chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm hurts to the touch; rash is hot to the touch; has a rash, a big red spot of 6 inches around; has a rash, a big red spot of 6 inches around; was achy; didn't feel really well, was achy; didn't feel really well; stomach hurt; her arm started to get a rash; arm was really sore; slightly sore arm; A spontaneous report was received from a consumer, a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch.  The patient's medical history was not provided. Concomitant products used included Vitamin D gummies.   On 02 Feb 2021, few hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: [021M20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, after few hours of vaccine administration the patient experienced slightly sore arm. After 8 days on 10 Feb 2021 patient experienced arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt, rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch. Treatment for the events included children's Tylenol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, arm was really sore, didn't feel really well, was achy, arm started to get a rash, stomach hurt, arm hurt was resolved and rash, a big red spot of 6 inches around that is hot to the touch. And arm hurts to the touch was unknown.
small purpuric macule (~0.75cm) around 5 cm above vaccine site, evolved into slightly larger pruritic papule, is now resolving
I woke up on Sat April 17th the day after my 2nd dose of Moderna and went to the bathroom. I was sitting on toilet and next thin i know i'm waking up on the ground looking at the shower. I had blacked out. I then managed to pull myself up and was looking at the mirror in my bathroom and next thing i know i am waking up.  I had blacked out again.  My wife then discovered me on the floor and helped me up and to bed.  There is a cracked tile in my bathroom so i believe i knocked my head pretty good. I felt woozy and had a large scrape on  my right shoulder from one of the falls.  I was put into concussion protocol by wife;  The rest of the day i had the normal side effects of moderna: Fever, chills, headaches, sore left arm, and took tylenol extra strength, rested, hydrated, etc.  I felt better later in the day and by the next day Sunday April 18th i felt much  better;  I was able to drive and get errands done, but felt "Foggy".  I felt back to 100% maybe by Tuesday April 20th.  My concern is the blackouts not being known. If someone was operating heavy machinery or driving the day after their 2nd shot and blacked out that is a major cause for alarm.
This spontaneous report as received from a physician via a company representative refers to multiple unspecified patients of unknown age and gender. On unspecified dates, the patient was vaccine with a dose of M-M-R- II (lot#, dose, route, indication no reported). The physician reported that "in the past" these patients had " low titers for 1 of the 3 M-M-R II , after receiving M-M-R II.  The physician stated that he had been "re-administering M-M-R II" to those unspecified patients. Concomitant medications were not supported. Additional information has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Janssen COVID-19 Vaccine  Body ache, fatigue, cold or flu like symptoms.  Ate lunch and took 500mg Tylenol  and one aspirin and feel better.
Patient stated around 7:30pm on the day of vaccination she began having a pounding, racing heart and noted resting heart rate remained at 90bpm for a full 24hrs. Patient states she is still having occasional heart pounding and racing episodes and is taking electrolytes multiple times a day which is helping keep the episodes controlled. Patient has not gone to any healthcare providers nor has the patient had any tests run since the vaccine. Patient states she will continue to do what she is doing at home.
DIZZY; NOT THERE MENTALLY OR CONFUSED; RACING HEART EVEN WHEN LAYING DOWN; FEELING FATIGUED; NAUSEATED; VERY INTENSE HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced not there mentally or confused. On 10-APR-2021, the subject experienced racing heart even when laying down. On 10-APR-2021, the subject experienced feeling fatigued. On 10-APR-2021, the subject experienced nauseated. On 10-APR-2021, the subject experienced very intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigued, nauseated, dizzy, not there mentally or confused, racing heart even when laying down, and very intense headache. This report was non-serious.
Information has been received from a mother, who is also a nurse, concerning her 20 year old daughter, with possible polycystic ovarian syndrome and a history of adenoidectomy as a child, who in February 2008, was vaccinated in the right gluteus with her first dose of Gardasil (lot #not reported).  The patient was lying down when she received the vaccination and the patient stated she felt "a little funny, like you hit a nerve."  The patient was told to lay there for awhile.  On 14-Mar-2008, the patient was vaccinated intramuscularly in the right arm with her second dose of Gardasil (lot # not reported) while sitting on the exam table.  There was no concomitant medication.  The patient fainted after receiving the second vaccination.  She fell to the floor and hitting her right eye on the stool.  There was a laceration of 1" above the eye.  The mother took the daughter to the ER where they glued and steristripped the laceration.  While at the ER, a Cat Scan of the head was performed with the result being positive for a possible shadow.  The patient was not hospitalized.  On 15-MAR-2008, the patient went to a different hospital for follow-up.  Another Cat Scan of the head was performed but the result were normal.  The hospital wanted to keep the patient overnight, but she refused.  The patient is scheduled to have a MRI.  The reporter stated that patient is "feeling good now".  Additional information has been requested.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of the vaccination, the patient tested positive for COVID-19. She questioned if she can take the 2nd dose of the vaccine (her schedule would be more than 21 days). The clinical outcome of tested positive for COVID-19 was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 25Jan2021, and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
TODAY SHE RECEIVED HER 2ND DOSE (IT WAS APPROVED BY HER MD). 5 MINUTES AFTER RECEIVING IT, HER LIPS STARTED TO TINGLE AND RECEIVED 25MG OF DIPHENHYDRAMINE ORALLY. ON SITE EMS RESPONDED. SHE SAID SHE HAD THE SAME REACTION WITH THE FIRST COVID VACCINE 3 WEEKS PRIOR. WITH THE FIRST DOSE SHE WAS GIVEN 50MG DIPHENHYDRAMINE AND WENT HOME, TOOK A NAP AND WAS FINE.  SHE FELT BETTER AND WAS RELEASED TO HOME
pt has severe syncope, during vaccine pt experienced syncopal episode doesnt remember recieving vaccine, in between receiving vaccine and transport to med obs pts wife states pt had 4 more syncopal episodes, pt transported to med obs via wheelchair, at 1100 pt sitting in wheelchair experienced another syncopal episode x20-30 seconds  given ammonia inhalant and pt became arousable with ammonia inhalant alert and oriented. pt transferred with little assistance to stretcher  vs taken,  pt found to be hypertensive, pt instructed to lie down and further bps were taken as noted,. pt denies further symptoms no further syncopal episodes noted  EMS called due to bp. 1125 EMS arrival report given to EMS personnel 1131 EMS departed VS: 1103 BP 211/127 HR 73 RR 20 O2 98 automatic Bp sitting up in bed, 1105 BP 231/146 HR 71 RR18 O2 96 lying in bed, 1110 BP 183/108 HR 69 RR 18 O2 98 1115 BP 177/101 HR 73 RR 20 O2 95  1125 BP 176/107 HR 74 RR 18 O296
Approximately 10 minutes after receiving her vaccine, the patient fell to the floor and appeared to have a seizure that lasted approximately 30-60 seconds. She hit her head on the floor as she fell to the ground. She had a clear pulse and clear respirations in the duration of the event. 911 was immediately called and an ambulance dispatched. The patient's father was with her and refused to be transported to a medical facility. The patient insisted that she was fine and she left with her father after further assessment. She had an appointment on Monday, January 14th with her PCP for follow-up.
She had Rapid eye movement and loss of consciousness immediately on removal of the needle with tremors and snoring. She regained consciousness after approximately 1 minute, Responded coherently, then had vasovagal syncopal episode with rolling back of eyes, sweating and LOC. She was placed on her back and she regained consciousness. Dizziness lasted approximately 10 minutes following episode.
MERALGIA PARASITIC; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoporosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced meralgia parasitic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of meralgia parasitic was not reported. This report was non-serious.
Pentacel was administered without reconstitution of the HIB component approximately 2 weeks ago with no reported adverse event; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown demographic patient who vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstitution of the HIB component approximately 2 weeks ago (lot number and expiry date not reported) via unknown route at an unknown administration site on 30-Aug-2021 for prophylactic vaccination (product preparation error).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to product preparation error (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
rash started on thighs and spread all over body, rash has decreased each day and now he has a small amount on thighs.
This spontaneous report as received from a registered nurse refers to an adult patient. On 27-FEB-2013 the patient was vaccinated with an expired dose of (oka/merck)VARIVAX. The (oka/merck) VARIVAX (lot number reported as 16832) expired on 09-DEC-2012. It was unspecified if the patient had sought medical attention. Additional information has been requested.
arm swelled up and turned red; arm swelled up and turned red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "arm swelled up and turned red".  Additional information: Patient's arm swelled up and turned red, but she had no itching after getting the Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Fever; Terrible fatigue; Join pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "I have arm pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "Terrible fatigue"; ARTHRALGIA (non-serious), outcome "unknown", described as "Join pains".  Additional information: The patient took their second shot and for now a few months the patient had arm pain. The patients brother experience the same pain. The patient took the first booster a couple of days ago and hoped that this will not happen. With the 1st booster, the patient was experiencing fever and a terrible fatigue and join pains. The patient wanted to know if there was a medical solution for this problem.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client recieved first dose of Pfzier vaccine on 03/31/2021 at 10:30 am. By 3:00 pm on 3/31/21 the client stated her face was "red and puffy" Client stated lip swelling as well. Lip and face swelling subsided by evening. Client has no history of dermal fillers. Face redness continued until the next day, 04/01/21. With all facial redness resolving by the afternoon. Did not seek medical care for event.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with the doses of improperly stored GARDASIL (doses, routes, lot numbers and expiration dates not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of meningitis in an unspecified number of patients who received BEXSERO (batch number 16G201, expiry date unknown) for prophylaxis. This case was associated with a product complaint. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO and MENACTRA at an unknown dose. On an unknown date, less than a day after receiving BEXSERO and unknown after receiving MENACTRA, the patient experienced meningitis (serious criteria GSK medically significant), general body pain, fever and pharmaceutical product complaint. On an unknown date, the outcome of the meningitis, general body pain, fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the meningitis, general body pain and fever to be related to BEXSERO. Additional details were provided as follows: The licensed practical nurse (LPN) reported this case. The age at vaccination was not applicable for this report. The reporter stated that they noticed a trend of administering BEXSERO and patients returning within the same day complaining of adverse events (3 adverse events in 1 week). The patients experienced symptoms of meningitis, body ache and fever. The reporter believed the co-administration issue with MENACTRA and BEXSERO. The reporter stated that since administering BEXSERO only and no other vaccines at the visit; they had not seen any other additional incidents. Once they stopped co-administering BEXSERO with MCV4, the adverse event trend stopped. QA department reported lot number was valid and the product was not returned. This case has been linked to US2018GSK133021, reported by the same reporter.
This case was reported by a healthcare professional and described the occurrence of myalgia in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). On 3 June 2013 the subject received 1st dose of Hepatitis B vaccine (unknown details). In 2013, within months of vaccination "since the vaccination" with Hepatitis B vaccine, the subject experienced myalgia, joint stiffness, and decreased ability to perform daily activities. The reporter described the myalgias as "significant" and reported that the joint stiffness was "in her upper and lower extremities." The reporter also documented that the events have caused "her difficulty with her job and limiting her activities." The reporter stated that she had "screened for other causes and feel this may be a vaccine side effect." The reporter was considering how to proceed with additional doses of hepatitis B vaccination series. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with Hepatitis B vaccine.
Arthralgia & SkinRash Missed work x 2 days, due to pain in joints (ankels, hips, knees)
2-3 days after vaccine patient experienced lightheadedness 18 days after the vaccine patient experienced muscle aches 19 days after patient experienced neuropathy of  hands and feet
Information has been received from an administrator concerning a 15 year old female patient who approximately one month ago in September 2010 was vaccinated with a dose of GARDASIL (lot #, route and dose not reported). Concomitant vaccines given on the same day included a dose of hepatitis B vaccine (manufactured unknown) and meningococcal vaccine (manufactured unknown). The administrator reported that approximately two weeks ago, on 24-SEP-2010 the patient developed shortness of breath and chest pain. The patient underwent a pulmonary function testing, electrocardiography and an EGG, all with result that were within normal limits. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: FL3249), on 08Feb2021 as dose 2, single (Lot number: EL9261), on 03Oct2021 as dose 3 (booster), single (Lot number: FF2588) and on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "allergic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: (with h/o gastric ulcer); "remote h/o asthma" (unspecified if ongoing), notes: remote h/o asthma; "remote h/o alopecia areata" (unspecified if ongoing), notes: remote h/o alopecia areata; "h/o depression" (unspecified if ongoing), notes: (weaned off Lexapro 10/6/2022, after being on it for 25 years); "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: Jan1990, stop date: 25Oct2022; MONTELUKAST, start date: Jan2000, stop date: 25Oct2022; PANTOPRAZOLE, start date: Apr2019, stop date: 25Oct2022; FISH OIL, start date: Jan2010, stop date: 25Oct2022; PROBIOTICS, start date: Jan2015, stop date: 25Oct2022; LEXAPRO taken for depression, start date: 1997, stop date: 06Oct2022. Past drug history included: Wellbutrin, reaction(s): "Wellbutrin allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Positive rapid COVID in clinic; (21Oct2022) Negative, notes: Neg home tests 10/21 and 23; (23Oct2022) Negative, notes: Neg home tests 10/21 and 23. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 15Oct2022 to 20Oct2022. Clinical course: Patient experienced positive rapid COVID in clinic 15Oct2022; started Paxlovid that day. Neg home tests 21Oct and 23. Symptoms improved, but lingering headache, brain fog, fatigue, and sleep disruption.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.