chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same events for two patients. This is the second of two reports.   A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) via unspecified route of administration on 17Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that she got the shot on Sunday (17Jan2021) along with her husband (patient). The patient's wife informed that all of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The reporter informed that her husband (patient) was getting it also. The reporter informed that the dizziness for both of them started today on 19Jan2021. The outcome of the event dizziness was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061733 same reporter/drug/event and different patients
Chills and general body aches.  Took two tylenol , went to bed.  In bed almost all of next day.  Unable to eat.
AS PER THE MOTHER 24 HRS AFTER VACCINATION, SHE WAS SEEM IN THE ER AT HOSPITAL. THE PATIENT DEVELOPED HIVES AND ERYTHEMA ON THE FACE AND LEFT ARM, IN ADDITION, THE PATIENT DEVELOPED A FEVER OF 104 WHICH LASTED FOR 4 DAYS BUT WAS RESOLVED ON THE DATE OF FOLLOW-UP VISIT ON 02/25/2023. THE PATIENT WAS TREATED WITH BENADRYL FOR 3DAYS, RASH ALSO RESOLVED.
Two weeks after receiving my first dose, I experienced my first ever seizure which lasted approximately three minutes. I completely lost consciousness and regained it during the ambulance ride to the E.R. I have been referred to a neurologist. My C.T. scan and blood work at the E.R. were normal.  I do not know if this is related to the vaccine, but thought it warranted reporting.
Infection; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 for COVID-19 immunisation. It was reported that patient had the second dose of the vaccine on 08Apr2021. After a week on an unspecified date in Apr2021, she had an infection and her doctor gave her Prednisone as a corrective treatment, "she started taking this medicine today". She wanted to know if the drug will interfere with the effectiveness of the vaccine. Were any unaddressed medical questions referred or forwarded to Medical Information reported as yes. The outcome of the event was reported as unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Patient was expecting the Pfizer Bivalent booster, but was given another dose of mono-valent. No adverse reactions have occurred.  Error occurred due to the nearly identical packaging of both the mono- and bi- valent vaccines, and the lack of a double-check before injection.
1 day after the vaccine, I had tingling in my left leg.  Over the next 3 weeks, I had tingling in both hands and my left leg and foot, and weakness/fatigue in both legs.  These symptoms lasted for just over 3 weeks before they resolved.  I made an appointment with a Neurologist, but there was no treatement.
This report described the occurrence of shoulder pain in a male patient 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 healthcare professional. On September 3, 2003, the patient's attorney alleged that the patient received injections of Lymerix on July 12, 2000. August 19, 2000 and August 15, 2001 according to the client." The attorney further alleged, The patient suffered pain and disability of his shoulder, decreasing range of motion and increasing pain. The onset of his symptoms is not clear at this time."
1 day, post vax, the child had hives on her arms and legs. Also, she had a fever but had concurrent viral illness.
Patient was given the shingles vaccination. Zostavax subcutaneously. Patient was given the VIS sheet and also was counseled on expected side effects such as swelling, redness and tenderness. Patient went to her PCP and was given cephalexin 500 mg capsules and mupirocin oint to be applied locally as a preventative care.
Pt presented to the ED on 8/3/21 with 1 week of cough, weakness, and nasal congestion. She was started on antibiotics  for a sinus infection, but her symptoms worsened despite this. She was tested for COVID on 8/2 at her PCP's office and the test came back positive despite receiving both doses of Moderna vaccination on 2/10 and 3/8. Pt started to feel worsening shortness of breath on 8/3 and presented to the ED for work-up. Pt was found to be hypoxic and was started on 2L O2. She was admitted to the hospital on 8/3 for COVID treatment (remdesivir and dexamethasone). Pt has a hx of Parkinson's, CLL, HTN, and dyslipidemia. She was also given IVIG on 8/5 per Hematology d/t hypogammaglobulinemia due to CLL.
pneumonia; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and THROMBOSIS (Blood clot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and THROMBOSIS (Blood clot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: pneumonia and blood clot (abnormal) pneumonia and blood clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  The patient reported that he done with A computed tomography by which pneumonia and blood clot was documented.  Treatment information was not provided.  Company Comment: This case concerns an uknown age uknown gender patient with no medical history provided, who experienced the unexpected events of Pneumonia and Thrombosis. On an uknown date the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced Pneumonia and Thrombosis (Blood Clot).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an uknown age uknown gender patient with no medical history provided, who experienced the unexpected events of Pneumonia and Thrombosis. On an uknown date the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced Pneumonia and Thrombosis (Blood Clot).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Low fever (101F°), pain in the injection site with swelling and limited mobility. Severe period cramps even though I had a period 2 weeks ago.
Moderna COVID-19 Vaccine EUA: Vaccine recipient reported that on 1/28/2021 they developed chest tightness, chest pain, shortness of breath and mental fogginess about 10 minutes after the vaccine was administered. She was sent to the ED for evaluation. By the time she reached the ED, her symptoms resolved. Experienced unusual back/chest pain that resolved in <4 hours. She reports she did not have these symptoms after her 1st vaccine dose. She reported that the EKG was done and it was okay. Her lungs sounded okay.  She was then discharged to home. On a follow up call she reported that she has chest tightness that lasted overnight.
Pt recv vax on 11/12/98; 45 min later pt exp itching, tight throat, runny nose; tx=Epinephrine IM Rt arm, Benadryl
Patient's spouse stated that she was vomiting the next day and felt extremely tired. It was difficult for her to get out of bed.
Terrible pain left shoulder  (deltoid) terrible flu like symptoms,  felt like throwing up. .. bad enough  symptoms that I called 911 fever of 103.1 for a few hours.  This woke me up at 2:30 am Now at about 12:30 pm arm still sore but most other symptoms gone away,  but still feel like I got hit by a truck.
Pt recvd 2 doses of Engerix B. 2nd dose was admin 13Nov91. Middle of noc on 14Nov91 pt woke up with facial puffiness, "full" ear & throat tightness.Sxs resolved 15Nov91.Also mild tenderness of lt arm.
fever; muscle pain; Joint pain; swelling; soreness; couldn't move arm; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of fever in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis. This case was associated with a product complaint.   On 28th June 2019, the patient received the 1st dose of Bexsero .5 ml. On an unknown date, less than a week after receiving Bexsero, the patient experienced fever, muscle pain, joint pain, injection site swelling, injection site pain, injected limb mobility decreased and pharmaceutical product complaint. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The reporter administered the 1st dose of Bexsero vaccine to the patient in her left arm. The patient had significant fever, muscle ache and joint pain, swelling and soreness at the injection site and she could not move her arm.   The patient was down for the entire weekend and she was taken to the emergency room and they put her on Intravenous (IV) fluids. The patient was released the same day.   On the day before reporting date, the patient's symptoms had improved.  The emergency room physician believed that, the patient's reaction was related to the vaccination.   The physician of the pediatric practice had a concern that there could be quality issue with the box of Bexsero because two separate patients had similar reactions to the vaccine .  They had three doses remaining in the Bexsero box that they would return to GlaxoSmithKline for investigation. They were not requesting replacement of the vaccine because the physician would not administer the Bexsero again.   The reporter consented to follow up and also provided physician's details. This is 1 of the 2 cases reported by the same reporter.
Not able to sleep for three days; Headache in the back of her head; Having tremors in her hands and arms; Fever; Flu like symptoms; Shaking all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ear infection. Concomitant products included AMOXICILLIN for Ear infection, VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced NERVOUSNESS (Shaking all over her body). On 19-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On 20-Mar-2021, the patient experienced TREMOR (Having tremors in her hands and arms). On an unknown date, the patient experienced INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and PHENYLEPHRINE HYDROCHLORIDE (AFRIN [PHENYLEPHRINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 24-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, TREMOR (Having tremors in her hands and arms), NERVOUSNESS (Shaking all over her body), INSOMNIA (Not able to sleep for three days) and HEADACHE (Headache in the back of her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included Multivitamin.
gastritis; heart burn; Chest pain; The EKG said she had a heart attack; This is spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 13:00 at single dose at right arm for covid-19 immunization. Medical history included heart attack from Apr2019 to an unknown date, covid-19 from Jul2020 to an unknown date (really sick with it). The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got the first COVID19 vaccine and a few days after started having chest pain on 02Jan2021 at 1:00AM, event was serious per medically significant. She went to the doctor and they did an EKG on 08Jan2021. The EKG said she had a heart attack. The heart attack was about the time she had chest pain after the first injection. Patient called her doctor on Monday, 04Jan2021. She had a televideo appointment on 06Jan2021. She went to the doctor's office and had EKG on 08Jan2021 and was sent to the hospital. She didn't get admitted because there were no beds. Outcome of the event chest pain, she would say she had recovered on 02Jan2021 with lasting effects because she was in the hospital again for the same thing. She went to the hospital the second time for chest pain that woke her up on 11Jan2021. It started at like 3AM. She thought it was heart burn. She tried to go back to sleep. It continued while she was at work. She told her supervisor who sent her to the hospital. They did not admit her. They did do an EKG on 11Jan2021 and it was abnormal, but not indicative of heart attack. Thought it was gastritis. Her doctor thought the heart attack was on the 02Jan2021. The same thing happened with her heart and she had a heart attack in Apr2019. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. Patient stated she didn't go to the ER, but called doctor's office on the following Monday. There was no adverse event following prior vaccinations. Outcome of event chest pain was recovered with sequel, and outcome of other events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Based on the available information, a possible contributory role of the suspect BNT162B2 in the development of the events chest pain and heart attack cannot be excluded. The events are confounded by the patient's underlying cardiovascular conditions. The impacts of this report on the benefit/risk profile of the 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.
i received the covid first shot  and i am feeling fatigue, headaches, and some fever.
Arm became warm and sore half an inch below injection site. A 2in x 2.5in red, raised rectangular, tender swollen area arose.  The affected area always remained below the injection site with only a light red mark that led from the injection site to the affected area.  The following morning (6/2/21) the area had more than doubled. It remained hard, warm, tender, and raised with swelling. It was mildly painful.     6/3/21 the red area had spread out over more of my bicep and the stiffness began to diminish slightly. It was still warm and slightly painful.  6/4/21 the swelling is down considerably and the redness has almost completely cleared. The area is still tender.
Swelling, severe pain. Severe shoulder pain and reduced range of motion in the arm where a shot was given can happen.
A nurse reported that an 11 year old male received Tetanus and Diphtheria Toxoids Adsorbed, Purogenated and Engerix-B vaccines on 08/04/00. On 08/06/00, he developed a rash on both hands and a 3 to 4 inch area of redness at the site of Tetanus and Diphtheria Toxoids administration. He was noted to be improving on 08/08/00. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated. A copy of this report has been forwarded to SKB, manufacturer of Engerix-B.
Severe migraine, body aches and Hives two days after second dose. Currently still experiencing hives.; body aches and Hives two days after second dose. Currently still experiencing hives.; Hives two days after second dose.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route, administered in right arm on 23Jul2021 at 10:00 (at the age of 36-years-old, Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none and had no known allergies. The concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 02Jul2021 at 17:30 (at the age of 36-years-old, Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 26Jul2021, at 06:00, the patient experienced severe migraine, body aches and hives two days after second dose. Currently still experiencing hives. The patient was prescribed Singular 10mg, as a treatment to events. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
PALPITATIONS. Waited an extra 15 mins- Evaluated by EMS-Cleared
Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  It was reported that it was their 1 and 2 doses.
administered MMR II that was improperly stored in the freezer; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 03-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Recombinant human albumin (rHA), lot # S020161, expiration date 30-JUN-2021 (exact dose and route of administration were not reported) for prophylaxis.  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -10 degrees of F for an unknown time. There was a previous temperature excursion reported: below 36 degrees of F (10 degrees of F) for 50 minutes.
No additional adverse effects reported; the patient received his second dose of VAQT A on 06/29/2020; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided.  On 11-MAY-2020, the patient received his first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On 29-JUN-2020, the patient received his second dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S023220, expiration date 20-OCT-2020; strength, dose and route were unknown) for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse effects reported.   It was reported that hepatitis a vaccine, inactivated (VAQTA) was inform in the product section as the strength of the hepatitis a vaccine, inactivated (VAQTA) was unknown. No product quality complaint (PQC). The outcome of the events was unknown.