chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA). At the time of the report, DERMATITIS PSORIASIFORM (PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA) was resolving.            No information on concomitant medication were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. The reporter's causality for the event (s) PSORIASIS LIKE OUTBREAK AFTER FIRST INJECTION WITH MODERNA with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details were 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.
03/23/2021 awoke with felt pulled shoulder, heat, pain on the backside of a pull shoulder like a knot and had shoulder issue of pulled shoulder to severe pain still had function of arm but still had use of arm. Had difficult time sleeping and had pain presented at the injection site and the top of the arm. It took a day for the pain to change from the shoulder to the injection site to the top of the arm. 9/10 for pain for three weeks starting not able to use the left arm and inflammation of the was restricting the nerve and pain. Lack of sleep for three weeks do no sleep and shoulder, neck, torso, and ribs, not able to sit down. Not able to user the left arm with daily test that required the use of the left arm. Week three doctor for appt. early April No imaging, observation and range of motion, flexibility and strength evaluation then they prescribed the Gabapentin because of lack of sleeping . Went to a Dr. a week later for the doctor did the same test and pain evaluation was wanting to do imaging. Same the timeframe of the J &J being pulled from market and they did not want to image just increased the dosage Gabapentin. Symptoms  that he had did not show side effects of blood clotting.
Headache, Myalgia, Fever, Chills, Narrative:  Received 2nd dose on 2/16/21. Early in the morning 2/17/21 noted onset of fever/chills, myalgias and headache. Symptoms lasted 48 hours. Missed work x 2 days due to severity of symptoms. No known prior COVID infection  Other Relevant History:
Left upper arm 5cm X 5cm round, erythematous lesion, warm to touch with pain and itching. Advised pt to give Advil for pain and use warm compresses.
Pt. had shivering x 2 days, 3 days cough, temp 38.2, dry mouth, no appetite, nausea diarrhea and burning of eyes. Night of 5/3/05 attached as seen by MD.
Received HBV#3 and Menamune left deltoid on 6/6/05.  6/7/05 red blothy bumps left arm, few days later right arm.  Face 6/11/05 or 6/12/05 red 7 felt bumps underneath skin, 6/13/05 thighs and lower legs red rash. Recovering after Benadryl.
Symptoms:  throat swelling, lips swelling, face turned red, racing heart and blood pressure, feeling faint.  This happened 10 minutes after shot was given.  Benadryl shot was given in arm and didn't help and then epipen was administered.  Then taken to ER and given Decadron and Pepcid.  Was monitored for 4 hours and sent home.
On 12/29/2022 I was not feeling well and contacted my Physician because I had a post nasal drip and assumed it was a Sinus infection. But I was positive for COVID-19 over the next few days I was very tired and hoarse I still have lingering fatigue to date. I was prescribed and completed a course of PAXLOVID.
I am currently pregnant.   I was 6 weeks pregnant was when received the second dose vaccine.   I went to get Covid test, rapid test, came back negative, and a lot of my symptoms seemed like to resemble having Covid, congestion, cough, diarrhea, fatigue, fever, headaches (intense), muscle and body aches, vomiting and sore throat.  I believe I had Covid in 2020 which I had intense SOB and ended up in the hospital due to my SOB.  My EDD: 01/06/2022.   As far as today, I till have a headaches, I take Tylenol for pain, and had cough at times and sore throat and a bit of an upset stomach but it is not as intense as before.
pt recvd vax & exp arthus-like rxn (erythema & tenderness, resembling a cellulitis
subcutaneous tissue loss to rt deltoid p/vax;unk if r/t 23AUg97 Td shot or 15OCT97 hep B shot;not reported to pub hlth until 12AUG98;
First dose: Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster; First and Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster; Caller clarifies this was the patient's booster dose.; ,06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial; 06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 06Dec2021 16:30 (Lot number: FJ1620, Expiration Date: Feb2022) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Moderna (Dose: 01), administration date: 03Apr2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose: 02), administration date: 01May2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "First dose: Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "First and Second dose: Moderna; Received expired Adult Pfizer Covid Vaccine as Booster"; IMMUNISATION (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "Caller clarifies this was the patient's booster dose."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as ",06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 06Dec2021 16:30, outcome "unknown", described as "06DEC2021 at 1513 and the patient received the Adult Pfizer Covid 19 Vaccine on 06DEC2021 at 1630, past the 6 hours of the Adult Pfizer Covid 19 Vaccine being at room temperature in a diluted vial".  No follow-up attempts are possible. No further information is expected.  Additional information: The reporter stated that event was not serious since it seems the patient was still stable at that time and did not cause any harm to the patient.   Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a 7 year old male patient. On 21-JAN-2008 at 12 months age, the patient was vaccinated with first dose of VARIVAX (merck) (strength, dose and unit unknown) with lot number 1095U. On 25-MAR-2011 at the age of 4 years, patient received second dose of VARIVAX (merck), (strength, dose and unit unknown) with lot number 0962Z. Approximately on an unknown date in February 2014, the patient experienced severe leg pain and visited physician approximately on 09-FEB-2014 (4 days ago) who received 2 doses of VARIVAX (merck). No other symptoms were present at the first visit. On 13-FEB-2014 today, the patient came back to the office and presented with shingles on his thigh and rash. No treatment was given for shingles rash and was not hospitalized. Physician stated that she collected specimen from this patient and specimen was submitted to Merck for analysis. The outcome of severe leg pain, shingle rash and shingles on his thigh was unknown. No additional information provided. This case # 1402USA007533 was linked to case # 1402USA010748 via same reporter link. Additional information has been requested.
ACHY; FATIGUE; MILD HEADACHE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the subject experienced achy. On 17-APR-2021, the subject experienced fatigue. On 17-APR-2021, the subject experienced mild headache. On 17-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98-99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild headache, achy, fatigue, and slight fever. This report was non-serious.
Sore arm, severe fatigue, shortness of breath, numbness and tingling in lower half of arm and last 3 fingers on right hand, showing symptoms of Grave's disease (burning, red and dry/gritty eyes, left eye bulging).
Client presenting to clinic to receive today a Hepatitis B, Meningitis B and flu shot.  Nurse in administering these vaccines mistakenly administered two doses of the Fluarix vaccine.  Following administering the vaccines, nurse noted that the Meningitis B vaccine had not been administered and instead the Flu vaccine had been administered twice in left and right deltoid.  Nurse spoke to supervisor who contacted agencies for counsel.  Nurse brought client and guardian back to treatment area with interpreter to advise of error and need for dose of Meningitis B.  Client and guardian verbalized understanding and nurse administered dose of Meningitis B to client.  In discussion with agency, client and guardian were advised that there should be no side effect of the double dose of the flu vaccine.  Client and guardian advised to contact clinic if he begins to experience any side effect and to go to ER or call emergency services for any emergent symptoms.  Client observed in clinic for twenty minutes and then left clinic with no reports of feeling ill.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unspecified dates in August 2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L032396, expiration date: 26-AUG-2017. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 6.9F for 30 min on 02-AUG-2016, 9.8F for 30 min on 04-AUG-2016, 7.8F for 30 min on 07-AUG-2016, 6.9F for 30 min on 09-AUG-2016, 6.9F for 30 min on 10-AUG-2016, 8.6F for 30 min on 15-AUG-2016, 6.8F for 30 min on 20-AUG-2016, 6.8F for 30 min on 22-AUG-2016, 5.9F for 30 min on 23-AUG-2016 and 6.0F for 30 min on 24-AUG-2016. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
PATIENT EXPERIENCED A LIGHT HEADACHE AFTER 3 DAYS OF VACCINATION ON 4/06/21. IT BECAME MORE SEVERSE AFTERWARD TILL TODAY (4/14/21) AND HAD A HARD TIME BREATHING. PHARMACIST ADVICED PATIENT TO GO TO EMERGENCY ROOM FOR TREATMENT.
6/12/12 at 11:15 pt called and stated at approximately 0900 she started to have tremors all over and was very light headed, nausea and (L) sided sharp (stabbing) pain. She also verbalized having a low grade fever 99.2. She said the tremors lasted approx 30-45 minutes and she was losing consciousness during this time and having shortness of breath. Denies having any hives or other rashes. Does voice having some left foot swelling says she believes that was swollen before the injection was given. I encouraged her to go to ER for the SOB and she state she doesn't feel she needs to (cont). 6-12-12 Strongly urged her to be seen due to the SOB. State she is seeing her personal provider today (6-12-12) at 1415. Instructed to let me know what happen after appt and told her to try some BENADRYL and she states she cant take BENADRYL. 6-12-12 at 1636 Return call and states provider believes she should go to ER to have an MRI or "other testing". No other dx given. 6-13-12 at 1131 States she went to ER and waited approx 4 hours without being seen and decided to leave and return in am when they were less busy. She says she still having light headedness, headaches and has passed out 2-3 times more since last H8. Also reports seeing rainbows arms feel fine. No numbness tingling, rashes, or hives. Denies SOB and sided stabbing pain pain also at this time. 6-13-12 at 1350 Calls and reports that all testing has come back okay and the only symptoms she is currently having is a headache. Says physician believes she's having migraines new her home and told her to f/u her primary physician in couple of days or return to ER if symptoms get worse. Instructed her to call should she have further c/o with this incident.
received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist thought she got a piece of rubber stopper in the syringe. Then, she looked better and there were like black specks floating in it.  No concomitant medication was provided by reporter. No treatment information was provided by reporter.
redness, swelling, hot to touch & blistering of skin @ inject site; t102.5 orally-tired, flu like sx for approx 1 wk; APAP given -nodule @ site persists 1JUN94;
nearly killed my dad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (nearly killed my dad) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (nearly killed my dad). At the time of the report, VACCINATION COMPLICATION (nearly killed my dad) outcome was unknown. Not Provided          No concomitant and treatment medications details were provided.
Phlebitis (warm,red,tender) appromiately 10x10 inches in upper right deltoid extending around back of arm. Observed 48 hours after vaccine, symptoms still present. Patient consulted family physician and placed on antibiotics and to follow-up in 5-7 days.
Pt presented to Doctors office 4/27/21 with left leg pain and cramping.  Pt advises this started over the weekend and became worse.
Pt given the vaccine on 4/19/04; doctor notified that evening of a large quarter sized lump with redness surrounding. Seen by this doctor on 4/20/04; Redness/ erythema about 6 induration with no streaks. No fever. Prescribed with Omnicef for a cellulitis, right thigh.
I developed centralized lower back pain about noon the day following my vaccination (Thursday). The pain continued to get worse until 12/28 when it began getting better. Today (12/30) my back feels about 80-90% better and I have not required any tylenol or motrin to get through the day. In the days following my vaccination, I required tylenol, motrin and heating pad to aid in pain management. It took effort to walk upright. On Sunday (12/27) I felt so bad I could not get out of bed until late.  I was also very thirsty in the days after vaccination, my mouth felt like "cottonmouth" and I needed to sip water.
Pt. blacked out x serval seconds when up during the night.  Pt. reports on & off mild dizziness x 6 hrs. since.
I obtained my COVID Vaccine and I became very sick on the day received. It was the J and J vaccine. I am sensitive to the flu vaccine where I have gotten ill. The first time was the live Flu vaccine. Once I received the COVID vaccine I began having arm pain and then I had symptoms. The symptoms lasted for 10 days approximately. They were symptoms of the flu/ COVID.Myalgia, runny nose ect. I was COVID negative. I still have post - nasal drip and I need to be prescribed antibiotics because it won't resolve.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. Three administrations were on 22 Jun 2023 and on 10 Jun 2023 vial was thawed. No treatment medication reported.   This case was for the 20th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
First COVID-19 shot on 8/20/2021. On 8/21/2021 developed a headache, possible fever and leg cramps (flu-like symptoms). On 8/22/2021 and 8/23/2021, his sense of smell was way off. Everything smelt like a "nasty rotten harsh chemical."
No additional AE reported; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 01-SEP-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, lot number W002601 which was determined to be a valid lot number with expiration date: 24-JAN-2024, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided) (product storage error).   The temperature excursion occurred for 1 hours (h), 45 minutes (min). It was reported that there was a previous temperature excursion.   No additional adverse events (AE) were reported.; Sender's Comments:  US-009507513-2210USA001064:
This spontaneous report concerning a female patient of an unknown age, and was received from the patient's mother, who was part of a patient support program. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced a rash generalized described as "her entire body broke up," and she felt terrible for several weeks (feeling abnormal). The patient's mother stated that "it was really scary." The outcome of feeling abnormal and rash generalized was unknown. The relatedness between rash generalized and feeling abnormal, and therapy with M-M-R II was not reported. Additional information is not expected, as the reporter did not consent for further follow up.