chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient passed out; patient was shaking uncontrollably; patient had "painful muscle spasms, especially in his hand"/patient "could not move his fingers"; Information has been received from a medical assistant referring to a 16 years old male patient. The patient had no concomitant medication, pertinent medical history or allergies.  On 25-OCT-2019, the patient was administered a dose of hepatitis a vaccine, inactivated (VAQTA) (lot number S002460 and expiration date 15-MAY-2020; dose number was unknonw) intramuscularly in the left upper arm for health maintenance.         After administration of the vaccine on 25-OCT-2019, the patient did not wait 15 minutes for observation but got up and left shortly. On his way to the car, the patient passed out and was shaking uncontrollably. The reporter stated that the patient did not had a seizure but had painful muscle spasms, especially in his hand. Entire event lasted 20-30 minutes and during the event patient could not move his fingers. The patient was assessed at office and upon recovery was sent home on the same date.  No product quality complaint (PQC) was involved. No treatment was given for the events and no labs was performed. The patient sought medical attention. The causality assessment between the events and hepatitis a vaccine, inactivated (VAQTA) was not provided.  Upon internal review, the event passed out was determined to be medically significant.
@ 18 hrs after injection erythematous confluent raised rash appeared on dependent surface of L upper arm.  1% Hydrocortisone cream bid, extending into lower arm.
pt had a positive COVID test from Hospital on 1/13/22; requested med records but only received GIP hospice records from Hospice; pt was DNR; admitted with ARF; on O2; pt passed away inpatient hospice; DC and med records sent to vaers
I was in the hospital for a knee surgery: a couple of days after my surgery my asthma flared, I started coughing a lot and producing a lot of phlegm. I did have to have breathing treatments while in the hospital. I also contracted an UTI infection right before I left the hospital, I was given medication to take home with me so that I could get rid of the infection. In March I got COVID-19, I had a high fever of 102F-103F, loss of appetite, aching. I took a home COVID-19 test and was positive. I was given the antiviral Paxlovid, but it did take a month before I started to feel better.
he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy; had all kinds of bad side effects/had so many problems; sirva injury; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems), LIMB INJURY (sirva injury) and SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems) and LIMB INJURY (sirva injury). In November 2021, the patient experienced SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy). At the time of the report, VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems), LIMB INJURY (sirva injury) and SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. patient had neurological nightmare. Patient had not received his 2nd dose.
Four hours after receiving vaccines patient started screaming for 20 minutes, local reaction - redness & swelling at site.
Warmth, redness, itching and nerve tingling on the left side of the face.  Started about 90 min after the injection.  Symptoms resolved after taking two Benadryl and sleeping.  Most were gone by about 4 PM.
I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; I began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 20Dec2020 at 14:30 (at the age of 52 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included asthma from an unknown date.  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included progesterone (PROGESTERONE), estriol (ESTRIOL), diazepam (VALIUM) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Dec2020 at 19:00, the patient experienced she began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included steroids and benadryl. The clinical outcome of began intense itching & redness that began in hands & feet, then head, arms back of neck then torso turned red and itchy was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a 14 year old female who was vaccinated IM with a dose of GARDASIL. Subsequently the patient "came down with some syndrome", may have been Guillain-Barre syndrome. Medical attention was sought and the patient recovered. The consumer noted in this report was not one of the physician's patients. Upon internal review, Guillain-Barre syndrome was considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to identify the existence of a patient. Additional information has been requested.  3/10/08 Per FDA contact-DX: Bell's Palsy not GBS. Confirmed. Infrmation has been recieve from a physician concerning a 14 year old female who was vaccinated IM with a dose of HPV vaccine. Subsequently the patient "came down with some syndrome", may have been Guillain-Barre Syndorme. Medical attention was sought and the patient recovered. The consumer noted in this report was not one of the physician's patients. Additional information was obtained for the patient by telephone call froma physician.l The physician informed that patient was his niece and she developed Bells Palsy. He put on his wife who provided that patient was 16 year old. She did not believe that there were any other vaccines given with HPV vaccine. The patient had no pertinent medical history and no known allergies. She was treated at the hospital and seen by a neurologist. The Bell's Palsy "slowly resovled". When asked if it was disbaling the physician;s wife responded "it was disfiguring the side of her face drooped. Additional information has been requested.
Patient aquired a red, swollen, hot area, somewhat painful to touch, the size slightly smaller than a baseball on her upper arm surrounding the injection site, within 24 hours after pneumonia vaccine injection. Patient was treated with Benedryl and cold compress on localized area. 48 hours after injection the pain and swelling was decreased.  96 hours after injection all symptoms had resolved.
Was in perimenopause and hadn't had a cycle in almost 10 months then started the day after my first vaccine.  Had another period a couple days after my second dose on 9/30/21.  Hot flashes oddly on my lower legs and hadn't had that prior to vaccination.  Pain left lower leg that did get better.  On 8/27/21 went to urgent care with dizziness-woke two days in a row so dizzy couldn't get up and now it's an on/off nausia/light headache feeling.  More anxious.  On/off feeling of my heart beating fast.
after shot on 1/19 I had headache and felt not so good about 2 hours after, that night I started with body aches, chills, very uncomfortable that all lasted awhile, 1/20 was pretty much the same feelings, then 1/21 I started with nausea and vomiting also I was painty, blood pressure a lil high, and heart rate lil high, went to the clinic here at hospital, 1/22 still very nauseas and feeling ill, with very lil diarrhea then on 1/23 woke up to spot red big rash on arm where I received  shot but way underneath where shot was given was very itchy, and feverish, still to this day have a very mild to slight headache
Left upper arm soreness began 02/12/2021 with and  rash developing approx. 2-3 inches at injection site.  Rash with soreness as of 02/19/2021.
Had vaccine late PM 10/27/2005, developed swelling of left upper arm, redness of skin, warm to touch, tender to palpation.  Able to use arm, no difficulty breathing or swallowing, no shortness of breath.
Vomiting started at 10:25 pm.  Leading up to the vomiting was fever. Chills, body aches and headache and nausea
21JUN91 pt recvd 2nd dose of Engerix-B vax about 10 days p/2nd dose pt exp general weakness, fever, fainted (syncope) & achiness; pt treated in ER & lab work was done; pt remained sick x 10 days;
covid vaccine breakthrough case  dose 1 Pfizer  1/13/21  EL3248 dose 2 Pfizer  2/3/21  EL9265 dose 3 Pfizer  9/27/21  FC3148
Patient states that 3 days after getting flu shot she began to have numbness on her entire left side, brain was foggy, walked into walls, had a black out spell and couldn't talk or think didn' tknow who she was. She was in hospital 10/28 and 10/29. Her left arm was numb the entire week and she had heart palpitations. Hospital discharge paperwork said. BP was 147/120.
DTaP vaccine site with large area, almost all of anterior thigh with swelling, redness and tenderness. Tx - Zithromax and Prelone. Time course 2 days after vaccine.
pain at injection site; redness at injection site; pink spots on skin in different areas; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema and skin discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pink spots that would appear on her skin in different areas and would go away and then reappear and this happened for 4 months after the dose. The reporter denies that the pink spots were raised, they did not itch and were not painful. The reporter did not consent to follow up.
Generalize weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Generalize weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Generalize weakness). At the time of the report, ASTHENIA (Generalize weakness) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-026102 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Patient came to pharmacy on 3/31/14 and stated that she got the shingles vaccine on 3/28 and then spent the majority of the day at the ER on 3/29 and the doctor diagnosed her with cellulitis at site of injection.  She was prescribed Bactrim DS which she got at another pharmacy and is currently taking.  Site was raised, blistered, and rashy with a bright red tint.
Hospitalized with cough and dyspnea on exertion. Covid positive SX from increased chills with rigors, fever, fatigue, weakness, headache. Remdesivir 5 day course.
Initial unsolicited report received from a consumer on 24 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine (manufacturer: unknown, batch number, dose, dose in series, expiry date were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was reported that the patient was not allergic to eggs, latex. On an unknown date, following the vaccination, the patient showed sensitivity to the ingredients and also the patient get the flu each time she takes a shot. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
7/23/13 Hard lump at VARIVAX injection site - applied ice. 7/24/13 Lump 3" across and painful. 7/26/13 Lump resolving - 1" and no longer painful.
Felt liquid go into arm. I was able to walk and had no issues at the time of administration. By 4pm, felt burning back sensation. Next day, heart was hurting and felt burning sensation on chest as well. Have been to ER twice, but they have not found any issues. Back pain still continues to this day. Lung area feels painful. Intense headaches and dizziness. Legs hurt and fingers feel like they have neuropathy.
Patient came to clinic with reaction to PNEUMOVAX given three days previously. Right arm is red and edematous from approx 2 above elbow to shoulder. It has been painful and swollen - he applied cool compresses with minimal relief. Had fever and chills the 2nd day, along with malaise and muscle pain at injection site.
8/11/02 child presented with fever and erythema multiforme (iris lesions).
First 8 hours fine, body aches severe 102 fever for 12 hours, fever then left and severe headache for another 12 hours. Tired weak for 3 days.
Increased heart rate, chest pain, extreme stomach  pain, vomiting, fever, body jerks and weakness in extremities . Had to call 911 to assist.
This spontaneous report as received from a pharmacist. He stated that he had unspecified number of doses of (Merck) VARIVAX which had been exposed to 70F for 18 hours. The pharmacist declined to provide lot numbers and expiration dates for doses to be evaluated. It was unclear as to whether or not doses were administered to patients after exposure. This is one of several reports from the same source. Additional information is not expected.
Pain in eye within 36 hours or administration and then vesicular rash on day 3, with diagnosis of  Cranial Nerve 2 shingles.
Myalgia, Arthralgia, Chills, Fatigue, No taste Narrative:
Rash around incision from hip surgery and on botton of feet Stinging going thru-arms, hands and feet also aching arm up thru neck where shot was given Dr. prescribed Antibiotics for a week seem to help
It felt like the throat was bruised, I thought I had pulled a muscle so I was having my physical the following week so I waited and I had anemia and thyroid hormones were very low. My doctor had done lab work and that led to ultrasound of my Thyroid. They are still checking my blood work every 6 weeks to check on thyroid.
3 days after the second dose, I experienced severe muscular lower back pain. The pain started that night on the 3rd day, and increased in intensity as the night progressed toward 3AM. I tried to keep water and Ibuprofen down to treat the pain, but after several hours of intermittent dry-heaving after initially being unable to keep the painkiller down, I was taken to the ER at 9:30AM. After puking, I would experience a small reprieve before the pain would slowly increase again, as would my feeling of nausea. The nausea correlated with my pain level.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2568 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
pt received flu and tdap on 11/7/20. pt called today reported she has a knot on her left arm where the vaccine was given. she also noticed pain and weakness/less range of motion in that arm. she stated the next day after getting the vaccine, she was feeling drowsy. Mentioned to pt, it's common to get a knot after tdap shot and should go away after a week or two. have pt try hot compresses at home to help decrease the knot and improve the range of motion. told her I'd check up on her in a week.
non-stop screaming x 2 1/2hrs;began 4 hrs p/vax;APAP given a vax q 4hrs
I ended up in an unspecified hospital with what the doctors thought was a UTI but it traveled to my kidneys.  A few weeks later I started to have issues with my thryoid disease and went in for a battery of tests.  My immune system was on overdrive and everything was off with my blood work.
localized rash on left thigh, red patches around injection site about 1 inch around, non tender and no swelling. advised to give benadryl q 6 hrs, hydrocortisone cream, warm compress. resolved in 3 days.
Numbness/weakness/somatosensory symptoms in legs and torso, rapid onset within 20 minutes. Progressed to urinary difficulties, inability to walk. Diagnosed as transverse myelitis @ Medical Center. Lingering effects two months later.
This is a spontaneous report received from contactable reporter(s) (Nurse),   A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Dec2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Any other medical condition, consumer stated, "I only have high blood pressure. Concomitant medication(s) included: CARDIZEM [DILTIAZEM] taken for hypertension; TRIAMTERENE/HCTZ taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she took the Paxlovid on the 17th and also she got the COVID 19 vaccine and the booster shots". The events "she took the paxlovid on the 17th and also she got the covid 19 vaccine and the booster shots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results, notes: they just give me they took my blood pressure took care of everything the doctor team; SARS-CoV-2 test: (Dec2022) positive, notes: I think I have the COVID back. The way I feel, the way I am sick now, I am not going to do the test again; Weight: (unspecified date) 202 lbs. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: Reporter stated that she just reporting that she took Paxlovid for five days and had a rebound case and as per the caller she took the Paxlovid on the 17th and also she got the COVID 19 vaccine and the booster shots (Unspecified booster).  Consumer stated, she finished taking it and threw away the package.; Sender's Comments: Based on  available information, the causal association between the events Drug ineffective/Covid-19 and suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded.
This spontaneous report was received from a medical assistant, concerning an 11 months-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot# M042322 and expiration date of 21-FEB-2019 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccine was stored at a temperature of 1 degree Celsius for a time frame of 9 hours. No prior temperature excursion or adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.