chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a health care professional concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: Patient was not pregnant. Patient was not being on Methotrexate. The patient previously received (dose number in series 1) (unspecified manufacturer) Covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse events with Covid-19 vaccine ad26. cov2. s (dose number in series 1). The batch number was not reported and has been requested. Concomitant medications included golimumab in Oct-2017 for rheumatoid arthritis. On 04-APR-2022, the patient experienced extended period of feeling unwell, mild blister style rash without injury, did not feel good, not a headache, but her head felt different (all events with dose number in series 1). The patient received booster of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination (dose number in series 2). It was unknown if the patient experienced any adverse event after vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extended period, mild blister style rash without injury, did not feel well and head felt different was not reported. This report was non-serious. This case, involving the same patient is linked to 20100510627, 20040401101, 20210121863 and 20220409325.
Mother of patient states 1.5-2 hours after immunization given, patient became very sleepy, "limp and lethargic".  Patient did not wake on his own for feeds for approx 4 hours.  He was eating routine by middle of the night.  He was fine by next morning
New onset Bell's palsy L face on 5/8/2021. Confirmed on examination 5/12/2021
Pt. c/o L arm "tingling", numbness & difficulty with any weight bearing L upper extremity.  Symptoms started approx 5-> 6 hrs after injection.
diahrea after first shot; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced diahrea after first shot. The reporter wanted to know if not receiving second shot would cause further adverse reactions. The outcome of the event was unknown.  Information on lot/batch number has been requested. Additional information is expected.
ice pick had gone thru her arm; arm was sore; very tired/exhausted; arm was killing her; sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick), FEELING ABNORMAL (ice pick had gone thru her arm), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 021C21A) for COVID-19 vaccination.     No Medical History Information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (sick), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her). On 04-Apr-2021, the patient experienced FEELING ABNORMAL (ice pick had gone thru her arm). On 04-Apr-2021, MALAISE (sick) had resolved. At the time of the report, FEELING ABNORMAL (ice pick had gone thru her arm), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her) outcome was unknown.            Concomitant medication include Progesterone and estrogen patch. Treatment includes soaked in Epsom salt and Aspirin.   This case was linked to MOD-2021-100460 (Patient Link).
According to pt's dad, child complained of dizziness, 5 minutes after receiving TD and HAV. He laid him on the floor and he observed that ... stiffened...upper..motion and rolled his eyes back for 10-15 seconds x2 at a minute interval. BP 110/80 HP 82, Resp 24/m
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot #M038728, expiration date 25-APR-2018. No adverse effects were reported.  Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012843: US-009507513-1706USA004569:
body aches; a fever of 101; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), intramuscularly on 06Jan2021 10:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose in Dec2020 10:00 intramuscular at left arm for covid-19 immunization. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches and a fever of 101 on 07Jan2021 14:00. He fully expected this immune response from his body and it only lasted 12-24 hours. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 08Jan2021. The events were reported as non-serious.  Information about Batch/Lot number has been requested.
Extremely erratic menstruation patterns since vaccination; I have had gotten my period multiple times in a month, heavy each time with fresh red blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:15 (Lot number: EW0173) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA. Vaccination history included: Bnt162b2 (Product=COVID 19,, lot number=EW0153,, Administration time=11:15 AM,, dose number=1,, vaccine location=Left arm), administration date: 09Apr2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 14May2021, outcome "not recovered", described as "Extremely erratic menstruation patterns since vaccination"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14May2021, outcome "not recovered", described as "I have had gotten my period multiple times in a month, heavy each time with fresh red blood". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding.  Additional information: Extremely erratic menstruation patterns since vaccination. My typical cycle is very regular occurring once a month, lasting about 3 days, with little dried blood. Since my vaccine, I have had gotten my period multiple times in a month, heavy each time with fresh red blood. I can bleed through a maxi pad within a few hours. During the month of Jul2021, I had my period 3 times. First starting on 28Jun2021-05Jul2021, then from 11Jul2021-16Jul2021, and again from 28Jul2021-04Aug2021. Now I have it again from 8/10 to today. Serious : No, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Early pain lt sinus area tx w/Cipro early DEC; On 20DEC91 approx enlarged lymph nodes, difficulty swallowing, sl pain in lt ear area; On 27DEC91 severe pain from lt side of head to lt eye orbit, lt cheek & around ear to jaw; unable to chew;
developing a cold sore (herpes simplex type 1) the following morning/She usually develop a cold sore with an illness; developing a cold sore (herpes simplex type 1) the following morning/She usually develop a cold sore with an illness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 16Dec2020 16:15 at a single dose for immunization. The patient's medical history included cold sore and celiac disease. The patient was not pregnant. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient reported that it was not necessarily an adverse event but she noticed that she was developing a cold sore (herpes simplex type 1) the following morning on 17Dec2020 10:00. She usually develop a cold sore with an illness. She also typically take valacyclovir to treat but opted not to take it (did not want to interfere with the vaccine and body developing antibodies). No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination neither had been tested for COVID-19 post vaccination. Outcome of the events was recovering. The events was considered non-serious.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, cold sore (herpes simplex type 1) onset more likely represents the recurrence of the underlying herpes viral infection.  Currently no biological plausibility indicated the event is attributed to the vaccine use.
Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022; Patient received vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 24-Jan-2022 and administered on 2-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given.  The Reporter reported that the pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients and the pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022.   The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022
HEAD HURT; LITTLE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced head hurt, and little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head hurt, and little fever. This report was non-serious.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 16-JUL-2013, the patient was vaccinated with an expired dose of 0.5 milliliter (ml) of M-M-R II (lot number and expiry date reported as 671320/1121AA and 12-JUL-2013 respectively), subcutaneously. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Chills-7:00am Fever-12:30pm- continued until late at night No appetite-11:30am No energy- 12:30pm- all day and night
Nausea, vomiting, headache, severe abdominal pain- intensity is 7, painful to breath, rib and shoulder pain.  Referred to clinic  Admitted 6/2/2021 Diagnosis: Ruptured spleen with massive hemoperitoneum Splenectomy performed
Shortness of breath, fever, lethargic, admitted to the hospital on 7/27, discharged 7/29
The pt came in for a well visit on 1/12/01, received vaccines. Immediately after the vaccine, the child developed an erythematous rash on the face and extremities and a petechial rash on neck. Benadryl was given and within 45 minutes the child was fine. No swelling or redness to the leg.
blood pressure from the 11 patients increased right after the vaccine to dangerous levels; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) 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 BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Pt reported swelling and redness at the injection site.  It started out the day after injection as a quarter-sized welt.  By the fourth day post injection, pt reports that area of swelling has increased to a 5''x7'' area.
Moderate soreness in upper left deltoid; treated with OTC acetaminophen; soreness resolving over time.
I have had months of horrible neuropathy that is spreading very quickly. I was diagnosed with small fiber neuropathy via biopsy; I also nowhave vision and balance issues; I also nowhave vision and balance issues; This is a spontaneous report from a contactable consumer or other non-health care professional.   A adult female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for covid-19 immunisation. It was unknown whether the patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was unknown that whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown that whether the patient has been tested for COVID-19 since the vaccination. It was unknown if covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient had any known allergies. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient reported that the patient had an adverse reaction to the second Pfizer shot. The patient had months of horrible neuropathy (medically significant) on 14May2021 that is spreading very quickly on. The patient was diagnosed with small fiber neuropathy via biopsy, but all blood tests/MRI/EMG are normal. The patient had been to so many doctors and no one knows how to treat this or help. The patient had trying to get to a specialist. There are many others that are suffering with similar or worse symptoms. The patient also had vision issues on an unspecified date in 2021 and balance issues on 14May2021. Symptoms started 12 hours after the second shot on 14May. Vision issues began 5 weeks after second shot. Patient said she had been dealing with medical issues prior to the shot. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: small fiber neuropathy on unspecified date in 2021, blood test: normal on unspecified date in 2021, electromyogram: normal on unspecified date in 2021, and magnetic resonance imaging: normal on an unspecified date in 2021. It was unknown whether the patient received any treatment for the adverse event. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine at approximately 6:30 pm on 06-06-2023. She woke up at approximately 2:30 am on 06-07-2023 with  stomach pain, nausea, and headache. She also complains of back pain so severe that she had to leave work.
spots; eczema is getting bad; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of 78 (age units was not reported) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient stated when she got her first Pfizer vaccine dose they asked if she had taken any steroids. The patient stated she have a topical cream 5 percent steroid. The patient stated her eczema is getting bad (on unspecified date) and she need to use it. The patient asked will it have some effect with the Pfizer vaccine, it has been bothering her, but she have not been using it. The patient stated she have new spots stared (on unspecified date) which occurred after getting the vaccine. The patient stated she know the vaccine raises the immune system and her eczema is like an auto immune condition. The patient asked will you have more information regarding drug interactions with the vaccine in the future. The outcome of the events was unknown.   Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HD9835) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer Unknown, Primary Immunization Series Completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2023) Positive, notes: testing positive again on antigen self-test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Treatment included Paxlovid. Patient had no known allergies.
In November 1998 the pt developed 50-75 rash consistent with herpes zoster on her legs and buttocks. The pt was afebrile. It was indicated that she experienced pain only when the rash touched or rubbed. The reporter indicated that she had no known exposure to natural varicella. She recovered within 7 days after the onset of episodes.
Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she felt dizzy, shortly thereafter she noticed that her speech was slurred. Her daughter saw that her mouth was droopy and called 911. Pt took 3 baby ASA at that time as well.  Patient evaluated in ED for stroke, CT/CTA normal, TPA not given. Admission diagnosis CVA vs Bell's palsy (mild). MRI consistent with changes suspect acute infarct. No arrhytmias noted. ECHO unremarkable.
abdominal pain; colitis; This case was reported by a other health professional via sales rep and described the occurrence of colitis in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 2nd September 2019, 6 days after receiving Shingrix, the patient experienced colitis. On an unknown date, the patient experienced abdominal pain. On an unknown date, the outcome of the colitis and abdominal pain were unknown.   The reporter considered the colitis and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient went to hospital on 2nd September 2019, because of abdominal pain and diagnosed with colitis. The reporter stated that, the patient does not want to take second dose of Shingrix when due. The reporter was agree to follow up from GlaxoSmithKline.
sudden onset of chest pain 05/19/2021 night into 05/20, unable to sleep. Troponin elevated on arrival to ER. He received his 2nd dose of Pfizer CoVID vaccination on Sunday 05/16/2021. Diagnosed with acute myocarditis, probable cause post-CoVID vaccination.