as injection; lot # and expiration date were unknown) as a preventative measure for shingles, as she has had "shingles" previously before(Intentional misuse). No adverse effects were reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03FA21B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            relevant concomitant products usage were not reported by the reporter. Treatment details not included. Action taken with mRNA-1273 in response to the drug was not applicable.
This spontaneous report was received from a health care professional refers to a unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with, Oral, ROTATEQ (dose, route and frequency unspecified). No medical history and concomitant medications were provided. It was reported that the doses administered on an unknown date to an unspecified number of patients may have been improperly, stored doses of either GARDASIL or ROTATEQ or improperly stored doses of both GARDASIL. No adverse effects reported. The outcome of the medication error was unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Nurse requested information about revaccination of VARIVAX after the titer showed no immunity to varicella virus. The patient believes she received the varicella vaccine as a child, but does not have any records to confirm it. Precautionary AE filed.; This spontaneous report was received from Other Health Professional and refers to a 38-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, nurse requested information about revaccination of  varicella virus vaccine live (oka/merck) (VARIVAX) after the titer showed no immunity to varicella virus (Antibody test negative). The patient believes she received the varicella vaccine as a child, but does not have any records to confirm it. Precautionary AE  filed. At the time of reporting, the outcome of the event Antibody test negative was not known. The action taken with VARIVAX regarding Antibody test negative was reported as Not Applicable.   The causal relationship between Antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe
tested positive for covid 11/25/21- known exposure to family member who was positive- sx include low grade temp, body aches
Patient came in 15 days after receiving the first dose and was vaccinated before the normal 21 days.
102.5 Temperature  Fatigue  Shakes Cold Spells Nausea  Headache  Hot flashes  Aches and pains throughout body Neon color bowel movements/ diarrhea  Injection site inflammation swollen large area very painful to touch, hard knot
At 2:30pm: at the doctor's office he told her blood pressure and it was 138/90 got lightheaded, and dizzy, flushed. Was brought in to the room, took another BP 160/100, pulse 120. Swelling at injection site, 4" all around at 3pm started to have chest tightness, SOB, EMS was called. BP still at 100/60, P=100, Benadryl was administered, taken to hospital ER, EKG and CXR done, and lab works. Released at around 7:30 or 8pm.
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Caregiver reported patient had a rash at vaccine administration site. Will take to pediatrician for an assessment.
shot site to bend of lt. arm was swollen and hot to touch on 10/28/04. Pt. f/u with dr. He state she is allergic to something in vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Within a few hours of vaccination the patient experienced rash across the chest. On 19th July 2018, the patient came into office and healthcare professional reported seeing rash on chest from shoulder to shoulder and on the front and back of neck area. No pain or itchiness was there. It lasted for 3 days. The healthcare professional would like to know if the patient should receive the 2nd dose based off these reactions. No additional information provided.
On the morning of November 18th, I woke with a small rash on the right side of my back. No redness, but small bumps (less than 20) running from bottom of ribs to shoulder blade. By noon I had  itching throughout my trunk, neck and head, and by 4pm I had hives on my lower back and lower abdomen. The hives continued to worsen in severity, appearing without any pattern. The areas affected were by back, abdomen, chest, face, neck, forearms, hands, and thighs. Benadryl and Zyrtec provided minimal relief, improved with steroids. Continues to randomly appear, but not as severe.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2018, the patient was inadvertently administered one dose of (Oka-Merck) PROQUAD (lot: M042500) subcutaneously which was expired on 17-APR-2018 (expired drug administered). No adverse effects reported.
Abnormal cry, cyanosis w/02 sats 88-90%; t101;
For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible; A little headache; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 18-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 VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache). At the time of the report, VACCINATION SITE PAIN (For the first shot she almost had no reaction. She had a little bit of sore arm that wasn't that terrible) and HEADACHE (A little headache) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-294225 (Patient Link).
Flu Like Symptoms; Fever; Chills; Vomiting; Nausea; Loss of appetite; Diarrhea; Headache; Painful arm; Blisters in mouth; She could not move or do anything and was in bed; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 1st May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired. The patient was treated with ibuprofen and emetrol (nos) (Emetrol). In May 2019, the outcome of the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, vomiting, nausea, appetite lost, diarrhea, headache, pain in arm, blistering of mouth and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm and at that night she woke up with flu like symptoms, fever, chills, vomiting, nausea, loss of appetite, diarrhea, headache, painful arm and blisters in mouth. The patient could not move or do anything and was in bed. She missed 3 days of work.  The patient mentioned the first three days were worse. The patient took Emetrol and Ibuprofen. Vomiting and nausea were resolved after lasting for 3 days. Influenza-like symptoms, fever, chills, appetite lost, diarrhea, headache, pain in arm and blistering of mouth were resolved after lasting for 5 days. No further details were provided. The reporter consented to follow up.
seriousness for facial and throat swelling; seriousness for facial and throat swelling; This serious case was reported by a consumer and described the occurrence of facial swelling in a 71-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25-APR-2023, the patient received the 2nd dose of Shingles vaccine. On 29-APR-2023, 4 days after receiving Shingles vaccine, the patient experienced facial swelling (Verbatim: seriousness for facial and throat swelling) (serious criteria clinically significant/intervention required and other: Serious as per reporter) and throat swelling (Verbatim: seriousness for facial and throat swelling) (serious criteria clinically significant/intervention required and other: Serious as per reporter). The patient was treated with methylprednisolone. On 30-APR-2023, the outcome of the facial swelling and throat swelling were resolved (duration 1 day).   It was unknown if the reporter considered the facial swelling and throat swelling to be related to Shingles vaccine.  It was unknown if the company considered the facial swelling and throat swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2023 The patient experienced facial and throat swelling and urgent care issued Methylprednisolone tablets. The symptoms lasted for 36 hours. The reporter consented to follow up via email.
I HAVE HAD ACHES AND FATIGUE BEYOND WHAT I NORMALLY SHOULD EXPERIENCE ALSO HAVE RAN A TEMP. OF 99.1 TO 100.4  ALSO MORE CONGESTION THAN USUAL.  THIS WAS MOST PREVELENT UNTIL MARCH 31ST.  AS OF TODAY I DO FEEL BETTER BUT I AM NOT AS WELL AS ON THE DAY OF THE SHOT. [3/24/21]
VOMITED; 25 PLUS TIMES DIARRHEA; SEVERELY RUNNY DIARRHEA; CHILLS; ACHY MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. No concomitant medications were reported. On an unspecified date, the subject experienced vomited, 25 plus times diarrhea, severely runny diarrhea, chills, and achy muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy muscles, vomited, severely runny diarrhea and 25 plus times diarrhea was not reported. This report was non-serious.
PATIENT COMPLAINED OF SEVERE ITCHING ON FACE, NECK, TORSO, ARMS. SHE HAD SMALL TO VERY LARGE (JOINED) HIVES FROM HER HIPS TO HER CHEEKS. SHE WAS QUIET AND DID NOT HAVE AN APPETITE. ITCHING AND HIVES HAVE REAPPEARED DAILY.
DIZZINESS; COLD SWEATS; CAN'T EAT MUCH; NAUSEA; VERY DRAINED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, cold sweats, can't eat much, nausea, and very drained. Treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, nausea, cold sweats, can't eat much, and very drained. This report was non-serious.
Seizure at school on 1-9-13 and had first HPV (GARDASIL) on 11-26-12. Dad got a call at 1045 today that she had a seizure; teacher with her said she had a grand mal seizure; lasted 6 minutes. Had a few more minutes of incoherent confusion; not recognizing anyone. Teacher who witnessed this has a child with seizures; had difficulty breathing at the time; no cyanosis; coughing and breathing erratically, thought she bit her tongue; blood flowing from mouth that stopped at end of seizure. Leaned on desk, fell onto floor, didn't hit head but spasms caused head to bounce. Gets migraines and had one yesterday, lots of stress yesterday and more than average in the last couple of months. School didn't call 911. No incontinence. Dad took her home, she was still "kind of out of it" (like when she has 'bad migraine'). She can't remember much until she got to bed at 1145; could walk on own but not stable. Slept 3 1/2 hours. Feels tired now; no headache. Migraines have been present since age 3; sees Dr. Has her on RELPAX, ibuprofen and BENAGRYL/REGLAN. No chest pain. Usually ibuprofen at onset of HA works.
Cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed.            Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. company comment-This spontaneous case concerns an adolescent female patient aged 15 years with no medical history reported, who experienced the fatal serious (medically significant) unexpected event of Cardiac arrest which occurred after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. The reported cause of death was Cardiac arrest. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to doses was available in the report. Patient died on an unknown date. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up  Non-Significant information accepted.; Sender's Comments: This spontaneous case concerns an adolescent female patient aged 15 years with no medical history reported, who experienced the fatal serious (medically significant) unexpected event of Cardiac arrest which occurred after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. The reported cause of death was Cardiac arrest. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to doses was available in the report. Patient died on an unknown date. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Reported Cause(s) of Death: Cardiac arrest