chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of COMVAX lot # J013884 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002369:
Hives, itchy, rash, tongue tingly, ears exploding, headache, head pressure, flushed, nausea, dizzy, tired.
About 15 minutes after receiving COVID 19 Pfizer vaccine client stated complain of feeling funny and feeling anxious. NO SOB noted skin warm and dry to the touch Resp. regular Requested a paper bag to breath into .After about 1-2 minutes using paper bag she stated she was better. Client monitored for 33 minutes.
Pt's arm swelled at site of injection, became red and swollen and felt warm to the touch. Pt called the pharmacy and was told to take an antihistamine and apply ice.
Fever of 105.3; tightness in chest; burning when breathing rapidly onset; fatigue; slight breathing issues; chills without fever; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 25-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 08:45 as single dose for COVID-19 immunization. Historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) was administered as a first dose on 21Jan2021 in arm left for COVID-19 immunization. The facility type for vaccine was hospital. Known allergies were reported with Penicillin, Cephalosporin, Ceclor, Sulfas and Tetanus Vaccine from an unknown date and unknown if ongoing and experienced drug hypersensitivity. Concomitant medications in two weeks included galcanezumab (EMGALITY), propranolol hydrochloride (PROPANOLOL) and armodafinil (NUVIGIL) taken for an unspecified indication, start and stop date were not reported. There were no other vaccines in 4 weeks. Patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, sore arm and chills without fever began approx. 3 hours post inoculation at 11:45 on 13Feb2021 and persisted through the day. Chills progressively worsened throughout the day. Fever of 105.3, tightness in chest, and burning when breathing rapidly onset while sleeping (approx. 02:00). Symptoms lasted until approx. 19:30 the next day 14Feb2021 with fatigue and slight breathing issues (tightness and burning) lasting until two days post-inoculation 15Feb2021. The patient underwent lab tests and procedures which included body temperature as 105.3 on 14Feb2021. No treatment was taken for adverse event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
No side effects or symptoms reported; Patient received his 3rd dose of GARDASIL 9 four weeks after second dose; This spontaneous report was received from a Licensed Practical Nurse (L. P. N.) concerning to a 16-year-old male patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On an unknown date in August 2022, at the age of 15-year-old, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided). On approximately 03-APR-2023 (also reported as "March 2022", conflicting information), the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided). Then, on 01-MAY-2023 (also reported as "yesterday" and "four weeks after second dose"), he was vaccinated with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided), which was administered at incorrect dosing interval, four weeks after second dose instead of the recommended 12-week interval (inappropriate schedule of product administration). Al three vaccine doses were administered as prophylaxis.   No side effects or symptoms were reported (no adverse event).
Sore throat started 16Oct2020 and is continuing on 17Oct2020. This is the first time the patient has ever received the flu vaccine of any kind.
RECIEVED DTap,HIB AND FLU ON OCT 19TH. MOM REPORTED YESTERDAY THAT SEE NOTICED RED RAISED BUMPS ON THE TRUCK OF HIS BODY AND BOTH ARMS AND LEGS. MOM REPORTS THAT CHILD HAD NO FEVER. HAS BEEN ON 9DAY THERAPY TREATMENT OF AMOXILLICIN, WHICH MOM REPORT THAT SHE IS ALLERGIC TO AMOXICILLIN.
This report as received from a health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of GARDASIL that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
she had soft tissue inflammation in her hands,  and joints.  this was a few weeks after her second dosing.   she complained of muscle pain, upper extremities and her back.
Red blotches to face and head within 5 minutes post vaccination.  Redness resolved after 15 minutes.
Had vaccine yesterday.  Last night had body ache and fever 98.  Today only had body ache.  But when she check the temperature it was the same as yesterday.
Pt with core temperature of 95.5 rectally. Evaluated by ED. Warmed with warm blankets.  No hypoperfusion. Discharged home after work up.
tightness of throat; Rash on her chest; This spontaneous case was reported by a health care professional and describes the occurrence of THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies with anaphylaxis to Bee), Drug allergy (sodium nitrate) and Drug allergy (sulfa).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest). At the time of the report, THROAT TIGHTNESS (tightness of throat) and RASH (Rash on her chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 157 Blood pressure 157 sats 97. On an unknown date, Heart rate: 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been received from a 61 year old female who, on an unspecified date, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# unspecified). The patient reported that she has been continuously experiencing rashes all over the body since being administered ZOSTAVAX (Merck) (date unspecified). She said her physician has provided her treatments and "none seem to work". It was reported that "the patient asked if there was anything that could be done to alleviate her pain. Patient stated she was admitted several times to unspecified hospitals, as well as occasionally visiting hospitals but not being admitted. At the time of the report the patient had not recovered. Additional information has been requested.
nausea; shivering; injection site very hot; injection site red; injection site swollen; fever blister; bumps which are itchy; bumps are scabby; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th July 2019, less than a day after receiving Shingrix, the patient experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. In July 2019, the patient experienced itchy rash and scab. On 12th July 2019, the outcome of the nausea and shivering were resolved with sequelae. On 16th July 2019, the outcome of the injection site warmth, injection site erythema and injection site swelling were resolved with sequelae. On 21st July 2019, the outcome of the fever blister was resolved with sequelae. On an unknown date, the outcome of the itchy rash and scab were recovering/resolving.   It was unknown if the reporter considered the nausea, shivering, injection site warmth, injection site erythema, injection site swelling, fever blister, itchy rash and scab to be related to Shingrix.  Additional details were provided as follows: On 11th July 2019, the patient received the 1st dose of Shingrix and experienced nausea, shivering, injection site warmth, injection site erythema, injection site swelling and fever blister. The patient stated that the nausea and shivering resolved the next day of vaccination. Injection site reaction took around 4-5 days to resolve. The patient stated that around two weeks later she started to notice bumps which are itchy located below the injection site on her left arm but around 2 inches above the elbow. The patient stated that the bumps were scabby, maybe because she was scratching it in her sleep. The patient consented to follow up.
While drinking hot cocoa, she got lightheaded, warm feeling and nauseated.  30 minutes after onset, she vomited.  She felt better a few hours after injection.
Large swelling area, Very Red with slight streak, Feverish, Sore to touch. I took the recommended Tylenol or Motrin. I had to go to our Occupational Health office on 10/4/12 because the swelling was still present, redness area had tripled, pain/fever. Was provided Hydrocortisone Cream for itching (helped) and instructed to place warm compresses hourly and after 48 hours to begin the cold compresses.
p/vax pt exp pigmented rash to arms; swelling to arms to elbows; no treatment given
some soreness in left arm; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261), via an unspecified route of administration on 25Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization.  Medical history included high blood pressure and a-fib (atrial fibrillation) both from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included lisinopril (LISINOPRIL), amlodipine (AMLODIPINE), atenolol (ATENOLOL), apixaban (ELIQUIS). Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced some soreness in left arm next day, 26Jan2021. The patient did not receive any treatment for the event. The outcome of the event was recovered. The event was reported as non-serious.
This report was received from Pfizer Inc. and was assigned manufacturer report number 2011083177 and case # 11792512 concerning a 55 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). It was reported that the patient did not respond to the PNEUMOVAX 23, so it was being considered to use PREVNAR 13 instead. On an unspecified date, the patient had a specific antibody deficiency. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 20-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Narrative: COVID infection following COVID vaccine series 04/07 Janssen, dose #1 09/08 pt cc: headache exposure: unknown 09/17 COVID swab, result: detected 09/17 pt admit ED cc: headache, sinus congestion dx: covid infection LOS: 1 4day 09/17 CXR impression: lung hyperinflation may be secondary to vigorous inspiratory effort versus air trapping, otherwise, no radiographic evidence of acute cardiopulmonary disease. 09/19 clinically resolved
Information has been received from a physician concerning a female who on 04-Oct-2008, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 653937/0637F), second (lot# 654389/0961F) and third (lot#657617/0384U) doses, respectively, of GARDASIL. Concomitant therapy included "experimental medication for plantar warts" (therapy unspecified). Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on and off since May 2007, 2 months after she had her 3rd dose of GARDASIL. Unspecified medical attention was sought by seeing her doctor. It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist. No additional information available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Initial and follow-up information has been received from a physician concerning a 19 year old female who on 04-Oct-2006, 08-Dec-2006 and 19-Mar-2007 was vaccinated with first (lot# 657617/0384D) doses, respectively, of GARDASIL by intramuscular injection.  Concomitant therapy included "experimental medication for plantar warts", also reported as chemoprophylaxis.  Physician reported that on 21-Jul-2007, the patient had reported that she had pain in the shoulder, hip, knee, and in general on an off since May 2007, 2 months after she had her 3rd dose of GARDASIL.  It was reported that on unspecified date the patient "saw her pediatrician, orthopedist, and rheumatologist.  Laboratory tests included rheumatic work up, lyme, EBV tests, which were all negative.  It was also reported that patient underwent chemoprophylaxis for warts by a dermatologist around the time of complaint.  At the time of this report, the patient's events persisted.  Additional information is not expected.
CHEST PAIN; HIPS AND SHOULDERS HURTS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 09:30 a.m. vaccinated at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 21:30 p.m., the subject experienced chest pain. On 17-MAR-2021 21:30 p.m., the subject experienced hips and shoulders hurts. On 17-MAR-2021 21:30 p.m., the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle aches, chest pain, and hips and shoulders hurts. This report was non-serious.
Drug ineffective; COVID-19; This is a spontaneous report from a Pfizer-sponsored program received via contactable consumer or other non-health care professional (patient).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.The patient got tested positive for Covid after that. The 2nd dose was coming up and she was wondering how long she can put it off. She states there's no information published out there that recommends getting the vaccine outside of the 21-day period. She states CDC mentions to get the vaccine as soon as you feel better. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt slumped over in chair, w/eyes rolled back, tongue protruding out; body stiff, no shaking or answer to name; pt seen by MD;
Rash/hives on left lower leg around scare tissue from Pyoderma Gangrenosum. Using Benedryl cream and capsule.  Came about 5 days   after dose 2. Itching and read splotches.
Site: Pain at Injection Site-Severe, Additional Details: Pt said she have been experiencing a throbbing pain on her arm after receiving the vaccine that doesn't go away. It's has been more than 3 weeks and she is experiencing the pain and would like to be contacted.
Pain; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced pain, the event took place after use of product. The patient outcome of the event was unknown.    No follow-up attempts are possible, information about Lot/ Batch number cannot be obtained.
urticaria on her shoulder; Red; itchy; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 22-Jan-2021, the patient experienced URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy). At the time of the report, URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
now it is radiating up to the side of neck.; Over the weekend she was in pain from injection site reaction; She also has a joint pain that started 3 days after receiving 2nd dose; 3 days later it got worst.; 2 days later, the injection site was puffed up; It became red; It was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (now it is radiating up to the side of neck.), CONDITION AGGRAVATED (3 days later it got worst.), VACCINATION SITE SWELLING (2 days later, the injection site was puffed up), VACCINATION SITE ERYTHEMA (It became red) and VACCINATION SITE PAIN (It was sore) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBAMAZEPINE (TEGRETOL), LOSARTAN, OMEPRAZOLE, SIMVASTATIN, SUMATRIPTAN and TRAZODONE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (2 days later, the injection site was puffed up), VACCINATION SITE ERYTHEMA (It became red) and VACCINATION SITE PAIN (It was sore). On 16-Apr-2021, the patient experienced CONDITION AGGRAVATED (3 days later it got worst.) and ARTHRALGIA (She also has a joint pain that started 3 days after receiving 2nd dose). On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (Over the weekend she was in pain from injection site reaction). On 29-Apr-2021, the patient experienced PAIN (now it is radiating up to the side of neck.). At the time of the report, PAIN (now it is radiating up to the side of neck.), CONDITION AGGRAVATED (3 days later it got worst.), VACCINATION SITE SWELLING (2 days later, the injection site was puffed up), VACCINATION SITE ERYTHEMA (It became red), VACCINATION SITE PAIN (It was sore) and VACCINATION SITE PAIN (Over the weekend she was in pain from injection site reaction) was resolving and ARTHRALGIA (She also has a joint pain that started 3 days after receiving 2nd dose) outcome was unknown.            Treatment details included Steroids cream, Ibuprofen, flexeril.  Action taken with mRNA-1273 in response to the events was not applicable.
PATIENT REPORTS NUMBNESS, PINS, AND NEEDLES FOR 2 TO 3 DAYS POST VACCINATION. THIS AFFECTED HER LEFT JAW, LEFT HAND, FINGERS AND HER LEFT FOOT.
16 year old received 1th shot of Moderna vaccine; A spontaneous report was received from a healthcare provider concerning a 16-year-old patient of unknown gender who received the vaccine.  The patient's medical history included Sickle Cell Disease. Concomitant product use was not provided by the reporter.     On 10FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    HCP reporting 16-year-old patient with Sickle Cell Disease has received 1st shot of Moderna vaccine on 10Feb2021. HCP is asking if the patient should receive 2nd Moderna shot.   The event, vaccine at inappropriate age (16 years old), was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Mom called 8/26 AM the day after patient received her 3rd HPV #9. Reported fever of 101 at 9 pm she also had leg aches, body aches and muscle cramps. She had a bad headache and extreme exhaustion. 8/28 - headache and fever better. Patient is a runner and unable to run more than 10 mins over next 3-4 days. Pain in arms. Experiencing pain in arm and legs, unable to run, extreme fatigue. Later pt reported that she felt like she was getting a cold for 24 hours after first two shots. She did not report this until after 3rd shot.