chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was suffering from it, I was not able to move my mouth so, I tell my husband I couldn't move; tired; had a chills; it also made my back (incomplete sentence), I have problem with my back; My back pain was worsen; I was getting out of breath too; I can hardly walk; Bell's Palsy/she can move the rest of her body except for her face; paralyzed; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 at 10:15 (Batch/Lot Number: ER8736) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 06May2021 night the patient woke up paralyzed which was what a little bit she can find out was Bell's palsy. The patient was not able to move her mouth so, she tell her husband she couldn't move. The patient was also tired and had a chills too and other than that it also made her back (incomplete sentence), the patient have problem with her back. Her back pain was worsen for some reason. The patient do not know if it was from the shot or what. She have concerns with paralysis. The patient can hardly walk and it was outside and it will take a little while. She got a bad back, a bad her and a bad shoulder. The patient was falling apart. Hopefully she can get a new her and a new shoulder. The patient was getting out of breath too. Other things are tiredness and my back hurting a lot. Yesterday she was like getting tired and out of breath, usually she do not get out of breath like this. The outcome of the events was unknown.
In mid-October I realized I had a ringing in my ears, tinnitus.  It is constant and in both ears.  It has not progressed or decreased since it began.
Turned rash/red on upper body, itching, no anaphylaxis but given sub Q epi 0.3 mg with much improvement.
Pt had long complicated course spanning almost a month.  He was initially admitted for right intertrochanteric hip fracture (following a fall at home) for which he required surgery. Also had bacterial pneumonia and received Zosyn.  He was close to discharge at 1 point but then  had Covid testing done which came back positive.  He gradually worsened from there with acute hypoxic respiratory failure and very poor oral intake.  He had multiple episode of hypoglycemia and required D5. He was made care only but improved on his own and was back on medical Mx. It did not last long and he again became very tachypnic in 60s and hypoglycemic. He was made care again. Pt passed away peacefully with his daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1. Cardiopulmonary arrest due to reason #2 2. Failure to thrive due to reason #3 3. Old age and COVID-19 No autopsy performed.
This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported. On 28-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) intramuscularly (IM) as prophylaxis (dose number, anatomical site of vaccination and vaccine scheme were not provided; lot number 1602284 has been verified to be valid, expiration date reported and established as 26-SEP-2021) (expired product administered). No additional adverse events reported (no adverse event).
WEIRD FEELING; NO STRENGTH IN HAND; GROGGY HEAD; HEADACHE; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced weird feeling. On APR-2021, the subject experienced no strength in hand. On APR-2021, the subject experienced groggy head. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-APR-2021, and the outcome of weird feeling, no strength in hand and groggy head was not reported. This report was non-serious.
After the vaccine the pt said she felt like she had the flu. She was tired and sore and achy. And a week later she went to bed and woke her husband up to help her to go the the bathroom, she collapsed on the way and the husband called 911 and was taken to the hospital and the doctor said she had a massive brain bleed, she was put on life support, she passed away five minutes after being taken off of life support.
Pt received vaccine on 7-2-21 @ 10:41am that was time expired.  J&J vial was pierced on 7-1-21 @ 9:46am
Apnea, seizures, 48 hours, post vax. May need anti-convulsants. Awaiting more testing and reports. Pt is a 4 month old girl referred because of recent spells uncertain origin. History was obtained from the pt's parents. Medical records was also reviewed. She received multiple immunizations including DTaP, inactivated polio, and HIB 02/20/2001. Over the next few days, she may have had a few episodes in which she dropped off to sleep more rapidly than usual: however, these incidents were not of great concern to the parents or grandparents. The patient was afebrile. Four days after her immunizations, she had a brief dusky spell which was associated with apparent alteration consciousness. She became pale and there was perioral cyanosis. She appeared to suck on her lower lip. The pupils were dilated. She started vacantly and was minimally responsive. Parents describe a "distant look." Toward the end of the brief episode, she bacame limp and soon thereafter she slept. She was admitted to hospital where additional, similar episodes occurred. Similar spells occurred in greater number in the second hospital day. On the third hospital day she had only 2 episodes, and there have been non subsequently. Parents state that the pt's personality and behavior changed during her illness in that she was less social and vocal for several days: however, these changes have not persisted, and the pt has returned to her premorbid level of functioning. As noted above, the pt has not been frbrile. There have been no convulsive episodes. Although perioral cyanosis was observed and the question of apnea was raised, no apnea or bradycardia was documented when the pt was monitored during the episode that occurred in hospital. An EEG was normal. MRI scan of the head showed a small cyst in the right choroidal fissure (adjacent to the mesial temporal lobe). The films are not available for review. No associated change in the signal intensity of the temporal lobe is mentioned in the report. Prominent frontal CSF spaces were also noted, and the radiologist raised the possibility of atrophy. The parents major concern revolves around the question of barin atrophy. A lumbar puncture was not performed
flu; Initial information received on 30-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via social media.  This case involves an unknown age and gender patient who experienced flu ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I rarely get a flu shot but when I do, I get the flu...when I don't, I'm actually fine. "  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Severe fatigue Sore throat Abdominal distention Dyspepsia/GERD  Shortness of breath intermittently  Moderate to severe headache Left arm pain (mild) Angina at rest Right claviclular/subclavian pain
Lt upper arm with swelling redness heat and pain from shoulder to elbow starting after DTaP inj on 2/18/03.
Developed infection; This is a spontaneous report from a contactable consumer (reported for father) via a Pfizer-sponsored program, COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of Covid vaccine on 25Feb2021. The patient was due for the second dose yesterday (18Mar2021). The patient developed infection on an unspecified date and was put in ICU (Intensive Case Unit). The outcome of event was unknown.  Information about lot/batch number has been requested.
Patient received Moderna full dose instead of Moderna booster dose.  Patient was immediately notified of the dosing error.   Patient reported no reaction immediately following the vaccine administration.   No adverse reactions observed or reported, patient waited 15-20 minutes after injection before leaving clinic site.
Day of:  MILD discomfort at injection site.  Day 2 sore arm no redness...pretty sore all day.  Days 3-13 nothing of note. Day 14 awoke with discomfort. Upper arm was slightly swollen, hot to the touch, and redness that spanned about 6-8 inches long and about 4-5 " wide.   Today, Day 15 post injection (if injection day is day 1) less red, less swollen, less heat, less discomfort.   Also.  PERHAPS TOTALLY UNRELATED...after I had been awake for awhile I had a dizzy spell and felt like I might faint but I didn't.  Wearing my O2 ring:  currently 98% 02 and HR around 70 -75% but I'm typing and moving around.
Received HPV and Tdap at which time patient passed out and was non responsive for about 10 minutes. Patient did not come to several seconds after passed out before passing out again. She was transported to hospital per ambulance after IV started and blood work done.
On 8/19/00 at 01:00, mom was sleeping with child when he awakened her with jerky movements of all extremities, head thrown back and eyes rolled back, lasting 5 minutes. EMS arrived and transported to ER. Temperature was 103.3F. Another episode of jerky movements when arrived at hospital, lasting 2-3 seconds. He was dx'd with febrile seizure and URI.
Severe Rash, Dizziness, Severe Headache, Nausea, Fever, pain & swelling at the injection site. Treated with tylenol, Advil, Hydroxyzine, Prednisone Headache & fever came overnight on the 16th, rash, Dizziness & nausea was present when I woke up on the 16th. Arm was sore & swollen also.   Fever broke & nausea subsided  Evening of the 17th. Rash, slight headache & dizziness still present on the 18th.
Extreme headache, fever, nausea, every joint ached - it was painful to even draw fingers into a grasp to hold a glass - lasted approximately 24 hours. Left upper arm where vaccine administered was completely swollen, red and hot for 48 hours - swelling reduced to size of baseball at 49 hrs.   800 mg of Tylenol given within 24 hr period. Did not address headache so I took 160mg of aspirin then waited 4 hrs and took another 160 mg of aspirin to reduce headache. Not supposed to take this med with 1 kidney but only option under conditions.
patient still complaining of itchiness and soreness surrounding the vaccine site and around her arm and under her arm
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (injection) (lot#, dose and route not reported) 1 year after the the first. No adverse effect reported. Additional information has been requested.
A pediatrician reported that a child received an injection of Prevnar. Approx. 24 to 48 hours, post vax, the child developed a "non-hive" rash. No further information was available at the date of this report. The reporter indicated that 5 or 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Received GARDSASIL #1 on 5/11/10 in (R) deltoid. Pt returns today with complaints of (R) arm pain at injection site. No redness, swelling, heat or hardness noted.
Patient reports she began having soreness at the site of immunization a couple days after being vaccinated, and it has continued for the last 3 months. She has not brought it to the attention of her physician.
I did not have any adverse side effects in the short term after taking these vaccines (short term here is from the time of the shots which was 9/11/2022 to about 3-4 days later). However, starting 9/19/2022, I started experiencing a moderate to severe headaches. They would come in waves and were sometimes quite debilitating. I would have to stop working and lie down quite often. I tested negative for COVID (PCR at drive through) and the flu, so I chalked it up to the vaccine. The symptoms only very recently resolved, on 9/23/2022, and still feeling a bit of fatigue (though this might be unrelated). This was adverse for me because never have I had side effects nearly two weeks after a COVID vaccine let alone any sort of vaccine.
Information has been received from a licensed practical nurse concerning a 12 year old female who on 08-AUG-2007 was vaccinated with her first dose of Gardasil, intramuscularly (lot# reported at "0727U").  Concomitant therapy on that same date included Tdap and MENACTRA.  On 09-AUG-2007 the patient experienced severe nausea, vomiting and was bedridden.  The physician advised the patient to stay hydrated.  On 10-AUG-2007, the patient recovered from severe nausea, vomiting and bedridden.  Additional information has been requested.
Seizures; Bad autoimmune reaction; Encephalitis; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (son received the first Pfizer COVID-19 vaccine for 5-11 years), administration date: 27Dec2021, for COVID-19 immunization. The following information was reported: MALAISE (hospitalization) with onset 10Feb2022, outcome "unknown", described as "Sick"; SEIZURE (hospitalization), outcome "unknown", described as "Seizures"; AUTOIMMUNE DISORDER (hospitalization), outcome "unknown", described as "Bad autoimmune reaction"; ENCEPHALITIS (hospitalization), outcome "unknown". The patient underwent the following laboratory tests and procedures: Lumbar puncture: within normal limits, notes: had several scans and a spinal tap which all were within normal limits; Scan: within normal limits, notes: had several scans and a spinal tap which all were within normal limits.  Clinical course details: The caller reports that her son received the first Pfizer COVID-19 vaccine for 5-11 years on 27Dec2021, his second dose on 20Jan2022 and began getting sick on 10Feb2022. The caller said her son began having seizures, developed a bad autoimmune reaction, had to be admitted to the ICU, was vented, had several scans and a spinal tap which all were within normal limits. The caller asked if there were reports of children having encephalitis. The caller said her son was a healthy child previously, was up to date on care, never missed a well check appointment. The caller also said there was no toxic stuff in this house. The caller said the physicians could not rule out the vaccine. The caller said the vaccine was the only thing new.
Formation of half-dollar size hematoma, soreness and thickening of the tissue. Applied warm compress two to three times each day.  Soreness subsided on 10/27/2011.  Hematoma and thickening of the tissue still present on 10/28/2011.
Patient experienced urticaria on arms, chest, back. Occurred approximately 30 mins after administration. Patient notified pharmacy the following day. Patient was itchy and the hives had spread. Patient was given BENADRYL 25mg one time dose. Primary physician was notified.
Initially, the injection site was only slightly red and itchy, and no cause for concern. Two days later patient's entire front upper left arm was visibly swollen, very red, and hot to the touch. He experienced no pain or tenderness. His temperature remained normal, he was given a cold compress, no medications and recovered the following day.
7 year old male that received a dose of Adacel with no adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 7 year old male that received a dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 30-Oct-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection at an unknown dose (lot U6984AA, strength, expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination(immunisation).  On 30-Oct-2022, 7 year old male that received a dose of adacel with no adverse event (product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
BLOOD CLOT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient had blood clot. The action taken with covid-19 vaccine was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210621271- covid-19 vaccine Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Broke out in hives, headache, lips started to swell. intense itching. Was treated at the Emergency room with IV's of Benadryl, steroids and an antihistamine. Sent home with a scrip for Prednisone.
1st dose Sep2020, didnt get 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   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: 09-FEB-2023 Reporter's Comments: The patient called if she should restart her Shingrix series, having received the 1st dose, and not getting the 2nd dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  This case is linked with case US2023021219 reported by same reporter.; Sender's Comments:  US-GSK-US2023021219:Same reporter.
The next morning following the vaccination, my right lower eyelid started severely twitching every 10-15 minutes for 4 days throughout the entire day, usually subsiding at bedtime. Each time it lasts from 30 seconds to 1 minute every single day. on the 5th day, the twitching stopped for approximately 15 hours but returned when I went to sleep and kept me up through the night. THis has really taken a toll on my livelihood and I am afraid of it progressing to Bell's Palsy. I have never had this happen.
Information has been received from a physician concerning a 14 year old patient of unknown gender. In 2003, the patient was vaccinated with M-M-R II and VARIVAX via an unknown route (no adverse events reported). The patient's concurrent conditions and concomitant medications were not provided. On 17-JAN-2017, at age of 14, the patient was vaccinated with PROQUAD, lot # M014302 with expiration date 22-SEP-2017 (dose, strength and anatomical location were not provided), subcutaneously, for prophylaxis. No adverse effects were reported. Additional information has been requested.
10 minutes after vaccined.  pt felt dizziness, feeling lightheaded, cold skin and sweating. mom had pt lied on floor and elevate the legs.  after symptoms subsided and was checked by paramedic. pt left without any help.
Chills, SOB, Hypoxemia, generalized tremors, Heart faint and hard to hear, Unable to palpate pulse and O2 sat registers in the 60's, unable to obtain BP. Pt was sent to ER had test and IV and discharge home. Pt was given TORADOL 15 mg, BENADRYL 12.5 mg, SOLU-MEDROL 60mg, NS 0.9 100ML.
Day 1- out of it, lightheaded Day 2-4 flu-like symptoms, temperature regulation issues, upset stomach Day 2-6 skin flushed, facial skin extremely dry and patchy/scaly- eventually went away Day 2-6 easy bruising- mostly on legs; small fingerprint sized bruises- common for me
Marked pain and swelling left arm (shoulder to mid arm) NOS. Patient febrile. Cellulitis treated with 4 days antibiotics then PO antihistamines.
Itchy, red, raised bumps on bilateral arms and legs; started one week after first Moderna vaccine, itching lasted for about 2 weeks