chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness, chills, headaches, arm numbness in arm of shot admin, malaise, sharp electric pain through the body, loss of appetite., muscle pain, muscle spasms in abdomen.
Redness/adverse events such as a streak down the arm; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix. On 25th July 2020, 1 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient was asking about the safety of a second dose of Shingrix after the first presented with adverse events such as a streak down the arm of the patient and redness.  This adverse event resolved after some days.  The reporter could not provide more information, such as for vaccine or vaccination information, since this was performed by the pharmacist. The reporter did not consent to follow up.
Left arm red and swollen near varicella inj site. Pt txt with BENADRYL 25 mg cap.
This spontaneous report was received from a pediatrician who was referring to an 11 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 23-MAY-2017, the patient was vaccinated with the expired dose of GARDASIL 9 lot number L044475, expiration date 12-MAY-2017, intramuscularly for prophylaxis. There was no adverse event reported. There was no product quality complaint. Additional information has been requested.
Following IM injection flu vaccine - FLUVIRIN, Lot # 1206901, Exp date 06/30/2013- I developed pain and persistent soreness at injection site. The pain still persists more than one month following injection. No erythema seen, mild swelling present.
Extreme pain in her left shoulder and she cannot move her arm at all; This is a spontaneous report from a Pfizer-sponsored program.  about a contactable consumer or other non-health care professional (patient).   A 62-years-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administrated in left arm on an unspecified date (on last Saturday) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 4-5 hours after vaccination, patient experienced extreme pain in her left shoulder, a lot of pain in her shoulder and she was in serious pain, and she cannot move her arm at all and has it in a makeshift sling. Patient stated that pain was between the shoulder blades, and she cannot pull her arm away from her side. Patient stated that this was going on the seventh day. She would like to know if that was normal or has been reported before. She has called the CDC as well and no one wants to tell her anything they keep sending her to someone else. She spoke with her doctor, and she was taking 1600 mg of ibuprofen and a muscle relaxant for the pain, but it was not helping, and the doctor does not want to do anything else. The outcome of the event was reported as unknown.   No follow-up attempts are possible; Information on Lot/Batch number cannot be obtained.
Swelling around mouth and in lips and swollen red lump adjacent to injection site(not at site)
ERECTION FOR 16 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced erection for 16 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of erection for 16 hours was not reported. This report was non-serious.
Patient presented to the ED and was subsequently hospitalized for peripheral artery disease on 4/15/2021. She also presented to the ED and was subsequently hospitalized for sepsis & VT on 5/22/2021. She died on 5/27/2021.
pt recvd vax 28APR93 woke on 29APR w/stabbing pain in front of shoulder arm felt very numb; 30APR pain worse-spread from finger tips to under ear; seen by MD that day; repeat MD visit on 3MAY; had sense of feeling/pain; hemianesthesia in ar
Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
sz (5min) temp 38.1 in ER p/sz;8/5/99 pt had fever @ noc prior to vax;
I began feeling tired the night of the vaccination. The next day around 11am I began feeling nauseous. Around 11:30 or 12 the body aches  and joint pain started. I also got chills and a headache.  Around 4pm, the chills and body pain went away. Later that night the headache and nausea subsided. The following day, I noticed a red mark around the injection site (COVID  arm), but all other side effects went away. The spot on my arm is still there three days later.
Patient fainted after receiving Covid vaccine;  reported tingling in arms & being hot & cold compress Applied to forehead; no injuries; symptoms resolved w/ patient remained in pharmacy for 30 minutes; VARS stated no history of syncope but mom lateR sAid  shots  make patient anxious.
Week after receiving Johnson & Johnson vaccine in left shoulder, patient overnight developed first left shoulder pain (resolved), followed by left ulnar wrist pain. Tender left wrist without other significant findings. X-rays negative.
This case was reported by a physician via a sales representative and described the occurrence of abdominal pain in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). The subject concurrently received unspecified vaccines on the same date of receiving ROTARIX. On an unspecified date the subject received 1st dose of ROTARIX at 1.0 ml. Within 12 to 24 hours following ROTARIX administration, the subject developed severe abdominal pain and vomiting. The subject was hospitalised and the physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject ended up in the intensive care unit due to vomiting green material. It was first suspected that the subject may have had an obstruction, but the subject started to do better. At the time of reporting the events were improved, but the subject was still not feeling well and was on a proton pump inhibitor due to continued stomach pain. The physician considered the events were possibly related to vaccination with ROTARIX.
had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic; had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2021, stop date: Nov2021, notes: The first time she had COVID 19 was in Nov2021. She had asymptomatic COVID before receiving the COVID 19 vaccine. The patient's concomitant medications were not reported. There was no other conditions, investigations, nor other products. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovered with sequelae" and all described as "had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic". The report was not related to a study or programme. The transfer agent has a caller reporting an adverse event for the Pfizer BioNTech COVID 19 vaccine. The caller has had COVID twice.  She thought it was Omicron. She had asymptomatic COVID before receiving the COVID 19 vaccine and has had COVID after receiving the COVID 19 Vaccine and this time was symptomatic. The first time she had COVID 19 vas in Nov2021.  She clarified that the time she had COVID after receiving the COVID 19 Vaccine was in Jan2022. Event End Date: If she had to guess, she took a test 10 days after she got COVID.  It took her 10 days to come back to work.  She tested 5 days after and was positive and went back to work 10 days after.  They are very strict in her office. Event Outcome:  Recovered with lasting effects.  Her eyes seem very dry all the time.  Her vision seems a little blurry.  She had dry eyes before she got COVID.  She has had trouble focusing with her eyes.  She had her eyes checked by her doctor and her eyes are just dry.  It could be an age thing but she does know she got COVID before she had the dry eye problem.  She clarified that her dry eye problem occurred before she received the COVID 19 vaccine. She first received the COVID 19 Vaccine in Apr2021. She hasn't had additional doses.  She did ask about if she should get the booster now or should get the November one.  She tried to ask the Pfizer Medical. Formulation: It was a prefilled syringe maybe. She clarified that it was in little bottle. She declined to complete the supplemental form. The caller had a question about the booster dose to get it now or wait until November but the transfer agent wasn't able to make recommendations but did give the caller some information.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 30-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Syncope (lost consciousness) in the morning after the vaccine. Accompanied by fever, chills, dizziness/presyncope, nausea, headache, body ache, stiff neck on same side as vaccinated arm, sore throat and excessive saliva production
Intense heavy crushing feeling in entire body, as if gravity was suddenly ×10. Slight tightness in throat
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that patient could feel the vaccine working.  Treatment information was unknown.   This case was linked to MOD-2022-531854, MOD-2022-531860, MOD-2022-531856, MOD-2022-531849 (Patient Link).
nausea; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) 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.   No treatment information was provided.
In 24 hrs after administration of vaccines, she felt dizzy. Had to stop walking and sit down. Seen in clinic 4 days later continued dizziness while laying down. Vertigo sensation. Symptoms continue 7 days since administration will be following. She is vomiting a couple times and not dehydrated.
pt recvd vax & exp blurred vision & retinitis both eyes which were treated w/a steroid;
Bells palsy is what I got two weeks later - on the left side of the face. All way from forehead to chin. Including the ear which is actually the worst part. It hurts. I went to the doctor on 6/11/2021 and was given  steroids for a week. It helped with the ache in my neck and ear but once I was off the steroids all that came back. They didn't help with my face. Bells Palsy takes months to heal - so I didn't notice any healing on face. Ibuprofen and Tylenol OTC for pain is what I'm currently taking.
Patient received a flu shot and immediately experienced a small dome, about quarter size, raised lump about 5 mm. No bleeding, no systemic issues. Subsequent follow-up -day later- patient's left deltoid was present with a large erythema at the site of injection.
This spontaneous report was received from a nurse and refers to a patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. Since 12-AUG-2016 to 16-AUG-2016, the VAQTA (lot # L009455, expiration date 01-JUN-2017) was stored in 9 Celsius degrees for 5 days. In September 2016, (excursion day unspecified), the VAQTA (lot # L009445, expiration date 01-JUN-2017) was stored in 8.1 Celsius degrees for 45 minutes. Total time out of range was 120 hours, 45 minutes. There were no previous excursions. Information was received from Digital Data Logger. On 27-SEP-2016, and on 07-OCT-2016, an unspecified patients were vaccinated with a improperly stored doses of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration were not reported) for an unspecified indication. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient presents to the emergency department with complaints of chest pain. He was subsequently admitted for management of musculoskeletal  pain, end stage renal disease on dialysis. He was discharged 5 days later in stable condition to a skilled nursing facility.
First issue began 8 days after vaccine with eruption of heavy bumps on scalpThey eventually erupted into open bleeding sores over the next 2 weeks .  I never made a connection to the vaccine but also never had scalp issues, so I used a shampoo for psoriasis. Without much success.   Within 10 days of my second shot, I had a firestorm outbreak of lesions on my scalp again,  and a few weeks later in  my mouth.  I saw my physician,about my scalp, and he did a biopsy with inconclusive results.  I made an emergency appt in June with my periodontist due to the pain, and he immediately suspected PEMPHIGOID and did 2 biopsies from my mouth.  His biopsy confirmed PEMPHIGOID.    My first appt is in November for treatment.
she has known two people to get the EUA vaccine and 'drop dead'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "she has known two people to get the EUA vaccine and 'drop dead'". The patient date of death was unknown. Reported cause of death: "she has known two people to get the EUA vaccine and 'drop dead'". It was not reported if an autopsy was performed.  Reporter stated she was being forced to get the vaccine or lose her job. She relayed that she had known two people to get the EUA vaccine and 'drop dead' she did not specify which Covid 19 vaccine these people had received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201476 same reporter/drug/event, different patients;; Reported Cause(s) of Death: she has known two people to get the EUA vaccine and 'drop dead'
This 47 year old female applicant alleges onset of a number of symptoms which incapacitated her from continuing her work in a medical office. She alleges that she took the mandatory flu vaccination administered by PA at a medical office where she worked. Shortly thereafter she began having pins and needles and numbness in her hands, feet, fingers and toes with weakness in her legs that spread to her arms and hands, with dizziness that impaired her gait, plus difficulty speaking ("my tongue was messed up"). In addition she remembers having abdominal cramping pain, loss of control of bowels and bladder, rapid heart rate, low blood pressure, and difficulty breathing. These symptoms were associated with severe fatigue which has persisted and unsteady gait, poor concentration, decreased cognitive functioning, inability to drive due to dizziness, anxiety, depression, headaches, weight loss, incoordination, and lower extremity weakness. She indicates that during the most severe symptoms she had trouble being understood, likely due to effects on the tongue. Of all the above symptoms, she says she has persistent (1) dizziness, (2) being off balance, (3) numbness in the legs, arms and hand (on and off), (4) weakness in the legs, and (5) easily fatigued. She states that her physician has told her the symptoms are compatible with Guillain Barre Syndrome. Also her cognitive functions have been impaired she says because she now has trouble reading and understanding what she has read, a problem which she did not have before. Furthermore she has back pain at severity 6-7 on a 0/10 numeric rating scale of intensity, causing her to seek chiropractic care. The pain interferes with standing longer than 10-15 minutes, sitting longer than 30 minutes w/o moving, completing household chores, participating in social activities, religious activities, recreational activities, bending, standing, walking. The pain in the back is described as sharp, stabbing, and tingling and numbness. The pain interferes with her ability to stand and balance herself she says.
After she left she had a splitting headache and by time she got home she could hardly breathe. She is having bad joint pains all over. It hurts when she tries to move and have a fever of 100.9 and have chills. She is also having mental confusion. She can barely walk
Redness; Headache; Fever; This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, headache and fever. On an unknown date, the outcome of the erythema and headache were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the erythema, headache and fever to be related to Shingrix.     Additional Information: GSK receipt date: 07-FEB-2023 Reporter comment: The medical assistant shared her own experience after having gotten the 2nd dose of Shingrix.  She mentioned she experienced redness, headache, and fever (1 day). The reporter did not consent to follow up.
Provider D/C note:  "83-year-old male with a past medical history significant for persistent atrial fibrillation not on anticoagulation, dilated cardiomyopathy with history of have breath that was recovered, aortic stenosis, hypothyroid, hypertension, BPH and dementia who presented with weakness and fever.  Patient was treated for a right lower lobe pneumonia but ultimately was found to have COVID prior to discharge.  Patient defervesced and was in isolation for 10 days.  Patient had no acute events and was doing well.  Patient has had a recent decline per the hospital visits and a recent decline in mental status as well.  Moca 2/30 was repeated this hospitalization as well the last patient has severe dementia.  Patient was discharged for rehab unlikely placement.   Hospital Course:  COVID PNA, resolved - patient was treated with antibiotics prior to COVID(+), completed course with possible right lower lobe pneumonia - COVID positive 07/07/2022, discontinued precautions 07/17/2022   Persistent Atrial fibrillation, CHADS-VASC=5 - not on anticoagulation due to intermittent hematuria - rate controlled with metoprolol   Dilated Cardiomyopathy w/ Hx of HFrEF, recovered - continue home bb, mra, ace-i - stopped home lasix as patient is euvolemic, monitor weights, can restarted patient needs.   Severe Aortic Stenosis - follows with cardiology they were monitoring progression   Hypothyroid - continue home levothyroxine   HTN, controlled - continue ace-i   BPH - continue home tamsulosin   Severe Dementia with Depression, High risk delirium - seroquel nightly  - sertraline, bupropion - MOCA 2/30 - Severe dementia   Issues Requiring Follow Up:  PCP - post hospital follow-up and to help with placement with PACE"
on 5/2/19 pt advised pharmacist she had reaction to 2nd shingrix dose administered 04/18/2019, experienced soreness on day of administration, the day following administration an itching, sore welt began to develop on the patients left upper arm, by day 3 swelling had expanded to emcompass the upper left arm from elbow to shoulder, patient self medicated with diphenhydramine, swelling slowly subsided over the following week, patient did not contact her doctor or Pharmacy