chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vet reporting tender, warm and slightly swollen R shoulder. Afebrile, no  erythema, signs of infection, severe allergy symptoms. He had Pneumovax  injection @ 1500 yesterday and started to have warmth and pain ~ 2000 last  night. It was difficult for him to sleep, because he was awakened each  time he rolled onto injection site. He feels better just now, as he's  taken Vicoden earlier. Home care treatment advised with the caveat that he  call back if SYMPTOMS WORSEN, CHANGE or PERSIST.  PATIENT EDUCATION Vicoden may be used for injection site pain. Aspirin or ibuprofen also OK.  Tylenol NOT advised if you're taking multiple Vicoden's daily. Ice  treatments to site--20" on, 20" off-- prn may greatly reduce pain.  Symptoms may take a few days to go away and are not expected to worsen.  Call back for signs of infection or allergic reaction (explained).
Started with an extremely sore left arm all the way down to wrists a couple of hours after vaccination. Later in the day developed muscle aches and chills. Overnight into the next 24hrs I had a fever (highest was 102 degrees F); extreme muscle aches, chills, headache, and an extremely sore left arm. Left arm was tender to any touch, other muscles were sore to firm touch. Treated with Ibuprofen. 36 hours later the fever, extreme muscle aches and chills subsided. Next day fatigued, slight headache, mildly sore arm.
Information has been received from a licensed practical nurse concerning 4 females (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL vaccine (yeast) (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL vaccine (yeast) due to nursing error. Each patient received 0.25 mL dose of GARDASIL vaccine (yeast) given subsequently near the wrist on 17-OCT-2007. The person was administered the doses split a 0.5mL dose of GARDASIL vaccine (yeast) equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site was red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL vaccine (yeast) (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL vaccine (yeast) by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN reported that one vial of purified protein derivative (PPD) was delivered to one office one day. On the following day one vial of GARDASIL vaccine (yeast) was delivered to the same office. The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from GARDASIL vaccine (yeast) vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccine (yeast) vaccination would only be administered at another office and not in the current office to assure that this error would no occur again. The patient that received GARDASIL vaccine (yeast) was treated with cold/warm compresses and recovered. Additional information is not expected.
behavioral changes, encephalopathy, change in eye contact, speech delays, social regression 3/17/09-records received-evaluation 8/31/07-Impression-normal visual motor problem solving skills and gross motor skills, mild delay in receptive and expressive language, does not have good eye contact and is not socially interactive. Pervasive Developmental Disorder. Encephalopathy unspecified. Developmental problem noted at about 22 molnths does not turn to his name. Visit on 3/3/08-improvements noted MRI brain not performed. 6/2/08-possible seizures. Staring spells and eye clinching.  Fever-24 hours after vaccine no longer responding to name. No longer communicating with others, regression of social and verbal behaviors.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with PNEUMOVAX23 (dose, strength, route not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Pt called office 1/12/10 AM to report that she had developed following symptoms last night @ 19:30: throat swelling, chest and back pain, blurry vision, irreg rapid heart rate, cough. She did not seek med. attention. Did not take antihistamines. All sx resolved without intervention.
Fatigue; Fever; Chills; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EN6206 and Expiration Date: Unknown, at the age of 35-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism, drug hypersensitivity, known allergies, Sulfa based medications, mollusks, allergy to animal known allergies, Sulfa based medications, hypertension. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received dose 1 BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) administered in right arm on 12Mar2021 12:45 PM and experienced raised rash about 2 in diameter, red, itchy. On 31Mar2021, the patient experienced fatigue, fever, chills. Patient did not receive any treatment. Outcome of all events was recovered on 04Apr2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 28JUN91 & devel 5x4" area of erythema & tenderness on 29JUN & 30JUN;
Blister; continues to contract shingles; continues to contract shingles; administer Shingrix despite patients age being younger than the indicated age of 50 years; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (cases of shingles since before patient turned 25 years old).   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 29th January 2019, the patient received the 1st dose of Shingrix. On 25th June 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced off label use in unapproved age group. In November 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced blister. On an unknown date, the outcome of the vaccination failure, blister and off label use in unapproved age group were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix and experienced shingles. The patient received 2 doses of Shingrix, at the age below than recommended, which led to off label use in unapproved age group. The patient was suggested to receive a fluid sample from current blister and to have a medical test to analyze it. The reporter mentioned that, patient had an appointment to dermatology office that week. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. This case has been linked with US2021AMR036064, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR036064:same reporter
Upon receiving Pfizer Bivalent, it was improperly stored in the freezer. This vaccine should have been stored in the refrigerator. Due to the incorrect storage patient received vaccine that was expired.
unusual side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (unusual side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE REACTION (unusual side effect). At the time of the report, ADVERSE REACTION (unusual side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sore Left Arm; Stomach Messed up; Diarrhea; Severe Headache; Fever; Severe Muscle Pain; Joint Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache) and PYREXIA (Fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills). On 04-Apr-2021, PAIN IN EXTREMITY (Sore Left Arm), ABDOMINAL DISCOMFORT (Stomach Messed up), DIARRHOEA (Diarrhea), HEADACHE (Severe Headache), PYREXIA (Fever), MYALGIA (Severe Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication was reported.
bedridden; so sick; I had a crushing headache; starting to feel warm; I got the second vaccine at 10am and started feeling extremely tired about 8 hours; did not sleep due to the pain in her bones and fever with sweats and chills; I started feeling aches.; I woke up a couple hours later with excruciating pain in my bones.; I had a fever of 104; chills; sweats.; This is a spontaneous report from a contactable nurse (patient reported for herself).  A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 28Feb2021 at 10.00 (at the age of 24-years) as dose 2, single for covid-19 immunization in hospital. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 06Feb2021 at 10.00 (at the age of 24-years) as dose 1, single for covid-19 immunization. The patient was not pregnant at the tie of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the second vaccine at 10.00. On 28Feb2021 at 19.00 the patient started feeling extremely tired about 8 hours after the vaccine. By the time the patient went to bed around 22.00, she had a crushing headache and starting to feel warm. The patient started feeling aches and woke up a couple hours later with excruciating pain in her bones. The patient had a fever of 104 and chills with sweats. The patient did not sleep due to the pain in her bones and fever with sweats and chills. The next day (01Mar2021), the patient was bedridden, so sick and it took a full 48 hours for her to feel back to her normal self. The patient did not receive any treatment for adverse event. The patient did not had vaccination prior to covid. The patient was not tested for covid post vaccination. The patient went lab test: body temperature: 104 (unit not reported) on an unknown date. The outcome of the events bedridden, so sick were recovered with sequel on an unspecified date in Mar2021 and rest of the events was recovered with sequel on an unspecified date in 2021.   No Follow-up attempts are possible. No information is expected further.
This case was reported by a physician via a representative and described the occurrence of an 88 year old female subject not responding to therapy following vaccination with TWINRIX, GlaxoSmithKline.  On 29 January 2008, the subject received 3rd dose of TWINRIX (unknown) to complete the vaccination series.  The 1st dose was given on 24 July 2007 and the 2nd on 28 August 2007.  On 28 April 2008, the subjects titers were tested and it was found that the subject had not responded to therapy.  She was hepatitis B antibody negative.  The physician felt that there might be something wrong with the TWINRIX vaccination (product complaint).  At the time of reporting the events were unresolved.  The physician considered the events were probably related to vaccination with TWINRIX.  The reporter gave details on two separate subjects (A0730576 and A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection.  For these additional subjects, refer to case A0731173A.
Presented with SOB; + covid 9/8; Admit to OBS med 9/20; inpatient 9/21 withCovid infection, SpO2 95% at 2 LPM; tx with 9/20 steroids, lovenox, singulair, zinc ; O2 remained at 2 LPM throughout stay
This spontaneous report as received from a female consumer of unknown age reporting on herself with a history of shingles diagnosed on 25-APR-2010 and who on 21-JUL-2010 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that a few days ago in approximately August 2013, she came down with a shingles but this time there were only seven small sores which were more itchy than painful and which had resolved themselves without any need of professional medical attention or drugs. The consumer reported that she believed that ZOSTAVAX was responsible for the minor of this shingles attack. Additional information has been requested.
Fever, headache, chills, nausea for roughly 24 hours beginning nearly 12 hours after administered vaccine
floaters in both eyes after the first dose which went away in few dayswithout any treatment 4 days after the second dose noticed more floaters again which still persists but getting fewer
Mom reports that nurse/vaccine administrator injected son/patient at a higher than usual site on the shoulder and the needle did not go in all the way, in fact of the needle was outside his skin. The skin around the needle puncture "bubbled" up and it caused him pain (more than the 1st dose when he received it). No leakage of vaccine fluid was observed. He had some soreness in the arm. The next day he did develop some nausea, body aches, and slight fever. He is feeling a bit better today (6/14) and only has some nausea remaining. Mom will take him to PCP to evaluate his Left shoulder since it is still achy.
After the vaccination on Nov.4, 2021, I felt headaches, muscle pain and not comfortable for about 2 days. Then on Nov. 16, 2021, I had very bad pain on my right leg. It lasted for 4 - 5 days.  Adround Dec.28, 2021, I started getting the pain in my right leg again and lasted for about one week.  In addition, my latest lab test report on Dec.8 /2021 shows my AIC has increased significantly from the last test 6.4 in Jun 2021 to 7.3  in Dec. 2021 (one month after the vaccination). Also from this lab report, the BUN/Creatinine value is significantly increased to 39 (abnormal result).  My eyes have often felt blurry and dry now.
3 seizure-like events occurring approximately 48 hrs after administration of vaccines. All three very brief, all occurring over a period of a few hours. No further signs or symptoms before or after. Observed in hospital for three days.  Nurse follow up on 07/09/04 states: "Unresponsive."  Nurse follow up on 07/20/04 states: "Reaction to Pertussis vaccine, Gastroesophageal reflux."
Lack of response. Information received regarding an adult female who received vax. Subsequent laboratory evaluation revealed no immunity. No further information is available.
Information has been received from a consumer concerning her 18 year old daughter with asthma who in the summer of 2008, was vaccinated with the first dose of GARDASIL (lot # was not reported). Concomitant therapy included ADVAIR. The patient's mother stated her daughter had 2 doses of the vaccine and reported that around the first week of September 2008 the patient's hair started to fall out. The consumer stated that her daughter's hair started to fall out in clumps and within months all of her fell out. The patient was seen by a rheumatologist, her primary care physician, and a dermatologist; numerous amounts of blood work were done for all auto immune disorders, vitamin deficiency, Lyme disease and many others. The only thing that the blood work has shown is that she was slightly anemic. They still can not find anything that would cause her hair to fall out. The consumer stated that she did not let her daughter get the third dose and stated that she did research that the vaccine can cause alopecia and she can not figure anything else but the vaccine that could cause this. This is one of several reports received from the same source. Additional information has been requested.  4/3/09 Office note received for DOS 2/26/09 with DX:  Alopecia areata, approaching universalis.   Pt presented with c/o progressive, extensive hair loss involving scalp, eyebrows, eyelashes and body hair since 9/2008. PE confirms c/o. Tx: steroids.
10 hrs p/shot felt exhausted, nauseated, h/a, body ache, froze to death, fluctuating heart beat; stayed in bed 11 hrs, then went to work, felt "puny" w/intermittant nausea x 2 days;
This spontaneous report was received from a healthcare worker and refers to a 15 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
major congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (major congestion) in a male 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (major congestion). At the time of the report, NASAL CONGESTION (major congestion) outcome was unknown.            Concomitant medications was not reported. Treatment medications was not reported.
Developed Granuloma Annulare on my elbows, knees, ankles and Achilles? tendons. Red spots that start out small like pea dived and grow larger to quarter size or larger.
Vaccines were given on 12/19/2000. Cold symptoms on 12/29/2000 were the first signs of a reaction. Doctor was notified of cold symptoms on 01/02/2001. Fussiness, sore throat, and 100+ temperature had been going on for three weeks by 01/26/2001. Atypical varicella suspected on 02/20/2001. Skin and sinus conditions rapidly deteriorating as well as evident behavior changes by 03/01. Skin problems are out of control by 04/16/2001. Referred to a dermatologist. Open skin sores four months old by 07/16/2001 will not heal. Hearing test requested by us on 08/07/01 due to obvious developmental regression. Continued sinus and skin problems occasionally acoompanied by diarrhea 08/01 thru 12/01. Autism is suspected. Pediatric neurology referral given on 12/21/01. First neurologist gives autism as diagnosis and orders testing on 01/17/02. A second neurologist makes diagnosis of autism on 04/29/02. ABA (Applied Behavior Analysis) intensive behavioral intervention treatment program through CARD (the Center for Autism and Related Disorders) was began on 06/17/02. Pt is making some progress but the program is so expensive we will not be able to carry it on for very long. The estimated annual cost of implementing the program correctly is $35000-$55000. Social security, Medicaid, nor insurance will help with expenses. The 60 day follow-up states that, "I have been advised by my attorneys not to submit any additional info concerning this adverse event."  Annual follow up on 07/28/2003: "Patient did not recover from adverse event.  'Patient has autism spectrum disorder.  He has not recovered.  I feel that vaccines are the leading cause of regressive autism.'"
Within 5 hours of receiving the vaccine, I developed red bumps that itched on both legs, my lower back and lower abdomen. There were over fifty in total and they itched. All previous vaccine doses were Moderna.
1/1/21 minor lip swelling. Took 1 dose of Benadryl and it resolved within 2 hours.  1/2/21 minor eyelid swelling . Took 1dose of Benadryl and condition resolved overnight.  1/4/21 significant lip swelling. Took 3 doses of Benadryl. Condition resolved in 24 hours.
1 day post injection. ( 14 hrs after injection) Severe headache. (Migraine level) nausea. Fatigue.  By that evening. Also had chills. Was hot but so cold but no fever. Body aches.   Symptoms are better (but not gone) by day three. Still very tired. Nausea is only there after I eat. Headache is mild. But now I have a huge red rash at injection site.  Bicep is swollen and hit. I noticed it when it itched.
12 DAYS POST VACCINE 2X5" AREA OF REDNESS, SWOLLEN AND ITCH AT INJECTION SITE.