chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was feeling like I was getting a cold, about two days later I was having fever of 100.3 and chills with bad body aches and I took a COVID-19 Home Test, and it was positive. I did reach out to my health care provider and had a telehealth appointment; they did give me a prescription for Paxlovid. At 4am that morning I had temperature of 100.4 when my spouse left for work, I had been taking ibuprofen for my fever, but they said to try not to take it unless I was miserable. The Paxlovid helped a ton with the symptoms, and I was feeling much better as soon as I started taking it that Tuesday evening. I could tell when I went off that because I did have congestion and a runny nose when I stopped taking the Paxlovid. I did have dismissed taste, smell, and appetite.
Swollen and painful lymph nodes in armpit and on neck.  On same side as injection so far, but this also happened with third shot (Moderna) and lymph nodes on opposite side near groin were affected.  (Did not report at that time)
Headache; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she was scheduled to receive the second dose of BNT162B2 "today" (as of 02May2021). She stated she had a headache in the morning, and she took ibuprofen. She inquired if she should still receive the second dose that day or if she should postpone it. The clinical outcome of headache was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approx 10 min after H1N1 vaccine was administered attempted to walk she fell resulting in laceration to her chin. Student was noted to be lethargic clammy and plae, BP 80/50. EPI PEN Jr administered by nurse. 911 call and dsng applied to chin.
The reaction started out with slow with swollen raised marks (looked like mosquito bites) as I thought they were which was about 2:00 p.m. (6/9/2020) first noticed the marks on her legs then a huge one on her arm. Later that evening I gave her Benadryl the hives got worse so I continued giving the Benadryl as prescribed (4 to 6 hours). During this time the reaction was only getting worse. Thursday I gave them a call and told them about the break out I took her to the doctor on 6/12/2020. Once we had arrived to the doctor her Left eye was swollen shut she was covered in hives and very itchy.
Soreness and mild swelling at injection site within 4 hours, lasting 2 days. Severe fatigue and headache at 12 hours, lasting 12 hours, treated with ibuprofen.
Shooting pains into neck on injection side and malaise and then next day 2 cm redness around injection site
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case was for patient 95 out of 104. Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away.  I got home around six pm.  I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .
Running a temp of 99.5-100.5 and on Aug 24th had sores in her mouth.
She seemed to be fine, was talking normally.  It was as if it came out of nowhere.  She has never fainted before, nor had she ever had an adverse effect until now.  Syncope and collapse from a sitting position landing face first onto the hard concrete floor.  Causing a two chipped teeth, two fat lips (upper and lower) on the left side, concussion, and a black eye on the left side. A CAT Scan was given, along with anti nausea meds to control the repeated vomiting.
Spoke with Dad - area was red/warm about size of quarter on (L) arm - after BENADRYL/Ibuprofen given - great improvement. Spoke with Dad on 12-13-13 area completely back to normal - per Dad wouldn't even known he had a vaccine.
One week after injection: Large 3 x 4 irregular shaped red area near the injection site on upper arm.  Intense itching, redness, and swelling along edges.
About 19 1/2 hours after receiving 2nd dose of Moderna vaccine I had a seizure. I had been asleep, but woke up feeling nauseous, got out of bed to get to the bathroom and my husband said I collapsed, stiffened and had spasms, when I regained consciousness, I had buzzing in my ears, and couldn't feel my extremities for a few minutes.
6 hours after shot woken up with tachycardia. Fast  pulse came and went for next 24 hours. Fast heart and shaking. On day 5 after shot got rash on chest and itchy redness on side of face.
C/O left side of axillary and spreading to the left arm and leg pain and heavy feeling 1 wk after HPV vaccine. The sx lasted for couple weeks.
The patient stated that she had the 2nd SHINGRIX Vaccine on Monday afternoon (9/10/18), the next day (9/11/18) she felt severe flu-like symptoms throughout her body, and by Friday, when she came to the office she could hardly move, and had a fever of 100.0.
Patient is a nurse and received her 2nd COVID vaccine dose 1/25/2021. She knew she was at risk for anaphylaxis so she was kept under observation at the vaccine administration site. Ten minutes after receiving her shot she felt her lips starting to tingle along with lightheadedness. She did not have any other symptoms. She was given 50mg IM benadryl, and the patient was transported to the emergency department. Her symptoms resolved after receiving benadryl. After being evaluated in ER, where no further treatment was warranted, she was discharged with Pepcid, prescription for 4 days of prednisone, and EpiPen. She was given a referral to allergy clinic.
HSV1 outbreak; left thigh stabbing pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 56 years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma in situ, osteomyelitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium, zinc, calcium (CALCIUM MAGNESIUM ZINC), collagen (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all for unknown indication from an unknown date. On 19Mar2021 at 19:00, the patient experienced left thigh stabbing pain and after 10 days of vaccination, On 25Mar2021, the patient experienced herpes simplex virus type-1 (HSV1) outbreak. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event left thigh stabbing pain and HSV1 was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient expired 3/8/2021 at home.  Coroner pronounced time of death at 0415 and assumed cause of death was history of transplant and cardiac.
15AUG91 @ 710PM mom was bathing pt;  Pt acted as if was having sz & choking; mom called ambulance, pt to Hosp, t102, dx by MD OM; tx Amoxicillin;
Nausea, vomiting, diarrhea, (L) deltoid swelling 8cm diameter. Red welt.
at the side sight the patient sees rainbows; vision changes in the peripheral sight; This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    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 VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight). At the time of the report, VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
15JUN arm very warm, swollen, hard, painful, no redness, dec ROM of aim; 6JUN redness upper arm below inject site; 7JUN inc redness, more swollen, firm & warm to touch; 10JUN still swollen, less pain, better ROM, no redness, no systemic sx
sore arm for a bit less then 48hours starting 10/16/21 , went away on it's own. Headache for 2.5 weeks starting on 10/16/21 , relieved with Tylenol diarrhea, gas and stomach discomfort starting 10/16/21 - ongoing vaginal bleeding- spotting , starting 10/16/21 , heavy bleeding  from11/11/21  - ongoing--- possibly  unrelated to vaccine as some previous issues with this had already occurred. The reoccurrence could have been coincidental.
used 5/8 needle to inject the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine). On 31-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (used 5/8 needle to inject the vaccine) 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 drugs were reported.  Treatment information was not provided.
Information reported by individual involved as follows.  AFTER 2ND VACCINE OF PFIZER I HAD SEVERE MUSCLE ACHES AND FEVER ABOUT 12 HOURS POST VACCINE WHICH IS EXPECTED  DIAGNOSED MILD CASE OF BELLS PALSY.  LEFT SIDED FACIAL NUMBNESS TO CHEEK, TONGUE, MOUTH GUMS, INCREASED SNORING, THESE SYMPTOMS WERE NOTED SHORTLY AFTER VACCINE #2.  I DID NOT PUT IT TOGETHER AT THE TIME THAT I WAS HAVING REACTION TO THE VACCINE ONLY AFTER DOING SOME RESEARCH ON WHAT COULD BE LEADING TO LEFT SIDED TONGUE NUMBNESS  DID I REALIZE I COULD BE HAVING BELLS PALSY A REACTION TO THE VACCINE.  WENT TO EMPLOYEE HEALTH ON 2/1/21 AND THEY NOTED POSTIVE MILD CASE OF BELLS PALSY.    AFFECTED IS LEFT SIDE OF FACE, GUMS CHEEK TONGUE AND SLIGHT DROOP
Next morning severe headache to the point of delirium....2nd day a little better...headache gone....fatigue...3rd day still tired..got up in late afternoon....tiredness lasted about 5days
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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 age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Original Case : US2021223559 US-GLAXOSMITHKLINE-US2021223559:same reporter
Pt received ZOSTAVAX shot 12/7/12. Had a little pain around site. Arm hurt when trying to sleep. In morning had 2 to 3" of swelling. Area red and tender. Pt notified pharmacy 12/09/12. As of 12/12, have not heard back.
Patient was given a vaccine in date at the time of administration, but then was found later to have been expired due to a recall.
Death; Dysarthria; Lethargy; This case was received via FDA VAERS (Reference number: 1358542) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), DYSARTHRIA (Dysarthria) and LETHARGY (Lethargy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (History of multiple back surgeries including a rod placement.).    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), DYSARTHRIA (Dysarthria) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 27-May-2021. The cause of death was not reported. An autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported. On 27 May 2021, autopsy was performed. As per the spouse, the autopsy results were pending.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Information has been received from a physician concerning a male patient in his 30s who was vaccinated during routine immigration exams with a dose of Varivax. Subsequently the patient developed a mild to moderate chicken pox-like rash. The lesions were noted to be papules. The patient's outcome was not reported. Additional information is not expected.
sore throat; cough with yellow phlegm; back ache; chills; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041B21A) for COVID-19 vaccination.     NO medical history was reported by reporter.  Concomitant products included IBUPROFEN for Arthritis, SALBUTAMOL (ALBUTEROL HFA), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), FOLIC ACID (FOLIC), TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), HYDROCHLOROTHIAZIDE, AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM, MAGNESIUM OXIDE, ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.   On 12-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS (chills) outcome was unknown. Not Provided      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.
Narrative:  Patient was placed in observation area for 30 min. post covid-19 vaccine dose #1 administration. After 30 min patient was released from observation.  Approximately 2-3 minutes later she came back to the drive thru c/o her throat  feeling like it as starting to close up. Patient stated "I feel like it is hard for me to swallow." AN EPI pen was administered to patient. ER was called and arrived.  ER assumed care of patient. In the ER patient felt better and left not wanting to wait for further evaluation. Pt was given another epi-pen Rx to take home in th eevent of a second episode. Md advised her to return to any ER if symptoms worsened.
Only a partial dose of an unknown quantity was administered to the patient; The patient's parent did not fully secure the patient's leg and the needle came out of the patient's leg upon movement during administration of the vaccine; This spontaneous report as received from a medical assistant and refers to a 18 month old patient of unknown gender. The patient's concurrent and historical conditions, as well as the concomitant medications, were not reported.  On 27-NOV-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T008698, expiration date 04-JUN-2021, for prophylaxis on the leg (dose, strength, and route were not reported).  During the vaccination, the patient's parent did not fully secure the patient's leg and the needle came out of the patient's leg upon movement (product usage process). Only a partial dose of an unknown quantity was administered to this patient (incorrect dose administered). The medical assistant disposed the hepatitis a vaccine, inactivated(VAQTA) syringe after administration. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0; operatorofdevice: Medical Assistant; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability