chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen wrists; swollen feet; edema; possible myositis; This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet), OEDEMA (edema) and MYOSITIS (possible myositis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet) and OEDEMA (edema). In April 2021, the patient experienced MYOSITIS (possible myositis). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet), OEDEMA (edema) and MYOSITIS (possible myositis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood creatine phosphokinase: elevated level (High) elevated level.         Concomitant product use was not provided by the reporter.  The patient is currently seeing a Rheumatologist and has had a muscle biopsy to get a conclusive diagnosis, however the results were not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
About an hour after he got the shot on Wednesday 9/20/17 (around 9:15pm- got shot around 8:10pm ) when he went to leave the store and drive home, he said he felt like he was a little dizzy, his vision was "kind of blurry", and felt almost like his tongue felt like swollen. Said when he got home he took some Benadryl and felt fine after that. Said he wasn't sure if it was even related to the vaccine, but I thought it best to report it just in case. He needed no further treatment. He reported this 2 days later 9/22/17 to me at the store via a phone call.
hearing loss; Bell's Palsy; dental issues; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.   The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 09-AUG-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered left facial weakness and numbness and was diagnosed with acute Bell's Palsy. Plaintiff also suffered hearing loss and dental issues as a result of his suffering Bell's Palsy.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  Upon internal review, Bell's Palsy and hearing loss were considered a medically significant event.
Allergic type reaction, extremely itchy nostrils and eyes, day 3-8 sinus drainage/nausea, day 5 earache, sore throat - wondered would I live to see day 6. Still SOME sinus drainage and allergy nose and eye allergy symptoms 22 days after shot.
Pruritus, redness, dermatographia, warmth, swelling, tenderness at injection site.
Adverse effect of vaccine, initial encounter, Moderna 3/23.  Few minutes after developed throat/ear itching, chest flushing  No other sx  Monitored for total of 30 min  3/24: flushing has resolved, mild throat itching, no other new sx  Had similar reaction with vancomycin and contrast in the past
Information has been received from a physician concerning a female patient who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient developed localized cellulitis at the injection site and swelling in the arm. Unspecified medical attention was sought. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Dysautonomia; POTS Syndrome; This is a spontaneous report from a contactable pharmacist (patient's sister-in-law). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiration dates were not provided), via an unspecified route of administration on an unspecified date at 1st dose, single dose and via an unspecified route of administration on an unspecified date at 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of Pfizer COVID-19 vaccine. She had mild but prolonged symptoms after the first dose, and she had similar symptoms after the second dose but was more severe and was not resolving. She has seen and consulted medical professionals and may be diagnosed with dysautonomia and POTS syndrome on an unspecified date which the pharmacist mentioned they have seen to be reported as a complication from the COVID-19 disease, but not with the vaccine per se. Dysautonomia was described as very rare and serious. She has been bedridden for six weeks. The patient was perfectly normal and healthy before she was vaccinated. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The patient was 53-year-old female, and postural orthostatic tachycardia syndrome (POTS) syndrome was not uncommon in her age group. The events POTS syndrome and dysautonomia were unlikely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
A couple of hours after receiving the mix and match covid vaccine booster (Pfizer initial doses, Moderna booster), I was having persistent hiccups that would not subside until the expected side effects (fever, chills) went away.
CHILLS; FEVER; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced muscle aches. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache, and the outcome of fever and muscle aches was not reported. This report was non-serious.
papular rash on the left upper arm where vaccine was administered. It is itchy. Topical benadryl has not helped much. began two days after vaccine
Information has been received from a registered nurse concerning "several" patients who were vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patients subsequently complained of a little arm soreness after the vaccination. All patients recovered from arm soreness. On unknown dates, patients were vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patients experienced pain, swelling and irritation at injection site. The nurse noted that she used 3 or 4 different lots, and the patients were complaining that "it hurt quite a bit when the medicine was being injected into the arm". The nurse further commented that the patients did not complain about this with the first dose. The patients went home after the office visit.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
This spontaneous report was received from a physician's assistant via unspecified, multiple parents and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with  GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported). No information about the patients' concomitant therapies was provided. On unknown dates, the patients experienced mood changes, fertility issues, seizures and lethargy.     The outcome of the events and the causality between the events and GARDASIL 9 were not reported. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Pediatric Pfizer Covid-19 dose given as #3 vaccine instead of adult dose.
vomiting, diarrhea, malaise & chills w/fever are reported in a pt who recvd 1 dose of flu vax; sx occurred 24-48 hrs p/vax given; pt recovered;
Rec'd 15 mo immunization at age 18 mo, on (T) 01/14/14. Seen again in office next eve. with 8 x 12 cm of firm, mildly warm erythema to (LT). Tx with ibuprofen and ice pack prn. To return if s/s increased or pt. develops fever.
At 15:30 patient was administered MCV4, Tdap, HepA, Influenza. Immediately after pt c/o feeling dizzy. Patient pale, slight diophoretic, oriented to person, place time. Pt's skin clammy to touch. Nurse assisted pt to sitting position. v/s 90/60 60 pulse, resp 18 regular. Patient answering questions when asked. SN monitored pt for 30 min. No other incident noted. Patient oriented x3. All time monitored. After mom arrived pt escorted to car. Followed up for the remainder of the week by SN.
Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative:  Patient taken to ER for evaluation.
states she tested positive on home antigen test- has had primary series of pfizer, no boosters
Norovirus with Diarrhea; Throwing up; Had dehydration; Diarrhea; Was shaking so bad; Soreness in arm; This case was reported by a consumer via other manufacturer and described the occurrence of gastroenteritis norovirus in a 77-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included heart transplant. Concurrent medical conditions included diabetes, asthma and immunocompromised (has compromised immune system).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gastroenteritis norovirus (serious criteria hospitalization and GSK medically significant), vomiting (serious criteria hospitalization), dehydration (serious criteria hospitalization), diarrhea (serious criteria hospitalization), tremor (serious criteria hospitalization) and pain in arm. On an unknown date, the outcome of the gastroenteritis norovirus, vomiting, dehydration, diarrhea, tremor and pain in arm were unknown.   It was unknown if the reporter considered the gastroenteritis norovirus, vomiting, dehydration, diarrhea, tremor and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient's parents had heart problems, his mother recently passed last year and was 100 years old. The mother of the patient did not have too much going on expect age. The patient had the Shingles shot, had soreness in arm and it was worst. The patient had Norovirus prior to the report and was hospitalized with diarrhea and other symptoms. The patient was throwing up, had dehydration and diarrhea. The gastro physician took sample of stool and he ended up in the hospital with Norovirus. The patient was shaking so bad because of the dehydration and diarrhea. The reporter consented to follow up. The case had been linked with case US2021AMR057562, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR057562:Same reporter, same patient, different vaccine (Flu shot)
Patient came back on 7-14-20 said she got rash at injection site  no pain
Patient reports 3 weeks prior to presentation to our hospital bruising and petechial rash as well as gum bleeding. At time of presentation she was found to have platelets <5K, normal hemoglobin and WBC . Diagnosed with ITP and started on treatment
Three days later notice swollen tongue. Spoke to doctor and was prescribe over the counter Lysine Vitamin. Anti viral medication was prescribed, participant didn't remember the name. Within a week the swelling had gone.
Red hard itchy swollen area at injection site.  Swelling heat redness itch extending length of arm. Swollen axilla lymph nodes swollen and sore also left neck nodes tender each day worse   Starting to use cortisone pint topically
Patient's wife reported redness, warmth and rash at injection site, wife said it was about the size of her hand.
AFTER RECEIVING VACCINE, PATIENT FAINTED IN LOBBY AREA. PATIENT WAS UNCONSCIOUS, BLOOD PRESSURE WAS LOW.
My first visit was 2 days after my symptoms started. I had pain in my ear, I had a slight ear infection. The doctor prescribed a steroid and ear drops. I was good for awhile and then the symptoms came back after a week. My PCP looked at my ears again and she diagnosed me with Bells Palsy. She told me to use ice and a take two ADVIL at breakfast, lunch, and dinner. It has relieved a little but not much, so I have continued the ADVIL and ice. My ear infection was not that bad which she stated can bring on Bells Palsy.
shot didn't work, got them now/Suspected Vaccination Failure; got them now; 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: shot didn't work, got them now/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient stated the shot did not work for him/her and he/she got them now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR059667, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR059667:Same reporter
Sudden wave of heat/warmth and felt like I was going to pass out and was nauseous .  This happen about 12 minutes after the shot.  It continued to happen off and on through out the day until about 5:00pm.  The shot was at 10:00am on Monday Today is Wed and I still feel nauseous and dizzy.  Other symptoms have been bad headache with neck muscle pain.  Injection site is swollen, red and sore.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 1st dose of SHINGRIX. On 18th December 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and headache. The patient was treated with PARACETAMOL (TYLENOL). On an unknown date, the outcome of the chills and headache were not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the chills, fever and headache to be related to SHINGRIX. Additional details were provided as follows: On 18th December 2018 at night, the patient experienced chills, fever and headache. The patient received Tylenol and the fever went down a little bit. The reporter did not consent to follow up and the patient did not want to receive any follow up for the adverse event.
-Bell's Palsy-facial paralysis (partial), ongoing. Prednisone prescribed. -Developed flu for 48 hours following shot.  1/15/08 Reviewed pcp office note which reveals tongue started feeling numb then right side of face & right ear "clogged" x 1 day.  Currently pregnant.  Tx only w/tapering steroids & eye gtts. FINAL DX: Bell's palsy.
experienced a rash on his arm that has moved to his back; A biopsy showed some skin irritation; Itching; got a MRSA boil from a sore on his leg; got a MRSA boil from a sore on his leg; He still has a little itch and bumps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 76 years, in right arm for covid-19 immunisation; atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. it was all before the COVID vaccine 6-7 years ago.; "gallbladder taken out" (unspecified if ongoing), notes: He had a heart attack and his gallbladder taken out. It was all before the COVID vaccine 6-7 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First vaccine: given on 14Apr2021; lot ER8731, Anatomical location: He got them in his right arm because he is left handed.), administration date: 14Apr2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Second vaccine given on 10May2021; lot EW0176, Anatomical location: He got them in his right arm because he is left handed.), administration date: 10May2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Third vaccine given on 19Nov2021; lot FH8030, Anatomical location: He got them in his right arm because he is left handed.), administration date: 19Nov2021, when the patient was 76-year-old, for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "experienced a rash on his arm that has moved to his back"; SKIN IRRITATION (non-serious), outcome "unknown", described as "A biopsy showed some skin irritation"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; PAIN IN EXTREMITY (non-serious), STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown" and all described as "got a MRSA boil from a sore on his leg"; MASS (non-serious), outcome "unknown", described as "He still has a little itch and bumps". The events "experienced a rash on his arm that has moved to his back", "a biopsy showed some skin irritation", "itching" and "got a mrsa boil from a sore on his leg" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for atorvastatin calcium was unknown. Therapeutic measures were taken as a result of rash, skin irritation, pruritus, pain in extremity, staphylococcal infection, mass.  No follow-up attempts are needed. No further information is expected.
A wave like feeling came over her, followed by a transient tightness in her throat. Very brief "dark vision" without classic tunnel vision. No SOB, itching, tongue thickness, or diaphoresis. VSS throughout without orthostasis.    Initial BP - 131/76, Pulse 66, Resp - 19, O2 sat - 99%  All symptoms spontaneously resolved before arriving at Observation Pod. Suspect simple anxiety.
DROWSINESS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced drowsiness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and drowsiness was not reported. This report was non-serious.
Patient experienced extreme shortness of breath and asthma attacks for 2 days, as well as series of rashes that started off as papules (non-leaking) and turned to a hard solid mass that was tender, red and itchy.  Currently the rash is still present but not raised.
34 after my 2nd vaccination I had severe palpitations. Knocked me out of bed.  Lasted for hours.  Have had palpitations and sequela since, including elevated BP, some shortness of breath, nausea.
Reaction occurred within 1 hour of administration. Patient developed a large raised red area approximately 5cm in diameter that was tender and warm to touch. She applied ice and took Benadryl. By 10/16/2010, all symptoms had resolved.
Diarrhea. Short , about 10 min Headache, about 2 hours
At midnight on Tuesday September 6, 2022, I woke up with a severe sore throat and bad cough.  I took a rapid COVID test, which came back negative.  The symptoms persisted, at about 6:00 a.m. on September 6, 2022, I took another COVID test, which also was negative.   Around 10 pm on September 6, 2022 I took 2 rapid tests, both came back positive within 3 minutes of the 15 minute wait period.  I scheduled a remote medical visit that evening, was prescribed Paxlovid, albuterol sulfate HFA 90 mcg/actuation aerosol inhaler and benzonatate 200 mg capsules.   I had extreme fatigue, only able to stay awake for 30-60 minutes at a time and would sleep for 3-4 hours.  Symptoms persisted until September 10/11.  September 11 and September 12 I tested negative for COVID.