chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart flutters; rigors; very weak; vomiting for hours; migraine; shaking; full body pain; unable to sit upright/ unable to function; sharp left chest pains; palpitations; This is a spontaneous report from a non-contactable female consumer report for self. A 39-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 03Apr2021 15:30 (Batch/Lot Number: EW0150) (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. Medical historied included allergies: Shellfish, almonds, penicillin, dogs, and asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Apr2021, 48 hours after 1st vaccine: rigors, very weak, vomiting for hours, migraine, shaking, full body pain, unable to sit upright. 1.5 days of being unable to function. Few days later: sharp left chest pains (still ongoing 06Jul2021), palpitations and heart flutters. Went in 2 weeks ago, because it won't go away. 2 EKGs abnormal, 2 weeks apart. Getting stress test and heart monitor etc now, working with cardiologist to figure this out. Events result in Doctor office clinic visit. Treatment included pills to lower heart rate as needed for palpitation. The outcome of event was not recovered. Patient received second dose administered in left arm on 30Apr2021 15:30 (Batch/Lot Number: EW0172). Since the vaccination, has the patient has not been tested for COVID-19 since the vaccination.
Swollen lymph node above clavicle on the left side, began one day after vaccination. Then 3 weeks after vaccination noticed the above clavicle on the right side is also a little puffy. These areas are non-tender and are not red.
Woke up with severe joint pain in shoulder and elbow of arm where injection occurred. Felt fatigue, weakness, sore throat, cough, urinary discomfort, and gastro issues. After 5 days the joint pain went away, but everything else remained. 2 weeks later brain fog and more fatigue. As well as tingling in face, the sensation of cold water running from the corner of my mouth to my jaw line, tingling in right arm, hand, right calf, and foot. Pressure in calf and foot. Light sensitivity. Menstrual cycle issues - spotting off and on for a week or two. An experience of intense anxiety - my face got all hot. All the symptoms except for the sore throat and menstrual issues disappeared in late May. Then in September the tingling in face and weird sensation of cold water running from my mouth to jaw is now back. I have tingling in right arm, hand, right calf, and foot. Sometimes I feel tingling in my left hand and foot now. Also pain in my finger tips or tips of my toes. Sometimes it keeps me up at night. None of this is devastating and I would say it is relatively mild. It is uncomfortable and would be better to have it fixed then not. I am scared to get future vaccines as I believe the reaction would be much more severe.
This case was reported by a physician and described the occurrence of an urticarial rash in a 3 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On 05/25/2004, the patient received the third dose of Infanrix.  On the same day, the patient also received injections of hepatitis B vaccine and poliomyelitis virus vaccine.  The site of injection for these three vaccinations was not provided.  On minute after the administration of the immunizations, on 05/25/2004, the patient experienced an urticarial rash over face and body.  The physician also reported that at the time of the event the patient, had no problem breathing.  The patient was treated with diphenhydramine.  The event resolved on 05/25/2004.  The physician considered the event to be serious and to require intervention to prevent life threatening sequelae.  The physician reported that the patient has received hepatitis B and IPOL again without incident.  The physician considered the urticarial rash to probably be related to vaccination with Infanrix.
(R) shoulder is still painful at injection site when lifted above head in full extension 2 weeks after vaccine received. No redness or swelling at site. Symptoms remain at this time.
Pt called office after administration of GARDASIL vaccine #2 (8/18/10). C/o canker sores in mouth 2 days after rec.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-OCT-2012 14:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-nov-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Dizziness at the 15 minute mark after 1st dose of COVID vaccine. No other symptoms noted. BP 126/78, pulse 68, Resp. 18. After another 5 minutes,  patient has no complaints and states " feels back to normal"
Narrative: Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chills
kind of fussy; woke up @ 7PM mom c/o projectile vomiting; APAP @ 8PM, vomited; & slept soundly p/that; temps 99 ax @ 830, 99.5 @ 9PM @ 930 100 all ax temps; called MD on call re: vomiting & temps; couldn't get pt awake;
At 2 mo PE received Pentacel; Prevnar and Rotarix - had hives all over after 2r hrs on 11/7/13. Receive red Prevnar 13 and IPV.  36 hours later hives all over again.
Cardiac issues; Neurological issues; Postherpetic neuralgia; Herpes zoster; Information has been received regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for its intended purpose: for the prevention of shingles (herpes zoster) (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided). After receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, cardiac issues and neurologic issues. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the symptoms have resulted in physical limitations not presented prior to using the company's product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of the company's conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, postherpetic neuralgia, cardiac disorder, and nervous system disorder was not recovered and the causality assessment between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The lawyer considered the events herpes zoster, postherpetic neuralgia, cardiac disorder, and nervous system disorder to be disabling.
Patient was given HIB vaccine that was diluted with sterile diluent instead of the diluent that the powder is supposed to be reconstituted with. Patient did not have any reaction or require treatment. Patient will have to get revaccinated with another dose of HIB.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash) had resolved.            Concomitant medications were not provided.
PT REPORTS SWELLING, TENDERNESS AND REDNESS AT INJECTION SITE. SWELLING TO THE SIZE OF A BASEBALL.
Patient received 2 doses of Moderna COVID-19 vaccine  dose 1: March 25, 2021 (lot 028A21A) dose 2: April 22, 2021 (lot 029A21A)  On Aug 19, 2021, he tested positive for COVID-19 through the Abbott at home test, as well as a PCR test (1 hour results).  He has sore throat, coughing, and achiness.
I woke up the next day and my armpit area as well as my breast area was hurting. My lymph nodes were swelling and were the size of a thumb. I took either Ibuprofen or Aleve for the pain. I used a heating pad as well but it was still hurting. I recently told my doctor and she told me that my lymph nodes need to be checked and that there is a possibility that they need to be removed.
Redness around injection site - told her to try some BENADRYL to help redness.
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of VAQTA (dose, route and lot number not reported) that was improperly stored. Nurse reported that VAQTA was exposed to temperature as low as - 1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
3 weeks after the vaccine my left eye began to twitch and continued for about 2 weeks.  During this time I began to have muscle twitching in my left and right arms.  My left leg at the inner calf area became intermittently numb and the muscle twitching began in my legs as well at the same time.
Itchy; Warm to touch; Small red circle on upper left arm at injection site; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE ERYTHEMA (Small red circle on upper left arm at injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PRURITUS (Itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B12A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE ERYTHEMA (Small red circle on upper left arm at injection site) and VACCINATION SITE SWELLING (Swollen). On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 14-Apr-2021, INJECTION SITE ERYTHEMA (Small red circle on upper left arm at injection site) and VACCINATION SITE SWELLING (Swollen) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Less than 30 second episode of syncope s/p GARDASIL vaccination. Patient regained consciousness and was laid supine 2 legs elevated, ice pack to back of neck. Patient remained in office for 15 additional minutes, with boyfriend at bedside. No adverse effects noted. Patient pink, denied dizziness and was released to home with boyfriend.
Systemic: Tingling around gums-Mild, Additional Details: Pt hx: Contrast allergy 15 years ago. No anaphylactic shock. Symptoms remembered: Heart palpitations\r\nPt symptoms: tingling around gums, no swelling, no rash\r\n1830 Vitals; 158/102, HR 101, O2 Sta 99%, Temp 98.1\r\n1855 Vitals; 130/90, HR 88, RR 16, 98% O2 Sat.\r\recommended repeat Benadryl dose of 25 mg and contact/ work up with PCP.
shoulder pain with numbness down into my fingers; shoulder pain with numbness down into my fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) 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-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers). At the time of the report, HYPOAESTHESIA (shoulder pain with numbness down into my fingers) and ARTHRALGIA (shoulder pain with numbness down into my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Injection site soreness; This is a spontaneous report from a non-contactable nurse. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported), intramuscularly on the left arm on 12Jan2021 (14:45) at a single dose for COVID-19 immunization at the hospital. Medical history included adult onset asthma; gastroesophageal reflux disease (GERD); and breast cancer. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported), intramuscularly on the left arm on 22Dec2020 for COVID-19 immunization. On 13Jan2021 (06:00), the patient had injection site soreness. The patient did not receive any treatment for the reported event. The outcome of the event, injection site soreness, was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more.).    This case contains information of 13 patients out of 42 reported by reporter.  Concomitant Medication use information was not provided by reporter.  Vaccine was given to patients for long COVID between March 2023 and 1 August 2023.  42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65.  Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master Case (Patient 1out of 42 patients)
pt recvd vax & devel induration & erythema @ inject site & a tiny rash @ the area w/small dots in a vertical line;
Started as hive where shot was given, then, over course of 2 days, the entire arm and hand grew to twice its original size. The effects were swelling, itching and a burn-type feeling in the arm. The look and feel of the reaction resembled a 2nd degree burn - there was swelling, blisters, redness, and when that subsided, the skin started pealing.
developed cellulitis in her right arm on an unspecified date; This spontaneous report was received from an office manager via a company representative referring to a currently 76-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe (lot # S021740 with expiration date 25-MAR-2021; dose, frequency and route were not reported) for prophylaxis. On an unknown date the patient developed cellulitis in her right arm. On an unknown date, the patient was hospitalized due to the event. The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe was not available for investigation but the office had an unused pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe with same lot number which could be returned.  The outcome of the event was unknown. The causality assessment was not provided.   The reporter requested a lot check because this was the third adverse event report for this lot number of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(one of three reports from the same reporter).  Upon interval review, cellulitis in the arm was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2003USA003225: US-009507513-2003USA003005:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received SHINGRIX. Concomitant products included trazodone. On 26th February 2018, the patient received the first dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 26th February 2018, the patient experienced injection site pain and shoulder pain. On 27th February 2018, the patient experienced influenza-like symptoms and pain. On 27th March 2018, the patient  experienced joint pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain were recovered/resolved. The reporter considered the injection site pain, injection limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included Hytrone. The patient reported he received the SHINGRIX vaccine at 3:00 pm and less than a day post vaccination, experienced injection site soreness and by the 2nd day he felt like he got kicked by a horse. For a couple of days he had difficulty lifting his arm to put on his shirt and he needed assistance from his wife. The patient took MOTRIN for the pain and by Saturday or Monday he could press on his arm and there was no pain. The patient claimed that 1 day post vaccination, he felt like he had the flu for 5 days and his shoulder pain started right away after receiving the vaccination. The patient also had 1 day post vaccination, 5 days of feeling achy. All of the symptoms had resolved.
shivering beginning w/in several hr of vax; reported because several other pts reporting same-reports to follow;
February 4th or 5th I noticed eye sensitivity and redness while taking off makeup. The next morning it tenderness was worse and I was very light sensitive. Symptoms continued for a week and I made an appointment with eye doctor. The eye doctor diagnosed me with scleritis. Put me on eye drops. Helped with pain but not redness. Doctor then put me on prednisone which helped but the condition came back worse after course of prednisone. Was referred out to specialist who put me on  Humira and eye drops. Been seeing specialist monthly. After most recent appointment I began noticing vision changes and it was discovered that my vision degraded greatly.
Patient presented to the clinic for a booster following receipt of J&J for primary series. Was administered full-dose Moderna. Unable to reach patient by phone. Left message notifying her of dosing error.
COVID; COVID; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4245037-00.  A 23 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID". The action taken for adalimumab was unknown.  The reporter considered "covid" related to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events drug ineffective,  Suspected Covid-19  and the administration of the vaccine cannot be excluded.