chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), SECRETION DISCHARGE (started throwing phlegm out), VACCINATION SITE DISCOLOURATION (arm at the injection site was blank and blue) and INFLUENZA (I feel like I got the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SECRETION DISCHARGE (started throwing phlegm out) and INFLUENZA (I feel like I got the flu). On an unknown date, the patient experienced COUGH (cough) and VACCINATION SITE DISCOLOURATION (arm at the injection site was blank and blue). At the time of the report, COUGH (cough) had not resolved and SECRETION DISCHARGE (started throwing phlegm out), VACCINATION SITE DISCOLOURATION (arm at the injection site was blank and blue) and INFLUENZA (I feel like I got the flu) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       17 or 18-Mar-2021, the patient experienced cough
Day of shot: Mild pain, swelling, heat, small pink area; approx size of 10 year old palm of hand. Next day: Worse pain, larger area of swelling & heat & larger, darker pink area. Approx size of adult average woman hand, wrist to finger tip. Third day: Arm swollen & pain from elbow to shoulder, pink from middle upper arm to shoulder, skin hot, same symptoms  more days, then began to clear up. Pinkness last to clear up - thirteen (13) days after flu shot administered.
developed a blood clot in her stomach that went away after 2 weeks; an arthritic toe; Arthritis in neck; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (developed a blood clot in her stomach that went away after 2 weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 (Not sure but may have had in February or March of 2020 Treatment received: antibiotics) in 2020. Concurrent medical conditions included Blood pressure high (history of high blood pressure prior to getting any doses).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced THROMBOSIS (developed a blood clot in her stomach that went away after 2 weeks) (seriousness criterion medically significant), OSTEOARTHRITIS (an arthritic toe) and SPONDYLITIS (Arthritis in neck). In 2021, THROMBOSIS (developed a blood clot in her stomach that went away after 2 weeks) had resolved. At the time of the report, OSTEOARTHRITIS (an arthritic toe) and SPONDYLITIS (Arthritis in neck) outcome was unknown.            No concomitant medication was reporter.  The patient developed a blood clot in stomach that went away after 2 weeks, an arthritic toe and  arthritis in patients neck that comes and goes. No treatment medication was not reporter.  Company Comment: This is a Spontaneous case concerning a 75-year-old female patient with no relevant medical history reported, who experienced the serious (medically significant) unexpected AESI of Thrombosis (reported as: blood clot in her stomach) and non-serious unexpected AESI of Spondylitis which occurred after the primary series of vaccination with mRNA-1273 on the same year but unknown exact onset latency. It was reported that the event of blood clot resolved after two weeks, no relevant diagnostic test, concomitant medications or treatment was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-607347 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 75-year-old female patient with no relevant medical history reported, who experienced the serious (medically significant) unexpected AESI of Thrombosis (reported as: blood clot in her stomach) and non-serious unexpected AESI of Spondylitis which occurred after the primary series of vaccination with mRNA-1273 on the same year but unknown exact onset latency. It was reported that the event of blood clot resolved after two weeks, no relevant diagnostic test, concomitant medications or treatment was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Dizziness, fever, chills, body aches, severe headache. Taken Tylenol and ibuprofen for fever and pain for 3 days.
Pt had a cva  on January 29,2022. Her booster was given November 18,  2022
I had Severe side effects that lasted about a week, I have abodominal bloated with discomfort, low-grade fever 99 everyday on and off for two weeks ,headache on and off for two weeks now.  Legs Muscle aches and hip joint pain.   Doctors gave me dictclomine and was referee to GI specialist.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-NOV-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot number T033814, expiration date: 05-OCT-2022, administered as prophylaxis (strength, dose and route of administration were not provided). The vaccine had the following temperature excursions: at 8.5 degrees celsius (C) for 9 minutes, at 9.5 C for 23 minutes, at 9.6 C for 34 minutes and at 12.4 C for 53 minutes; no previous temperature excursions and no additional adverse events were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2112USA007442: US-009507513-2112USA006870: US-009507513-2112USA007443:
4 hours after receiving shot arm started to get sore. Redness developed 10-31-17 about noon. Redness dose not surround the injection site, rather it is lower and to the left of injection site. Patient is experiencing extreme muscle pain and limited range of motion. Does not itch, but had tightness. No papules and not warm to touch. Biggest complaint is soreness radiating up to top of arm has not taken any oral medication or applied anything topically or using cold pack.
In right arm pt was administered flu shot and pneumonia shot. Arm was shown to me on 10/15/15. Arm was red, warm and swollen.  Pt also reported fever on 10/10/15.
April 21, 2021 headache, fatique, runny nose,  chills, have not been feeling since vaccination.
Information has been received from a pharmacist concerning her 9 year old son with no pertinent medical history and no drug reactions allergies who on 8/29/06 was vaccinated SC with a second booster dose of varicella virus vaccine live. It was noted that the pot was vaccinated with the first dose of varicella at 1 year old. Concomitant therapy included fluticasone propionate + salmeterol xinafoate (Advair). On 9/8/06, 10 days after vaccination, the pt experienced fever and dizziness. This continued the following day, and by 9/10/06, he experienced fever, increased dizziness, vomiting, and double vision. That evening he was admitted to the hospital where he stayed until 9/13/06, He was diagnosed with acute disseminated encephalomyelitis. An MRI revealed 4 lesions on the brain and spinal cord. Test including a spinal tap have rule out viral encephalitis. A CAT scan was also obtained. The mother reported that her son was fine at the time of the report, and occasionally experienced headaches and dizziness. No specimen was available. The outcome was recovering. There was no product quality complaint. The mother considered the event to be disabling. Additional information has been requested. 8/4/08-records received for DOS 9/11-9/13/06-DC DX: Acute demyelinating encephalomyelitis. Presented to ED with C/O 2 days of fevers and diplopia.
Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke.
Headache, body aches, jaw ache, sore throat, skin sensitivity, fatigue and stomach pains.
Pt presented on 10/21/18 with erythema approximately 2 inch diameter surrounding the injection site. Pt proceeded to see an MD later in the day who determined this is a local site reaction. Pt iced the reaction and on 10/22 the reaction has decreased. No other symptoms were reported.
Information has been received from a health professional concerning his/her nephew, an 18 year old male who on 05-AUG-2010 was vaccinated the first 0.5ml dose of with GARDASIL (Lot number not provided). On 05-AUG-2010 the patient experienced dizziness and fainting immediately after being administered GARDASIL. It was reported that the patient was planning to get his second and third doses of the regimen (also reported that the therapy was discontinued on 05-AUG-2010). The patient sought unspecified medical attention. The adverse events improved after therapy. At the time of the reporting, the patient was recovering. The patient's twin brother also experienced dizziness and fainting after being administered his first dose of GARDASIL (WAES#1010USA02874). Additional information has been requested.
lt arm was sore initially then became swollen & red w/dark red dots throughout;applied ice & epsom salts & is talking APAp;hand hurt 10/31/99;feels better today, but still red & swollen;
First night after taken the vaccine, I developed  a soar throat, and a fever. The next day I continued to have a fever all day and night, with a slight soar throat, and extensive coughing difficulty breathing, The third day I had difficulty breathing still coughing up mucus and developing a headache. Fourth day my work had me go take a Covid 19 test, In which later that night I received my results and I was negative. I started to develop a bad headache in my forehead above my eyes. This headache has progressively gotten worse. As of day 8 I continue to have a migraine, as well as a bad cough, hard to keep an appetite as well as eat food.
The night of she had a bright fiery red rash on her upper arm that spread down into her bicep.
Body aches, muscle pain, joint pain, headache, fatigue, chills, feeling feverish without a fever.   Did not take any medicine to relieve symptoms.   Symptoms began a few hours after receiving second dose.
Kid was accidentally vaccinated twice; This case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving BEXSERO, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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: 8-Sept-2022 Reporter's comment: The case was received from the patient's parent via interactive digital media. The patient's parent stated that what happens if the patient was accidentally vaccinated twice with Bexsero. Additional supportive information: The patient was accidentally vaccinated twice with Bexsero, which led to accidental overdose. The follow-up could not be possible as no contact details were available. As per it was not clear whether the patient was vaccinated twice on the same time or on different time therefore in worst approach, it was considered that was vaccinated on the same time and event was coded as accidental overdose.
Sore arm; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced pain in arm and malaise. In May 2019, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. Sore arm and feeling of malaise were lasted for 3 days. The reporter did not consent to follow up No further details were provided.  This case has been linked with case US2019090293, reported by the same reporter.
Large area Redness, swelling, firmness, itching at injection site. Has not resolved after 7 days.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      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 medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter details updated ( Address): Follow-up contains no new information
Severe muscle aches, nausea, fever, sweating, chills, headache from severe eye muscle and head pain; 15hrs in, took cbd tincture and muscle relaxer--did not alleviate at all; 18hrs in, took another muscle relaxer and norco--1.5hrs later, fever "broke" (heavy night sweat), body pain lessened greatly, but not sure muscle /head pain. 40hrs in,  still eye muscle and head pain, nausea--took cbd tincture and norco, greatly lessened symptoms.
on an unspecified date, during the same office visit, an unspecified 4 monlh old baby was inadvertently administered MMR II, VARlVAX, and VAQTA outside the recommended age per lhe prescribing information.; No additional AE effects reported.; This spontaneous report was received from a medical assistant, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history and previous drug reactions or allergies were not reported.     On an unknown date, the medical assistan reported that, during an office visit, the patient was inadvertently vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, varicella virus vaccine live (oka/merck) (VARIVAX) injection, and hepatitis a vaccine, inactivated (VAQTA) injection (doses, dose numbers, vaccination schemes, routes of administration, lot numbers, and expiration dates were not provided), all of them as prophylaxis, outside the recommened age per the prescribign information (product administered to patient of inappropriate age). Concomitant therapies included a Merck sterile diluent (lot number and expiration date were not provided). No additional adverse effects were reported.
This 69 year old black male received the Covid shot on  2/27/21    and went to the ED and admitted on  4/18/21 with the following diagnoses listed below. G51.0 - Bell's palsy N17.9 - Acute kidney failure, unspecified
my arm at the injection site hurt.; couldn't move or lift arm due to the pain; couldn't move or lift arm due to the pain; This is a spontaneous report from a contactable consumer [patient]. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose at arm for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient woke up the night after the injection and arm at the injection site hurt. couldn't move or lift arm due to the pain. Took 400mg of ibuprofen and can move arm again. The patient was still on 400 mg ibuprofen twice a day for pain. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a registered nurse concerning a male patient who on 01-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 01-APR-2008, the patient "had a similar reaction and he was given (pneumococcal 23v polysaccharide vaccine)". Reaction reported was swollen arm and "it is very tight". At the time of the report, the patient was not recovered. The nurse requested a lot check for Lot#659149/1383U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested.
This spontaneous report was received from a physician referring to a 17 year old male patient. The patient did not have any pertinent medical history or concomitant medications; allergies and drug reactions were unknown by the reporter. On 28-AUG-2017, the patient was vaccinated with his first dose of GARDASIL 9 intramuscular, frequency was not reported (lot # N013695, expiration date: 21-MAR-2017) for prophylaxis. In November 2017, it was reported that after the first shot, the patient experienced "planter warts". The patient received his second dose of GARDASIL 9 and "a week after", approximately in November 2017, experienced plantar warts again. It was unknown if the patient received treatment for the events or if there were laboratory diagnostic test performed. The outcome of plantar warts was unknown at the time of the report. The reporter mentioned that the patient would not be receiving the third shot of GARDASIL 9. The relatedness between plantar warts and GARDASIL 9 was not reported.
Upon documentation of second dose in our state covid vaccination portal, it was shown that the patient had received his first dose on a day inconsistent with the date on the card he presented, and only 5 days prior to this administration. Recent analysis of the state vaccine portal now shows that he has received additional doses of both the Pfizer and the Janssen vaccines at multiple other locations.
FEELING TIRED; BAD MUSCLES ACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-SEP-2021, the patient experienced bad muscles aches. On an unspecified date, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad muscles aches, and had not recovered from feeling tired. This report was non-serious. This case, from the same reporter is linked to 20211011458.
Information has been received from a physician concerning a child who was vaccinated with a dose of MMR. The physician reported that 10 days post vaccination the patient developed a fever and a macular papular rash. The fever resolved, however, the rash turned into petechiae. The patient does not have thrombocytopenia. The physician was unsure if the rash was related to the vaccination or not. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
No adverse effects reported.; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an male child.. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 16-APR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R026548, and expiration date  17-SEP-2020 strength, dose detail and route were not provided) for prophylaxis (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX)was reconstituted with properly stored sterile diluent (lot & expiration date was unknown by reporter).   The vaccines were exposed to temperature excursion of 6 fahrenheit degree to 14 fahrenheit degree (also reported as 7.64 fahrenheit degree) for 45 minutes. The vaccines were exposed to previous temperature excursion of 6 degree Celsius to 14 fahrenheit degree (also reported as 11.28 fahrenheit degree) for 1 hour. No adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA008214: US-009507513-1904USA010534: US-009507513-1904USA010535: US-009507513-1904USA010531: US-009507513-1904USA010532:
Shingles; Hives; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and hives (Verbatim: Hives). The outcome of the shingles and hives were not reported.   It was unknown if the reporter considered the shingles and hives to be related to Shingles vaccine.   It was unknown if the company considered the shingles and hives to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and broke out with shingles and hives.  So he/she could not take the second shingles shot. The follow up would not possible as no contact details were available.
Information has been received from a nurse concerning a female who was vaccinated with a dose of Gardasil. Concomitant therapy included other unspecified vaccines administered the same day. Subsequently, approximately five minutes after the patient was vaccinated with Gardasil, she passed out and vomited. The patient sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.