chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild case of shingles; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA) taken from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 21:00, the patient experienced mild case of shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with antibiotics. The clinical outcome of the event shingles was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
While getting dressed, experienced dizziness and lost my balance.  I may have even blacked out for a few seconds because don't remember falling.  Lost coloring in my face, wife said I looked yellow.  Rested for the entire day due to continued slight dizziness. I may have been dehydrated since I didn't drink a lot of water after the vaccination and came home and worked around the house the entire rest of the day. Note: I wasn't advised to stay hydrated.
Information has been received from a healthcare worker concerning a 22 year old female with no medical history and no drug allergies who on 16-APR-2008 was vaccinated with the first dose of GARDASIL 0.5 ml by IM.  There was no concomitant medication.  The patient has no reactions with her first dose.  On 20-JUN-2008, the patient was vaccinated with the second dose of GARDASIL 0.5 ml by IM (lot# 658219/0755U).  Subsequently the patient developed injection site reaction, redness, swelling and soreness on her arm.  The patient was seen by the physician.  The reaction lasted about one week.  Then on an unspecified date, the patient recovered from the adverse experience.  The patient did not receive the third dose yet.  Additional information has been requested.
Approximately 3 minutes after the injection I began to experience palpitations and felt flushed.  My heart rate increased from about 70 to 110.  This lasted for approximately 5 minutes and then recurred about 10 minutes later.  After the second event I took Benadryl 50mg po.  I experienced palpitations and felt flush a third time about 5 minutes after taking Benadryl  lasting about 2 minutes.  Approximately 40 minutes after the injection I began to feel cold and clammy, this lasted about 35 minutes. My pulse was about 75 and BP 140/90 during this last event.  Approximately 90 minutes after the injection I went home and experienced intermittent chills for a few hours then I was asymptotic.
administered only the adjuvant portion; administered only the adjuvant portion; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number H755H, expiry date 9th June 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date:19-May-2022 Reporter's comments: The patient was administered with only the adjuvant portion of Shingrix. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient was administered with only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Pt stated he developed a rash  that started at the neck then gradually spread to all over the body - rash started on sunday 1/8/23 first pfizer dose, had previously been getting moderna
Nausea, High fever-102, Muscle pain, vomiting, Muscle weakness, stomach ache, dizziness, hot flashes, disorientation, fatigue
tinnitus; Patient recieved late second dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose). On an unknown date, the patient experienced TINNITUS (tinnitus). On 28-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient recieved late second dose) had resolved. At the time of the report, TINNITUS (tinnitus) outcome was unknown.            The patient stated that after couple of weeks  from the second dose of vaccine she felt tinnitus. She cannot confirm the exact date. Concomitant medications were not provided. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter details, product start date updated
Presented to the ED with complaints of increased shortness of breath and fever.  Tested positive for COVID-19 recently Prior to presenting at the ED, was given monoclonal antibody infusion Was given dexamethasone, insulin, rocephin, and zithromax Got better on room air. Awaiting discharge
Chest cold; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and no treatment Medication was provided.  This case concerns an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult female with a serious unexpected event of lower respiratory tract infection. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
24 hours after injection developed muscle aches and fever 102.2, 48 hours after develpoed sore throat and severe head ache.  Fever and headache persisted through 11/23/10.  Started to feel better 11/24/10.
Diagnosed with covid several days after receiving shot on 12/29/20.  Presented with covid symptoms  1/4/21
Pt received DT on 10/18/00. then 2-3 days later, she notes redness, swelling, itchy around injection site. (3" diameter circular, red, raised, lesion).
Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022 at 10:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna COVID vaccine on 4/7/22. vaccine expiration date for lot 069H21A was 4/6/22.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient's weight was reported as 185. It was unknown if patient had been tested positive for or diagnosed with COVID-19. Patient had no chronic illness. No adverse reaction to the vaccine was reported. No treatment medications were reported.
I did not receive treatment other than a prescription for a headaches.  I ended up having a bad headache after my J&J vaccine. My headache developed at the base of my skull and radiated to the top of my neck. I had another headache above my eye as well. I also had  intense joint pain from my upper leg all the way to my right ankle.  I also experienced nausea along with my headache.  An  ultrasound of the right groin was performed to check any clots in my right leg. The doctor who saw me prescribed Emetrex for the headaches and there has been no follow up since then.  I still have a headache today but is a lot less in intensity.
SYNCOPED EPISODE MONITORED BP CLIENT RESPONDED APPROP TO QUESTIONS BP 74/38 10:35 AM; 82/41 10:40; 10 45 88/54; 92/58 10:50 AM
11 year old female received 1st dose of Pfizer Vaccine and was inadvertently administered adult dose of Pfizer instead of 5-11 year old dose.
joint pain/joint ache; his patient may have some arthritis in his joint; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Physician was calling for his patient who had the Pfizer COVID-19 vaccine. Prior to vaccination, he was fine but after he got the vaccine, on an unspecified date he had joint pain. Caller already ordered all rheumatologic tests and they were all negative. He said that his patient might have some arthritis in his joint but no other major issues. Caller wanted to know if there had been studies for causal relation and long term effects of the vaccine to the joints. It was reported that, joint pain has been reported as an adverse event with the Pfizer COVID-19 vaccine. The physician stated, "So, recently I had a patient who received the Covid vaccine few months ago and after a week or so developed a lots of joint aches, joint pains". Among the Pfizer-BioNTech COVID-19 Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1 percent of participants across all age groups reporting severe pain. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to moderate in severity." and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. The patient underwent lab tests and procedures which included rheumatological examination which was negative on an unspecified date. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Pt reported nasal and throat congestion. Benadryl was given and pt was observed in the medical tent
Patient reports large, wide-spread, pruritic hives about 10 minutes after the injection. She had no other symptoms. She self-treated with and old prescription for prednisone intermittently for about 12 days.
DIARRHEA; NAUSEA; CONGESTION; FEVER; INJECTION SITE PAIN; This spontaneous report received from a female patient (health care professional) of an unspecified age reporting on herself. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and no alcohol use.  The patient had no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 99.8 degree. On 25-MAR-2021, the patient experienced fever. On 27-MAR-2021, the patient experienced congestion. On 27-MAR-2021, the patient experienced nausea. On 31-MAR-2021, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, congestion, nausea, and diarrhea, and the outcome of injection site pain was not reported. This report was non-serious.
Skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (skin rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (skin rash). At the time of the report, RASH (skin rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V2 virus at the time of administration".  Patient reported no adverse reactions.
erythema, induration, warmth to L deltoid: DTaP administered at site 2days prior
p/vax pt devel approx fifty bumps mostly on torso, head & face;pt sought unspecified medical attention;
Patient lived in a long term care facility. We had a clinic at the HCF on 12/10/21. Patient received a pfizer booster shot and a high dose flu shots. Nurse was giving the shots. Immediately after the two shots, Patient started to have seizure-like reaction. It can be a seizure or patient was having syncope, where her body make jerking movements. We had to call the ambulance, and patient got sent to the hospital
Hives and wheezing. Clinic treated child. Administered Benadryl, albuterol, and chest x-ray.
Information has been received from the wife of an 81-year-old male with no pertinent medical history and an allergy to "a certain antibiotic" who on 10-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included NEXIUM, OMEGA-3, CADUET, Bayer, ARICEPT and hydrochlorothiazide (manufacturer unknown).  On approximately 12-JUL-2007 "a couple days" post vaccination, the patient experienced blisters sporadically from his neck to his ankles that looked like chicken pox.  He also developed a purple discoloration at the injection site.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is reported as recovering.  No product quality complaint was involved.  This is one of several reports from the same source.  Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient was vaccinated with lot # (670754/0621AA, exp. 26-JUL-2012) ZOSTAVAX on 30-JUL-2012 (dose, route and site of administration not reported) and the product was found to have expired on 26-JUL-2012. No adverse symptoms noted. Additional information has been requested.
General joint Achiness; This is a spontaneous report received from a contactable male consumer (patient). A 58-year-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 58 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he had general joint achiness after COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (16Jul2021): 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 completed. No further information is expected.
during specified waiting period following vaccination, pt started to feel nauseated and vomited repeatedly.  Adterwards, complained of itchy throat.  We offered to call EMS, but friend with pt stated that she could get her to ER faster than EMS could arrive and did not want to call EMS then left the building.
Starting around May 19: chest pain, occasional nightly sweating. assumed would pass Starting around May 24: Moderate pressure in the left ear and a rapidly worsening sensitive+swelling throat, chest pain, nightly sweating, frequent hot flashes throughout day  Prescribed Prednisone 10MG as 5, 4, 3, 2, 1 each day. Taken as directed, minor improvement noticed Prescribed Doxycycline Hyclate 100MG 1 twice a day. Taken as directed, no improvement noticed  Emergency visit 06/14/2021 for partially closure and hypersensitivity in throat noted at 2:18am. Emergency Oral surgery at noon for impacted wisdom tooth after discussing symptoms Prescribed Hydrocodone-acetamin 5-325MG 8 each day. Prescribed Ibuprofen 800MG 2 each day.  Initially no notable improvement. After 9 days notable improvement to swelling Prescribed Amoxicillin 500MG 4 each day. Prescribed Hydrocod/APAP 5-325MG 6 each day. Notable improvement to swelling Prescribed Oxycod/APAP 5-325MG 6 each day (as alt for Hydrocod). Never taken After 1 week prescribed additional stereroid anti-inflamatory. Can't recall name  Since 07/25/2021 and Currently: Severe pressure behind eyes and ears, worsening sensitive throat, runny nose, worsening cough, chest pain, nightly sweating, frequent hot flashes throughout day  All symptoms of night sweat, chest, hot flash, sensitive throat, and ear pressure have been sustained from May. I just want to be healthy again please just help me figure out what the cause is I hope it has no relation to the vaccine I think its just chance I keep getting sick. But I don't get sick so it makes no sense! I've been sporadically out of work since vaccine for I believe over 5 weeks and it is incredibly disheartening
Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Swelling, rash, & red arm Mobility issues with moving my arm Muscle pain Range of motion has changed
Papular vesicular rash on face & forehead 1-2 cms in size large, concentration medial aspect of (R) leg - 1 on (L)arm, 1 behind (L) ear, itchy - hydrocortisone cream, AVEENO baths, BENADRYL.
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old male patient who was vaccinated with a first dose of IMOVAX RABIES lot M12962M via intramuscular route on 02-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; MENACTRA for Immunisation; and MMR for Immunisation on 02-Jun-2018. It was also case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
expired ACTHIB being administered to a patient with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient and reporter stated expired HIB (PRP/T) vaccine [ACT-HIB] being administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]).  On 28-Oct-2022, the patient received a expired 0.5 ml dose of suspect HIB (PRP/T) vaccine once ( 4th dose)(lot UJ594AA and expiry date 26-OCT-2022)(strength : standard) via intramuscular route in the left arm as Immunization, with no reported adverse event (expired product administered)(latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.