chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA. RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009229 and 1210USA009231). The follow-up information was received from the medical assistant refers to a 1 years 6 months old patient. The patient was vaccinated with improperly stored VAQTA on 18-SEP-2012 (intramuscularly in right thigh, lot # 672470/1697AA), expiry date on 22-SEP-2014). Concomitant vaccines administered on the same day included DAPTACEL(lot # C4154BA, expiration: 06-OCT-2014, IM) in the left thigh, ACTHIB (lot # 4H164AA, expiration: 16-SEP-2012, IM) in the left thigh, and PREVNAR 13 (lot # F62923, expiration: August 2013, IM) in the right thigh. The outcome of event was unknown. This is one of several reports received from the same reporter. The other patients' information was captured in 1210USA009230 and 1301USA001267. Additional information has been requested.
2/22/2020 6:30 pm arm  pain, chills Chills all night 2/23/2020 headache, chills, achy in evening, arm pain moved front of arm Bedtime felt better, slept well 2/24/2020 arm pain 2/25/2020 arm pain 2/26/2020 arm pain receded in afternoon
Right shoulder pain, erythema, fevers and chills, admitted for sepsis-- 2 nights in hospital, antibiotics given; sx resolved at d/c.
Mother stated that after the vaccines the left leg at injection site was red and swollen. Reassured mother that was a normal reaction. Mother also stated infant broke out in a fine pinpoint red rash over his body, no fever or problems breathing. Mother called Dr. regarding rash and was instructed to give BENADRYL q6 hours for 24 hours and if started having problems breathing go to ER. Mom states the next day the rash was starting to fade and no other problems. The infant still has a few pinpoint size red dots on abdomen and left leg. The patient had previously received only a PEDIARIX at 2 months of age at PCP. Mother states they were out of other vaccines.
Combine a status asthmatic event lasting  with a serious sinus and chest cold as well as occasional racing heart. That is how I felt. It felt like sudden pneumonia and chronic bronchitis onset. The second day was very serious in the third day and the fourth day I started to regain strength. I received an antibiotic on day 2 after my vaccine. I went from my normal daily activities to bedrest for 3 1/2 days straight. I called out sick from work because of it. I'm glad I was well versed with my chronic illnesses because it helped me handle the adverse event that started after receiving my vaccine. I feel that if I was a normal person I would have gone to the hospital.
after vaccine was administered it was discovered that the immunization had expired.  No adverse symptoms noted.  Student scheduled for redosing.
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
Swelling and redness has steadily increased  the past week right deltoid.  Throbbing, localized cellulitis. Very hot to touch. No fever. I feel otherwise fine. No hives, fatigue.
Patient reported tenderness/firmness at the injection site which had continued at day 3 post vaccine administration.
Sore and tender arm for first 3-4 days. About 8 hours after the vaccine , I felt uneasy in my stomach. I had aching as well down my spine and lower back for about 3 hours and felt tired. Mild body flu like symptoms that went away. Earlier in the day after getting my vaccine, I ran around in the park with children and was okay.  Felt back to normal but with a sore arm after 15 hours from getting the vaccine.  I noticed every day for over a week I had a small scab at the injection site and starting May 5th 2021 , the injection site was itching and I noticed a dollar sized bump had appeared. It is slightly itchy and raised like a swollen mosquito bite. The tenderness has come back, but very mild.
18 mo old child rec'd DTP/HIBTITER/OPV 16AUG90; No other meds was well at visit. Pt seen 17AUG90 @ 930 AM covered w/hives. Seen 20AUG90 23AUG90 hives present but almost gone. Tx w/Pediapred.
The patient received his Fluzone Quad vaccine on 10/25/20.  On 10/27/20, 2 days after the vaccination, the patient exhibited a marked left-sided facial droop and oro-facial palsy that affected his speech.  There was no pain reported.  These changes were directly observed by me (father and clinical pharmacist), his mother ( nurse) and his step-mother (PhD genetic scientist). These symptoms were of new onset.  He has no history of any reaction following previous childhood and adult vaccinations, including the 2019-20 Afluria Quad vaccination.  He was seen by his primary care doctor on 10/29 and by that time, the facial symptoms had nearly completely resolved and his speech returned to his baseline.  The provisional diagnosis was Bell's Palsy that resolved.
Fever, chills, dizziness come and go (almost passed out twice). Splitting headache and bodyache are constant. Have been taking ibuprofen every 4-6 hours as suggested by pharmacist.
First Dose (1/12/2020) - mild headache 12 hours after the shot Second Dose (2/9/2020) - horrible body aches, fatigue first 12 hours and then began long-hauler covid symptoms suffering from headaches, joint aches, chronic fatigue, heart palpitations,  light sensitivity that progressed until having to quit job in august and basically bedridden still.  Booster (1/23/2021) -  Headaches, body aches, joint aches, cough, fatigue, hoarseness, tinnitis, and return of covid-long hauler-like symptoms, 2negative covid tests one week after the booster.
Arm started to hurt at site of injection. Next morning, arm still hurting, vomiting, upset stomach, not able to eat much. Next morning, chills and sweats, dizziness, arm hurts worse and muscle swollen around injection site. Still very nauseous, not able to eat much. Still very tired. Unable to work.
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS).  The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Zoster vaccine with an associated reaction of pain. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was unknown when, the vaccine was given or when pain abated. The patient did rate pain as 8 by 10 but the patient was fine at the time of reporting. The health care professional stated she had zoster previously and this pain was better than having zoster.
This spontaneous report was received from a nurse and a physician via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. About 3 weeks ago(approximately in May 2016), the patient was vaccinated with M-M-R II injection (lot # L043704(reporter has requested a lot check), therapy type recombinant human albumin (rHA), Expiry date: 04-NOV-2017 and dose was not reported) subcutaneously. Within 3 minutes after receiving the vaccine dose(onset approximately in May 2016), the patient experienced "a welt about the size of a nickel and redness about the size of a 50 cent piece" at the injection site. The patient did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
small patch very itchy; 1 week later has a small patch very itchy and red, it still itching and growing on size; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included  (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size). At the time of the report, VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
This spontaneous report as received from a Registered Nurse regarding a 11 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 09-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. Had four other siblings with similar rash. one received Tdap, two recived TD, one received DTaP
Flu and Tdap 12-7-12. Surgery 12-13-12. Admitted Guillain Barre 12-22-12.
A non-serious report of expired dose of vaccine administered was received from a physician  concerning a 33-year-old male. No medical history or concomitant medications were reported. The patient received FluMist on 05-Feb-2008. The FluMist vaccine administered had an expiration date of 31-Dec-2007. Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse event after receiving expired FluMist vaccine. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a statement of causality. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received on 04-Mar-2008 : reporter confirmed that the patient did not experienced any adverse events. Additional info: received on 21-Nov-2008 : lot number and patient's date of birth.
Dizziness, Headache, Myalgia, Fever, chills, fatigue, injection site pain/arm pain Narrative:  Other Relevant History:
This report describes the occurrence of "serious brain problems" in a female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt's attorney alleges that the pt was vaccinated with LYMErix and, as a result, is now experiencing "crippling arthritis" and has "serious brain problems." No additional info was reported. On 15Sept04, the pt's attorney alleged that the pt, now 31 years old, experienced joint pain, swelling, tingling, headaches, dizziness, numbness with MRI (magnetic resonance imaging scan) demonstrating bilateral white matter lesions. Time to onset, treatment, and outcome were not reported. Legal case no futher information available.
Pt recv vax on 12/21/98; on 12/22/98 pt exp rash/ ecchymosis at vax site
patient lost the sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (patient lost the sense of taste) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Feb-2021, the patient experienced AGEUSIA (patient lost the sense of taste). At the time of the report, AGEUSIA (patient lost the sense of taste) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. The patient's past medical history included cervical radiculopathy. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain and cervical radiculopathy. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the cervical radiculopathy was unknown. It was unknown if the reporter considered the muscle pain and cervical radiculopathy to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cervical radiculopathy, but was not having any symptoms prior to getting SHINGRIX. At 10:00, the patient received SHINGRIX in the left arm. Within 2 hours, she had pain in the muscle of her left arm that was enough to distract her from the meeting she was attending. A little later, the pain seemed to be running down her nerve from her neck down her left arm. The pain was a recurrence of her cervical radiculopathy and had continued since she got the vaccine.  She had an magnetic resonance imaging (MRI) and had been to the emergency room for pain relief. She had an appointment scheduled with an orthopedist. The reported batch number J4D5F for SHINGRIX did not exist and was updated as J4D5J as per sales database.
menopausal pt who began bleeding 24hr p/vax underwent gyn test to determine why all negative;advised that vaccine would be in system x 32 days & that bleeding would stop p/that;It was determined by gyn that bleeding not r/t menopausal sx
Reddened, warm, raised area at injection site.  Complainted of  burnig and itching at injection site.
Patient briefly became unconscious shortly after receiving the first dose of her moderna vaccine. She began sweating profusely and stated that she felt weak and "tingly" in her extremities. She also stated that her head "felt cold" and her throat was hurting. Her breathing was labored but she was able to take deep breaths.
This case was reported by a 39 year old female pharmacist who developed joint pain after she received Engerix-B. The pt stated that, "approximately 10 years ago", on an unspecified date in 4/93, she received the first dose of Engerix-B (lot ENG1039A4). "Approximately one week later", on an unspecified date in 4/93, the pt experienced "disabling severe" joint pain, a bilateral leg rash that extended from the "knee to the lower legs", weakness and fatigue. The events resolved "approximately two weeks later". On 5/14/93, the pt received the second dose of Engerix-B (lot ENG1039A4). "Approximately one week later, the pt again experienced disabling severe joint pain, a bilateral leg rash that extended from the knee to the lower legs, weakness and fatigue. The pt was seen at an ER. The events resolved approximately two weeks later. The vaccination series with Engerix-B was discontinued. The reporting pharmacist considered the events to probaby be related to Engerix-B.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient received treatment of COVID-19, brand: paxlovid, treatment start date: 22Aug2022, treatment stop date: 26Aug2022. No Known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' concomitant medications included sterile diluent (MERCK STERILE DILUENT) lot# N026286, expiration date 06-FEB-2020. The patients' medical history, historical drugs and drug reactions/allergies were not provided. On 08-MAR-2018 and 09-MAR-2018, the patients were vaccinated with  an improperly stored doses of VARIVAX injection, lot # N028711, expiration date 13-OCT-2019 for prophylaxis (route and antomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -9°C to 8°C during 8 hours. The vaccines had not had any previous temperature excursions. There was no adverse effect reported.
Patient got vaccines at 11:30 AM.  By mid-afternoon patient should not bear weight or move his back.  Patient seen at an urgent care center and found to be neurologically and ostepathy intact.  Patient awoke next day and was completely fine.
Child went to her father's house right after the shots on Feb 23. Mom got her back on 3-1-10 & noticed the top of her right leg from knee to groin had a red lacey rash (smooth) & was "puffy" esp around the injection site. Mom states child could walk o.k. but leg was tender to touch. Child's father did not notice so he was unable to tell mother when sx began. I referred pt to Dr. Mom took child on 3-1-10 to family health clinic. The Dr said it was probably a local rxn and he thought the lacey rash was a contact dermatitis. Child was given a OTC hydrocortisone cream to use & was given an antibiotic for URI. Mom was also told to give BENADRYL. 3-9-10 PC to mom. Pt has recovered completely.
Patient received DTaP in left deltoid the following morning patient was noted to have LUE swelling with erythema and warmth of LUE from deltoid to elbow. Patient was seen.
Very sweet little 90 yo female adm after recent move to independent living with falls/ confsuion- behavioral disturbance. She has covid test positive, and abscess behind right ear.  I&D done in ER.  She is on keflex with 85% resolutionn of bscess  It is right where the arm of her glasses set on her ear posterior pinna- dtr aware if doesn to resolve copmletly- have eye glasses refitted. COVID_ nimal inflammatory markers. asymptomtaic D/w her quarantine- dtr is still testing neg- this could be old infection.  Dtr to mask and hand wash but no wneed for her to quarantine Pt to return to assisted living with help to get to meals, have meds passed and check on her.  Necklace for emergency alert. antibiotic therapy was completed.
Injection site warm to touch; Vaccination site knot; Itchy knot at injection site; Injection site a little sore; Injection site  pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE MASS (Vaccination site knot), VACCINATION SITE PRURITUS (Itchy knot at injection site), VACCINATION SITE PAIN (Injection site a little sore) and VACCINATION SITE ERYTHEMA (Injection site  pink) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact