chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzy; Weakness; Arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1B and 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy, Latex allergy, Penicillin allergy, Allergy to antibiotic, Lupus syndrome, Blood pressure high and Diabetes. Concomitant products included AMLODIPINE BESYLATE, ATORVASTATIN, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts) had not resolved.            No treatment medication was provided by reporter.    This case was linked to MOD-2021-038708 (Patient Link).
6 days after first vaccine dose, patient experienced a raised, red, itchy and somewhat painful area on her arm immediately below the vaccine administration site. She described it as approximately 4-5 inches in length, a couple inches in diameter. It lasted for about 24 hours and then disappeared. She did not require any treatment, did not see or consult a doctor, and did not take any over the counter medications. Pt. described it as similar to reactions she's had to a spider bite, but there was no indication that a spider had bit her in her arm.
Oral lichen planus; lichenoid mucositis; This is a literature report.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; hydroxychloroquine (HYDROXYCHLOROQUINE), (Batch/Lot number: unknown) for covid-19. The patient's relevant medical history included: "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: diagnosed in March 2021. The patient's concomitant medications were not reported. The following information was reported: ORAL LICHEN PLANUS (medically significant) with onset Apr2021, outcome "unknown"; STOMATITIS (non-serious) with onset Apr2021, outcome "unknown", described as "lichenoid mucositis". The action taken for hydroxychloroquine was unknown. Therapeutic measures were taken as a result of oral lichen planus, stomatitis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event oral lichen planus and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202201330243 Same article/ drug/event and different patient:;US-PFIZER INC-202201330242 Same article/ drug/event and different patient:;US-PFIZER INC-202201330241 Same article/ drug/event and different patient:;
Screaming-fever 103, vomited, fever to 105 - MD called; Also loss of appetite; rt thigh sore sl swollen;
In 9/97, a 1st dose of Engerix-B was given previous to a travel to India. At that time, the blood pressure was 110/70. Hep-B serologies were negative. The night following the 1st vaccination, this subject experienced fatigue, malaise and eye pain, which resolved over days. In 10/97, the 2nd dose of Engerix-B was given. Post vax, she rapidly developed fatigue as well as low-grade fevers, anorexia and headache. Over the next month, she experienced a weight loss of about 13.5 kg and by 11/97, she had developed hypertension (230/140). A retinal hemorrhage was noted. A rise in her serum creatinine to 2.8mg/dl prompted referral to the hospital. Exam in 2/98 showed blood pressure 140/104 in the right arm and 180/104 in the left arm. Bruits were noted over both axillary arteries, the left supraclavicular area, the left femoral artery and the abdomen. The right brachial and radial pulses were diminished. The serum creatinine was 2.8mg/dl and ESR 18mm/h. Angiography showed long bilateral subclavian stenosis with the right extending to the axillary artery. Bilateral selective renal angiogram in 11/98 showed evidence of arteritis in the small and large renal arteries. Despite being treated with prednisone and multiple immunosuppressive drugs including monthly pulse cyclophosphamide, her renal function continued to deteriorate and there was no change in the stenosis. Progressive renal failure was ascribed to her hypertension and underlying arteritis. Immunosuppressive therapy was discontinued in 6/99 and hemodialysis commenced 2 months later. She successfully underwent living related renal transplantation in 11/99. It is discussed that the above mentioned vasculitis in this pt also suggests Takayasu's arteritis. However, her advanced age and the sparing of other vessels would be unusual for Takayasu's. A dx of giant cell arteritis would fit her onset of disease after age 50 and the subclavian changes, which may occur in QCA in the absence of temporal artery involvement. However, QCA would not explain the bilateral renal artery disease this pt had. The underlying rheumatic disease of the pt in this article (polymyalgia rheumatica) suggests she possibility that a pt with immunologic dysfunction may be more susceptible to developing vasculitis following vaccination.
Loss of appetite, high fever 102, severe body and muscle aches to the point that walking or bending is nearly impossible, severe nausea not controlled with prescription meds, severe headache
Right after getting shot, pt c/o seeing dots and coughed, became cyanotic, O2 sats 78-69% Given DUONEB and O2 with increased AE and resolution of cough and cyanosis. Late that day had SOB-> evaluated in ED via ambulance.
malaise; nausea; muscle pain; chills; joint pain; Headache, level of migraine; Lymph node discomfort in axially node; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Deltoid Left on 24Feb2021 13:10 at the age of 73-years-old as dose 1, 0.3 ml, single for covid-19 immunization. Medical history included menopause, osteoporosis, ongoing drug hypersensitivity, arthritis, and migraine. Concomitant medications included ongoing MEDROXYPROGESTERONE and PREMARIN taken for osteoporosis, arthritis, menopause. Patient historical vaccine included small pox vaccine with which she experienced her hip swelled up like a basketball. Patient stated initially she did not have any symptoms until three days after getting the vaccine. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. She clarified she had malaise. She further explained she had a headache that continued to get worse. The headache was on the level migraine. She has migraines historically, but it was not an ordinary one. She had muscle pain, joint pain, chills, nausea, and lymph node discomfort in axillary node. The chills were mild on 26Feb2021 and increased through up to 28Feb2021, then it started going down, and started to disappear. Patient reported she has arthritic joint pain. Therefore, she can't say this was the first time she had joint pain. However, the joint pain got worse from what she normally had. Confirmed since the time it started it is better. The nausea increased as the headache increased. However, she confirmed at this time she no longer has nausea. The outcome of events malaise was unknown, headache, level of migraine, muscle pain, joint pain, and lymph node discomfort in axially node was recovering, chills, and nausea was recovered on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
ABDOMINAL PAIN; UNABLE TO EAT; ANXIETY; SEVERE HEADACHES; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart problems, and diastolic heart failure, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced unable to eat. On 02-APR-2021, the subject experienced anxiety. On 02-APR-2021, the subject experienced severe headaches. On 09-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, abdominal pain, unable to eat, and anxiety. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Redness, swelling, itchiness at site of vaccination. One week after FIRST DOSE of Moderna Vaccination
exp an episode of fainting p/vax, assumed a fetal position, extremities easily distended, knees flexed, radial & carotid pulse present;w/in several min responded to name, asked how long had been asleep VS T99.5, P72, R20, BP 100/60;
First couple days: Headache, Fever, body aches, fatigue First week after initial couple days: headache, fatigue for three weeks: fatigue ENTIRE TIME: HOT FLASHES  I should have gotten my period the weekend after the sht. As of today I still have not gotten it.
Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left in Mar2021 01:00 AM (at the age of 47-year-old) (Batch/Lot Number: EN6198) as single dose, and dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 01:00 AM (Batch/Lot Number: ER2613) as single dose for COVID-19 immunisation, administered at hospital.  Medical history included autoimmune disorder. The patient's concomitant medications were not reported. Past drug history was none. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Patient was not pregnant. The patient experienced psoriatic arthritis (medically significant) on 02Apr2021 with outcome of not recovered. The adverse event psoriatic arthritis resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative on 22May2021.  Therapeutic measures were taken as a result of psoriatic arthritis: topical solution.
lt arm sore to touch on surface of skin, feels as if arms is asleep w/pins & needles feeling in hand;location of administration is sore to touch, hurts, upper arms feels swollen from elbow to shoulder, into armpit;itchy;queasy, nausea, hot
Experienced high pitched crying day of vaccines, as well as day after. Developed fever of 102. Extremely fussy. Fever is related to vaccination and was diagnosed on 06/16/2006.
Ear ache, pain in jaw, hives in several areas-neck, jaw, side, thigh, leg, buttocks.  Prednisone 20mg tables for 5 days; Benadryl
This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication was unknown. The physician reported to the field representative that the patient developed shingles a few days after receiving SHINGRIX. The field representative thought, it was the patient's 1st dose, but was not certain. The physician also commented that, it was a weird coincidence, but did not seem alarmed.
Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to dust mite and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and budesonide/ formoterol fumarate (SYMBICORT); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 13:00, the patient experienced dry mouth. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event dry mouth was unknown at the time of the report.  No follow-up attempts are needed. No further information is expected.
Fatigue, loss of appetite, aches, fever, chills, vomiting and diarrhea, nausea, incontinence. Symptoms have lasted 8 days without improvement.
Developed rash that was later diagnosed as shingles. Multiple swollen lymph nodes in neck and face.
sore arm; little fever; tiredness; achy joints; she noticed a red spot on the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Pre-diabetic. Previously administered products included for Product used for unknown indication: covid-19 vaccine (Lot number: EN6198) on 05-Mar-2021, covid-19 vaccine (lot number: ER7828) on 26-Mar-2021, covid-19 vaccine (lot number: FF2590) on 23-Oct-2021 and covid-19 vaccine (lot number: 049L27A) on 15-May-2022. Past adverse reactions to the above products included No adverse event with covid-19 vaccine, covid-19 vaccine, covid-19 vaccine and covid-19 vaccine. Concurrent medical conditions included Blood pressure high and Stress.    On 13-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Nov-2023, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness) and ARTHRALGIA (achy joints). In November 2023, the patient experienced VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (little fever), FATIGUE (tiredness), ARTHRALGIA (achy joints) and VACCINATION SITE ERYTHEMA (she noticed a red spot on the injection site) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  A consumer stated that she had the Spikevax on 13-Nov-2023.   On 14-Nov-2023, she had a little fever, achy joints and tiredness and sore arm. The pharmacist, she stated did not use the usual band aid - it was like a foam that was placed on the injection site and it came off last night, 15-Nov-2023. That was when she noticed a red spot on the injection site.  No treatment medication information was provided.
Developed rash on torso that started in April and has persisted for the last 8 months. Treated partially with hydrocortisone cream in 11/8/1999. Rash now involves face, trunk and groin.
Racing heartbeat, dizziness, felt like I was going to be sick and pass out, heart palpitations
Rash over trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over trunk) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash over trunk). At the time of the report, RASH (Rash over trunk) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.
LITTLE LETHARGIC; TENDERNESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced little lethargic. On 08-MAY-2021, the subject experienced tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little lethargic and tenderness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518102.
Seems my heart hurt; every bone in my body hurt; I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was; made me feel like I had a flu; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (made me feel like I had a flu). On 17-Jan-2022, the patient experienced CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CARDITIS (I was treated for heart inflammation, which I got better after two weeks. Now I am back the same as I was) had resolved and INFLUENZA LIKE ILLNESS (made me feel like I had a flu) and PAIN (pain scale level is 5 when he is sitting and 10 when getting up in the morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, Computerised tomogram: fine (normal) Fine. On 17-Jan-2022, X-ray: fine (normal) Fine. On an unknown date, Pain assessment: 5 level is 5 when sitting and 10 10 when getting up in the morning.         Patient went to the ER on 17-Jan-2022, X-ray and CT scan results were fine. Then patient was treated for heart inflammation, which got better after two weeks. Now back the same as previous. Treatment: Meloxicam for a month.   This case was linked to MOD-2022-482892 (Patient Link).
Developed high fever, 101.5F, body aches and head ache around 9:30pm on 2/13/21. Took 500mg paracetamol at 11pm on 2/13, the fever was still 101.5F and body aches continued. At 03:00am on 2/14 took another 500mg paracetamol, the fever was around 101F. At 09:30am on 2/14 the fever was 99.5F, body aches and head ache were stronger. Took another 500mg paracetamol.  By early afternoon on Saturday, the fever was down to 97.5F, body aches and head ache were mild and subsiding.  On Monday 2/15 - I was not experiencing any symptoms anymore.
FATIGUE; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, fever, headache and nausea was not reported. This report was non-serious.
Large, red area to (R) deltoid - (6" x 8" in diameter).