chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drugs allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 29Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient experienced body aches, chills and fatigue (from 3 days). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, chills and fatigue were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
This patient was admitted to Hospital on 1/11/2022 for COVID related symptoms. This is considered a breakthrough case.
Dr. gave 1st HPV 9-2-10. Within a few days, pt. passed out, in 2 weeks passed out again. Spit up blood, bad headaches, stomach ache, hives. Dr. gave her HPV shot; recommended booster in 1 month. She passed out a week later, had panic attack, bad headaches, stomach and pelvic pain, legs cramping up at night. Waking crying, couldn't walk at first.
At 2:Am I woke up freezing even though the heat was on high, I had goose bumps all over my body for hours. Then the injection spot became very painful. Hours later, I tried to get up, but every muscle my body felt like I got beat up, I was weak, nauseous, dizzy, I black out while taking a shower and almost threw up. I was weak and shaky for the rest of the day. I took some 800ml ibuprofen and slept the rest off. I feel better now, (the next day). But still a little weak in the muscles and stomach.
Information has been received from a physician concerning a 9 week old male with milk protein intolerance and a history of being breast fed without incident, who on 22-JUL-2010 was vaccinated with ROTATEQ oral (Lot#667989/0687Z, therapy dose unknown). On the same day the patient also received DTAP (manufacturer unknown) and HIB (unspecified carrier) (manufacturer unknown). On 28-JUL-2010 the patient developed vomiting, weight loss and dehydration. The patient was admitted to the local hospital. The patient became acidotic, coded and recovered without intervention. On 31-JUL-2010 the patient was transferred to another hospital. The diagnosis was difficult to determine, but after numerous diagnostic studies including endoscopies and colonoscopies, the diagnosis of allergic enteropathy was made. Assay results were not back yet. The physician considered the patient as recovered, but will not be giving this baby any further ROTATEQ doses. The physician was unsure of the relationship between the event and the vaccine. Allergic enteropathy was considered to be immediately life-threatening. No further information is available. A lot check has been initiated.
From 10/10/00 to 10/13/00, had extreme aching in arm, extreme fatigue, unable to lift arm (stiff) and tingling/aching neck and arm with 2cm-3cm lump at site. Instructed to follow-up with PCP.
Vaccine was given to person under the age of 18. Patient was age 17 years 8 months at time of vaccination. Patient had no adverse reactions to vaccine.
PARKINSON SYMPTOMS WORSENED; EXCRUCIATINGLY PAINFUL PRESSURE POINT IN THE WRIST/HAND; NUMBNESS LEFT ARM TO A POINT IN WRIST AND FINGERS; SORENESS IN LEFT ARM TO A POINT IN WRIST AND FINGERS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease affecting left arm and hand, alcohol use, seasonal sinus problems, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, balance loss, numbness left arm to a point in wrist and fingers, muscle tightness in neck, intensified shaking of left arm and soreness in left arm to a point in wrist and fingers. The patient had not visited his physician but consulted a chiropractor. Chiropractor was unable to do anything with his neck to do improve movements. On an unknown date in APR-2021, the patient experienced balance loss over the last 4 to 5 days. On 13-Apr-2021, by the third visit to the chiropractor, the patient had some relief as chiropractor could do some movements. The patient would try to visit the physician next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, numbness left arm to a point in wrist and fingers, and soreness in left arm to a point in wrist and fingers. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210428449-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Parkinson symptoms worsened. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE.
Swelling in leg developed ~ 24-48hrs after vaccine administered, ~ 12x14cm red/swollen/warm area; right leg involved.
patient stated that tuesday evening after vaccination she had chills and nausea. wednesday she still had nausea and fatigue and halfway through the day she started urinating blood.  patient stated it is a dark brown color and it has continued through this morning (thursday morning).  She also stated that on thursday she is also experiencing abdominal cramping.  recommended patient seek medical attention through urgent care , emergency department or physician visit.
Pt was given Influenza 6 days after receiving the Covid-19 Moderna vaccine. Pt did not experience any adverse reactions. Only issue was that pt had received vaccine before the 2 week window.
Information has been received from a nurse practitioner concerning herself a 73 year old female with hypercholesterolaemia and temporal arteritis and with no known drug allergies who in June 2006 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#, dose and route not reported). On 10-MAY-2012 the patient was diagnosed with a mild case of shingles. The shingles was located at the left knee in a horseshoe shape, and also a patch on the arch of her left foot. The pain would travel down from the left knee to the left calf to the left toes. The patient sought for unspecified medical attention. The patient stated the pain was managed with TYLENOL, and when the pain occurred she would get up and walk too. The patient was treated with an antiviral medication for one week's time and fluocinonide cream. The patient was recovering. Now all that remains on the leg was some small scars. The patient stated that she knew the shingles would have been much worse if she had not gotten the vaccine. Follow up information was received from the nurse practitioner reporting on herself with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no adverse events following prior vaccination, who on an unspecified date was participant in a study of ZOSTAVAX. Then she found to had been on placebo. After FDA approval in June 2006 the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX (dose and lot number not reported). It was stated that on 14-MAY-2012 (previously reported as 10-MAY-2012) the patient developed a mild case of shingles, however left leg lesion, plus 5 m lesion left arch of foot for three days. Atypical rash-looked like mosquito bites-slight itch. Not really sign of pain. The patient did not experience other systemic symptoms. Severe cramps started from knee then calf then ankle to toes. Relief from very few doses of TYLENOL. The patient recovered on 11-JUN-2012. The patient did not seek medical attention. It was reported that the patient was not recently exposed to chicken pox or herpes zoster. Fluorescent antibody or specimen collected for PCR were not performed. Relationship between shingles and muscle cramps and ZOSTAVAX was unknown. Additional information is not expected.
Chills and sweating occured approx. 35 hours after Yellow Fever vaccine. Continuing for 24 hours - at present. Also has stomach upset and mild diahrrea. Treated with Advil, Tums and Pepto Bismol. Advil helped a little. Tums and Pepto didn't do much
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 11-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805498 was crossed linked to original cases 201804863 due to same reporter.
Information has been received from a licensed practical nurse concerning a 34 month old healthy female with occasional otitis and no other pre-existing allergies, birth defects, or medical conditions who on 10/11/2002 in the AM was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  Concomitant therapy that day in the AM included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered subcutaneously in the right arm, and a fourth dose of pheumococcal administered intramuscularly in the left thigh.  On 06/10/2004 the patient presented to the physician's office with 50 plus blisters, papular and vesicular, on her trunk, face, and legs.  She was afebrile.  The physician recommended diphenhydramine hydrochloride and calamine lotion.  No other information was available.  There was no product quality complaint.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations of the patient or her siblings.  Follow up information indicated that the adverse event onset was 06/09/2004 at 11:25AM.  The patient presented to the clinic with papular weeping vesicles on her trunk, face, and legs (worse on legs).  She was afebrile.  The physician prescribed isolation, no aspirin, diphenhydramine hydrochloride, aveeno, and calamine.  The patient was instructed to return to the clinic in 7 days.  It was reported that the patient recovered on 06/18/2004.  No further information is expected. Follow up information received. The lot number for pneumococcal conj vaccine (CRM197) (PREVNAR) has been added.
8 hours after vaccine started having chills.  I had a fever of 99.5. My normal temp is always 97.3.   Never had chills with ANY Flu Shot. Ever.   9 hours after vaccine I had a headache really bad.  10 hours after vaccine I had muscle pain all over back, both arms, both hands, both hips, both knees and both ankles. Monday night VERY hard to sleep.  Tylenol did not help me at all with pain.   next day Tue 4/13/21, low grade fever all day 99.3 or 99.5  Didn't do much due to pain all over body chills were gone Thought my face was swollen around 3pm.   ER doctor said I was fine and I left ER at 8:30pm I felt fine Wednesday around 10am.  Normal reaction.   No other issues.
RASH DEVELOP APRROXIMATELY 10 HOURS AFTER ANTHRAX VACCINATION
Woke up in middle of the night freezing while being super hot to the touch. Realized I probably had a fever.
Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment; Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: En6205), on 05Apr2021 as dose 2, single (Lot number: Er8732) and on 14Feb2022 as dose 3 (booster), single (Lot number: Fk9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Other medication in two weeks: No.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "recovered" (17Jun2022) and all described as "Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: I took a covid test June 10 was positive; (17Jun2022) Negative, notes: Retested June 17 was negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
The pt developed small, red dots all over her trunk and face. No fever. This lasted 3 days. No treatment.
Patient contacts pharmacy on 5/1/19 concerning symptoms that have developed after receiving  the 2nd Shingrex vaccine on 4/30/19. Patient has been experienceing body aches, temperature (treated with acetaminophen),  shivering, and headache, which started later on 5/1/19.  Upon additional follow-up,  patient reports developing a round, raised welt on 5/2/19 that was feverish to the touch. Patient reports that the welt went away on 5/5/19, and that she used Benadryl to treat it.
LOSS OF SMELL; LOSS OF TASTE; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced loss of smell. On 03-JUN-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, loss of smell and loss of taste was not reported. This report was non-serious.
Pain, swelling and redness at injection site. Nausea, chills, fever, fatigue, tiredness, cough, hard to breathe, muscle pain & aches, joint pain and chest pain.
Claimant alleges she received the flu shot, and now has a contusion and hematoma to the left arm.
Discomfort / pain / cramping in ankles and knees. Progressed throughout out the day to intense pain / burning sensation in both legs to lower back.  Subsided by 09/30/12.
No longer lactose intolerant; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included lactose intolerance from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was no longer lactose intolerant after receiving COVID-19 vaccine. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (17Sep2021): Follow-up attempts completed. information about lot/batch number cannot be obtained. No further information expected.
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection.  high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
Headache at crown of head.; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), trazodone (MANUFACTURER UNKNOWN) and alprazolam (XANAX) for unknown indication from an unknown date and unknown if ongoing. The patient previously took naproxen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 09Mar2021 at 19:00, the patient experienced headache at crown of head. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache at crown of head was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed pain inboth knees on 11/12/2018. 1 week later, on 11/19/18, developed moderate edema and pain in all joints of both feet and hands and also in both ankles and wrists. No fever. Developed erythematous blanching flat target lesions in both legs, trunk, arms and face. Seen at the office on 11/19/2018: Started on Prednisone 40 mg PO QS x 5 days. Arthralgias and edema of joints resolved after 2 days. Rash seemed to be slightly better. Developed acute hives all over body on 11/23/18 with no other symptoms: started on ALLEGRA which helped with rash. Throat Cx positive for Group A strep: started on pen V K on 11/24/18.
Three or four days after taking the first dose, I noticed I was running out of breath after walking my dog. I had to stop and catch my breath multiple times, which was odd to me because I didn't normally used to do that.
Expired vaccine. No temperature excursion occurred. Moderna determined vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." No adverse events reported.
Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received from pharmacist considering a 61 year old patient of unknown gender, who on 11-OCT-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-Sept-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005680, 1212USA005679, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
headache; fever; This case was reported by a nurse via sales rep and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additiona details were provided as follows For tolerance to 2nd dose, refer case US2019AMR030300.
Headache; Muscle Pain on vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), (Age at vaccination :71 years) administered in arm left, administration date 20Jan2021 09:00 (Batch/Lot number: E18987) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pemphicus Vulgaris", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "blisters", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "High Cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL taken for hypertension (ongoing); IRBESARTAN taken for hypertension (ongoing); AMLODIPINE taken for hypertension; PRAVASTATIN taken for blood cholesterol increased. The following information was reported: MYALGIA (non-serious) with onset 20Jan2021 09:00, outcome "recovered" (21Jan2021), described as "Muscle Pain on vaccination arm"; HEADACHE (non-serious) with onset 21Jan2021 09:00, outcome "recovered" (22Jan2021), described as "Headache". The events "muscle pain on vaccination arm" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, headache.  Additional information : Patient did not receive any prior vaccinations. After Vaccine: 1. Absolute- 7363h.Lymphocytes-S/B-850-3900 .2. Absolute- 1799h  Monocytes- S/B-700-950.3.Platetet-713 Count-Sb 140-400.4.White Blood-11.7h Cell Count-Sb 3.8-10.8.Before Vaccine:06oct2020;1. Absolute- 1808 Lymphocytes-S/B-850-3900.2. Absolute- 540 Monocytes- S/B-700-950.3. Platetet-187 Count-Sb 140-400.4. White Blood-7.5 Cell Count-Sb 3.8-10.8.  No follow-up attempts are possible. No further information is expected.