chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA Original vaccine on 01/29/2021.  On 02/07/2021  a re rash appeared at injection site.  description: 4 inches long  down my upper arm and about 3 inches wide.  Warm to touch and itched,  swollen,  very red and inflamed.  firm knot at injection site.  Remained red and inflamed until 02/10/2021. Self treated with Diclofenac sodium gel 1% (VOLTAREN) for 3 days.  Symptoms did begin to subside. Remnants still present with no itch 02/11/2021.  Saw Physician today,02/11/2021 advised to get second dose in other arm scheduled for 02/26/2021.  No other reactions occurred.  Hardly even knew I had shot until reaction began probably on 02/06/2021 but unnoticed until itching realized.
Starting 16 hours after injection: body/joint aches, nausea, dehydration, headache, hot and cold flashes, mental slowness/fog and the injection site pain got much worse. These lasted for another 12 hours and then started getting better. 17 hours after symptoms started, all that remains is mild body and joint aches.   I have taken ibuprofen for pain control every 4 hours.
CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 18 year old female. 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) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and chills was not reported. This report was non-serious.
was sore / around the site; red around the site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported the case. The patient was vaccinated with Shingles vaccine and experienced sore and red around the site. The patient said it was better than having shingles. The patient did not consented to follow up.
Pain at injection site Narrative:  Employee reported pain @ injections site 1/6-1/8, 1/8 body aches. 1/9-1/12 fatigue
On 4/18/2023, 18 hours after vaccine administration, experienced fever, headache, very bad body aches.   Fever at height was 102.2.  Took 4 hours after tylenol and ibuprofen for fever to abate.  Fever gone by next morning, 4/19/23.
Chills same day, next day rash L shoulder, L hand with some swelling, right thigh, right lower leg.  Patient relates at this visit did have similar rash 3 years ago s/p flu vaccine.
HIS VOMITING BECAME WORSE, HE HAD A FEVER AND ENDED UP WITH ANOTHER BLOCKAGE. HE'S HAD 5 SURGERIES SINCE.
Headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 50-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via an unspecified route of administration, administered in arm left on 23Mar2021  (at the age of 50-years-old) as a single dose for covid-19 immunisation. The patient medical history included mitral valve repaired in 2017 (reported as 4 years ago). The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccines within four weeks. The patient experienced headache on 10Apr2021 15:00 (03:00PM). The event resulted in physician or other health professional office visit, disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Apr2021. The patient received treatment for the event as doxycycline and prednisone were provided. The outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of headache due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I ran a fever of 103+ for 24 hours followed by EXTREME mouth pain and NUMEROUS oral lesions lasting for 7 days.  The pain was so severe I was unable to eat without using the numbing medication prescribed by my health care provider.  My health care provider instructed me to report my symptoms.
Chills, fever (101), body aches, fatigue, very sore arm-lasted approximately 24hrs. Then slight fatigue and sore arm for another 24 hours.  I didn?t know it was alright to treat with otc Tylenol until about 10am the first day. This helped greatly. Took 2-500mg tabs every 5ish hours when symptoms returned. Took 800mg ibuprofen at around 10pm the first night.
I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.; It felt like every joint in my body hurt (back, Knees, elbows, hips).; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1,  030L20A , left arm) on 25-Jan-2021, Moderna COVID-19 Vaccine (2nd dose ,015M20A, left arm) on 22-Feb-2021, Moderna COVID-19 Vaccine on 22-Feb-2021, Moderna COVID-19 Vaccine (Dose 3, Lot 002F21A, left arm) on 16-Aug-2021 and Moderna COVID-19 Vaccine (felt out of sorts for 24nrs. It was Minor) on 16-Aug-2021. Past adverse reactions to the above products included Headache with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; Joint ache with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and No adverse event with Moderna COVID-19 Vaccine.    On 23-May-2023 at 1:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-May-2023 at 10:30 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).). On 24-May-2023 at 8:30 AM, FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) had resolved and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that on 23-May-2023 by 11:30 pm patient skin was on fire. Patient had to get out of bed and thought gonna die .One day while patient was working out in a field across the street from work, patient got stung by yellow jackets. Patient had to go to the hospital. The doctor counted 27 stings. That's how it felt. By 8:30am the next day on 24-May-2023, everything was gone. No treatment information was provided.   Reporter did not allow further contact
rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; but hives are there for the most time; rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at a dose of UNK dosage form. At the time of the report, PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Significant dizziness/off balance, shaky when upright, blurry vision with fast head movements or looking up/down and laterally; headaches base of skull into pressure behind eyes. Muscle spasms neck/back. Increased s/s of ? autoimmune; suspect autoimmune related flair. Multiple ED visits, PCP visits, specialist visits across the course of 2 months; time off of work >5 weeks d/t s/s. Not completely resolved at time of this submission.
pt vax on 9/15/98 6 days p/vax pt devel fever, cough & body rash.  mom stated fever was high but did not measure pt temp
Petechiae  (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate,  flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
Patient sitting in chair and lost full consciousness. Patient fell over out of chair, hitting head on floor. Patient face mask removed, patient noted breathing but remained unconscious for a about 30 seconds. Upon regaining consciousness patient is alert and oriented x4, and diaphoretic. Denies any pain or discomfort at this time. Denies any other signs and symptoms. Denies Hx of anaphylactic reaction to medications, food, or vaccines.  Patient denies adverse reactions to vaccinations in past. Vitals: 11:07: BP 123/55. Pulse 55, SpO2: 97%. Pain: 0; Rapid response called by staff. Rapid response team arrived and updated on patient's status. Patient transported to ER with rapid team per physicians recommendation at 11:10.
Swelling and redness 10cm x 10 cm. Area hot to touch. Complained of headache and fever after vaccination and pain had radiated to the neck.  Onset of symptoms were later in the day after receiving vaccination.  She said pain was less severe today, but still has some pain.  Pain in the neck has stopped.  Ice was applied in clinic today.
Vomiting diarrhea severe dehydration low grade fever unable to get air in pale severe sudden onset weakness.
not receiving the 2nd dose of the vaccine; having "a cold" after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) and NASOPHARYNGITIS (having "a cold" after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) and NASOPHARYNGITIS (having "a cold" after vaccination). In April 2021, PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) had resolved. In June 2021, NASOPHARYNGITIS (having "a cold" after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medicines were reported  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: AE Outcome Provided and 2nd dose was taken by the patient with no side effects reported.
No adverse events - MMRV was administered on 1/15/08 -> client age 16 and vaccine expired on 1/11/08.  No adverse event-only reporting dlt inappropriate age & expired vaccine.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 200, 352, 132, and 24 hours and the lowest recorded temperature reported were 200, 352, 132 and 24 Fahrenheit (F) (0, -1.666666667, 1. 111111111, and 0.555555556 Celsius (C)) respectively. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
(this booster) was given 5 weeks too soon (based on recent CDC Novavax COVID-19 vaccine guideline from 5-11-2023)
While on vacation my son experienced fever, mucus discharge developed a lot of allergies, felt sick on or around 06-16-2021. He also experienced sore throat, mucus discharge and cough and phlegm which lasted about three days. Then on 06-29-2021 he started again with fever, chills, sore throat. He also got tested for covid but was negative on 07-01-2021 with a different doctor. His heart palpitations were high, his heart palpitations were 120bpm. Today he feels better, and his heart palpitations were 105bpm yesterday. As far of today, he still has a cough that comes and goes today and mucus discharge. His doctor also said he does not have any infection. His heart palpitations today are 103bpm.
Approximately 1.5-2 hours after receiving the Pfizer-BioNtech COVID-19 vaccine (lot ER2613,) at approximately 8:40 am on 4/26/21, I started having mild jaw pain. At about 4 pm that afternoon the jaw pain worsened to the point where I was unable to chew without pain. Around this time, I started having chills. Immediately pre- and post- vaccine I was alternating Tylenol and Motrin every 6 hours. At around 11 pm that night I was experiencing chills and myalgias. Between 1-2 am on 4/27/21, I started experiencing right-sided facial drooping. I found it difficult to open my right eye and my entire face felt numb. The jaw pain was even more severe with these symptoms, and I had to pry my right eye open by tugging at my eyebrow region. Given enough time, I could get the eye open and my face began to look normal. I would lie back down and have the same difficulty each time I got up to use the restroom. These symptoms started lessening until they completely resolved between 7-8 am on 4/27/21. I have had similar symptoms with migraines (possible hemiplegic migraines) in the past, but I did not experience any headache with these symptoms. Now it is 11:44 am on 4/27/21 and the only symptom that remains is general malaise and mild myalgias. I thought about going to the emergency dept during the night due to the facial drooping, but ultimately decided to wait it out.
pain in the chest; headaches; abnormal EKG; he is very depressed; he cannot play basketball or do any sports activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FK9729) at the age of 14 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: The caller states that her son did have COVID-19 earlier in April of 2022 prior to receiving any doses of the Pfizer COVID-19 vaccine and he experienced breathing issues when he had COVID-19; "Breathing issues" (unspecified if ongoing), notes: The caller states that her son did have COVID-19 earlier in April of 2022 prior to receiving any doses of the Pfizer COVID-19 vaccine and he experienced breathing issues when he had COVID-19. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "pain in the chest"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "unknown", described as "abnormal EKG"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "he is very depressed"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "he cannot play basketball or do any sports activities". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: A 14 year old son who received a booster dose of the Pfizer COVID-19 vaccine last Thursday, 27Jan2022, at (address). The caller provided Lot #  FK9729 which is what her son received as a booster dose. The caller states that her son has been experiencing "pain in the chest, headaches and has had an abnormal EKG" since receiving his booster dose. The earliest appointment she could get for her son at a Cardiologist is this coming Wednesday 09Feb2022. The caller states that her son did have COVID-19 earlier in April of 2022 prior to receiving any doses of the Pfizer COVID-19 vaccine and he experienced breathing issues when he had COVID-19. At that time his pediatrician performed an EKG and it was normal. The caller states that since they have a normal EKG during the time of her son having COVID-19 versus an abnormal EKG during her son experiencing chest pain after receiving a booster dose of the Pfizer COVID-19 vaccine she and the pediatrician feel certain that these results and symptoms are related to the vaccine. A cardiologist that will see him because his EKG is abnormal and his pediatrician said that, he cannot play basketball or do any sports activities. Right now he is scheduled only for 09Feb to see a cardiologist.  Follow-up attempts are completed. No further information is expected.
Extra Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2019), Shingrix (received 2nd dose on 12th November 2019) and Zostavax (had shingles vaccine years ago and the patient meant they had Zostavax).   On 07-JUN-2023, the patient received the 3rd dose of Shingrix. On 07-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The pharmacist reported the patient came into pharmacystating he had shingles vaccine years ago and wanted to get the Shingrix. The pharmacy thought that the patient meant he had Zostavax and pharmacy administered a dose of Shingrix. The pharmacy later found the documentation that the patient had received the two doses of Shingrix. The reporter did not have the lot number and expiration date information for the first two doses. The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 3rd dose of Shingrix, which led to extra dose administered.
diagnosed with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
10 months following his last booster,  my father,   a previously robust and healthy man has developed Atrial fibrillation despite having no other risk factors. He also started getting sick with covid every 6 months after getting his covid vaccines.