chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor. The patient had no allergy and no COVID-19 diagnosis.    On 11-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 16-Oct-2023, the patient experienced HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j). At the time of the report, HEADACHE (headache) and RASH (rash/ she started breaking out/ she noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees, on her face but she noticed her joints had the rash too/ She said she noticed a rash on her thumb j) had not resolved.            Concomitant medication not reported.   She got both the Spikevax and flu shot on 11 OCT 2023. She was not sure which flu shot she received but says that it was the senior flu shot for ages 65 and older. Initially everything was fine and that she only had a headache which was not a big deal. However, 4-5 days later, around 16 OCT 2023, she started breaking out. They had gone camping and she was in the woods, so she thought they were mosquito bites. But the rash didn't go away, and she started noticing more. She did not have any skin problems otherwise, neither does she have any allergies. She started looking up skin conditions online and from what she can tell, her rash looks like atrophic dermatitis or eczema. She never had a problem with other Moderna COVID-19 vaccines. At most she experienced a headache or sore arm, but that's it.  She noticed rashes on her arms, trunk of her body, under her breast, in her hair, maybe on her neck, around her knees. She did not notice in on her face but noticed on joints. She noticed a rash on 2 Nov 2023 on her thumb joint.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748243, US-MODERNATX, INC.-MOD-2023-748238 (Patient Link).
Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine.  Ultrasound confirmed superficial blood clot from ankle to knee.
Left leg pain that continued for 10 days with eventual formation of vesicles on leg consistent with VZV infection.
Thrombosed Hemorrhoid (blood clot).  Rapid onset of initial pain. Still experiencing pain.
Toxic synovitis after receiving flu vaccine. Flu vaccine given 01/24/05, started complaining of leg pain on 01/25/05. Seen in doctors office 01/26/05 and 01/27/05. Treated with Ibuprofen.
Pharmacy intern administered 2 prevnar vaccines (one in each arm) instead of 1 RSV vaccine. patient was ok with still getting RSV so he got rsv+prevnar in left arm and prevnar in right arm.
Broke out in a really bad hives and rash. Has lasted over 3 weeks.
This spontaneous report as received from the Nurse Practitioner, for GARDASIL, a Pregnant Registry product, refers to a patient of unknown age. The patient's 26 years old mother received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. At the time of the third dose, the patient's mother was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis" which the nurse practitioner described as a "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality mentioned above with unspecified diagnostic testing, and the Nurse practitioner stated it had not resolved by her check up appointment in January. The mother's report was captured in Marss#1304USA013840. Additional information has been requested.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R010369, expiry date 25-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
FAINTED, LOST CONSCIOUSNESS FOR APOX. 1 MINUTE, REGAINED CONSCIOUSNESS AND RESTED FOR 30 MINUTES AND DRANK SOME ORANGE JUICE AND FULLY RECOVERED.
I just got the second shot but the first was Oct 2019; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   On 28th July 2021, the patient received the 2nd dose of Shingrix. On 28th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient had reported for him/herself. The patient received 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. The patient asked if he/she needed 3rd dose.
Dr. states, "developmental regression, encephalopathy, changes in tone, behavioral regression, oral motor apraxia onset".
Redness, swelling and itching of arm and reactive lymphadenopathy, persistent arm pain lingering months after initial reaction
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 13Feb2021 10:00 (Lot number: EN6201) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart attack in 2019", start date: 2019 (unspecified if ongoing); "asthma" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "obese" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; CLOPIDOGREL; MELOXICAM; METFORMIN ER; PANTOPRAZOLE; SPIRONOLACTONE; LOSARTAN; MONTELUKAST; ATORVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Patient became anxious, felt her throat closing and pressure in her chest.  Pulse rate  increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
Swelling, hives, itching. Still ongoing but in lesser places. I?m on antihistamines for about a week now. Diagnosis: Spontaneous Chronic Urticaria
Abscess to left hip seen by primary care manager and site was I & D with copious amts of pus diagnosed at time with staph infection because patient forgot to mention that smallpox site was approximently 18 inches proximal to site. Patient seen at this clinic for take evaluation of smallpox. Advised to return to PCM and tell them about his smallpox vaccination and proximity to secondary site. Secondary site approximately 15 cm in circumference with approximently 5 cm circumference open with yellow pus moderate amount. Unknown at present for diagnosis but strongly suspicious as an autoinnoculator.
Admitted on with lumbar disc herniation, managed with ESI with IR, discharged on 12/2 after declining rehab but fell trying to get into her home so was readmitted following Fall requiring PT/OT and rehab placement. Course complicated by acute blood loss anemia and upper GI bleed. ED Visits and hospital admissions. These visits were within 6 weeks of receiving the COVID vaccine.
Pt vaccinated with Influenza developed erythematous, warm, raised area localized to site of inject. Resolved w/o significant complications. Low grade fever associated w/event. Treated w/ PO Acetaminophen & Diphenhydramine,Triamcinolone crm
In the afternoon following the second Moderna dose on 3/11/2021 I began to feel extremely tired.  By early evening I had a headache, felt extremely nauseous, and had extreme chills.  I skipped dinner, went to bed but was unable to sleep due to the chills and nausea.  In the morning I still felt slightly nauseous but was able to eat some broth.  I felt better as the day went on and was able to eat a small meal at dinnertime and felt normal by evening. Seven days after my first Moderna dose on 2/6/2021 a rectangular red patch appeared on my left arm just below the injection site.  It was moderately and intermittently itchy. It lasted 5 days and disappeared.  My doctor said it's called "Covid arm".
Chills, extreme body aches, severe headache. At the injection site my arm was very swollen and very painful. The symptoms began overnight on the night of my 2nd dose and lasted for 24 hours.
Moderna: one giant hive on my left shoulder; swelling, redness (approximately 2"x3"); extremely sore; horrible horrible itching; the center of the red spot was hard and hot.  The redness went down my arm to my inner elbow down my forearm to my wrist. The redness going down my arm was not as bad after I took the Allegra.  It was all extremely painful. I had to go see Dr. because the itching was so bad. Dr. prescribed medicine for the swelling/itching.  At times my throat was sore and my face was flushed and I had a tightness in my chest. But that did not last long.
Red Arm; Swelling of the arm; Itching of the arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had been experiencing red arm, swelling and itching of the arm. The reporter consent to follow up
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K005428, expiry date 15-APR-2016 (administration site and root were not reported). No adverse effects were reported. Additional information has been requested.
Pain at the site of the flu injection which increased over the next day. Swelling at the site and up her neck and at her collar bone occurred two days after injection. She was seen at urgent care and given steroids and a muscle relaxer. Symptoms have completely resolved.
Received Hep B & influenza (preservative free) vaccines at approximately 145pm on 9/13/11. Awoke from sleep at approximately 930pm & proceeded to have generalized seizure approximately 5-10 mins duration. 911 called. Paramedics evaluated.
Immediately after my daughter started suffering from daily migraines for 3 months straight, then developed Epstein Barr, been diagnosed with chronic daily headaches. Continues to suffer from severe migraines.
Slight headache, dizziness and sharp to dull pains and left temporal area went on for four days!
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 75-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The following patient had ear pain/earache, onset 2021, with outcome of recovered (2021). Therapeutic measures taken as a result of ear pain included aspirin. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
BODY ACHES; SHAKING CHILLS; FEVER OF 101.4F; HEADACHE; NAUSEA; PAIN/SORENESS AT INJECTION SITE; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced shaking chills. On 12-APR-2021, the subject experienced fever of 101.4f. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced pain/soreness at injection site. Laboratory data included: Body temperature (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking chills, fever of 101.4f, headache, body aches, nausea, and pain/soreness at injection site. This report was non-serious.
When I first got the shot, I felt something warm all the way down my arm like when I had MRI with the contrast. I did have the person who did my vaccine check it out and they said it was fine. Around 6-8 hours later around 4 AM my left arm was hot and it  was red and it felt like I had a bump there. My arm was swollen and hot to  the touch. I called my doctor and he told me to give it a few days and so I did and it didn't go away. Dr told me if it continues go to after hours clinic but to give it a few days and take the tylenol.  It actually started getting worse 3 days later on  01/30/2021  and on the 8th day 02/03/2021 it didn't hurt so much. On the 10th day 02/05/2021 everything was gone. Everything was gone as far as the redness but when I touched the arm it still hurt a little bit but not as much before.
Fever, muscle aches, chills, sweats, nausea, vomiting, fatigue, tight chest, cough, soreness in shoulder (where I got vaccinated). Nausea lasted about 4 hours, fever lasted about 6-7 hours, aches and sweats lasted about 15 hours, fatigue lasted about 40 hours, chest tightness and mild cough lasted 48 hours and sore shoulder is continuing beyond 48 hours but slowly improving with time
Pt devel fever p/HIB/DTP/OPV; this lasted for 3 days followed by a rash when temp went down; this could be roseola that coincided w/immun; there was no f/u because pt did not come back;
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof- other) refers to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
The client reported approximately three hours after receiving the second dose of Pfizer COIVD vaccine she developed onset of "sore throat, headache, hay fever, coughing, chills, and body aches." The client stated she presented to a clinic the next day for evaluation. The client obtained multiple negative COVID test and stated she was diagnosed with pneumonia. The client stated she returned to the clinic once a week to receive evaluation and medications. The medications prescribed to the client at the clinic included Tylenol, "5-6 cough medications," an inhaler, and breathing treatments. The client stated the cough lasted for 3 months and the other symptoms lasted about 30 days. The client denied any history of pneumonia or bronchitis prior to receiving the Pfizer COVID vaccine. The client reported a current history of tumors in her cervix, colon, and breasts that are being monitored. The client reported a history of seasonal allergies currently controlled with an over the counter medication. The client denied any other regular medications. The client reported a history of flu like symptoms that occurred for 3-4 days after receiving an influenza vaccine a few years ago. The client stated her doctor has recommended her to not receive any other influenza vaccines. The doctors that treated her for pneumonia were not able to make a recommendation on whether or not she should receive the COVID vaccine booster.
Fever (102-103, severe arm pain and injection site swelling, dizziness, sore throat, difficulty swallowing, cough, nasal congestion, nausea, constipation,all-over body aches.  Treatment: fluids, advil (multiple, extra-strength dose, rest)
I started getting short of breath about an hour after the vaccine and it has been progressively getting worse since that time.
Patient noticed slight redness/itching at injection site 7 days post vaccination(08/09/2021). 8 days post vaccination(08/10/2021) looked like a bug bite and had redness extending outward onto arm. Morning of day 9(08/11/2021) patient awoke to redness/swelling to large portion of upper arm and shoulder along with vesicular/bullous blisters(approximately 3) in the area if injection site. Patient was observed in the pharmacy the night of 08/11/21 and advised to seek medical attention. last spoke with patient morning of 08/12/21 and she was at a local urgent care to have it looked at.
Miscarriage at 8 weeks of pregnancy, 2/14/21. Tissue passed naturally without medical intervention. Hormone levels dropped without concern. The week prior to miscarriage sharp sporadic headaches (migraine-like but only lasting a few minutes at a time and coming frequently) started, and have continued daily through today (2/22/21)
Pt developed pain in same arm radiating down the arm and up to the neck by the afternoon on the day of the vaccination. The next day she woke up with a red vessicular rash superior to the distal clavicle (ie not at injection site) on same arm consistent with herpes zoster (shingles)
Redness, pain at injection right deltoid. Raised rash from neck to middle of back. Referred to MD immediately.
High temperature; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (High temperature) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature). At the time of the report, PYREXIA (High temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High.     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 medications were provided. The patient got high temperature for half a day. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-719204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719204:Same reporter
Diarrhea for approximately 8 hours was the first symptom. A fever of 100.6 with over all muscle aches, extreme fatigue and no appetitie persisted for 24-36 hrs which began approximately 6-8 hrs after injection. I was told it was a Tetanus shot which I've had before but was not told that it also had the whooping cough virus in it.
hives all over body, intense itching, which still has not subsided 3 1/2 weeks later
4 days post vax, pt experienced a lot of nausea, some vomiting, a headache and dizziness.
A 48year-old female walked back into the clinic 1hr 10 mins at 12:32pm after being vaccinated (Pfizer booster).   Patient complained of lightheadedness, dizziness, and heart-racing.   She admitted she hasn't had anything to eat nor drink for the day and has been working all morning with this being her first experience of such symptoms post-vaccination.  Past Med Hx- Hypothyroidism  Past Surg Hx- Nil Meds- Levothyroxine( took this morning at 4:35 am). Allergy- Nil  Precautions taken : - -the patient was instructed to lay on the yoga mat while her Bp, pulse, and HR were taken.   -the patient was also given water, apple juice, and some snacks.  -Blood pressure, pulse, and heart rate respectively are as follows: *12:15pm was 140/92,116, 97%. *12:20pm was 128/84,102,98%.  *12:28pm was 122/82, 96, 99%. No rigors or chills or dyspnea were noted.  -She admitted to feeling a bit better 10 mins later and insisted on going home. Patient was advised to stay hydrated, get rest and visit the emergency department if she feels worse.  P.S- I got her contact for subsequent checking in.