chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The past medical history includes stage 0 leukemia; had lying been outside near wooded area, fully clothed, for hours; no new lotions or soaps; exposed multiple times to chicken pox from his kids. His past drug history was unknown. On 20-JUN-2015 the patient was vaccinated with ZOSTAVAX, lot# 6006380 with expiry date 25-MAY-2016, .5 ml, subcutaneous in the arm. Concomitant therapies included SIMVASTATIN TABLETS, USP, PLAVIX and PREVNAR. On 22-JUN-2015, the patient had one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm, unknown if right or left arm. The patient wondered if it was an allergic reaction. The pharmacist advised hydrocortisone cream. On 26-JUN-2015, the patient had raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center. On 26-JUN-2015, the patient experienced not feeling well, headache, no energy, being uncomfortable from itchy pustules. The pharmacist did not believe it was shingles and thought that the patient was having an allergic reaction. The pharmacist referred the patient to his physician, as concerned that he could possibly have a tick bite. On an unknown date in June 2015, the patient was seen at a clinic and started on acyclovir 800mg five times a day for a vaccine reaction, not chicken pox or zoster. On27-JUN-2015, the patient experienced worsening of not feeling well, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back. The patient had no relevant laboratory data. As of 27-JUN-2015, the patient no longer continues on with ZOSTAVAX and continues to experience vaccine reaction and worsening of not feeling unwell, headache, no energy, being uncomfortable from itchy pustules and his rash spread further to his torso, bilateral armpits, and back, and the outcome of one small, itchy, but not painful, red raised area, like a bug bite, on the lower portion of his arm and raised, itchy, but not painful, blotches on his lower legs, which were red on the outside and white in the center was unknown. The reporter did not provide the causality between with ZOSTAVAX and the events. Additional information has been requested.
HEADACHE; NAUSEA; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to allergy shots, abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 01-APR-2021 09:30 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99.6 F. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 01-APR-2021, and had not recovered from fever, body aches, headache, and nausea. This report was non-serious.
symptoms of Covid, had a PCR test and it came out positive; feel unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine and 5 days later she started to feel unwell, with symptoms of Covid. She had a PCR test and it came out positive. Can she still get the second dose? She was supposed to receive it this Friday. The patient underwent lab tests and procedures which included  PCR test: positive on an unknown date. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
One day post injection arm swollen, red and warm to touch. Treatment: warm and cold compresses, Motrin and Benadryl.
Joint pain Fever Chills Swollen adenoids/tonsils-lasted 1.5 weeks Sore throat Headache Pain just touching skin Loss of appetite  Woke up covered in sweat Dizziness
Patient had covid(omicron),her symptoms were mild; Booster dose: 12nov2021, She had Covid on 8jan2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 062G20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022). At the time of the report, COVID-19 (Patient had covid(omicron),her symptoms were mild) and DRUG INEFFECTIVE (Booster dose: 12nov2021, She had Covid on 8jan2022) outcome was unknown.            No concomitant medication details were reported. Patient did not get tested for the variant specifically No treatment information details were reported.  Company comment: This spontaneous case concerns a 69-year-old female patient with no relevant medical history, who experienced unexpected non serious event (AESI) of COVID-19 and Drug ineffective which occurred 1 months 28 days after the third dose of properly scheduled first and second dose of mRNA-1273 vaccine. Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed after 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Current ongoing pandemic remains as a confounder. The benefit-risk relationship of drug is not affected by this report..; Sender's Comments: This spontaneous case concerns a 69-year-old female patient with no relevant medical history, who experienced unexpected non serious event (AESI) of COVID-19 and Drug ineffective which occurred 1 months 28 days after the third dose of properly scheduled first and second dose of mRNA-1273 vaccine. Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed after 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Current ongoing pandemic remains as a confounder. The benefit-risk relationship of drug is not affected by this report.
No adverse reaction, Patient is a 17 year 10 month old 264 pound female that received the Moderna booster
Patient awoke morning after receiving vaccine and stated she had a large lump the size of a "baseball" at the injection site.  Patient stated site was "severely swollen"  red and "painful to touch".  Patient denied fever, trouble breathing or hives.  Patient stated she applied ice to injection site with little relief.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
on 12-20-2020 arm soreness, muscles aches, low grade fever and cough for 24 hours.
pt developed alopecia and saw dermatologist who believes may have been related to hpv vaccination.
No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 2nd dose of SHINGRIX. On 6th December 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented a very swollen, painful, itchy and 4-inch red area on her upper arm after receiving her dose of SHINGRIX shot. On the date of reporting, the same symptoms continued.  The patient asked what she could do to relieve these symptoms.
severe headache,patient had a syncopal event,went to er,headache subsided in 48 hours,mri brain negative
COVID-19; COVID-19; Vaccine brand=Pfizer/BioNTech/had 2 additional booster shots of Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Mar2021 at 12:00 as dose 2, single (Lot number: EN6299), in left arm and on 30Sep2021 at 12:30 as dose 3 (booster), single (Lot number: FD0809) at the age of 63 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Vaccine brand=Pfizer/BioNTech/had 2 additional booster shots of Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. No Known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Horrible Dizziness; Sweats; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid removed, obesity, asthma, autoimmune disorder, COVID-19 and allergy to ACE inhibitors. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) 175 mcg tablet and hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ), both taken from unknown dates . Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced horrible dizziness, sweats, fever and fatigue. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events  horrible dizziness, sweats, fever and fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
I experienced a rash on my whole body, with extreme inflammatory, redness, rash. My skin was all red over my body, my skin got crusty, ran a fever. The rash was very bad.  I felt very sick. I went to see a dermatologist who  put me on steroids. The steroids calmed the rash down. And 3 weeks later, same thing happened, my dermatologist again put me on steroids again and it was the same thing that occurred. Then my rash cleared up and then it also happened two more times, but not as severe.  I was unable to get my second vaccine, advised from two specialists, two allergists and internists and all advised me not to take the second vaccine.   All my blood work came back normal except my IEG was off the chart.  I do not have the lot # to provide.
Pt rec'd flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as "reactive changes" but was non-diagnostic. He had add'l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as "reactive changes" but was also non-diagnostic. The pt has a h/o "low-grade" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.
Quarter size reddened, non raised area at site without redness or itching. 2-3 hours after receiving vaccine developed red, raised welts on face bilaterally that itched.
I became progressively more sleepy the afternoon after the vaccination, as expected.  I did get up and make dinner, then went to bed at 9:15 p.m. on March 8th and slept until 9:15 a.m. March 9th.  I felt unstable walking into the bathroom to urinate, and even more unstable waking into the kitchen to take my meds. I passed out and woke up on the floor.  I was weak but managed to pull myself up holding on to the kitchen range. I headed for the living room sofa and passed out again, waking up on the floor by the sofa.  I'm guessing I was unconscious about 2 minutes each time, but don't really know. I lay down on the sofa and called a neighbor.  He thought I should call 911, and they came and drove me to  ER .  They did an EKG, chest x-ray, and CAT scan of my brain, and drew blood.  All results were normal. I returned home that same day (March 9)  and had little energy, and ate lightly.  When I was getting in bed about 10:30 p.m. I let my head drop on the pillow and the room started to whirl around me for about six seconds.  Sometimes when I roll over in bed during the night there is a pause before   it feels like the room gives one spin.  My scalp is very tender in the large area where I hit it twice when passing out.  I'm taking it easy again today, but do feel a little stronger.  I am normally exceptionally healthy for my age, and work , traveling to destinations to research and photograph my articles. Both the travel and article take stamina, and I thrive on the work.
Tingling of the face; swelling of the face; loss of strength in left arm, hand,ring finger, and pinky finger.; This is a spontaneous report from a contactable consumer. A 39-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Right arm on 26Feb2021 at 16:30 (At the age of 39 years old) as Dose number, Unknown, Single for COVID-19 immunization. The patient's medical history included mastocytosis, mast cell activation syndrome from an unknown date and unknown if ongoing. The patient previously took histamine and experienced drug hypersensitivity, gluten and experienced drug hypersensitivity, soy bean and experienced drug hypersensitivity, dairy care and experienced hypersensitivity. Concomitant medications were not reported. Other medications in two weeks includes antihistamines store bought allergy meds. On 26Feb2021 the patient experienced Tingling of the face, swelling of the face, loss of strength in left arm, hand, ring finger, and pinky finger. Outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient has history of faintness after vaccinations. Patient received her 2 nd dose of Moderna on 5/22/21 at 10:27am. Patient had bleeding at injection site and was stressed out. She then complained of feeling lightheaded and hot. She requested an ice pack to cool down. The Ice pack helped calm the patient and she complained of the feeling very hot for about 15 minutes. She remained in pharmacy area for a total of 25 minutes and then felt better and left with her husband. I contacted her at 5:55pm on 5/22/21 and she was doing fine minus a mild sore arm per her husband. The husband reported no problems minus a sore arm.
L arm has vesicles moving down the arm, the arm is swollen/red and he has swollen lymph nodes.  c/o chest pressure.
Swelling, red bump, soreness and heated at injection site; temperature,  chills, nausea,  tiredness.  Worst symptoms lasted 48 hours; redness and soreness at injection site still apparent.
General discomfort, sore arm the first evening; Malaise and lack of energy the next morning, no appetite. At about 12:30 PM I had an episode when my husband says I was unresponsive for 3-4 minutes, resulting in an ambulance being called and me being admitted to hospital.
It was reported in a newspaper article, initial information was received on 29-AUG-2010 regarding that a group of parents who brought a case in 1993 which was blocked after their legal aid was withdrawn in 2003. They claimed for various injuries including autism, Guillain-Barre syndrome, epilepsy, sensorineural deafness, diabetes and arthritis. The status of the patients was unknown. Upon internal review, the autism, sensorineural deafness, epilepsy and Guillain-Barre syndrome are considered to be other important medical events.
Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event. Additional information has been requested.  06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness, paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL.   Discharged from ED with DX of Anxiety and Dizziness.  Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet.  Increased paresthesias of her lower extremities including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup.  PE WNL except for DTR's were not elicited in the lower extremities.  Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre Syndrome.  Polycystic ovaries.  Migraine headaches.
Information has been received from a RN concerning a 17 year old male who was vaccinated with two doses of MMRII (manufacturer unknown).  The pt was exposed to an imported case of measles from a classmate while at school. Subsequently, the pt developed measles. He developed a sore throat, cough, coryza, and fever on 04/03/03.  On 04/05/03, the pt developed a rash and was seen at the pediatrician's office. The pt was again seen at the pediatrician's office on 04/06/03 and then at the local hospital ER. The pt tested positive for measles IgM and IgG on 04/11/03.  Additional information has been requested.