chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developing a headache; having general malaise; stomach discomfort; feeling sleeping / taking two naps; discomfort sleeping on left side due to sore arm; the injection was painful; noticing arm was sore and took Advil / arm is still sore; soreness in arm began to creep up neck; soreness in arm / extend down to wrist; still feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced neck pain, wrist pain and feeling bad. On 29th August 2020, the patient experienced injection site pain and pain in arm. On 30th August 2020, the patient experienced headache, general malaise, stomach discomfort, sleepiness and difficulty sleeping. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad were unknown and the outcome of the pain in arm and general malaise were not recovered/not resolved and the outcome of the headache and stomach discomfort were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, general malaise, stomach discomfort, sleepiness, difficulty sleeping, neck pain, wrist pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and the injection was painful.  The reported stated that cutting grass and noticing arm was sore and took Advil.  The patient developed a headache, having general malaise, stomach discomfort, feeling sleeping and taking two naps, and discomfort sleeping on left side due to sore arm. The soreness in arm began to creep up neck and extend down to wrist and wondered the soreness was not as localized.  The arm was still sore, but overall feeling a little bit better so far and not headache currently but she still feels off.  The patient had not eaten breakfast yet, so stomach discomfort not present yet. The reporter did not consent to HCP follow up.
Started to feel very dizzy about 3 hours after vaccination. Also felt some nausea and overall head felt very off. Very lethargic and spent many hours sleeping because of the extreme lethargy and woke up a few hours later, still experiencing some dizziness but not as severe as earlier. Also have mild headache but I chronically suffer from migraines so that is nothing out of the ordinary for me. Took one meclizine and two Tylenol after onset of symptoms. Symptoms are tolerable at this time, they were more debilitating earlier. I am still experiencing them now at 6:30 pm.
Left arm became hot and swollen 3 inches above and below the injection site. Moderate itching and swelling worsened over course of days.  Swelling lasted for over 3 weeks. Several upper respiratory infections over next months and extended fatigue.
Diagnosed with covid 19 and only had mild symptoms for covid-19 on 24 Aug2021. It started with sinus, loss of sense of taste and smell.
Employee developed a hot, burning sensation and an area of erythema on left jaw line and neck, measuring 2 1/2 " x 4" within one hour of having FluMist administered. Complained of itch. No breathing difficulties. Used Benadryl Cream and cool compress. Erythema resolving after 24 hours. Had Flumist in 2006, without problems.
Moderna COVID vaccine #3 given 12/9/21, lot #058H21A; pt had a positive COVID test on 3/23/22 at Care and Rehab Center; on supplemental O2; pt passed away in the facility on 4/2/22
Dyspnea; Migraine; More headache; Diarrhea; diagnosed with dyspnea, which stops breathing; Left side started hurting really bad/pain; This is a spontaneous report from a contactable consumer (patient).   A 42-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Sep2021, at the age of 42-years-old, (Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included anaemia and border line diabetic. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 450mg. After taking the 1st vaccine, patient stated that the left side started hurting really bad/pain and she had diarrhea from it, but the pain lasted about 7 days. She thought it was gone, the patient asked what does she have to do to getting stop hurting. The patient had been diagnosed with dyspnea, which stops breathing something like asthma and she had more issue in her breath. The patient also had migraine. She stated that she think have more headache now. The outcome of the event left side started hurting really bad/pain was recovered after about 7 days; the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sore arm; achy all over; little temperature; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number and Expiry date not reported) as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown, achy all over on an unspecified date with outcome of unknown, and little temperature on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: little temperature on an unspecified date. The events were reported as non-serious.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
no adverse event; a patient was administered ROTATEQ that had undergone a temperature excursion; This spontaneous report was received from a nurse, referring to 10-weeka-old female patient. The patients' historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 17-AUG-2021, the patients was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# 1742470, expiration date 16-MAR-2022, for prophylaxis (strength, dose, frequencywere not reported). No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA007324: US-009507513-2108USA007014:
Irregular/excessive menstrual bleeding from 4/21/21-5/30/21. Bled about 21/31 days that month. Monitored and resolved without treatment
Severe increase in activity of rheumatoid arthritis symptoms: arthralgia, swelling, and fatigue within week of vaccination. Symptoms have decreased in severity following aggressive medication treatment but are persisting through 7 months post-dose. Disease was previously well controlled for approximately 5 years.
This spontaneos report as received from a licensed practical nurse refers to a 13 month old female patient. On 11-APR-2013, the patient was vaccinated with improperly stored (Merck) PROQUAD (lot # H020137, expiry date, route and dose were not reported) tht was exposed to refrigerator temperatures not greater than 46F for 30 days (720 hours). The reporter stated that the patient was mistaenly administered (Merck) PROQUAD instead of M-M-R II. The patient also received a first dose of (Merck) VARIVAX (Lot number, expiry date, route and dose were not reported) on this same day. No adverse symptoms reported. Additional information has been requested.
Lymphadenopathy to left arm pit. Fever, chills, sweats, muscle pain, and a lot of fatigue. Was unable to work as had great deal of pain in arm pit it was like baseball swollen in size.
The signs started with light headiness, fatigue, unbalanced after walking a block. Felt like I was going to pass out. Next it was headaches and they got worst and felt like some one was pounding something in my head. Ear pressure with headaches and the next to unbearable is the feeling like my body is moving and I am not moving.  A wave  sensation that comes and goes almost like I am not in control of what's going on in my brain.  My blood pressure started to dropped for a week down to 105/68 daily. I went to emergency room because of pain in left arm. At times I feel things in my brain like moving around. I don't know how to explain it but it's scary. I have been to a previous Dr for help but lots of test no results.  I am not seeing Dr, had a balanced test done it came back very good. I will see a Neurologist on 7/13 to see if she can help. Please help me!!
sicker; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sicker (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Pump up the vitamin C and fluids.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Started itching quite a bit; local swelling; little red; little hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (little red), VACCINATION SITE WARMTH (little hot to touch), VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (little red) and VACCINATION SITE WARMTH (little hot to touch). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling). At the time of the report, INJECTION SITE ERYTHEMA (little red), VACCINATION SITE WARMTH (little hot to touch), VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling) outcome was unknown. Related      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.   Concomitant medications were not reported.    Reporter did not allow further contact
Came to ER with complaint of generalized weakness and diarrhea. Fell at home from weakness
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult female patient with use of Adalimumab (Humira) for chronic plaque psoriasis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. SARS-CoV-2 test was positive on an unknown date. No information on any other doses of COVID-19 vaccination was provided. Adalimumab is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with use of Adalimumab (Humira) for chronic plaque psoriasis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of event onset were not provided. SARS-CoV-2 test was positive on an unknown date. No information on any other doses of COVID-19 vaccination was provided. Adalimumab is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 15-OCT-2015 the patent was vaccinated with a dose of GARDASIL 9 (lot# L001312, expiration date: 24-FEB-2017, route and dose were unknown). Then on 14-DEC-2015, the patient received a dose of GARDASIL (lot # K023432, expiration date: 18-JUN-2016, route and dose were unknown). This was outside the recommendations per the prescribing information for both products. No adverse effects were reported. Additional information has been requested.
MY BROTHER AT THE AGE OF 44 PASSED AWAY FROM BLOOD CLOTS THAT TRAVELED FROM HIS LEGS TO HIS LUNGS.
Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1317402) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 51-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.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE and FISH OIL for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Computerised tomogram: negative Negative. On 27-Apr-2021, Electrocardiogram: normal normal. On 27-Apr-2021, Heart rate: 160 beats per minute.. On 27-Apr-2021, Toxicologic test: negative (Negative) Diagnosis vasovagal syncope and atrial fibrillation.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Magnetic resonance imaging head and Magnetic resonance imaging heart test was done 27-APR-2021.  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
Pharmacy intern accidentally administered an expired COVID-19 vaccine. We believe it is Moderna dose drawn out a few days 4 days prior, but we are not absolutely sure. Patient reported redness at the injection site and sore arm.
Patient reported a generalized headache minutes after receiving the vaccine. Became diaphoretic, pale, nauseated immediately.  Assisted him to a cot to lie down.  Pulse weak and thready. B/P 90/60. HR=42. Resps=20.  Pt. disoriented, lips slightly cyanotic. FSBS = 156. Pt. stated he had taken his insulin today and eaten prior to arrival.   Continued observation for 15 min with vital signs improved but profuse diaphoresis continued. Denied SOA, O2 sats 99% on RA . Denied chest pain.  Considering the history and ongoing symptoms, he desired to be evaluated. EMS notified and he was transferred to their care.
Client stated she felt "funny/flushed". Client denied nausea, dizziness, weakness or breathing difficulty. At 15:42, client self-administered 50mg Benadryl po. At 16:00, BP was 120/70; pulse 80 and client stated she still felt "funny". At 16:45, client stated she felt "fine", no longer "flushed" or any other symptoms. Client stated the injection site was "sore". Ice pack applied X 30 minutes. At 17:20, BP was 110/70, pulse 80, no further complaints. Client left clinic without assistance. On 2/13/02, client saw PCP and had no further treatment needed, no tests done and she stated injection site still "sore" but no redness, swelling or warmth to the site.
pt recvd vax & w/in 24 hrs of vax pt exp a local rxn which included induration, swelling & edema;rxn measured 5cm x 3cm;arm very painful;cellulitis r/o;no treatment initiated
On 9/9/2021 (7 days after 2nd dose) started experiencing "pins and needles" numbness in hands and feet. Told to monitor to ensure wasn't extending up arms and legs. Progressively worsened and started going slightly higher over next few weeks. Saw primary care doctor on November 1, 2021. Neurologist appointment on November 18, 2021 (ordered brain and spine MRIs).
Patient came in on 08/25/17 and reported soreness of the arm. Arm had redness, some swelling around the injection site. She reported body aches and headache and also reported that she was having trouble going to sleep. She was asked to take TYLENOL and see her doctor if symptoms do not improve. Tried to reach her today to check on her and unable to reach her.
swollen lymph nodes under arms and under chin, terrible headache, nauseous - started about 3 days after the shot.   still feeling ill on day 4 but better  did not go to the doctor, stayed in bed all day Wednesday.
DRY COUGH; BODY HURTING /PAINFUL; PAINFUL MUSCLES; FEELING BAD; LITTLE BIT LAZY; This spontaneous report received from a patient concerned a 35 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, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced feeling bad. On 11-APR-2021, the subject experienced little bit lazy. On 16-APR-2021, the subject experienced dry cough. On 16-APR-2021, the subject experienced body hurting /painful. On 16-APR-2021, the subject experienced painful muscles. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling bad, and little bit lazy on 13-APR-2021, and had not recovered from body hurting /painful, painful muscles, and dry cough. This report was non-serious.
April 7th, 2023. Vaccine administered at incorrect time. No adverse events. Notified patient and patient has no side effects.
Post vax, the pt developed a raspy cough, rhinorrhea, coryza, purulent eye discharge, aches, chills, and fever.
Nerve irritation between C6 and C7, numbness and pain throughout left arm and hand; treated with physical therapy and muscle relaxants; pain and limited arm/hand functionality greatly improved after 2 months but not fully resolved.
Donor felt lightheaded, nauseous and dizzy about 15 minutes after receiving 2nd Hep B shot.
Rash/hives developed on both twins;  location included front chest & back;  there was also a group of red bumps surrounding near the injection site on thigh.
No additional Adverse Events reported; MMR II was administered to a patient today 8/25/2022. Product expired 8/18/2022.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-AUG-2022, the patient received an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T027935 with expiration date 18-AUG-2022 (dose frequency and route of administration were not reported) (Expired product administered), diluted in sterile diluent. The product and the sterile diluent were stored according to prescribing information through the date of administration. No additional adverse event reported (No adverse event).
1) 6/10/02-swelling at site of injection-resolved. 2) 7/8/02-onset of illness subsequently diagnosed as Guillain Barre syndrome, Miller Fisher variant. Recovering undergoing rehabilitation. Per 60 day follow up letter: It is unknown if pt recovered from adverse event. States no longer pt at the practice as of 10/15/2002  partial recovery.
It goes on and on, and on.. it's happening everywhere, and is NOT normal Influenza; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves a 19 years old and unknown gender patient who mentioned that it goes on and on, and on.. it's happening everywhere, and is not normal influenza while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed mentioned it goes on and on, and on.. it's happening everywhere, and is not normal influenza (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (It goes on and on, and on.. it's happening everywhere, and is NOT normal Influenza).  At time of reporting, the outcome was Unknown for the event it goes on and on, and on.. it's happening everywhere, and is not normal influenza.