chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain and swelling at injection site- pain required ibuprofen to dull. Couldn?t lift or lay on injection site without significant pain. With 36 hours, developed chills, muscle aches, and fatigue in addition to the injection pain. Within 48 hours, chills subsided but fatigue, muscle aches, and pain continued. Developed shoulder and neck pain  along with significant dizziness.
Apprehension,Palpitations,  Observed for 60 minutes. Fully recovered.
Tinnitus in both ears (previously not present) onset around May 2 2021, is present 24/7 at a low level, is still occurring even now
This spontaneous report as received from a physician via a company representative refers to an approximately 10 week old patient. On 30-APR-2013 the patient was vaccinated orally with first dose of 2 ml oral ROTATEQ (lot # H010052). the patient developed diarrhea, bloody stool and experienced possible abdominal pain after receiving the first dose of oral ROTATEQ. The infant was breast fed, and was seen in the physician's office on 09-MAY-2013 and on 12-MAY-2013. During the 12-MAY-2013 visit, the patient's stool was negative for blood and positive for rotavirus. Intussusception was suspected and the patient was scheduled to see an unspecified surgeon and had a barium enema. The patient was treated with fluids and dextrose, electrolytes (unspecified) (PEDIALYTE). The patient's father told the physician that he was sure that oral ROTATEQ was the cause of this condition. The action taken of oral ROTATEQ and outcome of the events were unknown. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 6 months 10 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This si one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
2 weeks after first shot, pt. experienced stroke symptoms. Called 911 and brain scans found evidence of 2 stroke areas in back of brain. Weakness, inability to talk, droopy side of face. They put him back on prevastatin and eliquis. He was overnight in he hospital. Has had recurring sudden spells of weakness on right side, with subsequent falls, ever since - about every week or 2. Recovers in 1/2 hour. No new strokes observed. He had similar symptoms 2 weeks after his second shot, but no signs of new stroke. We have been trying new treatments to stop the weak spells, not sure if they are working.
While in observation after vaccine was given, 18 y/o male had a tension of body and fainted out of chair from sitting position.  Head did hit the concreate floor.  Male immediately jumped up once he hit the floor.  Syncopal event occurred.  HE was brought back into treatment area and placed on EKG along with vitals.  Normal sinus rhythm, BP and HR stable.  Small laceration to right side of temporal lobe about 1cm long, minimal depth, no stiches required, bleeding stopped immediately and ice pack placed.  Neurological intact, pupils equal and reacted to light.  AAOX4, No nausea, vomiting or dizziness.  Male is stable condition with brother.  Advised to seek further eval with x-ray of skull for precaution.  He was in agreement and understood.
Metallic taste in mouth. Received the antibody infusion yesterday  PT was in a hurry wanted to end phone call.  Did not get all the details.
I had almost continual muscle twitches on the left side of my abdomen below my chest and to the pelvic region.  I am not sure of exact time it began, but a few hours after appointment.  This continued regularly on Day 1 and 2, then less on Day 3, and ended on Day 4.  I contacted pharmacist on Day 4, who advised me only to contact if it persisted over next few days.   I was trying to find out if this could be related to the vaccine.
1) Sore, stiff arm for 3 days, including about half a day of stiffness and possible swelling underarm on vaccination side.  2) On 11/28/21, 12 days after receiving the booster, I woke up with mild dizziness/vertigo, nausea, and indigestion. Lasted until early evening. Kept me in bed, unable to eat or drink, most of the day.   3) Caught a cold, which started with a sore throat on 12/4/21, and led to head congestion and some coughing on 12/5. (Tested by PCR for Covid on 12/5; negative results received 12/6.) Still sick as of today, 12/7, but seems to be improving. I mention this because I  am not exposed to many people and wear an N95 when I go shopping.
Left deltoid red swollen. Treated Naproxen, better in 24 hr tender trapezius delt. Cont Naproxen, add BENADRYL. Improving,
Systemic: lips numbness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient had lip numbness after taking 2nd dose of COVID Vaccine
Shakes Fever Fatigue Flu-like Symptoms Muscle Aches Mental Fog Soreness at Injection Site All Symptoms Lasted about 8 Hours
Patient's daughter called stating her father has been having a really bloody nose for the past 30 minutes and was not stopping. He had received the Fluzone HD the day before. She believed it could have been the flu shot he got the previous day that was causing it, he usually does not get bloody noses. Recommended to call hospital to see if they would want him to come to be seen.
Pt experienced a case of shingles beginning on 6/05/08. ER MD Rx'd on 6-9-08 Prednisone - PCP Rx'd Gabapentin on 6-13-08.
Chills, body ache, fatigue.   Injection site was much more sore for 2nd dose (as compared to 1st dose).  Symptoms had subsided by the next morning.
5/15 sustained syncope, fall hypoxic respiratory failure COPD pneumonia vomiting/diarrhea admitted to the hospital acute kidney injury 5/15--ED--cervical fracture, acute MI, elevated troponin multiple cardiology appointments, follow up appointments since then another emergency room visit on 6/10/21.
(Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain in the arm).   At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Pt noted - "A lot of pressure during administration of flu shot in upper L arm - followed by immediate pain that worsened. Unable to lift (L) arm on 11-14-10, MD vs on 11-15-10. Unable to do ROM - grinding clicking sound upon movement. Ibuprofen, VICODIN.
Pain in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 23-May-2023 The reporter was medical doctor who informed GlaxoSmithKline Sales rep that one of his patients in his 50's had been with sequelae after received Shingrix vaccine 8 months ago. No other information provided. This agent tried to contact reporter by phone unsuccessfully. Consented to follow up.
Swollen lymph node in armpit of injection site (only left side); worsened eczema
Rash turned to hives on back, chest, stomach, inner thighs. triage nurse said to take antihistamine which I did.  It took two days to go away.  Skin continued to itch 1 more day.
Initial unsolicited report received from a health care professional on 06-Dec-2016. This case involves a patient 44 year old female patient who was vaccinated with a first dose of ADACEL via intramuscular route (Batch number: U5521AA, expiry date- 10-Dec-2018) in left deltoid on 01-Dec-2016. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 02-Dec-2016, one day following the vaccination, the patient reported nausea, headache and shortness of breath as well as a large local reaction of redness and warmth at the injection site. Patient required emergency room (ER)/ doctor visit. Laboratory investigations were not reported. Corrective treatment reported as MEDROL pack and SOLU-MEDROL for injection site reaction. The outcome of event was reported as unknown. List of documents held by sender: none.
Reporter noticed several hours after receiving the second dose some soreness and a small bump at the injection site, the following morning there was a golf-ball size bump that was very red at the injection site. 24 hours later the golf-ball bump has decreased slightly but the radius of redness around injection site has increased. Arm is very painful.
ENTIRE VACCINE VIAL GIVEN TO A PATIENT; ENTIRE VIAL OF JANSSEN WAS GIVEN TO A PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced entire vaccine vial given to a subject. The action taken with covid-19 vaccine  was not applicable. The outcome of the entire vaccine vial given to a patient was not reported. This report was non-serious.
This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD lot # L009209, expiration date: 17-SEP-2016 (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Throat tightness an hour after vaccine, arm pain,  swelling underarm, dizziness, fatigue.
Patient remained in the office for approx: 20 min. after the GARDASIL immunization. She left and w/in 15 minutes her mother called & stated "Patient was pulled over on the wise of rd., she feels like she is going to pass out". Patient & mother came back to office & remained for 15/20 minutes. Mother attributes to anxiety which her daughter has. Mom called after leaving office to state, patient had gone out to eat & to the mall. She was fine, still feels it was anxiety.
severe sweats; head aches; body aches; fever; chills; extremely tired; This spontaneous case was reported by an other and describes the occurrence of HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (extremely tired). At the time of the report, HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose-6-phosphate dehydrogenase: normal (normal) not G6PD deficient..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Pfizer report : dose number changed to 2nd dose This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by an other and describes the occurrence of HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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, the patient experienced HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (extremely tired). At the time of the report, HYPERHIDROSIS (severe sweats), HEADACHE (head aches), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose-6-phosphate dehydrogenase: normal (normal) not G6PD deficient..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Pfizer report : dose number changed to 2nd dose
pt developed fully body rash day 7 after vaccine, per mom started on abdomen and spread to limbs, neck, face. itchy. blister like upon exam. minimally responding to calamine/hydrocortisone/oatmeal bath.  treatment: have discussed with mom patient is likely experiencing a varicella like rash from the live varicella vaccine she received 1 week ago - timeline is in range of what is a known side effect of vaccine seen in around 6-10% of patients vaccinated per cdc/uptodate. have discussed this is not an allergic reaction, but rather a viral rash s/t the varicella virus.  have discussed chief goal of treatment plan is to keep patient comfortable - may continue to use calamine lotion, can use hydrocortisone 1% OTC, can give oatmeal baths keep patients nails short to prevent excoriation with scratching patient needs to stay away from pregnant women, elderly to avoid spreading to at risk categories for next 7-14 and until lesions are resolved. have discussed provider will report to VAERS and will weigh pros and cons before giving second dose of vaccine at age 4. seek ED treatment for any airway involvement, swelling, trouble breathing, shortness of breath call or return to clinic if rash is worsening or not resolved within 1 week
I accidently gave Kinrix to this patient, manager notified as well as NCIR
lost her sense of taste this morning. She developed a cough several days ago that has worsened. She also states that her "left side" is more painful than usual.  Pancreatic Transplant (2012(
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 20-JAN-2018, the patient was re-vaccinated with a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001551; US-009507513-1806USA001547; US-009507513-1806USA001548; US-009507513-1806USA001549; US-009507513-1806USA001550; US-009507513-1806USA001560; US-009507513-1806USA001559; US-009507513-1806USA001558; US-009507513-1806USA001557; US-009507513-1806USA001556; US-009507513-1806USA001555; US-009507513-1806USA001554; US-009507513-1806USA001553; US-009507513-1806USA001552; US-009507513-1710USA003103.
Arm swelling and pain, travelling from elbow up to neck. Pt took 2 benadryl, tylenol, and iced, and it has come down some, but still very hot and swollen. Pt is reaching out to provider to see if steroids are needed.
5-10 minutes post-flu shot patient fainted with shaking. Patient recuperated quickly and left pharmacy 15 minutes later.
Lesions behind his knee / Form on large scab / multiple lesions on the right side of his temple; multiple lesions on the right side of his temple/lession have combined to form on large scab; Diagnosed with shingles; Painful blister; noticed a painful blister which was red; left knee which was painful; Burning sensation; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced fatigue. On 24th October 2020, the patient experienced shingles, blister, erythema, pain and burning sensation. On 26th October 2020, the patient experienced scab and skin lesion. The patient was treated with valaciclovir hydrochloride (Valtrex) and sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion were unknown.   It was unknown if the reporter considered the shingles, blister, fatigue, erythema, pain, burning sensation, scab and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and experienced fatigue initially and then five days later noticed a painful blister which was red and burning sensation behind his left knee which was painful and was seen at the urgent care where diagnosed with shingles and given 10 day course of Valtrex and 7 days course of Bactrim 800/160 mg.  They were multiple lesions behind his knee and the lesion had combined to form on large scab.  The patient noticed multiple lesions on the right side of his temple. The reporter consented to follow up.
pt recvd vax & devel onset of bronchospasm, erythema, generalized edema; low grade fever, edeam, weakness, joint ache, tightness of chest, coughing, h/a, BP 150/90, serum sickness, T100.5, tonsils inflammed, lymphadeno, pain, lower abdo
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAR-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB lot # reported as J005672, expiration date reported as 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
vaginal bleeding; cramps; bloating; This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter which included that a 60-years-old female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198, patient was 60-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Right on 25Feb2021 at 08:00 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included post menopause (I am 15 years post menopause, Do not need increase in oestrogen. Onset of period in my 60s), breast cancer (Concerned due to family history of breast cancer), High blood pressure. Concomitant medication(s) included ongoing metoprolol succinate (TOPROL XL, 50 mg, via oral route) taken for High blood pressure; biotin; colecalciferol (VIT D [COLECALCIFEROL]). On 02Mar2021, the patient experienced vaginal bleeding, cramps, bloating. No treatment was received for events. On 01Apr2021, the patient underwent lab tests and procedures which included biopsy polyp, Hemoglobin, Post OC-light, Thin prep which all resulted as normal. The outcomes of events were recovered on 07Mar2021.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
No upward movement of shoulder after 3rd day of vaccination without severe pain; No upward movement of shoulder after 3rd day of vaccination without severe pain. After day 6 the pain is still there. I can hardly move my shoulder/ arm (left) to close my drivers door.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 02May2021 at 16:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via an unspecified route of administration in the left arm on 11Apr2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04May2021 at 07:00, the patient experienced no upward movement of shoulder after third day of vaccination without severe pain. After day six, the pain was still there. He could hardly move his shoulder/arm (left) to close his driver's door. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event no upward movement of shoulder after third day of vaccination without severe pain and can hardly move my shoulder/ arm (left) to close drivers door was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received dose #1 of Janssen COVID vaccine on 8/20/2021. Patient did not experience any side effects. Patient presented to local county health dept for Janssen booster COVID vaccine. Nurse went through side effects of Janssen with the patient and patient requested a dose of Pfizer for the booster. Nurse drew up and administer the Janssen vaccine instead of the Pfizer. Patient was notified of error and again of the possible side effects.