chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 8 year old white male status post submucuscleft palate (no pain) with an allergy to amoxicillin (+) clavulanate potassium (augmentin) who on 16-MAY-2007 in the AM was vaccinated IM in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot# 656608/0032U). there was no illness at the time of vaccination. On 23-MAY-2007 the patient experienced acute febrile illness, with sore throat and headache. Subsequently, the patient recovered from acute febrile illness, sore throat and headache. The reported indicated its unlikely vaccine related as sister had been sick earlier in week with the same. No product complaint was involved. Follow up information indicated that no adverse events took place. There were no relevant diagnostic tests or laboratory data. The patient's brother also experienced as adverse event (WAES #0706USA04457). No additional information has been requested.
general muscle soreness; tiredness; day of injection minor injection arm soreness; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 11:30 (Lot number: EL 3247) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; OLMESARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=COVID- 19 mRNA VACCINE BNT162b2, Lot number: EL 3247, Lot unknown: False, Administration date: 22Feb2021, Administration time: 09:30, Vaccine location: Right arm, Dose number: 1), administration date: 22Feb2021, when the patient was 61 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Mar2021 17:00, outcome "not recovered", described as "day of injection minor injection arm soreness"; MYALGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "general muscle soreness"; FATIGUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, fatigue.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive other vaccine in four weeks, had no known allergies, no COVID prior to vaccination, and was not COVID tested post-vaccination.   No follow-up attempts are possible. No further information is expected.
Patient received vaccine after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Patient received VARIVAX on 12/27/02 and returns to clinic on 6/2/04 with a diagnosis of shingles. She received the VARIVAX in the right arm. The shingles are described in the medical record as "right lateral breast with area of clustered rained vesiculopapules with erthem base, about 3-4 cm diameter. No other sensitivity or lesions anterior lateral or post chest. No discharge or crusting."
Malaise; Nausea; This case was reported by a nurse via call center representative and described the occurrence of malaise in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31st August 2023) for prophylaxis.   On 16th August 2022, the patient received Menveo. In August 2022, less than 2 weeks after receiving Menveo, the patient experienced malaise and nausea. On an unknown date, the outcome of the malaise and nausea were unknown.   It was unknown if the reporter considered the malaise and nausea to be related to Menveo.     Additional Information: GSK Receipt Date: 26-Aug-2022:  Reporter's comments: The nurse practitioner called to inquire about any additional information on reactions. The nurse practitioner reported the patient received Menveo of certain lot number.  The patient experienced malaise and nausea. The nurse practitioner stated read the adverse event section in the product PI (package insert) but wanted additional information on reactions. The reporter did not consent to follow up. Additional Supportive Information: This case had been linked with US2022124288, reported by same reporter.; Sender's Comments:  US-GSK-US2022124288:Same reporter.
pt has necrosed area on lt leg; seen by pvt MD who will w/ATB & f/u accordingly; reaction occurred approx 25 days p/inject;
stated when he took the shot that he is breathing harder than he was before; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Jan2021 (age at vaccination 93-year-old) at 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hearing problem, hearing aid user, amyloidosis. The patient's past drug included Coumadin and Vyndamax. The patient's concomitant medications were not reported.  On an unspecified date, the patient stated that he had a Pfizer shot on 19Jan and is due to get another on 09Feb. he is 93 years of age. He stated that he was diagnosed with amyloidosis and was using a Pfizer medication called Vyndamax to help him keep the protein off the major parts of his body. He took the shot that he was breathing harder than he was before.  He wanted to know if this is possible and also stated that he had a hearing problem and hearing aids before the shot. Stated that he was diagnosed with amyloidosis and taking Coumadin and Vyndamax before the shot. The outcome of events was unknown.   Reporter details: Stated that he was going for medicine many years ago but ended up in business.   Follow-up (01Feb2021): New information received from a contactable consumer.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.   Information on the lot/batch number has been requested.
16 weeks pregnant at time of dose 2, EDD 10/31/21  Arm pain- couldn't move at all  Severe fatigue Muscle pain- especially back pain Joint pain- hurt to move body  Chills Headache Chest pain - like I had a chest cold, but no coughing Sore throat Feeling fluish
Hair thinning at the top of her head; Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) and ALOPECIA (Hair thinning at the top of her head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced ALOPECIA (Hair loss). On an unknown date, the patient experienced ALOPECIA (Hair thinning at the top of her head). At the time of the report, ALOPECIA (Hair loss) and ALOPECIA (Hair thinning at the top of her head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided. Treatment medication were not provided.
Test positive on 12/29/2021, .  First dose 1/5/2022, Second dose 2/2/2022, booster shot 9/21/2021 at local Pharmacy lot number not readable
I have had persistent continuous heart palpitations starting the day after the vaccine. The palpitations are gradually subsiding but are still present and troubling a month after the vaccine. I do not have any other symptoms (no shortness of breath or chest pain) and have not sought medical help for the palpitations. I often get palpitations when I have a virus, and have had them checked out (in the past, not now) and they are benign, but these are really frequent and persistent, and do suggest some degree of heart inflammation.  I do not have Covid.
Body Aches; Rigors/chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of general body pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced general body pain (Verbatim: Body Aches) and chills (Verbatim: Rigors/chills). The outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the general body pain and chills to be related to Shingrix.     It was unknown if the company considered the general body pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023 and 24-MAY-2023 The patient about received 1st dose of Shingrix at the physician's office, given by another nurse employee.  The nurse stated that the patient experienced chills, rigors, and body aches which started about 24 hours after the vaccination. The only time frame provided was around the holidays in early December 2022, and it was not certain if this was the 1st or 2nd dose.  There were no other patient demographics.  The location of administration was not known for either dose.  The reporter did not have the lot number or expiry information. The reporter did consent to follow up. For tolerance to the 2nd dose refer case US2023AMR074160.; Sender's Comments:  US-GSK-US2023AMR074160:same reporter
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA002182: US-009507513-1802USA004692: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686.
Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 02-APR-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 29-FEB-2016, the patient was treated  by a physician for a painful rash that was diagnosed as shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Facial nerve pain" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medications included: PREGABALIN; CLONAZEPAM, stop date: 14Mar2023. Past drug history included: Wellbutrin, reaction: "Known allergies: Wellbutrin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 15Mar2023 to 19Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe chills over 2 hrs, body and muscle pain, extreme weakness, nausea, fever over 18 hrs as high as102
HEADACHE, CHILLS, FEVER , MUSCLE ACHES AND FATIGUE FOR 36-48HRS.  TREATED WITH ALKA-SELTZER COLD AND FLU X 3 DOSES OVER COURSE OF ILLNESS.  FELT FINE AFTER 2  1/2 - 3 DAYS
had DTP on 4JUN92 had high fever up to 106.1 on 7JUN92 early morning; seen in ER r/o any other cause; fever went away same day;
injection site had a red rash and was itching; injection site had a red rash and was itching; injection site had a red rash and was itching; This is a spontaneous report received from a contactable reporter (Nurse) from a sales representative.  A 61-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 06Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset Jan2023, outcome "recovering" and all described as "injection site had a red rash and was itching"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2023, outcome "not recovered", described as "injection site had a red rash and was itching". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site rash, vaccination site pruritus. Additional information: On 13Jan2023, the patient called the office and said the injection site had a red rash and was itching. She stated that those events occurred immediately after the injection. The nurse told her to take Benadryl and let her know if it did not resolve. On 19Jan2023, the patient called and stated that the rash had improved and there was only slight itching, but it had not resolved completely. The nurse and the treating physician felt that it was a moderate reaction to the vaccine. The nurse stated she did not feel it was a severe reaction. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After giving the patient the first dose of Covid vaccine, she started having anxiety attack and then shortness of breath. The patient is on clonazepam, she took a pill, but she insisted on getting the Epipen as well as she was getting worse and worse. I had to give her a dose of IM Epinephrine. Few minutes later, she started breathing normally again. I monitored her for two hours at the pharmacy and I was checking her vitals and heart rate. Everything was back to normal by 11 am. She went home safe afterwards.
Patient developed numbness in her hand and later moved up to her arm. 04/19/07-records received from PCP-for DOS 4/4/07-Numbness of right side of body, noticed right index finger numb and swollen, hands felt dry. Numbness later on same day in the right side of face and right upper and lower extremities. Numbness fairly continuous.  Subjective sense of numbness in right side of her body including face. Neuro exam WNL but subjectively she was perceiving reduced sensations of light touch, temperature and vibration on right side of body. Sensation was splitting right in the middle of her forehead. Differential DX: demyelinating disease or other CNS abnormalities with CT negative. Slight possibility of anxiety somatization disorder also exists. To return to neuro clinic in 2 weeks 04/25/07-subsequent visit notes received from neuro with DX of hemianesthesia. blurred vision NOS. Subjective hemianesthesia and neurological examination is now unremarkable. Normal symmetrical reflexes, no pronator drift. Possibility of organic disorder less likely.
After the vaccine I developed red, itchy welts under my Estradiol patches that never happened previously.  I changed my patches every 3.5 days before and after the vaccination as I was supposed to, and every single time after the vaccine I developed a red, itchy welt, that, like I said, never happened prior to the vaccine.  They are still there on my torso, but almost gone.  The patches I was using  were fine until I got the vaccine.  I ended up notifying my doctor and she requested to change the patches to the non-generic, but my insurance would not approve.  I then had to change to a gel, which is MUCH more expensive than my original patches.
Violent vomiting, extreme headache, uncontrollable rise in  blood pressure-EKG cause for alarm. Emergency room in Lander, Wyoming gave medication for vomiting and headache but it didn't help. The cardiologist in Casper spent 7 hours trying to relieve the problem w/ many tests. Finally consulted a neurologist who put him on a seizure medication which he is still on, still has headaches without medications.Neurologists diagnosed a type of meningitis
Pt received Hep B vaccine and left area, returned to c/o light headedness. B/P 110/60. Pt lie down and c/o headache for about 1/2 hour.
Anaphylaxis - Hives -Throat/Esophagus swelling  -Red Eyes-Hypertension- Tachycardia - Sinus Issues  The hives are continuous and only reside with antihistamine. If antihistamine is not in my system, the anaphylaxis will re-appear.   Benadryl (Feb - October 8 tablets 25mg per occurrence) - Hives occur every 2-3 days New treatment - (Oct unitl ) Zyretec nightly 20mg nightly; increase dose in response to tolerance build-up
1st dose on 09Dec2019, and then because of COVID she delayed receiving 2nd dose until 09Mar2022.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix series on 9th December 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK receipt date: 20-May-2022 Reporter's comment: Pharmacist reported that a patient received first dose of Shingrix series and then because of Covid, she delayed receiving second dose until 9th March 2022. The patient came in to pharmacy on the date of reporting for a third dose, stating this was what her physician told her to did.   At the time of reporting, third dose was not administered. The reporter declined lot number/expiration dates of the doses or further patient information at the time of the call.  The reporter consented to follow-up. Additional Supportive Information: The patient delayed the second of Shingrix series because of Covid, which led to social problem.
Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis A virus vaccine inactivated.  Subsequently, the patient developed symptoms of Hepatitis A and had elevated liver function tests.  Additional information has been requested.
numbness and pain top of both hands and left foot. pain in left hand between 1st and 2nd finger during movement
trigger seizures or epilepsy; trigger seizures or epilepsy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team, Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), EPILEPSY (medically significant), outcome "unknown" and all described as "trigger seizures or epilepsy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Seizure and Epilepsy and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
I am 10.5 weeks pregnant, was about 9 weeks at time of vaccination. I was experiencing lots of nausea and body aches before vaccine, as well as morning sickness. Friday, the day after the vaccine, I had a splitting migraine with dizziness and nausea from Friday to Monday afternoon. The pregnancy symptoms stopped as well, and i have an appointment on Feb 5th for a checkup with my doctor to check the baby.
After giving the vaccine, this resident informed me that he has already completed his covid vaccine series in January. He did not report any immediate side effects
Mother reported on 1/08/18 that when her child received MMR, Varicella, Hep A, Hep B, PENTACEL, and PREVNAR 13 vaccine she reacted to it with really hard nodules on the injection cite that lasted a few weeks/months. Per mom, patient had a fever she was sore and tender to the touch. Per mom pt was very moody after received vaccines and did not act like her normal self.
Heart issue - I believe I had myocarditis. The day after receiving the vaccine I felt pressure in my chest - similar to heartburn or just was an awareness that something didn't feel right inn my chest. Took aspirin and heartburn medication and waited a couple hours before going to bed. The next morning the doctor told me I should go to a heart specialist - see below. For months I felt like I had a hard time catching my breath especially with any type of exercise or just even walking up a flight of stairs.
fever, severe abdominal pain, diarrhea, blood coming from anus, extreme fatigue. Went to Emergency Room for fluids and ultrasound. Prescribed antibiotics for severe food poisoning, but i have never had food poisoning like that. Visited gastroenterologist on 3/16
Small red papules first appeared on neck and scalp, then spread to chest, back and genital area over next 2 days. Lesions on neck almost developed small central vesicle, but never truly became vesicular nor did they crust.  Over 50 papules were present. Patient did not seem febrile, and office visit showed normal temp. Patient slightly tired for 3-4 days. Totally recovered within one week.