chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm at injection site (left arm).  Stiff neck, chills, body aches, sleepiness, can't lift arm higher than chest.   Very tired but couldn't sleep. Body aches continue.  Slept as much as possible, but couldn't turn over.  Feeling very depressed the next morning.  Slightly dizzy and sleepy. Somewhat better the next morning, but still not feeling well.  I'm in good health, very fit, bike 6-10 miles a day. Did not contact my doctor.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On 28-MAR-2018, he was inadvertently vaccinated with two doses of PNEUMOVAX 23, less than 6 hours apart. One dose of PNEUMOVAX 23 (specific dose, site and route of administration, lot number and expiration date were not reported) was administered in an unspecified physician's office earlier in the day and an additional dose of PNEUMOVAX 23 one dosage form (DF), intramuscularly, lot number: N030111, expiration date: 21-APR-2019 (specific dose and site of administration were not reported) was administered in a pharmacy later in the day. No adverse effects were reported.
Severe Induration and cellulitis of left thigh spans interior surface 80- 90%. Advil Keflex.
Pt got both H1N1 inj and mist. (Someone at OK health dept adv.)
pt recv vax in ER as result of a wound;pt returned to ER for 2-day wound check;had a bruise @ inj site (1cm in diameter); reporter states practice has had multiple pt complaints that the needles on prefilled syringes are dull;
Given 0.25ml dose as a first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Given 0.25ml dose as a first dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Given 0.25ml dose as a first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Given 0.25ml dose as a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-406059 (Patient Link).
EM reported to emergency department on 3/29 with complaints of abdomianl pain, dirrhea, body aches , fatigue, weakness, hypoxia, headache and shortness of breath Admitted to Hospital 3/29 and discharged 4/1
This case was reported by a physician and described the occurrence of local allergic reaction at injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 10 November 2012 the subject received unspecified dose of FLUARIX (unknown, left arm). On 10 November 2012, immediately after vaccination with FLUARIX, the subject experienced local allergic reaction at injection site. The subject's reaction of redness and swelling was immediate around the injection site and was quite large in diameter, approximately 10 centimeters. The physician did not administer the vaccine, but thought it was FLUARIX. At the time of reporting the local allergic reaction at injection site, swelling injection site and injection site redness were unresolved.
thigh stiffness; pain at the injected arm; mild fever; body aches; body aches; mild fever; This spontaneous case was reported by a physician and describes the occurrence of the first episode of PYREXIA (mild fever), the first episode of PAIN (body aches), MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm) and the second episode of PYREXIA (mild fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced the first episode of PYREXIA (mild fever). On 12-Feb-2021, the patient experienced the first episode of PAIN (body aches), INJECTION SITE PAIN (pain at the injected arm), the second episode of PYREXIA (mild fever) and the second episode of PAIN (body aches). On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (thigh stiffness). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (thigh stiffness), INJECTION SITE PAIN (pain at the injected arm), the last episode of PYREXIA (mild fever) and the last episode of PAIN (body aches) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported.
High fever, severe fatigue unable to get out of bed all day 2/12/2022 beginning on awakening, 14 hours after injections. 2/13/2022 noticed left deltoid redness, swelling, itching, contacting MD on Monday 2/14, 60 hours after the vaccines, with photo of the left arm, showing bright red induration 10 cm in diameter transversely, extending 15 cm distally from center, and 5 cm proximally. Area is poorly demarcated, blotchy, c/w vaccine reaction. No central punctum, papule or drainage. Swelling, erythema spread distally to proximal forearm, not proximally to shoulder, with a blue color in the center 2/15/2022, but with less pain. Erythema, heat, and swelling nearly resolved by 2/22/2022, day 11.
A couple hours after shot, small hives all over face, scalp, neck, some on arms. Some difficulty in breathing. Called family doctor the next morning and was told to take antihistamine which I have been taking since Tuesday.  Helps some but I still have the samll hives and some in difficulty breathing. Have had flu shots in the past and only reaction was a little nausea.
A report has been received from a Physician concerning an 11 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that patient received last year's FLUMIST QUADRIVALENT. The outcome of the event of patient received last year's FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Then 5.5 month old child who had multiple episodes of eye blinking and eye deviation upward. Tightness of the arms and legs with twitching was also reported by the mother. Entire initial event lasted approximately 2 minutes. Cyanosis was also noted during the event. Diagnosed with new onset seizures.
Patient received a Moderna Covid-19 vaccine at our store for her first dose. She said her left arm where she received the vaccine was a little tender. 2-3 days after the injection, she said her arm became swollen, red, hot, slightly itchy but no pain and decided to seek medical treatment. On Jan 27, 2021 she had a Zoom telemedicine appointment where the prescriber assessed that she had cellulitis and prescribed a 10-day course of cephalexin. She said she has had cellulitis from a vaccine before 20 years ago when she received either her flu or pneumococcal vaccine. As of 2/6/2021, she said the redness is 95% resolved with only faint redness. She said the vaccine administrator swabbed her arm with alcohol but then injected the vaccine outside of the range that she cleaned.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received SHINGRIX. On 11th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th January 2018, immediately after receiving SHINGRIX, the experienced decreased appetite and injection site pain. On 12th January 2018, the patient experienced fatigue, upset stomach, fever and headache. On an unknown date, the outcome of the fatigue, upset stomach, decreased appetite, injection site pain, fever, and headache were recovered/resolved. The reporter considered the fatigue, upset stomach, decreased appetite, injection site pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event on SHINGRIX injection. The patient requested to remain anonymous and offered limited information pertaining to the adverse event. The patient stated she received a SHINRIX injection on 11th January 2018 at a local pharmacy. She stated immediately after the injection, she had localized pain at the injection site and decrease hunger. She stated the next day after the injection she had severe fatigue, headache, fever and upset stomach. The patient stated since the reaction happened in January, she was not sure how long it lasted. She did not have the lot number or expiration. The patient requested information about what adverse reactions to expect from the second shot in the series. The agent referred the caller to the SHINGRIX website and PI. The agent instructed the caller to contact her health care professional with medical issues. The patient denied receiving additional vaccines at the time of the SHINGRIX vaccine or within 4 weeks. The patient has denied permission to contact their physician.
difficulty concentrating; developed acute, progressive confusion; brain fog; agitation; This is a spontaneous report from a contactable physician. A 95-years-old non pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 04Feb2021 12:00 (age at the vaccination 95-year-old) as dose 2, single for COVID-19 immunization (Nursing Home/Senior Living Facility). The patient medical history was not reported and no prior history of dementia, living alone. Patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) intramuscular route of administration, administered in arm left on 14Jan2021 12:00 as dose 1, single. On 05Feb2021 12:00, the patient had experienced within 24 hours developed acute, progressive confusion- no focal neurologic findings - no fever and stated something happened to me and was aware of her confusion, agitation, difficulty concentrating, knew where she was but did not feel it was the right place, new people and personal information - sx similar to that de-scribed in covid brain fog after infection. The patient underwent lab tests and procedures which included medical workup as normal, sars-cov-2 test as negative on has had multiple negative covid tests in past on unspecified date. The patient did not receive treatment for the adverse event. No other vaccine in four weeks. Ae resulted in: Doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and unknown if covid tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Patient received first dose in error as was only 17 at time of vaccination. Moderna is only currently licensed for 18 and up. This was discovered when she came in for second dose.
having a total knee surgery redone; the nerve blocked it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (medically significant), outcome "unknown", described as "having a total knee surgery redone"; NERVE BLOCK (non-serious), outcome "unknown", described as "the nerve blocked it.". Therapeutic measures were taken as a result of arthropathy. Clinical course: patient said that she just came home from having a total knee surgery redone and the nerve blocked it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA Redness & tenderness to the touch at the vaccine site 8 days after vaccination - that's the date I filled out on the first part of the form. Not sure if this is related - but I also had chest tightness on days 4-6 after vaccination.
Slight fever (99.2) 24 hours after vaccine,     chills off and on for 3-4 days,       2 migraines so far (lasting at least 24 hours each),     and presently, I have had this same headache that either gets worse or just stays as is (pain at a 4 or 5) and will not go away no matter what I do.       I'm also having nightmares and seeing shadows.
The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending.
Right calf pain with leg swelling and heaviness over a couple of days then right medial calf pain with what appeared to be a bruise the size of my fist and a small central painful lump. Urgent Care appt.  US done and found a medial distal thigh venous clot.  started Aspirin 325mg once daily. On day 4 of taking this medication, my right leg completely resolved of the swelling and heaviness and the "bruise" completely resolved without any discoloration.  This makes me think the "bruise" was engorged capillary vessels that were not flowing due to the clot.
Pt reports L Arm pain beginning immediately following vaccine administration on 4/4/18. Later that evening she reports L Arm swelling, redness, heat, pain extending from shoulder to elbow. Pt states she immobilized her limb, used ice, and took ADVIL to alleviate the pain. The pain lasted for approx. 3 days, subsiding on Saturday 3/7/18.
My wife already had COVID-19 and started PAXLOVID on Tuesday. Wednesday night, I had two degrees above my normal temperature and I had my usual upper respiratory like symptoms. I called the next day for a doctor and was given PAXLOVID. My rhinorrhea increased and I had a terrible taste in my mouth. Everything resolved over time. I never had significant symptoms. I have been uncomfortable with nasal congestion and cough, but that's about it. No difficulties with oxygen, breathing, or cardiac issues. I had tested negative the day my wife tested positive for COVID-19. When symptoms began, I did not retest because I had been in close proximity to my wife, and we knew it was already COVID-19.
Moderna COVID-19 Vaccine EUA     - [ ] Lymph nodes soreness     - [ ] Large knot in left shoulder, progressively more sore each hour     - [ ] Tightness in chest     - [ ] Tight jaw     - [ ] Teeth aching, left side of face, lower jaw     - [ ] Slight nausea     - [ ] Slightly tired (but did play men?s night)
ONSET OF VOMITING & DIARRHEA P/ NASAL MIST #2.  FATHER CALLED PHD ON 11/20.  STATED SIMILAR REACTION P/ 1ST DOSE ON 10/23/09 RESULTING IN ER VISIT AND $1500 EXPENSES/PER FATHER.  AFTER 1ST DOSE HAD NAUSEA & VOMITING AND CONSTIPATION WITH IMPACTION.
He had Covid and turned negative; He had Covid and turned negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "He had Covid and turned negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Negative, notes: he had COVID and tested negative on 17Aug2022.  Clinical information: He had Covid and turned negative last August 17. He is asking if they should get the new Bivalent vaccine right away or should they wait for a while since he read in the CDC website that they can get it right away but may also wait for 3 months so he is asking what's the better thing. (Name withheld): Successful Sync Transfer. Caller is a patient that states he had COVID and tested negative on 17Aug2022. Caller requests information on when he may get the new Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older if right away or within 3 months after having COVID according to the CDC's recommendations. Caller stated he had completed his primary vaccination series and two boosters of an mRNA vaccine. It was not clarified with caller whether these vaccines were the Pfizer-BioNTech COVID-19 vaccine or other mRNA vaccines. Caller could not be referred to HCP as when above information was provided to caller, caller declined to receive any additional information and stated: "I won't waste any more of your time."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a female child with no past medical history, who on 11/05/98 was vaccinated with Varivax. There was no concomitant medications. The child subsequently developed varicella, It was reported that the child's symptoms began on 12/27/01. The symptoms were described as a generalized rash, not severe, and required only comfort treatment. Per a letter from the child's school, it was reported that the child had been exposed to children with varicella at school and had close contact with some of them. Unspecified medical attention was sought. At the time of this report, the outcome of the varicella was unknown. Additional information has been requested.
Severe fever, chills, aches, pain, headache  This was the booster. I had a one week reaction to the second vaccine in March 2021.
Shortness of breath, swelling at injection site & in upper right arm, congestion (nasal), lost sense of smell, runny nose, dizziness, lightheadedness. All of the above symptoms occurred around 5:00 pm - patient recovered that night & reported to her physician the following day. No treatment received.
I got the vaccine on the 20th 3 days later I was feverish I had body aches, and sweating profusely and I was very tired. On the 27th I went to the Dr and they gave me fluids and medication  but that didn't help and I gradually started feeling better 2nd dose - EL3248 9am January 9th, 2021 - I felt good the first day and the second day I started feeling lower half body aches loss of sleep achey no fever
I started experiencing chills and body aches approximately 12 hours after getting the injection.  I took my temperature (it was 99) and an Aleve. After the first 24 hours, my breathing became more shallow, and I had an increased hunger to add to the body aches.  I felt as if I had the flu.   At 36 hours after injection, I started having a head ache that caused me to be dizzy upon standing. I am making this report 46 hours after and I still have a slight headache and some nausea/excess saliva.
Several pts who had a series of 3 Engerix-B vaxs were seronegative/non-responders; rx: "unknown";
shingles after getting first dose, in throat; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number Y7D4B, expiry date 31st August 2023) for prophylaxis.   On 9th September 2022, the patient received the 1st dose of Shingrix. On 9th September 2022, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 26-SEP-2022 Reporters comment:  The patient received the first dose of shingrix and experienced shingles. His symptoms started the same day. He had lab work on 21st September 2022 and confirmed shingles in his throat, and his symptoms were improving. The reporter would like to know if patient should have second dose and if so when should it be given. The reporter had not heard since then. The reporter consented to follow-up via postal.
beginning 3 days after 2nd dose, the patient began experiencing fevers. Fevers occurred almost every day, often accompanied with headache and/or nausea. This continued for 6 weeks, at which point patient saw their primary care physician who prescribed a course of Prednisone for 9 days. Patient fully recovered following this treatment.
Developed sore arm and fever 100-101F by 2AM 1-4-2021.  Resting heart rate increased to 90-136 beats per minute (usual resting heart rate 60-65 beats per minute) by 6AM.
no other adverse events; nurse called to report a temperature excursion on Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) 1 time dose, lot # T035408, expiration date 14-APR-2022 for prophylaxis (exact dose, dose #, route and anatomical location were not provided). The temperature excursion was 8.258 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was involved. No signs or symptoms were reported. No other adverse events reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2106USA005098:
Swollen lymph nodes both armpits, spreading redness, itchy rash around injection site
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/09/21 2nd dose02/06/21 Diagnosed covid positive: Symptom onset:07/23/21 Exposure:community Symptoms:Asymptomatic
Fore arms were very itchy - both right and left Large hives on right cheek -facial and left jawline