chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 year old female with no pertinent medical history and no drug reaction / allergies, who on approximately 01-APR-2008 was vaccinated with 1 dose of VARIVAX (Merck) (lot number: 1511U). Suspect therapy that day included: a third dose of GARDASIL (lot number: /0978U). Concomitant therapy included: Ibuprofen and Seasonale. On approximately 02-Apr-2008 the patient reported having muscle pain within 48 hours of getting both vaccines. On approximately 04-Apr-2008 in the morning, the myalgia was remarkable. The patient had to slide down the stairs on her buttocks to get downstairs. There were no lab diagnostic studies performed. Unspecified medical attention was sought, the patient was seen. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
I'm experiencing chronic (5 months) body itching; hives; redness; rashes; sneezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (medically significant) with onset Aug2021, outcome "not recovered", described as "I'm experiencing chronic (5 months) body itching"; URTICARIA (medically significant) with onset Aug2021, outcome "not recovered", described as "hives"; ERYTHEMA (medically significant) with onset Aug2021, outcome "not recovered", described as "redness"; RASH (medically significant) with onset Aug2021, outcome "not recovered", described as "rashes"; SNEEZING (medically significant) with onset Aug2021, outcome "not recovered", described as "sneezing". Therapeutic measures were taken as a result of pruritus, urticaria, erythema, rash, sneezing. Addition information: The patient wonder known whether he need to take a booster shot (whether is it a Moderna's requirement). It was reported that: I've been taking Zyrtec (anti-histamine) and it greatly helps me so much, but after 24 hours, my body starts itching and redness again all over my body, then I have to take Zyrtec to relieve the itchiness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Fever, Fatigue Narrative: missed work following second dose due to above symptoms
Whole body aches; Shaking; Face deep red, very hot; Face deep red, very hot; Bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and experienced side effects. On an unspecified date, the patient experienced whole body aches, shaking, face deep red, very hot, bad headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
hematoma 3x4 cm notch on rt thigh; area sl bluish in color; no redness or fever noted; pt not irritable;
Developed urticaria and body rash approximately 2 hours after ingesting first dose of oral typhoid vaccine.
Pt recv vax on 9/11/98; post vax pt exp swelling/itching of IPV vax site-LA w/ pain in collarbone area
Slowly losing hearing in one ear; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Slowly losing hearing in one ear) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Slowly losing hearing in one ear). At the time of the report, HYPOACUSIS (Slowly losing hearing in one ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not reported. Treatment was not reported.
Rash on entire chest, stomach and down to hips and back, and forearms.  Started 10/11 and still there today.
Headache, fever(100.1) joint and muscle pain, nausea, weakness, fatigue
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 25-NOV-2016. As a direct result of the vaccine, the patient, suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles was reported to be disabling. Additional information has been requested.
Nausea; Vomiting; diarrhea; Chills; Headaches; quite debilitating; injection site red; Injection site hot; Injection site rash/raised 8 inch rash at the injection site; This case was reported by a consumer and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of no adverse event (received original vaccine at least 10 or more years before the reporting date).   On 16th April 2019, the patient received the 1st dose of Shingrix 1 ml. In April 2019, several hours after receiving Shingrix, the patient experienced papular rash, injection site erythema and injection site warmth. On 16th April 2019, the patient experienced nausea, vomiting, diarrhea, chills, headache and debility. In April 2019, the outcome of the papular rash, injection site erythema and injection site warmth were recovered/resolved. On 21st April 2019, the outcome of the nausea, vomiting, diarrhea, chills, headache and debility were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, papular rash, chills, headache, injection site erythema, injection site warmth and debility to be related to Shingrix.  Additional details were reported as follows: The patient was in good health and had never reacted to any vaccines in the past. The patient received Shingrix approximately 4:00 PM the first of the two Shingrix. In the same evening, several hrs after vaccination the patient experienced nausea, vomiting, diarrhea, chills throughout the night, splitting headache similar to a migraine.  The next morning on 17th April 2019, the patient had a hot, red, raised 8 inch rash at the injection site.  The most of these symptoms continued until last evening 5 days which seems to be an extended period of time. The patient also had attached a shot of the reaction site as of the day of reporting. Less than a week after, the symptoms were quite debilitating.  The patient was reporting these results in an abundance of caution and in the interest of further research and study.
kind of memory loss; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (kind of memory loss) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (kind of memory loss). At the time of the report, AMNESIA (kind of memory loss) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.  Patient mentioned that had experienced kind of memory loss and it lasted for about 2 or 3 weeks to a month.   Reporter did not allow further contact
Multiple macular rash along his arms observed during clinic visit about 10-15 minutes after vaccine was given.  MD prescribed Benadryl and Medrol Dose pack for treatment.
arm pain and swelling 5 days after vaccine, suspect COVID arm supportive care with tylenol/NSAIDs, PO antihistamine
Pt noticed the following symptoms the day after receiving vaccine: swelling/stiffness of the deltoid. Pt reported to aid station two days after receiving vaccine to be seen by provider and the following symptoms were noted: redness, swelling, induration around the site of injection as well as up the shoulder and down part of the arm. Pt was prescribed cephalexin and is to be treated for likely cellulitis vs reaction to the actual ingredients in Anthrax. Pt to return to clinic if symptoms worsen or persist.
leg @ DTP site golfball size & then thigh/leg swollen to socks next day; t100.9; nl p/5 days;
fatigue; headache; body aches; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular in the left arm on 23Dec2020 08:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included caffeine, paracetamol (EXCEDRIN), and paracetamol (TYLENOL). On 23Dec2020, the patient experienced fatigue, headache, body aches and dizziness. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of  ROTATEQ lot# L013202 and expiration date: 27-JAN-2017, orally. No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Heartburn starting at 48hr post vaccination; Headache; chills; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Feb2021 08:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation at a workplace clinic. Medical history included allergies to sulfur drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included probiotics, vitamin d [vitamin d NOS] and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3247) on 28Jan2021 08:00 in the left arm for COVID-19 immunization. The patient experienced heartburn starting at 48hr post vaccination, headache and chills on 20Feb2021 08:00. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of heartburn starting at 48hr post vaccination which included heartburn medicine. The outcome of the events was not recovered.
December 1, 2021 Vaccine Vile transferred from Freezer to Fridge  January 3, 2022 Vaccine dose administered.
Sore when lifting arm x 5 days - painful. Saw MD, prescribed TORADOL and naproxen. Had PT x 3 wks.
Day of initial vaccine - pt developed a soft tissue mass over the mid clavicle anteriority  aprox size of a ping pong ball  and ran had fever of 103 fir 3 days following each vaccine.  Soft tissue mass gradually dissipated but never went away completely.
Extreme fatigue; Muscle and joint pain; Joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 22nd March 2020) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd September 2020, 1 days after receiving Shingrix, the patient experienced fatigue, muscle pain and joint pain. On an unknown date, the outcome of the fatigue, muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the arm. The patient reported extreme fatigue, muscle and joint pain starting the day after receiving first dose. This was not resolved and continued to be bothersome. The patient was suggested to follow up with her health care provider. The reporter did not consent to follow up. No MD information was provided
I developed chest burning and chest pain midsternal. It was constant. Exercise did not affect it. Rest did not affect it. It was just constant. The pain would go through my back. That lasted for about 2 and a half weeks. I saw my doctor in between there and he diagnosed it as an inflammatory response. He started me in protonics. The chest pain was reproducible, like if you touched my chest you could reproduce it. He gave me a shot of Toradol and a shot of steroid. He did an EKG and the results were unchanged from previous. After the 2 weeks the chest burning went away. The pain became intermittent.
clogged ears, loss of hearing acuity. Sudden onset.; clogged ears, loss of hearing acuity. Sudden onset.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), via an unspecified route of administration, administered in left arm on 19Apr2021 14:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. On 22Apr2021 20:30, the patient experienced clogged ears and loss of hearing acuity, sudden onset. There was no therapy for the events. The patient had no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
A report was received from a health care professional on 22OCT2003 concerning a 57 year old male vaccinee who experienced low grade temperature, general body aches, joint pains and mild diarrhea 12 hours after receiving Fluvirin on 20OCT2003. On an unspecified date, 12 hours after receiving Fluvirin in OCT 2003 the vaccinee experienced low grade temperature, general body aches, joint pains and mild diarrhea. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending . Cross reference with PJP200300868.
pt recv vax 28JUN95 & OCT96 pt devel a full blown case of chickenpox & presented to MD;
Initial report received from a health care professional in the USA on 17 November 2006. A 36 year old, female patient (with a medical history of eczema, high stress and an allergy to penicillin) developed a red, scaly rash on her legs, arms and torso, approximately 1 week after she received an intramuscular injection of Decavac (lot number U1789BA) in the left deltoid on 26 October 2006. The reporter stated the rash "appear to be areas of inflamed psoriasis", where the majority was on the legs and lower arm. The patient denied a local reaction at the injection site. She had strep throat at the  time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 09 January 2007. The patient was taking a Z-Pak concomitantly, not Z-rock as previously reported. The patient's adverse event was additional treated with Benadryl, Prednisone, Zyrtec, Batamethasone 0.05 % ointment, and Drithrocreme 0.5%. IF the subject's symptoms persist. she is to see a dermatologist. At the time of this report, the patient had not recovered. Follow-up information received on 05 February 2007 from a health care professional. The psoriasis resolved as of December 2006.
Headache, Fever, NauseaVomiting, Narrative:  SX onset 1/4/21 after 1st vaccination: Fever, headache, nausea, fatigue, loss of appetite. 1/11/20 2nd vaccination, on 2/17 the same sx started again. At this point employee started seeing her PCP and has been seeing numerous specialists since. Now has sx approx 1 week out of every month.
The patients also experienced a Staph infection after the GARDASIL 9 shot as well; Vaccination failure; HPV; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a female patient of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies was not provided.  On an unknown date (reported also as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced human papillomavirus (HPV) (papilloma viral infection), so it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had a lack of effect (vaccination failure). It was mentioned that the patient experienced a "staph" infection (staphylococcal infection), on an unknown date, after the shot, as well.   Information about treatment for the events, if any laboratory diagnostics were performed, or if the patient sought medical attention was not provided.  At the time of report, the patient had not recovered from the papilloma viral infection. The outcome of vaccination failure and staphylococcal infection was not provided.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and papilloma viral infection, and vaccination failure was considered related by the reporter. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and staphylococcal infection was not provided.  Upon internal review, staphylococcal infection was determined to be a medically significant event.  This was one case, of two from  the same reporter.; Sender's Comments:  US-009507513-2105USA007258:
Patient states pain since date of administration on 10/14/19. Has been to see Dr and he is having her have xrays and then steroid shot/possible physical therapy.
Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (7 months after receiving Moderna vaccine).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) outcome was unknown.            No concomitant products were reported. No treatment information was provided.  Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.; Sender's Comments: Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.
Within a few hours of injection patient developed red spot on left arm about 2-3 inches in length complained of tingling in arm.
Breakthrough COVID-19 case with unknown symptom onset: low grade temp and diarrhea. Death 8/28/2021. From Vital Records COD = CHRONIC COMBINED SYSTOLIC CONGESTIVE AND DIASTOLIC CONGESTIVE HEART FAILURE, UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE. HTN, anxiety CHF Afib . Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: UNSPECIFIED ATRIAL FIBRILLATION. place of death: NURSING HOME-LONG TERM CARE FACILITY; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: EDUCATOR, EDUCATION
4-1-15 Called (husband) 2:35 pm-patient vomiting, dizziness, lightheaded, nausea-with some chest pain states like weight-did not call earlier-to see if she would feel better. Nausea, vomiting a little less-chest pain not as hard. Last meal-burrito from wagon at around 5:30 pm-everything started happening around 10 pm last night. Spoke with husband-checked Lt arm-slight redness-small amount swelling less than quarter size. Due to chest pain-to ER-has no regular medical doctor. Given name nurse and clinic and personal phone #. Call after ER visit. To let ER know about Tdap booster 3/31/15 and meal last pm.