chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It hurt to move it; i missed work; swelling in myleft arm; It hurt to move it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.    The patient's past medical history included Eosinophilic pneumonia chronic.   In May 2021, the patient started TOFACITINIB CITRATE (XELJANZ) (Oral) 5 milligram twice a day. In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work). At the time of the report, VACCINATION SITE SWELLING (swelling in myleft arm), VACCINATION SITE PAIN (It hurt to move it), VACCINATION SITE MOVEMENT IMPAIRMENT (It hurt to move it) and IMPAIRED WORK ABILITY (i missed work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  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.
reported at time: sore arm, headache, head fog - resolved within a week of injection  Did not report b/c thought unrelated: Did not have periods because of IUD but had a heavy period after second shot and different consistency than normal. Am continuing to have periods, blood looks fresher (more red) and mucousy which is not normal for me.
I had a hemorrhagic stroke beginning on 10/20/2022. I also had a hematoma in my brain that was discovered early 2023.
Pt. has had right shoulder pain following vaccination (Possible SIRVA).  Pt. has reported that she went to urgent care for treatment and was prescribed anti-inflammatories and recommended to get 2 weeks of physical therapy.  No physical therapy treatment has occured  as of 12/20/21.  Pt. also reported limited range of motion in her right arm and the need to sleep in a recliner to minimize pain.
Joint swelling and pain, itching. Tylenol and rest. Day 2 now.
13 cm by 10 3/4 cm swelling and induration left upper arm.
Exacerbation of Myasthenia Gravis.  Onset of significant shortness of breath and increased weakness resulting in hospitalization and added therapies.  (MG symptoms had been increasing gradually for months,)
Headache, Myalgia, Fever, CHILLS., FATIGUE Narrative:
2 large welts on back of her r/arm. Red with increased swelling/pain. Thurs pt had 2.5 x 4 inch red patch on back of arm. Went to Dr on 11/3/2011.
Quarter size swelling at injection sites. Ice pack to injection sites, and ibuprofen to help with any pain or swelling.
Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches; chills; fever; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL3247) at the age of 40 years as dose 2, single and administration date 04Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Covid Ag test positive/ due to exposure on 25Dec2021 family event CC chills fever body aches"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 26Dec2021, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive; (30Dec2021) positive. Clinical course: The events did not Result in death, Life threatening, hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. It did not know if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
pain in left arm at site has perisited unchanged until 11/17 despite treatment of heat and aleve
Pt developed redness at site of inj 2 days after inj. Then day 3 redness larger warm to touch.
Information has been received from a female consumer who on 10/27/04 (also reported as 11/27/04) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). The patient reported that 15 hours post vaccination, on 10/28/04, she was admitted to the hospital with PVCs. She was put on a heart monitor and underwent a stress test the next day. She was discharged from the hospital on 10/29/04. She continued to have PVC's for two weeks later. She had been under the care of her physician, and the PVCs had decreased without medication. She stated that she had never experienced this problem before. The patient also indicated that it had been brought to my attention that the PVC's have been a reaction of the vaccine. Additional information has been requested. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
2 stroke, on both sides of the brain; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced 2 stroke, on both sides of the brain (cerebrovascular accident) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
April 25th  emergency Droopy Eye, Chin, blurred vision and speech..  Diagnosed with Bells Palsey  Need script for O.T and P.T.. Speech and eye. Cat Scan, Blood Work  Nuerologist, complete work up. Seeing Dr.  eye ulcered, blurred vision slurred speech.. Seeing M.D. Today April 28th.
Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swollen lymph nodes. The reaction occurred 7days after the first dose and the next day after the 2nd dose. While the armpit started to feel better before the 2nd dose I wouldn't say symptoms resolved before the 2nd shot.
Patient discharged after (3) days inpatient stay 11/12-11/15/2021  PT is a 45-year-old woman with past medical history significant for prior pulmonary embolism 2 years ago not currently on anticoagulation, hypertension, GERD, morbid obesity presenting with worsening respiratory symptoms. Found to be COVID positive and desatting with ambulation. Has not required O2 at rest. Started on dexamethasone. Received regeron on 11/13/21. Symptoms improved but still with notable conversational dyspnea thus CTA ordered on 11/14. CTA neg for PE   11/15 Pt S+E. Alert.Room air and stable at discharge In agreement with verbal isntructions totake meds as directed. Follow covid recs. F/U with PCP
Pain around injection site (left arm deltoid muscle) then intense pain when attempting to move or raise arm above shoulder. Applied warm compress. Pain still  persists > 1 month later.
3rd dose of 5-11 year old COVID Pfizer Monovalent was administered to the pt when pt should have received the 5-11 year old COVID Pfizer Bivalent booster dose
On a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2; This is a spontaneous report from a contactable consumer.  This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EE3247), via an unknown route, on 23Jan2021 (at 11:20) at a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. Relevant concomitant medications included amlodipine. The patient stated, 'on a scale of 1-10, 10 being the greatest, I had a little slight, may be like a little slight headache like I will give that a 2' that night, the night I had got the injection". The outcome of the event was unknown.
ringing in her ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (ringing in her ear). At the time of the report, TINNITUS (ringing in her ear) outcome was unknown.            No concomitant drugs and treatment medications were reported.   This case was linked to MOD-2021-225542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Followup received contains  :-No  new information On 03-Aug-2021: Follow up received contains:- Updated reporter contact information, reporter email addressed.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD with lot # M001150 and expiration date: 05-JUL-2017; lot# M019233 and expiration date: 17-OCT-2017; strength, dosage and route unspecified. Temperature/time frame was 5.5 Fahrenheit (F) for 4 hours, 45 minutes. There was no previous excursions. No data logger involved. No adverse effects reported. No product quality complaint was involved. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
A physician reported that an 18 month old child received an injection of Acel-Immune on 5/15/00. The next day (24 hrs), the child developed an injection site reaction characterized by an area of redness, swelling, and warmth measuring approximately 7cm in diameter. The child recovered.
I got the shot and I still have them/suspected vaccination failure; I still have them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot and I still have them/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still have them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shot and still had them, might be every two months for two weeks at a time. The patient stated that it sucks. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
18 days after Covid Vaccine Dose 1, patient started to present with symptoms of a frontal lobe migraine along with nausea, dizziness, and L Sided Weakness. As time continued to pass while en route to local hospital, patient began to stutter harshly, saying every other word in a sentence, complained of a stiff jaw, and began to panic.
injection site red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red patch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red patch). At the time of the report, VACCINATION SITE ERYTHEMA (injection site red patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Moderna spike voh 202F23A - fever, shaking uncontrollably for over 2 hours, then sporadic. Achy and joints hurt.
Patient received the Pfizer vaccine on 3/31/21 and 4/21/21 so was fully vaccinated when they tested positive for COVID-19 on 9/23/21.
Big redness on upper arm (site of injection), warmness painful. Pt. took TYLENOL and did ice pack on.
CAN RESULT IN EXCESSIVE LOCAL OR SYSTEMIC CONCENTRATION OF ANTIGEN OR OTHER VACCINE CONSTITUENT.
Began to have shingles-like syndrome on 3rd day following shot.  Series of 8 red spots radiating in a line outward from the spine on left side of back below the should blade and extending about 3 inches.  Today the red spots seemed to have combined into 4 larger red spots.  The area is very tender and hurts when leaning against anything.
Spell of fainting or convulsive syncope resulting in dislocation of left shoulder and fracture of humoral right head. Seeing neurologist but recommended by internal medicine doctor to report event as it is possible it contributed or caused the episode.
Two days after the shot: Back pain, joint pain (knees, hips, shoulders... everything), lethargy, muscle weakness. I couldn?t hold a plank for 10 seconds. I?m a very active, athletic  person. 4 weeks later, still aching and fatigued to the point that my Dr suggested I don?t get the second shot. Family is all WFH, kids elearning, no exposure to other illnesses. My back and hips still hurt and I still have muscle fatigue.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
PATIENT RECEIVED 0.2ML DOSE AT 12 YEARS OLD. SHOULD HAVE RECEIVED 0.3ML DOSE. PER CDC, DOSE DOESN'T HAVE TO BE REPEATED.
I had severe chest pain, almost like I was getting stabbed. It lasted 4 min. After that I would get it every other day. The pain was in the center of my chest, this lasted till the month of May, so for about a month. At the end of May I went to the doctor because the pain was still there and they did a stress test and some other testing but they couldn't find anything. I went back for a follow-up in June 2021 but it had stopped by then. I haven't had any pain since last summer, it was more like a one month thing.
The pt developed swelling at the site of the injection, including elbow and shoulder. No pain or redness in left arm.
Approx 2 hrs p/vax pt started crying - cried approx 5 hrs later - she was seen by ER MD - given Tylenol w/cod.
PT HAD KNOT ON ARM THAT WAS HOT TO THE TOUCH AS WELL AS REPIRATORY ILLNESS THAT LASTED APPROXIMATELY A WEEK
Patient reports soreness and redness around injection site started on 3/4/21 . Also patient reports the development of a painful red area on her back that started on 3/6/21. As of 3/9/21, arm is no longer sore but painful area on back is still present and she will see her primary care doctor tomorrow.
Child received FLUMIST on 10/2/10 at office flu clinic. Seen on 10/19/10 for 30-month-well child exam. Parents stated child has been stuttering for past 2 weeks ever since receiving FLUMIST. Questioned if FLUMIST was the cause. To be evaluated by speech therapist. Most likely developmental. If no improvement, evaluation by Pediatric neurologist.
PT CALLED IN AND ADVISED SHE FELT SHE REACTED TO ONE OF THE INJECTIONS, CLAIMING LEGS ACHING, GENERAL WEAKNESS, AND HEADACHE
Chills - severe, mild headache, body aches, high heart rate (124 resting rate) began at 9 hours post injection. Took Tylenol to reduce body ache and chills. Took 5 mg diazepam to lower heart rate. Still chills and body ache at 30 hours post-injection Heart rate has returned to normal range
chest (below throat) began feeling raw/inflammed; I began  having intense hot flashes at about 45 mins post injection; Immediate unusual scent/vaccine was a medical scent; my eyes became thicker/puffy; my nose was completely congested; This is a spontaneous report from a contactable consumer. A 62-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiry date: Unknown, age at vaccination: 62 years) via an unspecified route of administration, administered in Arm Left on 12Mar2021 18:15 as dose 1, single for COVID-19 immunisation administered in Pharmacy or Drug Store. Medical history included drug hypersensitivity. The patient had known allergies to NegGram and Sulfa. The patient previously took pneumovax and experienced dysgeusia. Historical vaccines includes Flu vaccine and experienced a metal taste. Concomitant medication in 2 weeks included ibuprofen 800 mg. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. On 12Mar2021 18:15, the patient experienced immediate unusual scent/vaccine was a medical scent, her eyes became thicker/puffy, her nose was completely congested and chest (below throat) began feeling raw/inflammed, she began having intense hot flashes at about 45 mins post injection. Everything went away after 3 hours. No treatment was taken as a result of events. The outcome of the event were recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
unconscious; seizure; stopped breathing; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 10:30 (Lot number: 330368D) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0169, Location of injection: Arm Right), administration date: 29Apr2021, when the patient was 16 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Right), administration date: 04Apr2021, when the patient was 16 years old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "unconscious"; SEIZURE (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "seizure"; APNOEA (medically significant) with onset 02Jan2022 10:45, outcome "unknown", described as "stopped breathing"; IMMUNISATION (medically significant) with onset 02Jan2022, outcome "unknown", described as "booster". The events "unconscious", "seizure", "stopped breathing" and "booster" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: normal. Therapeutic measures were taken as a result of loss of consciousness, seizure, apnoea, immunisation. Additional Information:  No other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not covid tested post vaccination. No Known allergies.  During 15-minute wait period after receiving third vaccine Patient experienced events. Emergency medical service responded. He has never before had a seizure or passed out. EEG scheduled for tomorrow (unspecified date).
Dizziness, Myalgia, ErythemaMultiform, Chills, Fatigue, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
hasn't received the second dose in the series from Moderna's COVID-19 vaccine; 99 days have passed since first dose given in the series; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL XL) and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received the second dose in the series from Moderna's COVID-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (99 days have passed since first dose given in the series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.