chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of vaccination, patient started with nausea, vomiting and progressed to altered mental status.  Presented to the ED with  seizures most likely due to PRES in setting of acute reaction to mRNA booster dose. He was admitted to the ICU for status epilepticus and intubated for respiratory failure and airway protection. Patient was treated for sepsis and respiratory failure due to pneumonia, evaluated by neurology, transferred to medical floor after successful extubation.
20may90 pt vax hepta B. 29may90 pt devel fever, h/a, body aches. 4 days later, pt devel erythematous, blotchy pruritic rash on arms an legs which persisted for 2 days. edema in hands and feet w/ burning sensation. see worm...
On the day of vaccination, noticed impetiginous lesions on left buttock. Nine days after vaccine seen macular non vesicular rash all over body. By October 29th seen afain for rash that began 3 days prior as papular on trunk, buttocks, legs and arms. December 14th seen for maculopapular rash on left buttock. On Dec 19th, seen for rash and DFA + zoster. Rash reoccured Jan 22nd and given a course of acyclonir.
Extreme pain at injection site, radiated up and  across shoulder and down left arm to hand and fingers lasting months.  Improved but not 100% back to normal yet at 6 months post injection.
Colitis ulcerative aggravated/ulcerative colitis flare ups; Vaccination site swelling; This is a solicited report based on the information received by Pfizer from. (MFR Control No. # 21K-163-3796877-00).   A contactable consumer reported that a 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation; The patient medical history included in Apr2019, the patient experienced ankle injury. In Feb2020, the patient experienced tore cartilage in shoulder. In Sep2020, the patient experienced back pain. Concomitant medications were not reported. The patient previously took adalimumab (HUMIRA), subcutaneous from Jun2020 to Jun2020, at citrate free, weekly for colitis ulcerative. The patient experienced ulcerative colitis flare ups (Colitis ulcerative aggravated) and swelling under arm (vaccination site swelling) after covid vaccine. The action taken in response to the events for adalimumab was unknown. The outcome of vaccination site swelling was recovered on an unspecified date and other event was unknown. The reporter's causality for the events of ankle injury, tore cartilage in shoulder, back pain and swelling under arm after covid vaccine with humira (adalimumab) was no reasonable possibility. the reporter's causality for the events of back injury and ulcerative colitis flare ups was not provided.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event vaccination site swelling cannot be excluded. Based on information provided, the event ulcerative colitis flare up is secondary to the patient's underlying condition, thus unrelated to the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This serious case was received from a health care professional on 17 November 2008. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 22-month-old male patient received FLUZONE SV (lot number and date of administration not reported). Approximately 48 hours after vaccination, he developed Ketoacidosis, and was subsequently diagnosed with Type I diabetes mellitus. The reporter, a physician who was a friend of the patient's parent, did not have any additional information to provide. Of note, the reporter refused to provide contact information, but did agree to contact the patient's primary care physician directly to obtain additional information. Documents held by sender: None.
Sore injection site; 100 fever; Aches; This is a spontaneous report from a contactable consumer. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 06Jul2021 15:45 (at the age of 14-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 01Jun2021 (at the age of 14-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jul2021 12:00, the patient experienced sore injection site, 100 fever, aches. The patient did not receive any treatment. The seriousness of the event was considered as non-serious. Outcome of the event was recovering, at the time of this report. Device Date was 07Jul2021. Information on Lot/Batch number has been requested.
slight redness to injection site; slight pain; COVID-19 vaccination; This is a spontaneous report from a contactable consume (patients). This consumer reported similar events for 2 patients (Himself and wife) this report is for 1st of 2 patient. A 84-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E18982, Expiration date: UNKNOWN) in left arm on 06Feb2021 at 08:40 as a single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient experienced slight redness to injection site, slight pain and covid-19 vaccination on 06Feb2021. The reported said that their vaccine cards are handwritten and they got the same LOT, he provides unknown number PF1202, which he thinks means Pfizer with an ID number they may have given him and he says NDC/EXP were not provided on their handwritten vaccine cards. The patient was not given treatment for AE slight pain and it went away, also the slight redness went away, there was a little bump. The reporter said it was not bad, it was good that their side effects were small and not massive at all, and it was a little thing but they are concerned if their reaction could be considered unusual, like some people, or if should it could be a stronger dosage. He says at the time their vaccines were done in cars, so he has no knowledge of temperature or amount of dosage, and says that after they get their second dose on the 17th. The outcome of the event slight redness to injection site was recovered on Mar2021 and other outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Extreme bilateral joint pain, stiffness, soreness, and decreased range of motion in shoulders, elbows, wrists, fingers, SI joints, knees, and toes, along with symphysis pubis and neck; nausea secondary to pain; weight loss secondary to nausea. Symptom onset began 28 hours after receiving 1st COVID19 vaccination and has persisted everyday since 8/21/21.
Patient looked pale and passed out in chair after last vaccine (HPV) was given.  Elevated patient legs up in another chair, began fanning patient and also gave patient cookies to eat.  Asked patient how she was feeling and she stated she was dizzy.  Checked patient's blood pressure and it was 110/70.  After 10 minutes, asked patient if she was alright and she stated she was not dizzy anymore.  Told patient and family to wait another 10 minutes before leaving.
HER LEFT ARM WAS VERY PAINFUL, TINGLING OF FINGERS. HER DAUGHTER SAID THAT HER BREATHING WAS NOT RIGHT. SHE WAS TAKEN TO THE HOSPITAL AND OBSERVED FOR SEVERAL HOURS ALSO SHE WAS GIVEN SOME MEDICATION TO TAKE BY THE HOSPITAL. SHE WAS GIVEN HER VACCINE ON 11/02/06. SHE CALLED THE SAME EVENING ABOUT HER ARM WAS HURTING HER VERY BAD. THE PHARMACIST TOLD HER TO WAIT A COUPLE OF  HOURS BEFORE SHE WENT TO HOSPITAL AND SHE DID.WE TALKED TO HER THE NEXT MORNING AND SHE SAID SHE WAS DOING BETTER. HER DAUGHTER CALLED AGAIN ABOUT 1 HOUR LATER AND SAID SHE WAS NOT DOING WELL. I DO NOT KNOW IF SHE WENT TO THE HOSPITAL AGAIN.
sore injection site left arm,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm,) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Lung disorder NOS. Concomitant products included ALBUTEROL [SALBUTAMOL] for Lung disorder NOS.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site left arm,). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported.   This case was linked to MOD-2021-368036 (Patient Link).
Pain at injection site for about 3 days post vaccination. Slight headache for about 3 days post injection which made it hard to concentrate. Fatigue and muscle  ache for about 2 days post vaccination. Hot flashes since the vaccination and still happening. Had problem with them when I originally found out my thyroid was not properly regulated. Been on synthroid for over 3 years and only happened a few times a year since my thyroid levels have been regulated. Since vaccine they have been happening a few times a day and  also at night when sleeping. Checked my temp during episode and it is normal around 98.6 or below. Explanation of symptoms are  flushed, sweaty, HOT even when it is cold inside almost like there is an inner fire going on inside me
Flu like symptoms on second day then better. Red hard spot and very sore arm Day 2-3 then got better. Day 8 big red rash appeared on arm of injection site.
Injection site warm to touch; Huge red circle at the injection site; A spontaneous report was received from an adult female patient who was participating in the mRNA-1273 Emergency Use Program and experienced huge red circle at the injection site and injection site warm to touch.    The patient's medical history was not provided.  Concomitant product use was not provided.  On an unspecified date the patient received the first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly, for prophylaxis of COVID-19 infection.  On an unspecified date, ten days after vaccination the patient experienced huge red circle at the injection site and injection site warm to touch. It was noted the circle was about the length of her index finger. There was no treatment information provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, huge red circle at the injection site and injection site warm to touch, was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Two days after my vaccination I had extreme joint pain in what felt like all of the joins of my body.  A few days later the bodywide pain dissipated, but I had lingering pain in the site of three previously healed injuries:  plantar fasciitis in both feet (left foot worse than the right foot), a cracked tibia from 2016, and a broken coccyx from 2002.  The pain in the tibia dissipated after about a week and the coccyx after about two weeks.  The plantar fasciitis continues at a very painful level in the left foot now more than 30 days after the vaccination.  I have been treating the plantar fasciitis with weekly physical therapy and twice daily at-home exercises prescribed by my physical therapist.  I am also taking a daily prescription anti-inflammatory pill MELOXICAM prescribed by my podiatrist.  I am awaiting an appointment with Dr. to see if I will need a cortisone shot to relieve the pain in my left foot.
Pt vax w/ 3 doses hepta B; did not respond. Outcome no sequelae.
HCP administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The live follow-up information was received on 08-Jun-2022 which contains non-significant information.
This spontaneous report as received from a 59 years old female occupational safety nurse refers to herself. She was allergic to the following medications: penicillin, erythromycin, parathyroid hormone, tapezole and cardizem. The patient's medical history included chicken pox when she was a child. Both of her children had chicken pox. Her husband received ZOSTAVAX on the same day (01-FEB-2013) without incident. The patient was vaccinated with the first dose of ZOSTAVAX (lot# reported as H019042; expired date: 17-JAN-2014) intramuscularly in the left deltoid on 01-FEB-2013 07:00. No other co-suspects were reported. Concomitant medications included LIPITOR, aspirin (81 mg), SYNTHROID, COLACE and multivitamin (unspecified). She was fine during the day (01-FEB-2013), but late that night she had a feeling of being uncomfortable and itchy around the injection site. She did not get up to inspect the area of the injection. When she awoke on Saturday AM (02-FEB-2013) the site was "very red, itchy and hot to the touch". She did not measure, but stated that it was much larger than it was today (04-FEB-2013). Some improvement on 03--FEB-2013 but on 04-FEB-2013 AM it was still very itchy so she applied a steroid cream which helped with the itching. On 04-FEB-2013, she was well appearing and afebrile. The area of redness and warmth is a soft (no induration), erythematous patch that irregular surrounded the injection site and was approximately 2 inches by 3 inches in diameter. It was warm to the touch. There was no induration and no axillary nodes were felt. Samples obtained: blood and mouth swab. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Presented to ED with shortness of breath, myalgia, non productive cough  Received decadron, asprin, singulair, oxygen, out of window for remdesivir Discharged under stable condition.
Redness and swelling on (L) thigh at site of DTAP and Flu shot 12/4/17. Warm compress and prescribed cephalexin 125mg 3x a day for 10 days and Diphenhydramine 25ml PO TID.
9:30 am received vaccine - Fluzone; about 8 hrs after became dizzy, nauseous, diaphoretic for 2 hrs; resolved without medications.  no redness, tenderness, or swelling at injection site.  NOTE:  has had flu vaccine in the past - # doses unknown
Pt vomited while sitting during her observation period.  She was given a cup of water.  She appeared slightly pale but regained color immediately.  She said she felt instantly better after vomiting.  She reported that this has never happened before.
This case was reported in a literature article and described the occurrence of uveitis in a 16-year-old female subject who was vaccinated with HEPATITIS B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown). At an unspecified time after vaccination with HEPATITIS B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Sudden onset lethargy; patient slept remainder of the day; slept majority of the day 6/17, 6/18/, and 6/19. Very lethargic 6/20. Slight abdominal discomfort 6/17-not eating; maintaining fluid level; rapid strep test 6/18 NEGATIVE; culture-requested results 6/20, were told not available; advised too early to test for mono. Patient has remained afebrile for entire process. Patient still experiencing extreme lethargy and fatigue.
Shot given 9/23/14 at Health Dept. Flu (R) arm and Pneumococcal (PNEUMOVAX 23) (L) arm. 9-25-14 pt. came to H. D. to report (L) arm under and around shot area is warm to touch, red and sl. swollen - noticed today - unsure if there day before. Pt. afebrile.
C/O pain to L upper arm, redness, swelling, tenderness, warmth, and difficulty moving extremity due to pain and tenderness. Day of vaccination arm was sore and then the next day arm revealed above signs and symptoms. Instructed to use ice and TYLENOL and to go to ER if increased redness, pain and or streaking. Area marked by PA who saw patient.
Swollen, Red, Itchy. Oral Benadryl was given and Topical Benadryl cream was applied.
Right arm became red one day after receiving injection, then became more swollen the following day.  On exam (Day 2 after injection) the right mid to upper arm had 6 cm induration and 5 cm erythema with mild tenderness to palpation and warmth to exam.
Muscle pain at the site of injection, headache, upset stomach, lightheadedness, fatigue, redness upper arm, nausea
Information has been received from a licensed practical nurse concerning a 15-month- old white male male with a history of otitis with pressure equalizing tubes who on 14-DEC-2006 was vaccinated with a 0.5 ml first dose of measles virus vaccine live (Enders-Edmonston) in the left thigh. The patient was noted to have rhinorrhea for one month at the time of vaccination. Concomitant therapy included diphtheria toxoid AP (+) ACT Hib combined. On 19-DEC-2006, the patient was seen by a dermatologist for a rash on the chest, back, and face. There was no fever. He was treated with oral diphenhydramine (BENADRYL). The nurse did not know the patient's status at the time of the report. No additional information to report. There was no product complaint involved. Follow-up information was received by a doctor indicating that a rash began in the evening of 18-DEC-2006, (previously reported onset date was 19-DEC-2006) on the patients face and a cough. On 19-DEc-2006, the rash had spread to his trunk. Physical exam revealed pink macules on the face and a large area on the trunk. The diagnosis was "uticaria-like rash" which resolved after treatment with diphenhydramine (BENADRYL) and topical cortisone cream. No additional information is expected.
Extreme fatigue for 48 hours starting the morning after the vaccine Heart palpitations for 24 hours starting the morning after the vaccine
APPROX 3 HOURS AFTER RECEIVING VACCINE, PT DEVELOPED SMOOTH, PRURITIC, AND ERYTHEMATOUS AREA UNDER R ARM. IN ADDITION, HER R ELBOW BECAME SWOLLEN AND TENDER. WHEN I SAW HER IN CLINIC THE NEXT DAY, THE SYMPTOMS WERE SUBSIDING.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. Initially reported as RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were improperly exposed to 31 Fahrenheit (F) for 48 hours on an unspecified date, and to several other unspecified temperature excursions on unspecified dates. An unspecified number of patients received at least one of these vaccine on unspecified dates. Further it was reported that RECOMBIVAX HB (lot # J009374; expiration: 11-JUN-2016) and GARDASIL (lot # K005083; expiration: 04-NOV-2016) were exposed to 31 F for 15 days (360) hours. However later it was confirmed that GARDASIL was not administered to anyone. On 13-OCT-2014, the patients were vaccinated with improperly exposed RECOMBIVAX HB, intramuscularly, lot # J009374; expiration: 11-JUN-2016. Later it was confirmed with the reporter that RECOMBIVAX HB were improperly exposed to 33 F for 96 hours from 04-SEP-2014 to 08-SEP-2014, and to 34F for 48 hours from 09-SEP-2014 to 11-SEP-2014, and to 34F for 72 hours from 12-SEP-2014 to 15-SEP-2014, and to 33F for 168 hours from 15-SEP-2014 to 22-SEP-2014, and to 31 F for 240 hours from 26-SEP-2014 to 06-OCT-2014, and to 34F for 48 hours from 06-OCT-2014 to 08-OCT-2014, and to 32 F for 96 hours from 09-OCT-2014 to 13-OCT-2014, and to 31F for 24 hours from 14-OCT-2014 to 15-OCT-2014. No adverse effects reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional adverse events reported; incorrect product storage; This spontaneous report was received from other health professional and refers to 12-months-old patient of unknown gender. There were no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX), lot #: U020238, expiration date: 28-JUN-2023, dose: 0,5 milliliter (route of administration and dose number were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) (13.8 F) for 1 hour, 45 minutes and between of 14 degrees Fahrenheit up to 46 degrees Fahrenheit for (14.4 F) for 25 minutes.   There were no previous temperature excursions. No adverse event was reported (no adverse event).
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients concurrent conditions and medical history was not reported. On unknown dates the patients received doses of improperly stored (being exposed to temperatures outside of the recommended range) GARDASIL (dose and route not reported, lot# K007264 with expiration date 02-MAR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.