chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was unable to get up; Gillian Barre Syndrome; Drug induce coma; fell out of her car; she has difficulty writing; she has difficulty walking; numbness in left hand, then numbness in left leg and back; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received on unknown date).  In DEC-2022, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced coma (Verbatim: Drug induce coma) (serious criteria hospitalization and GSK medically significant) and fall (Verbatim: fell out of her car) (serious criteria hospitalization). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: Gillian Barre Syndrome) (serious criteria hospitalization and GSK medically significant), difficulty in standing (Verbatim: was unable to get up) (serious criteria hospitalization), writing impaired (Verbatim: she has difficulty writing), walking difficulty (Verbatim: she has difficulty walking) and hypoesthesia (Verbatim: numbness in left hand, then numbness in left leg and back). The outcome of the guillain barre syndrome, writing impaired, walking difficulty and hypoesthesia were resolving and the outcome of the coma, fall and difficulty in standing were not reported.  It was unknown if the reporter considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  It was unknown if the company considered the guillain barre syndrome, coma, fall, difficulty in standing, writing impaired, walking difficulty and hypoesthesia to be related to Shingrix.  Additional Information: GSK receipt date: 23-MAY-2023 The reporter was the patient who stated that, she received second shot of Shingrix vaccine late December 2022, previously had received first shot but does not remember the date. Then the reporter had developed numbness in left hand, then numbness in left leg and back. One-day reporter fell out of her car and was unable to get up. She was then transported to the hospital where she was in a drug induce coma, this event was in March.  Then reporter was diagnosed with Gillian Barre Syndrome. The reporter also stated that, she had difficulty writing and walking. Right now (at the time of reporting), reporter was in a rehab facility and was learning how to walk again, she was getting better. Reporter does not remember the exact dates for all the events reported in this case.  The reporter had consented to follow-up.
Information has been received from a physician concerning a 13 year old female who on 18-JUL-2007 was vaccinated with the first 0.5 mL dose of GARDASIL. On 26-SEP-2007, after the patient was vaccinated with the second dose of GARDASIL she experienced swelling and soreness in the arm. The patient also experienced fatigue and lymphadenopathy in her neck. The patient sought unspecified medical attention. The patient status was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Violent/severe shaking and chills for 4 hours, inability to get warm, severe headache for 18+ hours which did not respond to acetaminophen or ibuprofen, severe body and joint pain for 18+ hours, followed by mild fever for 4 hours, fatigue, nausea.
fatigue; Sore arm; low appetite; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient fatigue, sore arm, and low appetite. Clinical outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Pt was positive for COVID19 12/12/2020.  Pt received both doses of Moderna as documented above.  Pt works and reports healthcare exposure.  Pt began with c/o runny nose, congestion and cough on 04/17/2021.  PCR positive on 04/17. reports pt PCR negative 04/12, positive 04/15 and negative 04/18.
This spontaneous report as received from a healthcare worker refers to 4 patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly store VARIVAX (lot # L017142, expiry date 13-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the VARIVAX experienced a temperature of 19.9 degrees Fahrenheit for a 525 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare worker called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with therapy with VARIVAX was unknown. The outcome of the events was unknown. This case is linked to case number 1606USA009455 via same reporter link. Additional information has been requested.
c/o soreness @ inject site in the PM on 1st day; upon awakening next AM pt c/o arthritis type sx, fever (no taken) stattes poss t102 orally, joint pain over body; PM 17JUN92 edema of neck glands;
I had an ocular migranes 2 hours, 5 hours and 20 hours after the injection.  I usually have ocular migranes abour once per month.
Pt seen in ophthalmology clinic 3/16/21 for evaluation of c/o bilateral vision loss and admitted to hospital for further evaluation and management based on their findings. She has known history of cataracts, macular thinning of the left eye and bilateral pseudophakia, but no recent vision issues. Pt states that approximately 3 to 4 days after getting her first COVID-19 vaccination (Pfizer) on 2/16/2021 she noted blurred vision in left eye and over the course of the next several days, started to have worsening blurring as well as darkening of her vision to the point where she was only able to see faint outlines of objects. Did also have some associated visual hallucinations with this. Seen in clinic (exact date unknown but sometime between 2/16/21 and 3/8/21) where a visual acuity exam was done, and no further evaluation was recommended. But pt had ongoing issues and was ultimately seen by ophthalmology on 3/8/21 and was then directed to the ED on 3/8/2021 for possible stroke evaluation. In the ED, CT of the brain was negative for acute stroke. MRI was advised, but patient declined during that ED visit and voiced preference to schedule outpatient, however, she was never able to make that appointment. On 3/9/21, pt received her second COVID-19 vaccine, and 1 to 2 days later, she developed the same symptoms in the right eye, though does not feel that her visual acuity decreased by as much in that eye as it had in the left eye. Pt also has had mild associated frontal headache since her first COVID-19 vaccination, but it responds readily to acetaminophen. Pt seen in ophthalmology clinic again on 3/16/21. At that appointment, she had a funduscopic exam which showed mild temporal pallor and ophthalmology felt that this is likely inflammation of the optic nerve or optic nerve sheath, likely secondary to retrobulbar optic neuritis versus perineuritis possibly triggered by recent vaccination. Request was made for admission to Hospital for further evaluation and management. Hospital Course (admitted 3/16/21 ? 3/22/21): MRI of the brain and orbits revealed optic neuritis. In consultation with neurology and neuro-ophthalmology the pt was started on a 5-day course of methylprednisolone 1 g IV daily. The pt noted improvement in her vision rapidly. Primary diagnosis at discharge was optic neuritis, possibly triggered by covid-19 vaccination.
2.2 years post vax, pts parent the physicians office to report that the pt had developed chickenpox.  Pt was not seen in the office.
Fell out of bed, couldn't walk, talk and had severe heath palpitations sleep on floor. Later crawled to bathroom and could get on toilet. Wife helped me up.spent the rest of the night on floor. Next day the same situation got on bed  slept all day. Third day made it to the living room and slept all day.  Drowsy and confused for 3 days. I did not remember much of this my wife  helped me.
pt recv vax 12FEB95 & 12hrs later pt got up from lying down & had trouble seeing;went to a mirror & noticed that eyes were swollen;also exp a great deal of pain @ inj site;dx eventually subsided;
Big red circle on left arm at injection site. It is about the size of a silver dollar. it feels a little hard under red circle. It is a bit itchy. Not much soreness after injection. No real feelings of weakness or fatigue
Patient reported pain at the injection site within the first 24 hours of administration. She also has a red rash in the vicinity of the injection site that she noticed on Thursday (vaccine administered on Monday). She reports that the rash does not itch and it did not appear swollen.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ NEUROPATHY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
It's itchy; It's red; Cannot sleep; scratch; "bad rash"; Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"). On an unknown date, the patient experienced PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep), SCRATCH (scratch) and RASH ("bad rash"). At the time of the report, HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy) and RASH ("bad rash") had not resolved, ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Eucrisa, Mometasone furoate (0.1%) and Hydroxyzine (10 mg) are the treatment medication reported by reporter.  The patient had question if it is safe to take second dose of vaccine which is due on 05May2021 as she never healed from the "bad rash" and her "arm look ugly", "cannot were long sleeve as it itches a lot" and is uncomfortable. The patient did not have pre-existing medical condition as such. The patient said she had some allergy last year during 2021 but she did not go to any doctor due to pandemic lockdown.
Chest pain for 5 days, 4 days after the first dose of Pfizer Covid 19 vaccine.; Left lower eyelid involuntary twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 12:45 (Lot number: FD0809) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal Bronchitis." (unspecified if ongoing), notes: Other medical history: Seasonal Bronchitis.; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: BLEPHAROSPASM (non-serious) with onset 29Aug2021, outcome "recovering", described as "Left lower eyelid involuntary twitching"; CHEST PAIN (non-serious) with onset 29Aug2021 12:00, outcome "recovering", described as "Chest pain for 5 days, 4 days after the first dose of Pfizer Covid 19 vaccine.". Therapeutic measures were not taken as a result of blepharospasm, chest pain.  Additional information: The patient received bnt162b2 (BNT162B2), administered in arm left, on unspecified date (Lot number: FF2587) as dose 2, single for covid-19 immunisation. The patient had Chest pain for 5 days, 4 days after the first dose of Pfizer Covid 19 vaccine and left lower eyelid involuntary twitching,4 days after first dose of Pfizer COVID-19 vaccine, which up to the second dose persisted. The patient did not receive any other vaccine within 4 weeks. The patient did not have any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Received flu vaccine in left arm and non-PREVNAR 13 pneumonia vaccine in right arm. Not long after, on that day, experienced rather severe right upper arm pain. The pain subsided somewhat the next day, but has remained since then. No problem in left arm.
Two days after second dose, a large oval red rash appeared where I was injected. Now a raised welt looking like a psoriasis patch is on the inside of my elbow. This patch itches incredibly and is painful. My arm and joints are beginning to ache again after feeling better earlier this week.   I was in bed for three days after the vaccine because of body aches, extreme fatigue, and dizziness. Day four I felt fine.   My first dose produced no major side effects except for a large red itchy patch on arm , similar to the second dose.
Patient reports that on the evening of 9/15/2023, a few hours after she received her vaccination she began to feel chills and developed a fever. The following morning she noticed that her arm was red around the injection site, and noticeably swollen. The patient came back into the pharmacy with the area of her left upper arm swollen, but not near the deltoid muscle where the shot was administered. She stated that it causes discomfort to touch the swollen area and periodically itches. Patient has been using ibuprofen and was recommended use an OTC allergy medication as well as alternating heat and cold to reduce the swelling. Patient was also instructed to follow up with her medical provider if the swelling worsens or does not improve over the next few days.
This was the beginning of much hair loss. I began to lose hair much quicker and in much more groups than I had previously. It has been going on since the date mentioned, up until today.
second shot potentially greater than day 36; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot potentially greater than day 36) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was reported by reporter.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot potentially greater than day 36). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
t99, abdominal cramps, nausea, vomiting, body aches began 8 hrs p/inject; had h/a, nausea & nervous stomach x 3 days; no one in family w/similar sx;
1st dose in december 2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscular in December 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The reporters were a patient and pharmacist. The reporter reported that the patient did not received second dose of Shingrix vaccine. The patient plans to receive second dose. The reporter had nothing else to report. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022136473, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022136473:Same reporter
pt recvd vax; 25jul95 devel varicella like rash, fever & HA;
pt recvd vax as per school request;awoke 8dec94 w/ hive like rash all over face,arms,legs  & body; to clinic to see MD & was given epinephrine;
1/8/2022 (+) PCR for COVID, hospitalized 1/8/2022 extreme fatigue, cough, fever
After vaccine my mouth started to get dry while I was driving home. 1/2 body sore and chest pain felt like heart burn and I was having a heard time breathing. injection site started hurting all the way up to my shoulder. I started getting chills and tired.  i started feeling better last night but I did not sleep well. I still have body aches and my chest is feeling better. If I do not feel better in the next 24 hours i will be contacting my HCP.
The night I received the second dose I had chills, experienced low grade fever and arm redness at the injection site. Just a dull pain, nothing really major. The redness was much smaller than the first dose, I still have it. And a mild discomfort if I have to stretch my arm above my head or stretch my arm for some reason.
Fever of 102; Chills; Body ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration in left arm on 29Mar2021 at 15:00 (at the age of 20-years-old) at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 on an unspecified date prior to vaccination. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient was not pregnant. No other vaccine was given in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever of 102, chills, body ache, headache and tiredness on 29Mar2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sz-febrile since 1st vax over 20 in last 4 years. 60 day follow up dated 10/30/00 provided no additional data. Annual follow-up dated 2/5/01 provided no additional data.
Redness, swelling at site, warm to touch. Rash on legs & feet, hand, feet have persistent swelling. Inc muscle weakness, weight loss, tired.
Immediately after receiving the shot my jaw began to feel tight as if I was beginning to get lock jaw.  2 hours after my right side of my jaw only began to hurt with a dull achy pulsating pain similar to a cavity but the entire right side of my face.  Pain is a 6/10.  Relieved with NSAID and hot compress temporarily.  The next day I had a sore throat, began coughing and sneezing and producing too much mucous.  These symptoms are still persisting but are getting slightly better other than the jaw pain that I experience at least once a day for at least half an hour each time.  The right sided jaw pain emerges every night when I lie in bed to go to sleep.
Fever of 101.3, chills, body aches, headache, vomiting.
Pt with a history of varicella exposure, who was vaccinated with varicella virus vaccine live in May, 1999, subsequently experienced a small mosquito like rash consisting of no-vesicular bumps. The rash consisted of 15-20 lesions. Additional information has been requested. Follow up information reported that the patient was afebrile. Additionally, it was noted that the rash was "slight varicella" consisting of approximately 26 pox marks which resolved on 03/13/2000, approximately 5 days after initial breakout.
On Saturday, I was able to walk fine with no knee pain. When I woke up Sunday, I had severe pain behind my right knee, swelling, and I couldn't put weight on my right leg, or straighten my knee. I wasn't able to walk for 7 days, on day 10 I am able to walk without assistance. I had to elevate my knee, apply heat and ice, and take pain medication for 7 days.
Severe chills, tremor approx. 6 hours after injection(8 PM). Initial episode of chills/tremor lasted roughly one hour before calming. Recurrent chills of lesser severity followed for approx. 4 hours after, on and off. Fever ranging from 99.4-101.0 followed. Skin sensitivity akin to "feeling like a sunburn", muscle ache, and brain fog followed the next 30 hours.
no adverse reactions/symptoms. patient given extra dose of IPV (Polio) vaccine, FOC upset.
None stated. 12/21/09 DC summary and medical recs received for dates 11/10/09 to 11/13/09. DX: left arm cellulitis and myositis, leukopenia, neutropenia, hypernatremia. Pt had vax, shortly after developed fever, flu like sx, body aches, chills, arm swelling.