chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was pregnant 10 weeks along when I got my Covid shot on 1/11/2022 per my OBGYN?s recommendation. I had the common fever and chills and the next day started spotting. I spotted for two weeks and was told by my OBGYN everything was ok and even was evaluated and my cervix was still closed. I had my NIPT testing come back all normal and then my NIPT ultrasound on 1/19 and everything was normal the baby was fine. Then on 1/25 I started to have a miscarriage and ended up in the ER. I lost the baby and a week later had to have a D and C. No one knows what happened or why the miscarriage happened I was 13 weeks along and that?s late for a miscarriage especially when everything else was normal the entire time. I have had testing done and the POC came back with normal anatomy there was no reason for this miscarriage. I was fine until after that shot.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Dec 2 6pm vomit, fever; Dec 3 4pm & 5pm vomit, fever 101.2 F; Dec 4 all day- fever 103.2, jerking, clenched fist, sweats, rash; Dec 5 fever 103.2, sweats; Dec 7 rash. Treated with Ibuprofen and Tylenol.
After second dose within 72 hours a full body extremely itchy, bumpy/hive like rash developed.  Prednisone was give which brought relief to outbreak along with topical ointments.
Dose given past the 12 hour post puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  On 31-Aug-2021, Vial was put into fridge and opened on 01-Sep-2021.  Vaccine was kept a the appropriate refrigerated temperature the entire time.  Patient reported having no adverse events  Treatment information was not provided   This case was linked to MOD-2021-327879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up non-significant information added in narrative.
Low grade fever, slight swelling of both eyelids. No S.O.B, no inflammation to injection site. Physician called with recommendation to take over the counter oral Benadryl.
Swelling, heat and severe soreness at injection site Severe Nausea Headache  Muscles aches Fatigue Fever Exhaustion (flu-like symptoms All symptoms beginning within I hour of receiving the vaccine
As of today,  Jan 16, I still have a large red area at the vaccine site.
patient experienced tingling in throat 25 minutes after vaccination, patient given 25mg oral benadryl and returned to normal.
administered a 0.3 ml dose instead of the 0.5 ml dose; A spontaneous report was received from a consumer concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine and was administered a 0.3 ml dose (MedDRA PT: Incomplete dose administered).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 15 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient received a call from the pharmacy where she received her vaccine. Patient reports that the lady giving the dose was not used to giving Moderna Covid-19 Vaccine and administered a 0.3 ml dose instead of the 0.5 ml dose. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was unknown.  The event, administered 0.3 ml dose, was considered recovered/resolved 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015255:Lnked case- Sister case
low grade fever; very confused; mental issues; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lowgrade fever and mental issues.  The patient's medical history was not reported. Concomitant medication was not reported.  25-JAN-2021, prior to the onset of the events, the patient received their first  planned dose of mRNA-1273 (lot/batch:029K20A)  for prophylaxis of COVID-19 infection.  26JAN2021, she had a low grade fever and also started having mental issues.Between Tuesday and Thursday, 28JAN2021, she had a total of 2 episodes of confusion.  Laboratory details - she had an MRI, bloodwork and urinalysis done. All tests came back normal and she was released from the hospital on 28JAN2021.  Treatment information -Tylenol was given to the patient.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events pyrexia,mental issues,confusional state are  recovered/resolved.
administration of expired product; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Twinrix. On 27-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of expired product).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 It was reported that an expired Twinrix vaccine was administered to a patient which led to expired vaccine used. No adverse reaction noted. This was the first dose of a series of 3 doses given. It was reported that expired medication had been removed from office supply and retraining of 5 rights and medication administration will be given to the medical assistant. No known event occurred from administration of expired product. The reporter consented to follow up.
Information has been received from a medical assistant concerning a 7 year old female who on 08-JAN-2001 was vaccinated with one 0.5ml subcutaneous dose of VARIVAX (Lot # 636571/0928K).  Concomitant vaccines administered on the same day included a dose of MMR.  On 14-MAY-2007 the patient developed a chickenpox rash with 10 to 12 chickenpox vesicular lesions on her abdomen, back and arm.  She also had a low grade fever of 99.7 degrees Fahrenheit.  Unspecified medical attention was sought and the patient was treated with calamine lotion and TYLENOL.  Subsequently, the patient recovered.  No further information was available at the time of this report.  No product quality complaint was involved.  Additional information has been requested.  Follow-up information stated that this patient was vaccinated with VARIVAX in her left arm and with MMR (Lot # "099K") in her right arm.  The patient developed 10-20 vesicular lesions on her abdomen, back, and arms.  No medical attention was sought.  The patient had no prior medical history and no allergies.  The patient had no illness at the time of vaccination.
Muscle aches in both hips and both knees; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. In November 2019, 8 days after receiving Shingrix, the patient experienced myalgia. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine on left arm, approximately two weeks ago. Six days ago he began to experience muscle aches in both hips and both knees.   The patient was continuing to have the aches and they occurred all day till the day of reporting. The reporter was unable to provide any additional details.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 2:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 2:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.65. Concomitant products were not provided. On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On  29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 44, 4 PM: 45 and 5 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
BACK PAIN; LOSS OF FEELING IN LEFT POINTER FINGER; LEFT ARMPIT PAIN; WEAKNESS OF LEFT ARM; LEFT ARM PAIN; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, calcium carbonate/colecalciferol, cyanocobalamin, duloxetine hydrochloride, fingolimod hydrochloride, and meloxicam. On 20-MAR-2021, the subject experienced back pain. On 20-MAR-2021, the subject experienced loss of feeling in left pointer finger. On 20-MAR-2021, the subject experienced left armpit pain. On 20-MAR-2021, the subject experienced weakness of left arm. On 20-MAR-2021, the subject experienced left arm pain. On 20-MAR-2021, the subject experienced left shoulder pain. Laboratory data (dates unspecified) included: MRI (NR: not provided) Negative, and Ultrasound joint (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm pain, left shoulder pain, back pain, weakness of left arm, loss of feeling in left pointer finger, and left armpit pain. This report was non-serious.
90 minutes after receiving my 2nd dose of Phizer on December 14th 2021 , I experienced ringing in my ears. After visiting an EN that my heaT  December 17th, it was his opinion that the 2nd shot was the cause of the tinnitus. He prescribed me Prednisone. I have yet to feel any relief yet, and the 6 days of constant ringing has caused severe anxiety and depression.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently approximately 59-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date were not provided), for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was not reported. The reporter considered the event was related to the suspect vaccine.
I experienced symptoms of a swollen inflamed right arm, difficulty lifting my right arm, was unable to lay on right side, fever of 100.4, severe headache, sore throat, nausea, vomiting, abdominal pain, diarrhea, which began at 3pm the day I received dose 3 and progressed for 4 days. I did not recover until day 5, the symptoms did not begin to abate until day 4. I did not seek care from a doctor, and I am not experiencing any lingering symptoms.
Patient came back to pharmacy complaining of weak legs, chills, bad headache and some nausea. Said at one point she felt she could not stand up.
Patient began to develop symptoms of erythema nodosum beginning approx. 6 hrs after vaccination. This consisted of multiple red, tender nodules primarily over the extensor surfaces of all 4 extremeties; and painful, swollen knees. New painful red nodules erupted over the course of the next 4-6 weeks, each becoming purply then brown in color before fading completely.  After ~ 7 weeks she returned to normal with no apparent sequelae. OCP were discontinued on 10/24.  No other treatment/medication was given.
Within 3 hrs of vaccine, shingles reactivation. Broke out on left side of body, below "panty line". Could not sit or walk. Developed purulent and bloody blisters that have now turned into scabs. Felt stabbing pain. Went to urgent care,
No adverse event; Patient received a vaccine that under went a temperature excursion; Patient received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion). On 13-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    No concomitant medication was reported by reporter.  Patient weight was reported as 16 (units not specified) 3 Ounces(oz).  Patient received 1st dose on RQ and second dose on LQ.  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was  with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 08-Aug-2022. Those were administered and discarded. Proposed desired used by date was 18-Aug-2022. Storage condition at the time of the excursion was reported as refrigerated.  The patient side effects were reported as none.  No treatment medication was reported by reporter.
Low grade fever, 7 PM day of vaccination. Soreness and lump at vaccination site. Next morning, 2-28-19 had a severe headache, nausea, ached, shivered, generally felt awful for 48 hours.
Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In July 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In July 2022, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). In July 2022, VACCINATION SITE BRUISING (Vaccination site bruising) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.
This spontaneous report as received from a physician refers to a 12 month old female patient. The patient had no pertinent medical history and no drug allergy. On 13-SEP-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J003542325). There was no concomitant therapy. On 16-SEP-2013, the patient developed a few varicella like lesions on the buttocks, thigh and pubic region. Physician stated that when he saw the patient on 19-SEP-2013, he noted that the lesions are beginning to crust over. No treatment was given. No lab test was done. The outcome of event was reproted as not recovered/not resolved. Patient sought medical attention via office visit. Additional information has been requested.
high fever, full body aches, headache for 6 hours. Then mild body aches for 24 hours. Drank tons of fluids, took acetaminophen and electrolytes.