chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/24/22 presents to ED for "manic behavior". PMHx of "depression and hypertension".
FLU-LIKE SYMPTOMS(FEVER,ACHES,HEADACHE,PAINS); TOE CRAMPED UP; SHOOTING CRAMP PAIN BEHIND KNEE CAP AND PAIN IN CALF; This spontaneous report received from a patient concerned a female 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced toe cramped up. On 2021, the subject experienced shooting cramp pain behind knee cap and pain in calf. On 31-MAR-2021, the subject experienced flu-like symptoms (fever, aches, headache, pains). Laboratory data included: Body temperature (NR: not provided) 101.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms(fever, aches, headache, pains) on 01-APR-2021, and the outcome of shooting cramp pain behind knee cap and pain in calf and toe cramped up was not reported. This report was non-serious.
12 hours after shot I got extreme chills and fever once fever broke I was dripping in sweat and very hot to touch this happened 3 times in the full 20 hours than ended around 10:30 pm Sunday than Monday at 4 pm had the chills and fever again this happened two times last fever was 9:30 pm
Information has been received from a nurse practitioner concerning a 24 year old female patient who in 2007 was vaccinated with a second dose of GARDASIL. The nurse practitioner reported that after the patient received the second dose of GARDASIL, she experienced irritation and itching. The nurse practitioner also reported that the patient was recently detected with GARDASIL despite finishing the dosing schedule of GARDASIL in 2007. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Swelling, itchiness, soreness and fever lasting 1 1/2 to 2 weeks, after 3rd and 4th shots.
vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023).    No concomitant medications were reported.  Vial size was reported as 2.5 ml The vial was initially stored in the refrigerator 16-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 4th of 6th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809, US-MODERNATX, INC.-MOD-2023-717811, US-MODERNATX, INC.-MOD-2023-717812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717808: US-MODERNATX, INC.-MOD-2023-717809: US-MODERNATX, INC.-MOD-2023-717811: US-MODERNATX, INC.-MOD-2023-717812: US-MODERNATX, INC.-MOD-2023-717812:
Extreme tiredness, I slept or was in bed 20 out of 24 hours. This happened 24 hours after the injection. It exacerbated my usual back pain to the extent I became functionally immobile. The only side effect of the first injection 3 months ago was a very sore arm at the injection site.
RASH AT SITE OF INJECTION WITH MILD ITCH AND ALSO A MILD ITCH OVER RIGHT EYE. NO RASH THERE. PATIENT SAT FOR FULL 20 MINUTES AND GAVE HER BOTTLE OF BENADRYL ELIXIR GENERIC TO TAKE HOME WITH HER WITH INSTRUCTIONS TO CALL ME WHEN SHE GOT HOME AND IF SHE TOOK DOSE AND HOW MUCH. TP SAID SHE FELT OK AND TOOK 20ML OF BENADRYL GENERIC LIQUID. TOLD HER IF MAY MAKE HER DROWSY AND CONFIRMED THAT FAMILY WAS AT HOME WITH HER WILL CALL ME IF ANY FURTHER PROBLEMS AND DEFINITELY WILL FOLLOW UP TOMORROW 12/17/16.
she can't use her right hand after the 1st vaccine; This is a spontaneous report from a Pfizer-Sponsored program received by a non-contactable consumer (patient).  A female patient (unknown age) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown date, on unknown date , at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided.The patient stated she can't use her right hand after the 1st vaccine. The outcome of the event was unknown.  No follow-up attempts are possible.No further information is expected. Information about lot/batch number cannot be obtained.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported, age at vaccination: 49-year-old), dose 2 via an unspecified route of administration on 01Jun2021 as dose 2, single, and dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation. Medical history includes she does have some health issues which are hereditary. There were no concomitant medications. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other vaccination taken with 4 weeks of covid-19 vaccination. No AE following prior vaccination. The patient reported that she had both doses of the Pfizer COVID-19 Vaccine and had no side effects. But she and her husband, who is not vaccinated, tested positive for COVID-19 on 19July2021 and as she was experiencing some symptoms like started feeling a runny nose and stuffiness in the head and a headache. Her runny nose was ongoing, and no treatment was received for it, so she got tested and one test showed that she passed the POCT internal QC COVID-19 AG. But the POCT COVID-19 Allergen test showed it was detected. She was wondering if she is showing detected because she has the antibodies in her body from the vaccine. Her 17-year-old daughter is also in the house was also vaccinated and her boyfriend was not. And she was referred to her HCP for further interpretation of the results as well as contacting the manufacture or laboratory that performed the testing for interpretation of results. The patient reported that she went back to where she went for her primary last Thursday and showed him her card, it was a normal check-up. He asked if she was vaccinated, and she said yes and showed him the date. And when he saw 01Jun2021 he said she should have a lot of antibodies still left in her. She got her results back and her husband came in contact with someone and found out that he was positive. The patient did not visit emergency room or physician office due to AE. The patient underwent lab tests and procedures which included COVID-19 AG results showed passed and POCT COVID-19 Allergen test and results showed positive on 19Jul2021. The outcome of event was not recovered.
First shot I was tired and arm hurt. No bid deal. 2nd dose received end of feb. 2-3 days later started spotting. Had not had a period in over 8 months.  Hot flashes had subsided.  One month later having EXTREMELY bad period, with excessive bleeding. Could not even go to work. I truly believe it came from vaccine.  Figure I should report so there may be data. The second dose caused severe fatigue for 5 full days, my concentration was foggy.
Migraine; Stiff neck pain; Low grade fever; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 11:00 (Lot number: unknown) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: AMLODIPINE; OLMESARTAN and ZOLPIDEM.  The following information was reported: MIGRAINE (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Migraine"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Stiff neck pain"; PYREXIA (non-serious) with onset 08Jan2022 at 17:00, outcome "not recovered", described as "Low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, musculoskeletal stiffness and pyrexia.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Extreme chest pain, shortness of breath.  Gasping for air.  West to a walk in clinic who conducted an EKG and vitals.  They did not like the EKG and sent me to the ER stat.  I went to the ER, was admitted and they took blood tests to rule out a heart attack (which they did) and EKG and blood pressure as well as other tests.  After being there for hours, they came in and said I was healthy, it was not a heart attack and that they believe it was a bad reaction to the vaccine.  It was around 24 hours since I had taken second dose and they do not believe it was a coincidence.  They gave me something for the chest paid and my breathing returned to normal the next day.
Fever (flushed/warm), headache, joint pain, muscle weakness, skin sensitivity to touch, lips and circumoral area numb feeling, and hard to breathing. Had to my inhaler 2x and next morning. Started 6 hrs after flu vaccine. Improved overnight but still using inhaler. Also had blood shot injected eyes which have improved.
Daily/Nightly headaches began 15Oct and have continued. Waking up most mornings with pounding pain on one side of my temple or the other; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 12:30 as dose 1, single (Lot number: HG4665) at the age of 44 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Oct2023 as dose 1, single (Lot number: u8200da), in left arm for immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: until 24. Concomitant medication(s) included: AMITRIPTYLINE. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Daily/Nightly headaches began 15Oct and have continued. Waking up most mornings with pounding pain on one side of my temple or the other". Therapeutic measures were not taken as a result of headache. Additional information: The patient did not have covid prior to the vaccination. The patient has not been tested post vaccination for covid.
At 12hrs after injection: mild fatigue, very mild headache, very mild chills. All resolved within 24hrs of injection. At 30hrs after injection: continual and intensifying muscle/nerve pain in mid-pack with skin sensitivity in that area. Ongoing.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/8-9/13.
Client received flu vaccination without incident.  About 10-15 minutes later client returned with her child who said she was feeling light headed. School nurse was requested for interpretation and she asked client to sit down. Pulse 102 BP 118/78.  Briefly complained of heart palpitations . Client stated her symptoms were not severe but because she was driving with children in car she wanted to make sure she was okay to drive. Client refused to lay down but sat and said she had not eaten for  few hours.  Also stated she has had a similar reaction to vaccines in the past.  After about 10 minutes client felt better and good enough to drive and left with instructions to follow up with medical care if symptoms returned.
tested positive for Covid-19 as of 20JAN2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19 as of 20JAN2023) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot number 016B21A expiration date is 13-Aug-2031, Left Arm of administration) on 23-Mar-2021, Moderna COVID-19 Vaccine (Dose 2, Lot number 044B21A expiration date is 06-Oct-2021 and not known Arm of administration.) on 20-Apr-2021 and Moderna COVID-19 Vaccine (Dose 3 (First Booster dose)). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In December 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jan-2023, the patient experienced COVID-19 (tested positive for Covid-19 as of 20JAN2023). At the time of the report, COVID-19 (tested positive for Covid-19 as of 20JAN2023) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2023, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  Patient reports that, she had tested positive for COVID-19.  No treatment medications were reported.
Pt to clinic for vaccines. Pt was due for 3rd DTaP and 2nd Varicella vaccines.  Pt was given both vaccines and informed to wait in clinic 15 minutes after vaccines administered. One minute after leaving the room, pt's stepmother comes out stating pt is having a reaction to the vaccines. When entering the room, stepmother points at a rash under the patient's eyes. Pt has pinpoint rash located under both eyes. Pt remained in the clinic for 15 minutes after administration. Pt did not have rash noted anywhere else. Pt denied pain or difficulty breathing.  Pt referred to Pediatrician for follow up. Pt's stepmother informed to take pt to ER if any difficulty breathing.
Headaches, progressive and persistent fatigue, anorexia, leg pains within 2 days, after BEXSERO on 11-24-2015 and which have persisted to date (2-4-16). Weight loss of approximately 7 kg. Due to anorexia from 11/24/15 (65 kg to present 2/4/16 (58.6 kg) nausea, vomiting, diarrhea started 11-28-16
The vaccine triggered diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Family history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COMIRNATY (dose 1, single; lot number: unknown), for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (disability, medically significant, life threatening), outcome "not recovered", described as "The vaccine triggered diabetes". Therapeutic measures were taken as a result of diabetes mellitus. Clinical course: The vaccine triggered diabetes in the patient. There is a family history of diabetes but the patient had no symptoms or pre-diabetes before getting the second dose. The patient was on insulin at the time of the report.  The lot number for BNT162B2 was not provided and will be requested during follow up.
A little light headed; very tired; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 at 60-years-old (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included High blood pressure. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. Patient had no known allergies. Facility type vaccine: Other. Concomitant medications included amlodipine besilate (NORVASC). The patient experienced a little light headed and very tired on 10Mar2021 14:00 with outcome of recovered in Mar2021. No treatment received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccinated at 10:30am, took a nap until 3pm and woke feeling generally unwell. By 6pm I was vomiting, fever by 12am, chills and cold sweat all night, vomiting continues, diarrhea at 3am
adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (adverse event) 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 ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was reported.
Extremely irritability, spitting up with feeds, temp 102.7 x 2d.
mom & dad of pt came to office on 25SEP92; refused the DPT stating pt cried all noc unconsolable cried from 5PM to 11PM; there was no leg swelling & no fever but the pt was given APAP during that time period every 4 hrs;
Severe body aches, headache, upper back pain that made it difficult to sleep. Very little appetite. Could not report for work due to pain and exhaustion.  I took ibuprofen alternating with acetaminophen in accordance with the directions on the medication. Slept, drank lots  of water
This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection.  The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional.  On an unspecified date, the pt received either Engerix-B vaccine (lot number unknown) or Infanrix vaccine (Lot # DTPA958A2 or lot # DTPA524A2). On 12/10/03, the pt's attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths."  No further information regarding the specifics of their claims is available at this time.  It is unknown whether an autopsy was performed.
NO ADVERSE EVENT noted. Patient was administered a dose of intranasal flu vaccine that was expired.
Approximately 4 months after my booster shot (Dose 3) I contracted COVID-19 and had the following symptoms: Body aches, Sore throat, Low grade fever, Accelerated heart rate, Runny nose, Fatigue. I took Tylenol for treatment and was not prescribed with anything. I did isolate for 6 days then the 7th day I started feeling better but I still have a lingering chest pain.
Erythema, warmth, and induration of approx. 4cm diameter around injection site of Prevnar and Varivax.
Mild sore arm within hours,  chills for several hours later that night .   Took two Advil.  Chills stopped soon after.  Two days later on March 29, 2021, developed rash that started on midriff and spread up to my neck by next day.  Some small blistering in spots but mostly looked like sunburn.  Subsided after two days.
Children exposed at daycare and had Positive test results 8/25; Pt. developed sniffles and was COVID positive on 8/27/21 becoming a covid break through case.
Pt had 2nd shot and stated, had diarrhea X 3 days, arm pain from injection site, balance stated off-kilter
Mother contacted the office 10 days after 12 mo injections (Hep A, MMR, Varicella) to report raised, red rash that started 1 day prior. Associated symptoms: Subjective fever. Rash was not bothersome to patient , no discharge reported. At the time of call patient was active, playful and had normal po intake. Media uploaded to patient's Electronic record by Parent and reviewed by Physician.
Severe body aches, severe chills, uncontrollable full-body shaking - similar to a panic attack Anxiety Lasted several hours Treatment - hot shower, warm blankets, soothing environment, mainly time - waited for it to run its course
The patient was vaccinate @ 1300, waited 15 minutes and left vaccination site.  About 5-10 minutes later, the patient re-presented at the vaccination site stating she felt hot and was having problems focusing.   About 5 minutes later, after lying on a cot, she complained chest heaviness.  Her face also started to show evidence of blotching.  911 was called and an EpiPen was administered.  EMS arrived about 5 minutes after being called and 4 minutes after EpiPen administration.  EMS observed the patient for approximately 10 minutes.   Patient refused transport to hospital, but felt much better when she left the site.
Muscle pain down left arm that started evening after shot and became worse over the weekend. Today 03/21/2005 left arm aches and hand feels weak. swelling and erythema at site and left arm.