chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minor sensation loss; Cold feeling right side of face, including around R eye, R mouth corner, R back of throat and tongue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: PAA156051) via an unspecified route of administration on right arm on 20Mar2021 (at the age of 66 years old) at 07:15, as a single dose for COVID-19 immunisation. Medical history included high BP, cholesterol, osteoporosis, and sensory stroke from an unspecified date in Mar2020 (the patient was fully recovered). The patient was allergic to dust mites, and drugs erythromycin and dicloxacillin. Concomitant medication included unspecified medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 08:00, the patient experienced minor sensation loss, and cold feeling on the right side of face, including around right eye, right mouth corner, right back of throat and tongue. The patient underwent COVID-19 virus test on an unspecified date and the result was negative. No therapeutic measures were given for the events of sensory loss and cold feeling. The clinical outcome of sensation loss and cold feeling was recovered 4-5 hours later on 20Mar2021. No follow-up attempts are needed. No further information is expected.
Local reaction at injection, fever, chills, body aches, treated with ice on injection site.  Tylenol (500mg every 4hrs) Benedryl 25mgx1, edema under arm.
Pain and limited range of motion in arm that was debilitating for 6 weeks following vaccination. Minor fever and chills on day after receipt of vaccine.
migralepsy migraine; Head ache; nausea; fatigue; blisters in mouth; swelling of joints and face; swelling of joints and face; severely ill; This is a spontaneous report from a contactable consumer. A 45-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 02Apr2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number Erb8733) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included migralepsy migraine and arthritis. Known allergies included cefalexin monohydrate (KEFLZ), amoxicillin, penicillin, alprazolam (XANAX), ondansetron (ZOFRAN), cantaloupe. The patient's concomitant medications included naproxen sodium (ALEVE), cucurbita pepo oil (PUMPKIN SEED OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 12Mar2021 at 10:30 AM, at patient age of 45-year-old, as single dose (Lot number En6206) for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of bnt162b2 on 02Apr2021. The patient stated that "I think they tried to poison me". On 02Apr2021 at 16:00 PM, the patient experienced headache, set off migralepsy migraine, nausea, fatigue, blisters in mouth, swelling of joints and face, severely ill and only out of bed short periods at a time for two days now. The patient did not receive treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
elevated liver enzymes; This case was reported by a consumer and described the occurrence of elevated liver enzymes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that her physician informed her that the patient had also experienced elevated liver enzymes after receiving the Shingrix vaccine. This is 2 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter US-GLAXOSMITHKLINE-US2020AMR153873:same reporter
Extreme pain at vaccination site, redness extending around site (4x3 area).  Fevers, T max 103.5, chills, shaking.
From chin to shoulders, it looked like a sunburn and had fever in it. The area where the shot was given had a 3" diameter red place with fever in it. The rest of the body had a rash with large bumps about 1/4" in diameter. Treatment was, the patient took Claritin.
HCP has no further AE information.; HCP called to report that an expired dose of MMR II, was inadvertently given to a patient. HCP reports no side effects or symptoms. HCP reports that there have been no prior TE's. HCP gives permission to contact herself and gave permission to contac; This spontaneous report as received from a medical assistant and refers to a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 25-OCT-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # W034714 with the valid expiration date of 18-OCT-2023 (dose and route of administration were not reported) for prophylaxis (expired product administered). No side effects or symptoms were reported (no adverse event). There have been no prior temperature excursions (TE's). No further adverse event (AE) information was noted. No product quality complaint (PQC) was noted.
EE has had a previous reaction to the 1st covid vaccine she received, was told to go see her PCP or provider about getting the 2nd dose. She did so and was given instruction, she received the 2nd dose and had this reaction BP 127/90, abnormal for her she states to number is always between 101-107. had hives facial swelling, fatigue
Brief tonic seizure (approx 30 sec) T 96.3 evaluated by paramedics prior to coming to office. Pt acting normally and exam nl. in clinic. No tx no further problems to date. Unk if seizures will continue.
red blotchy spot in her chest her face, neck and chest and also at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red blotchy spot in her chest her face, neck and chest and also at the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red blotchy spot in her chest her face, neck and chest and also at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red blotchy spot in her chest her face, neck and chest and also at the injection site) outcome was unknown. Not Provided          No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-058370 (E2B Linked Report).; Sender's Comments:  MOD21-058370:Cross-Linked Case
Itchy red rash that felt hot and hurt to touch.  Also felt dizzy. Took about a day and a half to feel relief.
About 45 minutes after the vaccine was given, the patient became dizzy and felt faint. She was given a chair to sit in, and her blood pressure was checked (87/54 mmHg). She said she was hot, so she was given water, Ginger Ale & crackers. She sat for about 1 hour before being picked up and taken home.
H/o meningioma and left ICA occlusion w/ prior traumatic ICH sent from outpt clinic s/p 2nd covid vaccine with acute onset slurred speech, facial asymmetry and LUE weakness (?chronic), atraumatic, nml AC, pt HD stable, stroke alert on arrival, symptoms improving
Patient was given a dose of vaccine that was expired.  No complaints or reactions have been notified of.
nose bleeding; fatigue; stiffness; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (DOLIPRANE) at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Blood pressure measurement: 160/110 (High) high. On 18-Feb-2021, Blood pressure measurement: 140/100 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication provided
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: The pharmcist gave the vaccine to the patient around 2:15 pm ; pt was ok for first 10 min. she sat with her mom, then by 15 min, pt fainted. She regained conscience immediately, she was given some juice to drink, the new Rph on duty came to work at 2:30 PM and monitored patients blood pressure, it was 63/55, pt said she could talk, mean while we called 911. when the ems came, they checked her for the vitals. MOm told the ems people than the patient has a phobia of vaccination,
On 01/27/2023 I started experiencing a slight cough as my symptoms progressed I had severe body aches, fever, chills, rash and diarrhea. I tested positive on 01/28/2023. I had a telehealth visit and treated my symptoms with OTC TYLENOL and antidiarrheal medication. I tested negative on 02/10/2023. I have recovered at this time.
Same day of vaccination - injection site pain. Pain continued for next 2 days. Had few days of no pain but pain returned cannot lift arm sometimes. Pain on lifting things with that arm and pain continues or gets severe. Next day burning sensation in that area.
Information has been received concerning a 17 year old female who on 08-JUN-2007 was vaccinated with a dose of Gardasil. Subsequently, the patient experienced pain at the injection site. At the time of the report, the patient was recovered by 10-JUN-2007. No further information is available.
Left sided joint pain; Itching; skin peeling left and right armpits. Left armpit worse than right; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 14May2021 13:30 (at the age of 31-year-old) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included dysmenorrhea, left side sciatica. Concomitant medication(s) included herbal NOS (HERBAL NOS) and Chinese medicine. Patient was not pregnant at time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0158) at left arm on 16Apr2021 at 13:30 (at the age of 31-year-old) as dose 1, single for covid-19 immunization. No other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17May2021, the patient experienced Itching, skin peeling left and right armpits. Left armpit worse than right. Left sided joint pain. Reporter assessed case as non-serious. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment for event. No Covid prior vaccination and no Covid tested post vaccination. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
1 of 2 pts who recv vax 13JUL94 devel shrill crying x 2 hr & fever of 102 x 3 days; event occurred 6 hr p/vax; tx APAP; pt recovered;
Pt has bruising/ swelling at the injection site and a little lower towards the elbow. Pt complains that it was difficult to lift her arm on Saturday. Pt can lift her arm now but is experiencing a pulling of the muscle sensation. Rph will follow up on 10/23/18. If symptoms have not resolved pt was instructed to schedule an appointment with her primary care to make sure that the injection site is not infected.
01/11/2022 Covid symptoms started with headache, 102 fever, body aches, and sinus pressure. I tested positive at a drive-thru clinic that day. I still have the headache, sinus pressure, and congestion, but I never got a cough. The other symptoms lasted about 3 days.
Patient reports soreness and muscle weakness in PNEUMOVAX injected arm (left side). There was a bump that developed days later in shoulder area. Her doctor was notified and she will follow-up with an appointment.
Patient fainted andtwitched in chair in lobby after receiving vaccinations. Patient vomited 4 times over the next hour and 40 minutes, with c/o nausea, sweating, and headache.
Information has been received from pharmacy technician concerning a 79 year old male who on 26-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). One week post vaccination, on approximately 07-NOV-2007, the patient developed a "little itchy rash". The location of the rash was not reported. The pharmacy tech also reported this event to the VZVID program. At the time of reporting the patient was recovered from the "little itchy rash". The date of recovery was not reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe)(lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF);  devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA009779: US-009507513-2007USA010268: US-009507513-2007USA010269:
3/12/03: Pt comes in with reaction to immunizations. Injection site is red, warm and swollen. It is about 3-4 inches in diameter. Meds: none. Pt had her DPT on Monday, today her right leg is swollen, hot and red. Right leg 8 x 7 cm erythematous lesion with target in center where injection site occurred. Assessment: adverse reaction to DPT. Will consult in AM. Today will give Augmentin. Diagnosis: cellulitis leg.
I had to wait for 15 min and was released. I started getting a really bad headache about 5 min later above my ear. I then got nauseous. I went back to vaccination location and was given a cold compress. I was taken to the ER and given Benadryl and multiple nausea meds. I was there for about 5 hours. I was released and instructed to drink lots of water. I was told by the doctor that my body was doing what it was supposed to do, but to come back if I got worse. I took 2 days off and returned to work with no remaining complications.
Patient received vaccination in the left arm around 10:25am. Patient proceeded to sit down in the waiting area for the 15 minute period. During this period, patient was joking with her husband. Around 10:35 am, patient started feeling really dizzy and lightheaded. I was notified at this time about the dizziness. I rushed out into the waiting area and patient had lost consciousness. Patient did not gain immediate consciousness. Code white was called and 911 was also called. I kept tapping patient  for response. Patient was breathing and I kept checking pulse.  After at least one minute, patient regained consciousness and was able to speak to me. Patient stated she felt dizzy and hot. I had a technician grab ice bag packs and placed on her neck along with bottle of water. During this time, I checked patient's vitals and they were normal. Ambulance arrived and explained the situation to them and reported vitals.  Patient was becoming dizzy and lightheaded again so patient was taken to emergency room.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. Two weeks ago (Approximately on 17-JUL-2013) the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). The patient "had 2 seizures within 30 minutes" while still in the Physician's office after having received the first dose of GARDASIL. The physician sent the patient to an unspecified hospital, where the patient stayed for an unspecified length of time. It was not specified whether or not the patient was hospitalized. The out come of the events and action taken with GARDASIL was not provided. Upon internal review, had 2 seizures within 30 minutes was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Exhaustion, muscle pain, a headache, shivering, stomach pain, nausea.
This spontaneous report was received from a Registered Nurse referring to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 04-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004400.
itching on side torso bilaterally; blotchy rash; developed hives on her torso; entire trunk felt inflamed; bad headache; fatigue; achy; missed work; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included HEPATITIS B VACCINE (HEPLISAV B) for prophylaxis.   Previously administered products included Allergy injection. Concurrent medical conditions included allergic to dogs.   On 30-AUG-2023, the patient received Shingrix and HEPLISAV B. On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: bad headache), fatigue (Verbatim: fatigue), pain (Verbatim: achy) and activities of daily living impaired (Verbatim: missed work). In OCT-2023, the patient experienced pruritus (Verbatim: itching on side torso bilaterally), blotchy rash (Verbatim: blotchy rash), hives (Verbatim: developed hives on her torso) and inflammation localized (Verbatim: entire trunk felt inflamed). The patient was treated with ibuprofen (Advil) and benadryl (nos) (Benadryl). The outcome of the headache, fatigue, pain and activities of daily living impaired were resolving and the outcome of the pruritus, blotchy rash, hives and inflammation localized were not reported.   It was unknown if the reporter considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.     It was unknown if the company considered the headache, fatigue, pain, activities of daily living impaired, pruritus, blotchy rash, hives and inflammation localized to be related to Shingrix.   Additional Information: GSK receipt date: 08-NOV-2023 A woman received Heplisav and Shingrix and 3 days later she developed hives on her torso. As per primary care provider note on 31st October 2023, next day the patient suffered from bad headache, fatigue, achy and missed work however felt better next day, Advil helped. Three days later noted itching on side torso bilaterally, blotchy rash, looked like hives and entire trunk felt inflamed, Benadryl helped. The patient had allergy injections as a child, history of dog allergies, even had reaction to hypoallergenic dogs. There were no other medical notes documented between 30 August 2023 and 31 October 2023.
On March 11 I had shortness of breath laying down.  March 17 I was up all night with heart rate up to 125 and oxygen saturation as low as 80%.  On March 18 I went to ER and was diagnosed with Congestive Heart Failure after a 3 day hospital stay of tests.  I have no history of high blood pressure or heart issues except for high cholesterol controlled with Lipitor.  No family history of heart problems.  I am now on Entresto and Carvedilol.
15 minutes, post vax, pt became clammy and dizzy. Improved with rest and ice. Pt experienced a fever of 102.7, achy joints, nausea, pulse 106, blood pressure 108/52.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported an expired M-M-R II (dose, route and lot# were not reported, exp 09-AUG-2014) was given on 28-OCT-2014. No adverse effect reported. The pharmacist would like to know if this should be counted as an administration or should the patient receive 2 additional doses. Additional information has been requested.
On the morning of MArch 3, and for several weeks following, I woke up from sleeping overnight to find joint and muscle pain over my entire body, especially shoulders and hips. The pain gradually subsided over several weeks, only to resume ten days (on March 30) after the second vaccination on March 20, and again about two weeks after the booster on Oct 9. The pain after the booster persists to this day, especially in the shoulders.
Fever up to 105 deg F after vaccines. Not effectively relieved by Motrin. Pain in right thigh. No noted redness or swelling on 1/30/03.
Unsightly rash beside my nose down past my mouth on the right cheek, under the left eye, above both eyes, dotted across forehead. It did not itch or burn but looked like a burn scar, humped up. Treated with Benadryl Cream. Lasted 3 weeks.
Red, hot, swollen arm for about 3 days. I can submit pictures. It was really bad.