chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; tired; This is a spontaneous report from a contactable other health care professional, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via intramuscular route in the right arm on 04Mar2021 at 17:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for an unknown indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks prior to the COVID vaccine. On 05Mar2021 at 16:30, the patient experienced nausea and was tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events nausea and tired. The clinical outcomes of the events nausea and tiredness was resolved on unknown date in Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia, chills malaise Narrative:
Information has been received from a physician concerning a 62 year old female with no pertinent medical history or drug allergies who vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently the patient developed shingles "7-8 days after immunization with ZOSTAVAX." Medical attention was sought in the physician's office. Lab diagnostic studies performed included lesions that were cultured which revealed a positive result for HSV-type 1. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.  Follow-up information has been received from the reporting physician indicating that the 62 year old retired female with a history of chickenpox during childhood who on 15-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 656859/0357U) in the right arm. There was no illness at the time of vaccination. On 27-OCT-2007 the patient developed a rash of 24 to 36 lesions over her left breast/flank consistent with herpes zoster for a 2 week duration. It was noted that there was no recent exposure to chickenpox or herpes zoster. The patient had a moderate pain intensity level of 4. No treatment was given. On 15-NOV-2007 the patient was recovered. The sample of the lesion was collected on 08-NOV-2007. The sample was taken from a vesicular lesion on the flank. Additional information has been requested.
The patient's medical history and concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Information has been received from a physician concerning a 16 year old female who was vaccinated (date, route and site not reported) with a dose of the Gardasil vaccine (lot # not reported).  Subsequently the patient fainted post vaccination (exact date not reported).  It was unknown at the time of this report if the patient received medical attention or recovered.  Additional information has been requested.
This spontaneous report was received from a nurse referring to a 55-year-old female patient. The patient's pertinent medical history, concurrent conditions, and concomitant medications were unknown by the reporter. The patient did not have drug reactions/allergies. On an unknown date (as a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient went to the office for required vaccinations to operate a day care center. The reporter stated that a serology testing was conducted in March 2017 (one or two weeks ago), to detect immunity and the result was reported as measles and mumps were acceptable; but rubella was indeterminate, like less than 90, inconsistent with immunity (rubella antibody negative). No treatment was given for the adverse events. The reporter stated she did not have the whole report available, therefore, some information was not known. At the time of the report, the patient was "pretty healthy". No further information was provided. The outcome of the event rubella antibody negative and the causal relationship between the event and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) were not reported. Additional information has been requested.
12/24- developed a fever 38.6 body aches, chills, fatigue and headaches denies any cough sore throat , diarrhea and any loss of smell or taste
devel staring into distance spells 24-48 hrs p/vax episodes lasted several seconds each; resolved p/5 days of onset; was breathing but unresponsive during spells;
rash on: most of right arm, small patch on left arm, medium patch on upper right thigh, medium patch on right torso; appeared about 36 hours after booster shot
Patient experienced sensations of numbness and pins and needles in finger tips. Patient was treated with IM B12 injections 1ml once weekly. Patient had moderate Covid symptoms for 48 hours including headache, fever, body aches, and coughing.
mom reports around 8PM pt had temp 102.5 ax, cold sweats & shaking;tried to get pt to car & pt collapsed & had to be carried to car;when got home 915PM T104.8;c/o stomach cramps & nausea; T105 to ER;lethargic;T102.8;advised no more pertussi
5 weeks following (4/24) second shot lips swelled.  As of 5/19 still on prednisone and antihistamines and swelling is still prevalent.
Information was received from a consumer concerning her mother a 67 year old female with no known medical history or allergies who on 16-NOV-1990 was vaccinated with a 1 milliliter third dose of RECOMBIVAX HB. On 18-NOV-1990 the patient developed rheumatoid arthritis. Laboratory diagnostic studies performed, "blood work" results not reported. It was not known if the vaccine was given intravenously or intradermally. The patient's arthritis persisted. The patient was not hospitalized. The patient was not recovered. There was no product quality involved. Additional information has been requested.
Blood count was going up; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Pharmaceutical Company (manufacturer control number: US2021AMR058338). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Mar2021 (lot number was not reported) as dose 2, single for COVID-19 immunization; belantamab mafodotin via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient reported the blood count was going up on an unspecified date. The patient was doing really well (in regards to COVID-19 antibodies) - as reported. The action taken with belantamab mafodotin in response to the event was unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was sent to table 6. A young woman there started to swab my shoulder / very top of my arm.  I told her to stop- I could see my friend at the other end of the table getting an injection  3 inches below the shoulder. Told the woman not to give me the injection so high. She said it had to go into the muscle. Told her there was just skin and bones that high and no muscle. She said she knew what she was doing. And gave me the injection. My arm and shoulder hurt immediately. Really hurt. I should have talked to someone in charge about her. A nurse watching us for 15 min said that pain at that point was normal. It has been  almost 6 weeks and the pain is so bad that it wakes me up. Pain pills, Tylenol, Advil do not work. Please help me find a way to get rid of this pain.  I did take a photo of the injection site later that day as the pain was still there.  Went to my doctor and she said to give it more time. That was  2 weeks ago.  This is a true story. I hope that you can help me get rid of the pain.
the entire night after the vaccinations I was sweating very much; next day may portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat and I felt my heart strange beat; I couldn't sleep at all last night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:30 as dose 5 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I was Covid positive first week of May 2022", start date: May2022 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: flu vaccine vii, administration date: 27Sep2022, for Immunisation; Covid-19 vaccine (Dose 4 Booster), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Booster), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "I couldn't sleep at all last night"; HEART RATE IRREGULAR (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "next day may portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat and I felt my heart strange beat"; NIGHT SWEATS (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "the entire night after the vaccinations I was sweating very much". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported entire night after the vaccinations she was sweating very much and needed to change her PJ. She slept 10 hrs (in general  she was a very weak sleeper up to 5-6 hrs). The next day her portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat. This continued for the next following day (Sunday). There was a slow hear improvement but yesterday (3 day after the injection) but still not normal. She still sweat a lot at night, and on the contrary, She could not sleep at all last night.  She felt her heart strange beat.  She wish she never took this new vaccination as she concern that affected her heart. The patient had received other vaccine in four weeks included flu vaccine vII on 27Sep2022, administration date: 27Sep2022. Other medications in two weeks  included Metoprolol 12.5 mg per day. The patient had covid prior to vaccination. The patient had not tested covid post vaccination. The patient had no known allergy.
JANSSEN COVID 19 VACCINE LEAKED OUT OF SYRINGE UPON ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 39 year old female. 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced janssen covid 19 vaccine leaked out of syringe upon administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid 19 vaccine leaked out of syringe upon administration was not reported. This report was non-serious.
Per mother fever, vomiting. Advised acetaminophen or ibuprofen, bland diet, po fluids and close monitoring. Later that day fever of 105.1 reported advised ER.
Patient c/o right upper arm swelling, localized to immunization site. Hot, painful. Patient seen in clinic, states it feels much better, swelling decreased from last night. Now slightly red and raised.
got my menstrual cycle twice with 2-3 months between each cycle; loss of menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (loss of menstrual cycle) and OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin), Drug allergy (sulfur), Hair dye sensitivity and Perfume sensitivity. Concomitant products included MULTI VITAMIN & MINERAL from 01-Jan-2021 to an unknown date, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) from 01-Jan-2021 to an unknown date and BIOTIN from 01-Jan-2021 to an unknown date for an unknown indication.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MENSTRUATION DELAYED (loss of menstrual cycle). On an unknown date, the patient experienced OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle). At the time of the report, MENSTRUATION DELAYED (loss of menstrual cycle) outcome was unknown and OLIGOMENORRHOEA (got my menstrual cycle twice with 2-3 months between each cycle) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. vitamin c route of administration was reported which was not clear.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow-up received on 23 Jul 2021 contains concomitant list and events were added On 23-Jul-2021: NNI FU - No new information was provided.
On 8/24/99, the pt experienced a nodule at the injection site. On 8/24/99, the pt was again vaccinated with 2nd dose of hepatitis B. The pt experienced a local area of induration and erythema. The pt required no medical treatment.
Case PHEH2016US23188, is an initial spontaneous case received from a consumer on 12 Sep 2016. This report refers to an adult female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date (reported as 2012 to 2013). The patient stated that, after she received the 2012 to 2013 vaccine she had a bad reaction to the shot, for 6 months. She also stated that, she experienced flu, fatigue, body aches and pain, weakness, pain where the shot was given from an unknown date. She experienced heart palpitations on an unknown date. After 6 months, all the symptoms were stopped and the patient did not experience any further problems and the patient got her strength back. The outcome of events was reported as complete recovery after 6 months. The seriousness and causality of the events was not reported. The seriousness assessment of all the events (medically significant) was upgraded based on information available in the source document. The case is lost to follow up at initial.
Rash with raised red maculopapules on right arm and also pruritis.  Patient reports right sided chin swelling nodule inframandicular.
ALREADY VACCINATED TWO TIMES AND RECEIVED JANSSEN COVID19 VACCINE ACCIDENTALLY; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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: 1808978, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced already vaccinated two times and received Janssen covid19 vaccine accidentally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of already vaccinated two times and received Janssen covid19 vaccine accidentally was not reported. This report was non-serious.
On the eight day after receiving the vaccine, my Left arm had a knot the size of a fifty cent piece.   It was red swollen, hot to touch. The knot went down on the 9th day and was gone by the 10th day.  On the 14th day after the vaccine, my arm has mild swelling, red, warm to touch. I have used ice, hydrocortisone cream, Benadryl.
Patient age 5yrs 11 months received 5 vaccines. Immediately after vaccination patients left arm broke out in welds and was red. Patients eyes became red and itchy. Nurse offered Benadryl IM. Mother refused saying that she would give him PO Benadryl at home. No problem with breathing or other problems. Follow up nurse called pts home at 11:10am 09/16/2005. Pt was given Benadryl, above reaction subsided. No further problems. Pt has history of similar reactions from other things besides immunizations per mom.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted a few minutes after receiving the pfizer vaccine. Pt was positioned on the ground laying down and feet up on a chair. After a few mins, pt felt better. Pt asked to stay extra 30mins. Water was given. No other severe reactions were present.
This spontaneous report as received from a physician refers to a female patient of unknown age. Patient had congenital hearing loss. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. On an unknown date after receiving ZOSTAVAX, the patient lost all hearing abilities (medically significant), developed rash on her face and developed swollen glands. Patient was treated with unspecified steroids. The outcome of lost all hearing abilities and rash on her face was reported as recovering, reporter stated that some of her hearing has come back but not all of it and her rash was little bit better. The outcome of developed swollen glands was unknown. Upon internal review the event of lost all hearing abilities was considered to be medically significant. Additional information has been requested.
severe rigors; massive headache; extreme nausea; horrible arthralgia such that I could not get out of bed; This is a spontaneous report from a contactable physician (patient). A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 13:15 at single dose (Lot number= EL3246) on Left arm for covid-19 immunisation. Medical history included hypertension (HTN), covid prior vaccination. Known allergies: Yes. The patient previously took first dose of bnt162b2 (Lot number= EK9231) on 26Dec2020 01:15 PM Left arm for COVID-19 immunization. The patient experienced on 17Jan2021 02:00 AM reported as "14 hours after vaccine awakened with severe rigors, massive headache, extreme nausea and horrible arthralgia such that I could not get out of bed. Lasted several hours. Arthralgia then abated sufficiently enough to get medicines in bathroom". Treatment received included Anaprox, Nexium. Outcome of events was recovered. No covid tested post vaccination.
So the out come was a slow and steady improvement over a couple months left eye lid ptosis (drooping of upper eye lid due to paralysis or disease) eye lid was at half mass wouldn't open unless eye lid was opened up right eye lid was fine.
Information has been received from a pharmacist concerning a 70-year-old female with a medical history of high cholesterol, stomach disorder, seizures, osteoporosis, depression, and has allergies to sulfa and trimethoprim.  On 15-MAY-2007 she was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant medication included "many prescription drugs".  On 02-JUL-2007 the patient developed a red, vesicular rash on the right side of her face going from her temple down to her cheek bone.  Her physician thinks it might be shingles.  The patient was treated with LIDEX.  There were no laboratory or diagnostic tests performed.  Outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Two months after last dose had abnormal mammography and ultrasound, left breast same side as vaccines. MRI showed normal.  My gynecologist states vaccine may have caused inflamed lymph nodes.  Arm sore for months after vaccine. No thanks to a booster
As part of the trial we have to call in when we experience symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (As part of the trial we have to call in when we experience symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (As part of the trial we have to call in when we experience symptoms). At the time of the report, VACCINATION COMPLICATION (As part of the trial we have to call in when we experience symptoms) had resolved.            No concomitant medication and treatment information was reported.  The patient received the booster 01Oct2021. As part of the trial, we have to call in when we experience symptoms. patient work in school and have had kids test positive. Patient had symptoms close to 3 or 4 days.    Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up contains No new information.
Narrative:  Per observer: Pt experienced left sided weakness, difficulty with gait, slurred speech, difficulty with word finding one day after second vaccine. Pt was hospitalized to rule out CVA.