chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information on the patients' pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with VARIVAX, lot # M041513 with expiry date on 11-OCT-2018, lot # M038856 with expiry date on 14-SEP-2018, lot # M047660 with expiry date on 02-DEC-2018 and lot # N000682 with expiry date on 06-JAN-2019. The doses of vaccine were reconstituted with properly stored sterile diluent. Administered doses of vaccine experienced a temperature excursion between 15 and 46 degrees Fahrenheit for 1 hours 28 minutes. There was no previous temperature excursion reported. Data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004066.
Symptom onset 4/4/23. Treatment included medication, Oxygen, ISP, labs and assessment.
Patient was given Moderna 0.5ml instead of 0.25ml for booster. His initial COVID vaccine was Johnson & Johnson/Jannsen given March 2021.
DIDN'T SLEEP WELL; SHIVERING A LOT; ARM SORE; EXHAUSTED; LOW FEVER; 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced didn't sleep well, shivering a lot, arm sore, exhausted, and low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from didn't sleep well, shivering a lot, exhausted, and low fever, and the outcome of arm sore was not reported. This report was non-serious.
This case was reported by a consumer and described the occurrence of positive for Lyme disease in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypothyroidism (for 16 years) and incomplete right bundle branch block. Concurrent medications included SYNTHROID. On an unspecified date in 1999 the subject received 1st dose, 2nd dose and 3rd dose of LYMERIX (unknown). On 24 July 2012, 13 years after vaccination with LYMERIX, the subject experienced bug bite, slow healing, blister. On unspecified dates the subject experienced headache, exhausted feeling, low grade headaches. On 03 August 2012 the subject felt as if going to pass out. On unspecified dates the subject also experienced chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head, dizziness, pressure headache and vaccination failure. In 1999 the subject took the LYMERIX vaccine (three doses over a year). Since 24 July 2012 the subject had bug bite on point of elbow that turned into pea sized red blister (the subject thought it was West Nile) there was no bullseye. It took five weeks to heal. The subject had to take afternoon naps due to headache and feeling exhausted in the first week. Four days of constant low grade headache before travel and then in ER on 03 August 2012 due to feeling of passing out while driving. Then three weeks of chest, neck, shoulder, upper back pain with high pressure headache mostly top and front like sinus back also back of head, has gotten better. The subject reported having seen "heart doctor (ok with continued incomplete right bundle branch block (IRBBB) and heart rate of 40-45 like last year), have seen endocrinologist and waiting results". Relevant test results included ELISA: Positive Lyme and Western blot Lyme: reactive IgM bands 23 and 39, non reactive IgG. The subject started treatment on 05 August 2012 doxycycline 100 mg, twice daily for 21 days. At the time of reporting the bug bite, slow healing, blister and low grade headaches resolved. The chest pain, neck pain, shoulder pain, upper back pain, headache-pressure around head had improved. The outcome of Lyme disease, headache, exhausted feeling, felt as if going to pass out, dizziness, and pressure headache were not specified. This case was assessed as medically serious by GSK.
Family Medicine Acute upper respiratory infection Dx URI ? Generalized Body Aches  ? Fatigue
On 11/13/00, Maternal grandmother call at 8:00AM regarding child stating "On Nov 7, Tuesday evening, child had congestion. On Nov 8, she had an allergic reaction, asthmatic attack, sever wheezing, treated at ER with a 'shot' and a Nebulizer. Treated with Alupent. She was kept in the ER for 20 minutes and then released with the direction not to receive Pertussis over again. Pt know to have immune disorder with protein problem.
I developed symptomatic palpitations that started on 12/23 in the early morning, awaking me from sleep.  Palpitations became so frequent that I went to my PCP's office, where I was found to have an abnormal rhythm on my EKG (non-sustained V-tach, runs of 4-5 beats at a time).  I then went to hospital where I was admitted to observation in the ED for monitoring.
C/o neck pain, with headache, has twitching in right eye.  Lower blood sugar than usual.  Has rash on chest.
Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
pt recv vax lt arm;excruciating pain started immed & has cont off & on limited mobility of lt arm;has not seen PMD for dx/tx;
3 days after test patient notes occasional palpitations and redness at arm. She reports a similar reaction with 1st dose.
Patient was given Zostavax vaccine at approximately 12:30pm on 12/20/08 (subcutaneously per protocol) at Pharmacy. He had no problems at time of injection and stayed at pharmacy for approximately 15 to 20 minutes after injection). Later that evening, the patient experienced itching and warmth in groin and axillary areas. He also had a sensation of trouble swallowing but reported no problem breathing. He called his primary physician and was instructed to take diphenhydramine (or loratadine) and ranitidine. I spoke to him on Sunday (12/21/08) and he told me what had transpired the night before. He said his physician felt it was an allergic reaction to one of the components in the vaccine and not Shingles. On Monday (12/22/08), the rash had spread to other parts of his body but the difficulty swallowing had subsided. He saw his physician and was prescribed a methylprednisolone dose pak. I called him on Monday night and again on Tuesday and he was doing much better. The rash cleared completely by end of dosepak and patient has had no other problems (recovered completely).
Patient started to get a pain in the side of her neck, throat after getting the COVID vaccine. The paramedics came and looked her over, they said that she is okay to go home as long as she was up for it since her husband was here with her. They told him to stay with her and monitor and to call them if anything changed or got worse
Extreme migraine headache began within 12 hours of injection. Within 24 hours severe lower leg pain (calves) began. Reached out to my primary care and they said this was normal. Headache lasted for 60 hours and dissipated. However lower leg pain continued for weeks, with pain waking me up in the middle of the night. It took 4 weeks for the leg pain to resolve. I was very concerned about the leg pain  because of the blood clot issue. But I did read it could last for weeks.
This patient was admitted to the hospital, neurology consult. He had plasmapheresis 3 times. Then he was admitted to rehab at the hospital. Diagnosed with GBS, Hyponutremia, wound infect, leukocytosis, increased temperature
Six days after the Pfizer booster I began having red raised bumps on my left upper leg, buttocks and abdomen along with pain inside my buttocks and leg, a headache and some lightheadedness.  These symptoms were diagnosed as shingles on Saturday 4/30/22 after I had completed my 7 days of v-safe text surveys.  (I thought the bumps were spider bites at first so I didn't record them in v-safe.)  I completed  the Shindrix shingles vaccine series in January 2021, so it was a surprise to get shingles but I've heard it has happened after the Pfizer vaccine, though rarely.  I received a prescription for Acyclovir on Sunday 5/1/22 (800mg 5 times/day for 7 days).  I'm still taking it and after 5 days the bumps do not seem to be spreading but the area is still somewhat uncomfortable.
Pt. described nerve discomfort on right hand involving 3 middle fingers. Pt. states feeling much better w/hand exercise with ball.
Gradually worsening arm pain and decreased range of motion for 1-2 months, then gradual improvement to baseline.
Edema & erythema of left deltoid region on 07/15/2003.  Was slowly getting better on 07/16/2003 when patient was seen.
This spontaneous report as received form a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a dose of ZOSTAVAX (dose and lot number were not reported) for vaccination, was administered intramuscularly rather than subcutaneously to the patient on 15-MAY-2013. No concomitant medications were reported. No adverse event reported. Follow-up information was received from the Pharmacist. Patients demographics were updated. Illness at the time of vaccination was none. On 15-MAY-2013, patient was vaccinated with a dose of ZOSTAVAX (Lot # J000445, expiry date was 11-APR-2014) intramuscularly instead of subcutaneous route. Patient had slight tenderness on 17-MAY-2013 that went away on an unknown date in 2013. Additional information is not expected.
Onset of symptoms 12/1/2021 including: fever, chills, muscle aches, headache, fatigue, cough and nausea. Tested (+) for Covid 19 on 12/2/2021
Information has been received from a physician, concerning a 17 year old female patient with an allergic reaction to CECLOR and no other pertinent medical history, who in August 2007, was vaccinated with the first dose and in October 2007 was vaccinated with the second dose of GARDASIL (lot #'s not reported). After the second dose, in November 2007, the patient's mother noticed early lesions. In February 2008, the patient was administered the third dose of GARDASIL (lot # not reported). Concomitant therapy also possibly initiated in February 2008 ("a few weeks ago") included CELEBREX. Following the third vaccination of GARDASIL, the lesions worsened. Diagnostic studies included liver functions tests, elevated; renal function test, normal, a skin biopsy, medium vesicle vasculitis. The physician indicated the patient had polyarteritis nodosa, which he described as "another name" for medium vesicle vasculitis. The patient was a runner, and was uncomfortable and had difficulty running due to the symptoms. The patient's polyarteritis nodosa persisted. The physician considered the event to be disabling/incapacitating. Additional information has been requested.
In the evening of the inoculation the fever occurred, with the phenomenon of tachycardia and chills. Exhaustion for the next 3 days. Batch number required.
Post-herpetic neuralgia; This case was reported by a nurse via call center representative and described the occurrence of post herpetic neuralgia in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number HE2P5, expiry date 22nd February 2020) for prophylaxis.   On 30th November 2019, the patient received Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 6 weeks after experienced Post-herpetic neuralgia. Reporter did not consent to follow-up.
Myalgia, Arthralgia, cold chills, fever, lower back pain, achy knee joints, headaches Narrative:
lower back pain, worsened to thighs, spasms developed. Unable to walk, Ketorolac injection, prednison, and flexeril. 2  days later on 12/25/2021, symptoms resolved.
He reports changes in speech noted by neighbor on 5/8/21.  Admitted for acute stroke on 6/12/21.
A 63-year-old female with a medical history of Hashimoto?s Disease, on Levothyroxine 88 micrograms (4 days per week) and 100 micrograms (3 days per week), presented to the emergency department with a 7-day history of acute onset of severe, debilitating, fatigue, weakness, anorexia and malaise. She had no clear precipitating events, stated that she was in her usual states of health, active, working as an optometrist at a University hospital. Stated that 1 week before symptom oncer she had her first dose of Moderna COVID-19 Vaccine EUA. Stated that 24hrs later her symptoms started associated with low grade subjective fever, however her fever disappeared, and she persisted with severe fatigue. She was unable to do her regular activities of daily living and was hoping her symptoms would resolve but upon persistence and given the severity of her complains she presented to evaluation. She denied recently starting any new medications/supplements, or recent change in her levothyroxine dose. There were no headaches, cough, diarrhea, sore throat, rhinorrhea, myalgia, arthralgia, weakness, recent infectious illness or sick contacts. She was diagnosed with Hashimoto?s Disease over 10 years prior and had been on the same dose for more than 2 years.   VS were stable and within normal limits, physical exam was only remarkable for weakness on 4 extremities 4/5, lethargy, bradylalia, bilateral ptosis, no focal neurologic deficits, sensation intact. Laboratory workup revealed normal Hb 14.8, normal renal and kidney function, normal cortisol level, TSH normal 3.7, normal FT4: 1.2, normal CPK, negative tox screen. ESR and CRP were performed, and both were found to be elevated ESR 74, CRP 28, at that moment we decided to do immunologic workup showing high titers of ANA >1:320 with a nuclear speckled pattern, and a positive rheumatoid factor 60. At this point a full rheumatologic panel was performed which was negative for anti-Ach receptor Abs, negative anti-CCP, anti- dsDNA, anti-smith, negative anti-Jo1, anti-RNP, negative anti-TPO, negative anti-SCL70, normal C4 and C3 however elevated total CH50 > 60, positive anti-SSA and anti-SSB. Her symptoms of severe fatigue persisted throughout her admission and it was decided to give her a course of prednisone 40mg for 5 days and follow up as outpatient with a Rheumatologist. Repeat workup 2 weeks after discharge showed still elevated ESR at 72, high CRP 17, rheum factor elevated again at 67.  At this point no clear cause was identified as she did not have any symptoms of Sjogren or anything else other than severe persisting fatigue.  Another course of steroids was given and 1 month later she stated that she was much improved and was able to go back to work. Stated that she would not take her second covid MODERNA vaccine dose due to fear of recurrence of symptoms. It appeared that this vaccine triggered a severe inflammatory and autoimmune reaction in this patient with history of Hashimoto?s disease. The association between MODERNA vaccine and development of autoimmunity and inflammatory reaction needs to be assessed.
The next day after my 3rd dose vaccination I had the following symptoms: Pain in my left shoulder, My joint was very sore and it was difficult to move. I had an MRI and it showed that I had Arthritis and it affects my daily life. I had a steroid shot for treatment.
SkinRash, Rash & ErythemaMultiform Narrative: 9 days post vaccine developed red round rash at injection site. area was warm to touch and slightly raised.
A numbness occurred in the left arm and through the left side of the body on day 1-3. Medical attention was sought and it was determined that no signs of stroke were present. Numbness and pain continued and medical treatment was sought again on August 14, 2021. That examination didn?t find any cause to the pain and numbness but suggested pain reliever and icing/massaging the injection site. The numbness continues with no other direction on treatment.
21SEP92 pt recvd vax pt called clinic 23SEP92 1045AM stating has swollen legs, hands, face, no pitting edema states has gained 5 lb;
Patient has immunization approximately 11:45 am. Home/nap, no fever noted sitting on aunts lap. Arched/drool/rolled eyes back ---> confused after awakening lasted approximately 1-2 minutes tired rest of evening.
Severe fatigue, fever to 101, chills.  Lasted about 36 hours.  Felt great after 2nd night with no lingering symptoms
allergic reaction; numbness on her lips; lips started swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EK4176) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "lips started swelling"; HYPOAESTHESIA ORAL (non-serious) with onset 2021, outcome "unknown", described as "numbness on her lips". Therapeutic measures were taken as a result of hypersensitivity, hypoaesthesia oral, lip swelling.  Additional Information: Patient is reporting side effects to her previous doses of the Pfizer COVID-19 vaccine. She said all of her COVID-19 vaccine have been Pfizer Products. She said a total of five doses. She said when she got her first dose, she started to develop an allergic reaction. She got numbness on her lips and her lips started swelling. She was at the hospital when it occurred and they treated her with an anti-histamine and they observed her for an hour.
tingling in his hands; This is a spontaneous report from a contactable consumer or other non-HCP (patient father) via Medical Information Team. A 29-year-old male patient BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history included brain cancer and damage to his circulatory system. The concomitant medications included cisplatin, levetiracetam (KEPPRA) at a dose and frequency of 500 mg two times a day with a daily dosage of 1000 mg, lamotrigine (LAMICTAL) at a dose and frequency of 150 mg two times a day with a daily dosage of 300 mg. Father stated his 66-year-old brother received Comirnaty second dose and died in his sleep 6 weeks later. He reported his 29-year-old male son (history of brain cancer) received his first dose of the Comirnaty vaccine and after which he reported tingling in his hands. He reported his son had damage to his circulatory system from chemotherapy that resulted in ice cold hands and feet prior to the vaccine. However, he also reported he took a beet supplement as a treatment and now it was improved. He wanted to know if we have information on this as a side effect of the vaccine. He stated his son has taken or currently takes cisplatin, cyclafornite (father did not know spelling), Keppra 500 mg 2 times a day, and Lamictal 150 mg and 200 mg 2 times a day. The outcome of the event was resolving.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
No additional AE or PQC reported; only 0.4ml of GARDASIL 9 was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.4 ml, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (underdose).
MASSIVE ITCHINESS IN THE INJECTION AREA OF ARM; SEVERE COUGH; VERY FATIGUED; FEVER; RECURRING SEVERE FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 130 pounds, and height was 63 inches. The patient's concurrent conditions included: all kinds of terrible allergies (mainly environmental allergy), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. No concomitant medications were reported. On SEP-2021, the patient experienced recurring severe flu like symptoms, severe cough, very fatigued, and fever. On an unspecified date, the patient experienced massive itchiness in the injection area of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurring severe flu like symptoms, severe cough, very fatigued, and fever, and the outcome of massive itchiness in the injection area of arm was not reported. This report was non-serious.