chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It hurts.; Injection site has a rash on it.; arm is very red/The injection site is red.; It looks like lot of fluid in there.; tenderness; red rash; Swelling under my ledt armpit; Swelling at injection site; itchy on injection site; had fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (It looks like lot of fluid in there.), TENDERNESS (tenderness), RASH ERYTHEMATOUS (red rash), PAIN (It hurts.) and VACCINATION SITE RASH (Injection site has a rash on it.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gaucher's disease since 1991, Hypertension (High blood pressure) since 2019, Thyroiditis (Thyroid) since 1992 and Triglycerides. Concomitant products included LISINOPRIL and PROPRANOLOL for Blood pressure, VELAGLUCERASE ALFA (VPRIV) for Gaucher's disease, LEVOTHYROXINE for Thyroiditis, FENOFIBRATE for Triglycerides.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (itchy on injection site), PYREXIA (had fever), CHILLS (chills) and MYALGIA (body aches). On 25-Oct-2021, the patient experienced TENDERNESS (tenderness), RASH ERYTHEMATOUS (red rash), VACCINATION SITE SWELLING (Swelling at injection site) and LYMPHADENOPATHY (Swelling under my ledt armpit). On an unknown date, the patient experienced FLUID RETENTION (It looks like lot of fluid in there.), PAIN (It hurts.), VACCINATION SITE RASH (Injection site has a rash on it.) and VACCINATION SITE ERYTHEMA (arm is very red/The injection site is red.). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. On 25-Oct-2021, PYREXIA (had fever), CHILLS (chills) and MYALGIA (body aches) had resolved, LYMPHADENOPATHY (Swelling under my ledt armpit) had resolved with sequelae. At the time of the report, FLUID RETENTION (It looks like lot of fluid in there.), PAIN (It hurts.), VACCINATION SITE RASH (Injection site has a rash on it.) and VACCINATION SITE ERYTHEMA (arm is very red/The injection site is red.) outcome was unknown and TENDERNESS (tenderness), RASH ERYTHEMATOUS (red rash), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PRURITUS (itchy on injection site) had not resolved.            Patient had vaccinated first dose on 23-Jan-2021 at 2.30 pm and second dose on 25-Feb-2021 at 10.30 am and experienced events at 03.00 am on 24-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up received on 26-OCT-2021. Added patient details, dose 1 and 2 details, concomitant medication information, new events, outcome.
muscle aches; chills; general fatigue; fever; nausea; lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 13Apr2021 at 14:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. Concomitant medications included paracetamol (ACETAMINOPHEN), ibuprofen (MANUFACTURER UNKNOWN) and ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, retinol, pantothenic acid, riboflavin, Phyto menadione, nicotinamide, beta-carotene, iron, magnesium, manganese, chromium, copper, zinc, calcium, iodine, selenium, vitamin d nos, vitamin b12 nos, xanthophyll, lycopene, vitamin b1 nos, vitamin e nos (CENTRUM WOMEN MULTIVIT) all were from unknown date and for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on an unknown date in Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced the events muscle aches, chills, general fatigue and progressed to fever, nausea, and lack of appetite throughout the day. The events did not result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as the result of adverse events and included treatment with self-administered Ibuprofen and acetaminophen. The clinical outcome of the events muscle aches, chills, general, fever, nausea, and lack of appetite were recovered on 15Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient presented swelling with some redness and warmth to touch to area of immunization given. Mother stated child was fine; had no fever, some soreness to that area. Otherwise child running around normal.
tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing
I had my second shingles shot on Friday, February 1, 2019 at approximately 11:30 am. I then played bridge about 1:00 pm  and the longer I sat there the more my joints ached, starting at my neck and  shoulder  joints; then I had severe pains in all my joints. It was so debilitating that by 3:34 pm I had to be helped to my car. Upon arriving home I took an Aleve, but the pain lasted throughout the day and kept me awake Saturday night. It had eased up considerably by Sunday but I felt like I'd been beat up! I've only had one other reaction to a shot like that following my second infusion of chemo, followed by a patch. I was told to take an antihistamine three days before the next infusion and I never had that reaction again. My last chemo infusion was March 2018.
A few days after getting the second Shingrix vaccination (a little over 2 months after getting the first Shingrix shot), I started having heart palpitations. On the eighth day, the palpitations got markedly worse and I had extreme shortness of breath and felt faint. I had lie on the floor in order to not faint and I called 911 and was taken to the ER. An EKG showed premature atrial contractions. I also wore a heart monitor for a week and did a heart stress test, but no other problems were identified.
dizziness; I couldn't lift my arm; feeling very very bad; very fatigued; muscular pain; fever; felt lot of chills; A spontaneous report was received from a 49 year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, fever, and felt lot of chills.   The patient's medical history was not provided. Concomitant product use was not provided.    On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On the morning of 03 Jan 2021, the patient started feeling very very bad. The patient felt dizzy and had a 100.2 °F fever. They took 2 units of paracetamol and the fever dropped and never went up again. The patient was very fatigued, had a lot of muscular pain, and couldn't lift their arm. The patient also had a lot of chills. On the night of 03 Jan 2021, the patient took 2 more paracetamol, but didn't take anything on 04 Jan 2021 due to feeling much better. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events dizziness, couldn't lift my arm, feeling very very bad, very fatigued, muscular pain, and felt lot of chills was unknown. The event fever was considered recovered/resolved on 03 Jan 2021.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe body aches and fever for 2 days.  For 12 days I sweated profusely.  Itched behind knees and on thighs.  Right elbow had a weird sensation like my elbow was going to stop working.  To this day my calves ache and ankles ache (off and on).  Ankles feel like they are going to stop working.   I feel like I'm going to be sick/nausea (comes and goes) Just weird stuff that never happened before and continues off and on to this day.
INJECTION SITE PAIN Narrative:  MILD INJECTION SITE PAIN LASTED ~2 DAYS
No additional AE; HCP calling to report patient received GARDASIL 9 earlier than recommended; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 14-FEB-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 17-APR-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 12-JUN-2023, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: W030851, expiration date: 08-JAN-2025; strength, dose, and route of administration were not reported) for prophylaxis. The third dose was administered earlier than recommended (inappropriate schedule of product administration). No additional adverse events (AE) were reported (no adverse event).
Sweating, Dizziness Onset was approximatelly 35 minutes after administration Effect was transient 1-2 hrs. No treatment needed
SIGNIFICANT GI BLEED; DEATH; SUBORBITAL BLEEDING AROUND BILATERAL EYES; FATIGUE/ FEELING TIRED; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 240 pounds, and height was 60 inches. The patient's past medical history included thrombocytopenia, and concurrent conditions included cirrhosis of the liver, smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the patient experienced fatigue/ feeling tired. On 15-APR-2021, the patient experienced suborbital bleeding around bilateral eyes. On 03-MAY-2021, the patient experienced death. On an unspecified date, the patient experienced significant GI bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died, and outcome of significant GI bleed, suborbital bleeding around bilateral eyes was unknown and not recovered from fatigue/ feeling tired. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210516526-covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210516526-covid-19 vaccine ad26.cov2.s-significant GI bleed, suborbital bleeding around bilateral eyes. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Patient received this dose 4 days early. She received the following vaccines: 03/08/2021  Moderna 036A21A; 04/05/2021 Moderna 030B21A; 08/17/2021 Moderna 088D21; 01/13/2022 Moderna  041J021A; She would be due for her final booster vaccine on 01/17/2022.
Pt received 4 month immunizations with Prevnar, HIB, DTAP and IPV and 24 hours later, was admitted to PICU for respiratory failure. Still in ICU on 9/25/01.
This spontaneous case, initially received on 16-Nov-2016, was reported by a health professional and concerns a patient of unknown age and gender. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received ALFURIA. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: Not reported. No additional suspect drugs. Adverse event description: On an unknown date, AFLURIA vaccine was administered from the multi-dose vial more than 28 days after it had been punctured (outcome: not reported). Special circumstances: drug administration error without adverse event. Reporter comments: The healthcare professional considered the event as non-serious.
Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Lymphadenopathy, fever, fatigue, body aches, sore throat for 4 days. Symptoms started 2 days after first vaccine.
cervical lymphadenopathy swelling 48 hour post vaccine, on same side as vaccine administration
rash on her right arm; arm was a little itchy; Rash is red; This is a spontaneous report from a contactable consumer. This contactable female consumer (reported for herself). An 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737, expiry date: unspecified date in Jul2021) via unknown route of administration in right arm on 19Apr2021 (at the age of 89 Years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she got her first dose on 19April2021, about 12:00 because she got the shot and then had to wait and go into another room where she waited 15 minutes and maybe it was 13:00 when she got the vaccine. Caller stated so she had to wait 15 minutes and it was like 13:05 when she could leave so she had to have got the first dose of the vaccine sometime between 12:00 and 12:45 and had no problems everything was fine until this week on 05May2021, Wednesday she broke out with a rash on her right arm which was the arm she got the shot in, and also her arm was a little itchy but not worse than a regular rash but it was a rash. It was stated that she had not been ill or feverish she just developed a rash. Reporter stated she is due to get the second dose on Monday 10May2021 and was wondering if she should get the vaccine or not. Caller stated her rash was not as red but it had not disappeared but the itching was bad yesterday and it was not itchy now. Caller stated the thing that bothered her is that she is due for the second shot on Monday and it started to get more itchy last night and if it was not for the itching she would probably would not be calling now. Caller stated the itching stopped this morning and was not experience it currently. Caller stated she was not sure if she had recovered completely from the itching since it was still early in the day as it was 11:00 am where she was at and she was not sure what it will feel like at say 6:00pm. Caller stated she had not seen her doctor for a year, ever since the pandemic she had a telephone call and her doctor works in the afternoon Monday through Thursday and she had not been able to reach him. Patient did not have other vaccines Prior Vaccinations (within 4 weeks). Patient did not visit Emergency Room or Physician Office due to events. Patient did not receive treatment. The outcome of the event arm was a little itchy was recovered on 07May2021 and other events were recovering.  No follow-up attempts were needed. No further information was expected.
Dtap redness notice 10/30/08 swelling redness measure 20mm x 20mm apply ice right away
This case was reported by a physician and described the occurrence of hepatitis A virus A virus igm antibody positive in a 20-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates in June and July 2008, the subject received the 1st dose and 2nd dose of TWINRIX (unknown). On an unspecified date after vaccination with TWINRIX, the subject had a hepatitis panel to test for chlamydia. On 22 August 2008, at an unspecified time after having the hepatitis panel taken, the subject's test results came back hepatitis A virus IGM antibody positive. At the time of reporting the outcome of the event was unspecified.
experienced slight headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "experienced slight headache".  Additional information: caller clarifies they put the needle in her arm, and he says it sounds like maybe the vaccine came out around the hub, there was a significant amount leaking down her arm. Warm transfer from (###), CEP 159558. He is calling to ask for his patient that was supposed to have second dose 21May2021 however the syringe or the needle had a malfunction and the vaccine leaked out and they decided not to take the second dose that day. Now the patient is scheduled to have her second dose today and this caller wants to ask if that's okay. Agent says the administration of the vaccine was not succeeded. This patient mentioned that she experienced slight headache and she was not sure if it's from the vaccine. Agent clarifies she mentioned it to the pharmacist and said she was not sure if it's from the first dose or somewhere else. The caller confirms the details provided by the transfer agent. He confirms product as Pfizer COVID 19 vaccine. He clarifies the dose was attempted to administer. He clarifies they put the needle in her arm, and he says it sounds like maybe the vaccine came out, instead of going to through the needle, something happened maybe at the hub of the syringe and needle, the vaccine leaked out. They said there was a significant amount on the patient's arm, leaking down her arm, is what the caller gathers. Caller says he is not sure he is the appropriate person to give information about the event because he is receiving information fairly second hand from the patient and the pharmacist, he doesn't know that he would have a lot of detail to provide. Caller says he is going to defer the report for 2 reasons, one for lack of information and number 2 he is working otherwise, he is doing other things right now.  Follow-up attempts completed. No further information is expected.
Her face is almost paralyzed or something like that; This is a spontaneous report from a contactable consumer or other non HCP.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced no reaction on previous exposure to drug. On an unspecified date in 2021, the reporter stated that patient face is almost paralyzed or something like that. Patient was having all kind of complications. The case assessed as serious (medically significant). The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Per mother report, it was first puffy and then spread down his arm and became "hard" and "hot".  Mother reports giving him tylenol and benadryl without relief.  Mother took client in to the clinic and they treated him "like it was a reaction" and prescribed famotidine and cetirizine.  Per mothers report, arm is looking "so much better" after a few doses of these medications.
After receiving YF vaccine (L) tricep region (SC) pt developed pruritic wheal about 6 x7 cm. Induration/min warm non tender. Without adenopathy.
pt recv vax & screaming, arching back & pulling @ ears & everywhere constant crying until 9PM;slept until AM then intermittent screaming & jerking until to sleep;
Five hours after injection, intractable nausea, dry heaving, fatigue, then diarrhea. 3 to 4 days after vaccine, pruritus, erythema, swelling of fingers and hands, arms up to elbows, right shoulder, erythema and pruritus of buttocks, and then feet bilaterally. She was already on cetirizine but added fexofenadine and Benadryl without relief. Symptoms subsided after three days.
Pt recvd 2 doses of Engerix-B 19SEP91 & 20OCT91 & 20DEC91 pt exp transverse myelitis which reporter indicated was permanently disabling; PT has been given to treat the event;
Fever, Muscle Aches, Migraine, Shivering, Lethargy
I was diagnosed with Sinusitis on May 15, 2023 my symptoms were headaches, jaw pain, tooth pain, swollen eyes, congestion, fatigue and a cough. I was prescribed Prednisone for my symptoms.