chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100.5; Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150 ) via an unspecified route of administration in the arm left on 06Apr2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies. The patient did not receive any medications two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6267) via an unspecified route of administration in the arm left on 14Apr2021 at 17:30, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, the patient had a fever of 100.5 and chills. It was unknown whether any therapeutic measures were taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events fever of 100.5 and chills was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
States she started feeling sore and warm at injection site at about 9:30p on day of shot. Has a rash around injection site that was 4 inches across, but is slowly shrinking. Rash is warm,hot to touch. Elbow in right arm is tingling, but patient reports having long terms myalgias for other reasons.
-Heart palpitations about beginning of April 2021.  -Recurring petechial rash on face (always left cheek) documented photos on Aug 14 2021, then it briefly went away and recurred August 30, 2021.  Most recent episode started June 8, 2022. Nonblanchable, non raised, not itchy. Looks just like broken capillaries all over my cheek.
swelling; Slightly painful in temple area; Black, bluish, purplish discoloration below left eye; sweat; flu kind of symptoms; body ache; Chills, Shivering; myalgia; headache; This spontaneous case was reported by a physician and describes the occurrence of SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental implantation. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache). On 06-Feb-2021, the patient experienced SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye), SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area). On 05-Feb-2021, HYPERHIDROSIS (sweat), INFLUENZA LIKE ILLNESS (flu kind of symptoms), PAIN (body ache), CHILLS (Chills, Shivering), MYALGIA (myalgia) and HEADACHE (headache) had resolved. On 09-Feb-2021, SWELLING (swelling) and FACIAL PAIN (Slightly painful in temple area) had resolved. At the time of the report, SKIN DISCOLOURATION (Black, bluish, purplish discoloration below left eye) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient used for ice pack and unspecified pain killer as treatment medication.
The pt developed pain at the injection site, initially on 10/19/01, and the pain worsened. It went up the neck and down arms to chest and down hands to 4th and 5th digits which was prickly. Cannot move right arm. Seen MD and the flu vaccine could not be ruled out. It may be related.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes. A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA000697: US-009507513-1711USA010730.
I noticed sometime in October 2021 that I had reduction in left ear hearing. I went to see an ENT who did the hearing test and indicated I had a substantial general hearing loss in my left ear. My profile in both ears had a hearing loss in high frequencies. He noted he has never seen this before and didn?t know any treatments other than getting a hearing aid if needed. He noted that the profile for both ears were the same, but the hearing loss in the left ear was more profound. I didn?t really notice this until I was speaking on the phone and couldn?t hear in my left ear until I moved it to the right and could hear significantly better. This is why I contacted the ENT. ENT also did an MRI of the brain to look for any medical issues and that also came back negative. I contacted a doctor online who was indicating that he also had hearing loss as well. Looking to see if there was a study to figure out what was going on.
12/29/2020 Vaccination 12-13 minutes later started left arm was tight and sore. Wasn't feeling right; hot, hives, rash at injection site up neck and face; tightness in throat; tachychardic, BP increase.  I took benadryl and Pepcid . Sat for another 30-45 min. Palpitations, heaviness. Transported to ER. IV and medications.  Stayed till 1:30, went home, and then came that evening. 5:00 that same night, hives, chest pressure, burning sensation, 'didn't feel right', anxious. Benadryl. Tachychardic; admitted to  hospital that evening. Stayed in house admission till the 12/31/2020.  Went back to admission in house, 1/3/2021 - 1/4/2021. Two hospital admissions.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2013 ("several weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml/ once, subcutaneous for physician recommended (lot# and expire date not reported). In 2013 ("several weeks ago"), after the patient received ZOSTAVAX, she collapsed, her eyes were "flickering" and she was "totally out". The pharmacist stated a "rescue squad" was called and took the patient to an emergency room. The patient was not admitted to the hospital. No treatment was given for the adverse event. At the time of reporting, the pharmacist also stated that the patient was "ok now" but did not know the specific recovery date. Additional information has been requested.
APPROXIMATELY 5 MINUTES POST VACCINE ADMINISTRATION, PATIENT REPORTED TO FRONT COUNTER WITH WHEEZING. BOTH  PHARMACISTS ON DUTY ADVISED PATIENT TO WALK TO IMMUNIZATION ROOM. PATIENT ADVISED SHE IS ASTHMATIC AND SUFFERS FROM CHRONIC ANXIETY. PHARMACIST ASKED PATIENT IF SHE THOUGHT SHE WAS HAVING AN ANXIETY ATTACK, PATIENT WAS UNSURE. PHARMACIST ASKED IF SHE FELT LIKE SHE WAS HAVING AN ASTHMA ATTACK, PATIENT SELF ADMINISTERED 2 ORAL PUFFS OF ALBUTEROL MULTI DOSE INHALER. AFTER A FEW MINUTES, PATIENT SAID SHE MAYBE HAVING AN ANAPHYLACTIC REACTION AND SELF ADMINISTERED 2 DOSES OF EPI-PEN 5 MINUTES APART. AFTER EMERGENCY PERSONNEL ARRIVED, THEY CHECKED PATIENT'S OXYGEN ( PER EMT, OXYGEN WAS NEAR 100%), EMT ADVISED PATIENT TO SLOW HER BREATHING AND OPEN HER EYES, PATIENT RESPONDED POSITIVELY. EMT ASKED PATIENT ABOUT ALLERGIES, PATIENT ADVISED SHE MAY BE ALLERGIC TO EGGS. PATIENT WAS TAKEN BY EMT AND TRANSPORTED TO LOCAL HOSPITAL.
Pt got a flu shot at work through an offsite clinic program. She was given the immunization by a pharmacist but not at this location. She states she has had chronic migraines in the week since. She has had migraines in the past but is reporting up to 7 per day and consistently each day. She has a call into her MD office for a prescription.
Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, chills, body aches and headache. Tylenol and ibuprofen did not help with fever much. No notes on further escalation of care or resolution.
Facial area was swollen; Face was very stiff; Facial area was red; Headache; Sweating profusely; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of   in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGAN) for an unknown indication, HYALURONIC ACID (JUVEDERM).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included Diphenhydramine hydrochloride and Hyaluronic acid. Treatment medication for the event included Diphenhydramine, Loratadine and Famotidine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe migraine on Day 2 and Day 5. Nagging headache Days 3, 4, 6
On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/  , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.
Patient reported all energy and strength was wiped out of her.  She slowly regained over a few days.  She has numbness and loss of sensation in whole left side of body, limp and sluggish.  Went to ER 01/18/20 and they thought was overload of immune system.  They suggested her to report.  Symptoms did not subside until 01/22/21, gradually the feeling came back, with rest.  She was off work the last week to rest up.
Almost immediately became dizzy, with tingling in hand up arm, nauseous, shaky, tightness in throat, "fuzzy" thinking, severe headache.  Called Dr.  Took Benadryl for several days for throat tightening, Felt poorly for 8 days.  Her symptoms were similar to her daughter's for whom a VAERS report was also made.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced breakthrough varicella described as clear vesicles on an erythematous base on her arms and back. The pt recovered. No further information is available.
Patient received Fluzone Quadrivalent instead of Fluzone HD/ No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown gender (over the age of 65) who received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination instead of vaccines INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history and  concomitant medications were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Pt was admitted to Hospital 8/30 ? 9/4/2021 for covid pneumonia. Pt did not require ventilation and had no association with LTC, discharged home.  Patient is fully vaccinated.
Client was to old should  have received TDap but does not have to start series   No issues with shot
At approximately 09:05 am, the Patient, as mentioned above, reported to the RN she was having a reaction to the vaccines she had received. The Patient received Pfizer Covid-19 Bivalent, Tdap by GSK, Hepatitis B by Dynavax, MMR by MERK, and Gardasil-9 by MERK. Pt reports feeling SOB, and mild difficulty when swallowing, numbness to arm, and nausea. Vitals were immediately taken B/P 79/40 P: 59Pulse Ox: 100% R 20 T: 97.4  9:08 am Upon assessment from NP, patient was noted diaphoretic, cold and clammy. No Generalized urticaria, angioedema, or wheezing was noted on auscultation. A second set of vitals were taken B/P: 70/54 P: 68 Pulse Ox: 100% R 21, T 98. Patient leg elevated. Pt continues having mild difficulty when swallowing. Benadryl 50mg/ml 1ml IM given to Left Deltoid. No acute distress noted at this time.  9:17 am Patient continues in observation. No acute distress was noted.  9:25 am Patient continues in observation. Vital retaken B/P: 106/70 P: 68 Pulse Ox: 100% R18 T: 98.2. No acute distress noted.  9:45am Patient continues in observation. Vital retaken B/P 116/73 P 71 pulse Ox: 100% R 18 T97.7. Pt reports feeling better, no longer feeling SOB, nausea, or numbness. Pt is stable condition no acute distress noted. 10:03 am Vital retaken B/P: 116/72 P: 70 Pulse Ox: 100% R 15 T: 98.0. Pt discharged at this time with discharge instructions and referral to PCP. Pt advised to seek immediate medical attention (emergency services) should she present with any Urticaria, SOB, Chest pain, Angioedema, or difficulty swallowing. Pt verbalized understanding of all discharge instructions given. Pt left in stable condition, accompanied by family member.
Chills, body ache, arm immobility, brain fog, extreme fatigue for first 24 hours after. Then sweats fever and headache briefly on second day after. Now 3 days after 2nd shot I started my menstruation 6 days early.
spent the entire winter with several different kinds of flu. Never been so sick. Totally did not expect that to happen but it did. That also happened to my mom.; Initial information received on 13-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient's child) via social media.  This case involves an unknown age patient for whom influenza (spent the entire winter with several different kinds of flu. Never been so sick. Totally did not expect that to happen but it did. That also happened to my mom) was reported, while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient had influenza (spent the entire winter with several different kinds of flu. Never been so sick. Totally did not expect that to happen but it did. That also happened to my mom) (Unknown latency) following the administration of Influenza Vaccine.   No laboratory data was reported.  Action taken was not applicable. It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
discomfort, tired, swelling, warm to touch all around the injection site on left arm. This was all happening on the 28th of June about a week after the second shot. Did not have any side affects right after the second they came later on the 28th of May.
Low Fever 98.7, soreness, ache, chills, pain at injection site
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 12:15 (Lot number: ER8731) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Uterine cancer" (unspecified if ongoing), notes: Verbatim: Uterine cancer, Had about 30 years ago; "Covid 19 virus", start date: Mar2020 (unspecified if ongoing), notes: she did have the Covid 19 virus in Mar2020; "headache" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for headache. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity with Tylenol. Additional information: Patient did not have any AE(s) require a visit to Emergency Room/Physician Office.  Follow-up attempts completed. No further information expected.
Pain at injection site, aching joints, sore all over, chills, sweating. Given Benadryl, Advil.
No adverse symptoms reported; the patient was vaccinated with an expired dose of VAQTA; Information has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, drug reactions or allergies.  On 10-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection with lot number R010369 and expiration date on 25-MAR-2019,  for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported) (Expired product administered). No adverse symptoms reported.
11/21 PM developed localized swelling + hives to injection site. 11/22 AM awoke with generalized edema, muscle aches, fatigue, hoarseness. 11/24 AM developed 104 fever, delirium, vomiting. Taken to hospital - underwent lab work w/ blood cultures, ECG, head CT scan unsuccessful lumbar puncture (due to previous spinal fusion). Admitted to hospital w/ encephalopathy (per husband). Discharged 11/26/09, states Dr's Inpatient treated by Primary physician Dr said had a reaction to vaccine.  12/01/09 ED and Consult notes for DOS 11/24/09 - 11/26/09 -  DX: Febrile infection or possible viral meningitis  Pt developed injection site reaction with hives and later was weak, lethargic, had fever, and vomiting. Neuro exam: L side weakness and confused. tx: Rocephin and Vancomycin.  CSF unsucessful due to prior spinal surgeries and risk of bleeding. Fever resolved and Pt was more alert.  Pt discharged home.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red rash which is warm to the touch at the injection site) and VACCINATION SITE RASH (Red rash which is warm to the touch at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Red rash which is warm to the touch at the injection site) and VACCINATION SITE RASH (Red rash which is warm to the touch at the injection site). At the time of the report, VACCINATION SITE WARMTH (Red rash which is warm to the touch at the injection site) and VACCINATION SITE RASH (Red rash which is warm to the touch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: reporter contact details  was updated and patient age was updated
Woke up this morning and my armpit on the side that I received the shot was slightly swollen and tender.
11/24/99-Temp to 102, red raised rash, inguinal. 11/26/99-Fevers resolved. Rash covering body. Seen & Dx'd w/HSP. Tx'd with Benadryl, no other PE abnl. Poss. abd pain/decreased appetite.
A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period).  Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat  wheat--all over my body and itchy and it hasn't gone done.  Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.
This spontaneous report received from a patient concerned an adult male of unknown race and ethnic origin. 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, intramuscular, batch number: Unknown, expiry: Unknown) does not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced rheumatoid arthritis aggravated, migraine aggravated, and wearing off effect. The action taken with covid-19 vaccine was not applicable; and action taken with adalimumab was not reported. The patient was recovering from rheumatoid arthritis aggravated, and the outcome of migraine aggravated and wearing off effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220120812-Covid 19 Vaccine-Rheumatoid arthritis aggravated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.