chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terribly itching rash with large, red bumps after second dose; Large, red bumps after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Terribly itching rash with large, red bumps after second dose) and SWELLING (Large, red bumps after second dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinsonism. Concomitant products included FLUDROCORTISONE and MIDODRINE for Blood pressure management, ATORVASTATIN for Cholesterol, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease, LEVOTHYROXINE for Thyroid disorder, TAMSULOSIN, FINASTERIDE, POTASSIUM CITRATE, FOLIC ACID and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Terribly itching rash with large, red bumps after second dose). an unknown date, the patient experienced SWELLING (Large, red bumps after second dose). The patient was treated with CORTISONE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Terribly itching rash with large, red bumps after second dose) and SWELLING (Large, red bumps after second dose) outcome was unknown.            It was reported that the patient took Tamsulosin and finasteride for his prostate. Action taken with mRNA-1273 in response to the event was not applicable. Treatment provided also included antihistamine.   This case was linked to MOD-2021-036282 (Patient Link).
Localized induration, approximately 3.5 inches by 3.5 inches across the LEFT deltoid. No reaction on the right. Slight erythema and slight warmth. Mother of child also reports a tactile fever, which was brought to a normal range by Tylenol. MOC presented two days after vaccine date to clinic to report reaction. Consulted with Nurse Practitioner onsite. Recommended Ice and Ibuprofen. Reviewed red flag indications for which she should call the clinic.
Child had prolonged course of uncontrollable crying. Swelling, pain noted at DTaP site.
brief hint of dizziness about 4 hours after shot.  12 hours later (this writing) : dizziness, nausea, headache, body aches, fatigue ? all mild, but don?t feel like doing anything today.
Left arm red and swollen on 12/4/02. Seen on 12/5/02 and area was painful and warm to touch 6" X 3". Dx: Cellulitis and treated with Keflex. Still under treatment.
AFTER RECIEVING HER FLU VACCINE, THAT EVENING DEVELOPED COLD LIKE SYMPTOMS: ACHY, RUNNY NOSE, FEVER, SORE THROAT. DURING NIGHT SAID HER LIPS AND TONSILS SWELLED. WHEN SHE WOKE UP HER FACE, LIPS, TONSILS WERE REALLY SWOLLEN. EYES WERE SUNKEN INTO HER FACE DUE TO EDEMA AND THE SCLERA WERE BROWNISH RED. SHE WENT TO HER DOCTOR, AND HE GAVE HER A STEROID INJECTION AND 5 DAYS PRESCRIPTION FOR A STEROID. ALSO TOLD HER TO TAKE ASPIRIN AND BENADRYL AND NEVER TAKE ANOTHER FLU SHOT. SAID SHE ALMOST HAD AN ANAPHYLACTIC RESPONSE TO THE SHOT.
I had no immediate problems after receiving my vaccinations other than a fever and fatigue. I did notice that the day after I received my second does that I started my period, which was 2 weeks early. After that I started having severe migraines that would last for weeks. I have had migraines since I was a child, but this was a marked increase in length and severity and the only change I had noticed was the Covid vaccine. I don't know whether it caused the increase in my migraines, but I felt it was important to at least report it.
10/12/06 15:08 pt began to c/o left arm and neck pain after immunization, difficulty breathing, color became dusky appeared to have trouble catching breath, O2 at 9L per face mask applied Benadryl 50 mg/ml administered 15:09, Dr paged, 1510 pt c/o chest pain Nitro stat 0.4mg administered sublingually pulse oximeter @ 98% HR 89, BP 150/96, HR 82 15:30 EKG started, pt feeling better as stated by him, chest pain resolved, breathing normally, HR 82 pulse ox 97%, color pink.
Shoulder pain that moved from site of injection in arm, to shoulder, back, front of shoulder and neck.  Immediate onset that has lasted more than 3 months.
Skin was inflamed and hot to touch. Area around immunization site was slightly inflamed, most of inflammation was 2-3 inch below injection site.
Pt. received Pnueovax in right deltoid area SQ: the area was red, warm to touch, with about 2+ edema at site.
On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4,  Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.
Pt developed wheezing/coughing after getting the FLUMIST. He had no prior history of wheezing/asthma/bronchodilator use.
On 11/17/2022, I noticed a scratchy throat, a headache, and muscle aches. They progressively got worse throughout the day. The symptoms were getting worse rather than better, even with use of TYLENOL. The next evening, I called my doctor who advised that I take the molnupiravir that I already had at home from my recent trip out of the country. I began taking that Friday evening, and by Saturday, I was feeling on the mend. My symptoms just continued to progressively get better and by the next week, I was back to normal.
pain in my shoulder; flu like symptoms; This case was reported by a consumer and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the shoulder pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had a very bad response to the first injection, a lot of pain in shoulder, flu like symptoms, so patient would have expected the same with the second injection. For tolerane of 2nd dose, refer case US2020AMR035045.
After flu shot she waited 15 minutes and said she felt fine but by the time she got home her throat felt constricted. She called. I told her to call 911. She didn't want to and came here. I game 2 Epipens #7 10 minutes apart, I called 911, fire crew and ambulance arrived, they took vitals and told her she should go to ER. She signed a waiver that she didn't want (unreadable). She drove herself to (unreadable)...She then told me she was feeling awful when she left but wanted to leave, not sure if from shot.
Diagnosed with juvenile onset diabetes mellitus 17 days after live flu vaccine. 1/12/09-records received for DOS 12/14-12/15/08-DC DX: New onset diabetes mellitus. presented with C/O increased thirst, urination, sugar high.  02/01/2010 The original event reported was a temporal associatioon of the FluMist and developent of Juvenile diabetes.
Got lethargic & chronic fatigue a couple weeks after my second dose & been dealing with ever since (Mid April), Been taking vitamins like B12, zinc, vitamin c's to help alleviate the symptoms & fatigue here for a few weeks now as of filling this out & its been helping a bit.
Pt complains of itching and burning at the injection site even after more than 2 weeks after the vaccine administration
very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "very bad allergic reaction". Additional information: The patient got a COVID-19 Pfizer shot and had a very bad allergic reaction to it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt has diabetes and hypertension.  Pt went for evaluation of a 3-day history of shortness of breath, cough, and nasal congestion, as well as some diarrhea.  Pt was found to be COVID positive.  Pt was transferred due to NSTEMI.
Dizziness, Headache, Arthralgia, NauseaVomiting, chills, insomnia, Narrative:  Other Relevant History:
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter indicated that the physician at her dermatology office experienced bad reactions (unspecified) after receiving the SHINGRIX vaccine. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.
Received first Covid vaccine on January 29, 2021. One week after receiving injection in left  upper arm  he noticed redness, itching, pain and swelling (the size of an orange) and aching. No fever or other symptoms.  Applied warm compresses and took Benadry.  Made an appt. to see our local doctor for evaluation on Monday, Feb. 8. .  This was the first injection and don't know what to do about second dose that is scheduled for February 26, 2021.
thrombocytopenia (plt 92 000); menorrhagia; anemia (Hgb 11.8); This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in arm left on 06May2021 07:00 (Batch/Lot Number: EW0T76) as single dose for COVID-19 immunisation. Medical history included acne. Historical vaccine INCLUDED 1ST dose of BNT162B2 (lot: ER8735) on 15Mar2021 via intramuscular in left arm for COVID-19 Immunization. The patient's concomitant medications were not reported. Patient experienced menorrhagia, thrombocytopenia (platelet 92 000), anemia (Hgb 11.8), all on 12May2021 with outcome of recovering. All events resulted in physician office visit. Treatment included iron supplement for anemia.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of thrombocytopenia. The case will be reassessed once new information is available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Resumption of period at end Jul; Skin swelling; Skin swelling, discoloration and itching on face and neck.; Skin swelling, discoloration and itching on face and neck.; Rashes on neck; Psoriasis behind ears and broken skin; Face: swelling, discoloring, peeling skin; Face: swelling, discoloring, peeling skin; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on 16Mar2021 (at the age of 51-year-old), as dose 2, single in left arm for COVID-19 immunization at Workplace clinic. Medical history included asthma and hay fever. Patient had allergies to cats, pollen, wool and linen. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. Patient's other historical vaccine included Shingles taken 2 weeks prior to 1st shot. Concomitant medication within 2 weeks of vaccination included loratadine taken for hay fever, start and stop dates were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021, 16 days after second dose of vaccine, the patient experienced Skin swelling, discoloration and itching on face and neck. Treatment medication included tacrolimus and topical steroid creams. On an unspecified date in Jul2021, the patient experienced resumption of period at end of July. Patient had not had a period in over 2 years previously. 3 skin issues started in late March/April. On an unspecified date in Mar2021, the patient experienced rashes on neck; psoriasis behind ears and broken skin; face: swelling, discolouring, peeling skin. Patient received treatment with psoriasis cream, steroids, tacrolimus, elidel. All Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test: negative, on 30Jul2021. The clinical outcome of all the events was not resolved.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The nurse noticed that while preparing the product was coming out and leaking onto her hand no AE; The product was coming out of the back of barrel of the syringe, past the plunger stopper, and leaking no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00857505) and transmitted to Sanofi on 15-Nov-2021.  This case involves a 63 year old female nurse who noticed that while preparing the RABIES (HDC) VACCINE [IMOVAX RABIES] after reconstituting the product was coming out of the back of barrel of the syringe, past the plunger stopper, and leaking onto her hand (occupational exposure to product and syringe issue).  The nurse's medical history, medical treatment(s), vaccination(s) and family history were not provided.   The nurse had no other concomitant vaccines.  The nurse was not pregnant.  On 12-Nov-2021, the nurse was preparing the product RABIES (HDC) VACCINE (lot T1E943M, expiry: 14-Oct-2022, formulation: pre-filled syringe) after reconstituted the product got onto the skin of her hand product used for unknown indication.  It was a case of occupational exposure while preparing product for administration and syringe leak (latency same day).  It was reported "Nurse states that she was preparing IMOVAX on 12NOV2021; Nurse states she inserted syringe with diluent into the vial with the Sanofi provided needle, she reconstituted the IMOVAX by swirling it around with syringe still inserted into the vial, she then went to pull the IMOVAX back into the syringe. When she was pulling IMOVAX back into syringe, she was trying to get product out of the neck of the vial, as she was pulling back she noticed that IMOVAX was leaking out of the back of the barrel of the syringe, past the plunger stopper, and onto her hand. Nurse asks if there is any possibility a replacement will be sent. Nurse states product is available for return"  The nurse had experienced no side effects after exposure.  The nurse did not require an Emergency Room (ER) or Doctor (Dr) visit after being exposed.   The nurse washed her hands after the exposure.
pt states heat & reddness began in lt arm 3JUL93, really became noticable 5JUL93; today, 6JUL93, 3x3 1/4 inch induration, red & hot to the touch; c/o stiffness & itching w/o pain;
Vaccine dispensed to patient in incorrect age group. Patient vaccinated with Pfizer 5-11 dose. Patient current are 4 years old.
Vaccine administered 8-20-13. Within 24 hours started having rash 0.5 cm over left trunk, traveled to right side down to buttocks and pubic area. Described as a constant itch with no pain. Started 50mg Q4 diphenhydramine. Patient had no improvement. Today patient given 1% topical hydrocortisone for a trial. Referred to MD.
was feeling ill, weak, said she was having some kind of reaction to shot, fainted was taken by ambulance to the hospital , she got a concussion, broke her nose and chipped tooth, was in the hospital 3 days
A constant pain internally felt in shoulder joint on left side. Vaccination was given in left arm. Shot was given high on outside of the upper left arm. No relief from over the counter pain or anti-inflammatories.
Stated that she awoke with a sore throat, cough and phlegm on 7/17/19.  Today, sore throat/cough continue, with flu-like symptoms.
Patient developed nausea, dizziness, and diaphoresis within two minutes of injection. Patient was assisted to side-lying position and ice pack placed on head/neck, wet washcloth to face. No vomiting, no syncope. Patient returned to baseline within 10 minutes. Declined offer of juice and pretzels. Recommended to RTC should they experience any other symptoms.
exposed to COVID; runny nose; This is a spontaneous report from a Pfizer-sponsored Program. A contactable nurse (patient) reported that a female patient (age: 68, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and is asking if she can receive the second dose of vaccine after being exposed to COVID. She has not tested positive on an unspecified date. She does have a runny nose, and this is not uncommon for her. Patient asked "If I do get symptoms of COVID, what do I do? Can I get the second dose? How long is recommended quarantine after exposure to COVID-19? Can I get the second dose later than the 3-week mark? since her second dose is scheduled for tomorrow. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Patient received Janssen COVID vaccine on 4/5/21. On 8/27/21, patient was admitted to our facility (directly from the airport after he arrived in  a flight from another country). At the time, patient was noted to be febrile, tachypneic and hypoxic and is thought to have sepsis secondary to multifocal pneumonia and DKA. Patient's COVID status positive on 8/30/21.  Patient was admitted to the CCU from 8/28/21 to 9/5/21. During hospitalization, patient had acute renal failure and cardioembolism in setting of COVID-19 hypercoagulable state: with embolic CVA with L-sided weakness, embolic LLE acute occlusion without tissue loss.  As of 9/9/21, patient is still admitted in the med/surg setting.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Nausea-Mild, Additional Details: Took BP and pulse shortly after, 109/72 HR 83 (within normal limits). Monitored her for almost an hour, counseled on what to do if symptoms worsen (go to hospital). She left with her nurse guardian. I called her 1.25 hours later, she was doing much better and nurse guardian was still monitoring her. BP and pulse still normal (per nurse/guardian).
Child felt dizzy/faint and turned pale then vomited violently x 4 times. We had the patient lay down in the office for 20 minutes and felt a little better afterwards.
Face got very pale, eyes rolled back and she began tongue rolling and passed out for approximately 10 seconds. Skin around mouth turned green and she remained pale for approx 10 min. She was light-headed for approx 30 min and came home (20 min drive) and went to sleep for about an hour.
Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in right arm on 21Apr2021 11:30 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150) administered in right arm on 31Mar2021 12:45 AM (at the age of 38-year-old) for COVID-19 immunization. The patient experienced shortness of breath on 25Apr2021. The event was reported as non-serious. Patient did not receive treatment for the event reported. Outcome of event was not recovered.
16 days after smallpox vaccination patient noticed small bumps on hands, arms, back, and knees. Pt states that they itch.
Patient started to get a twitching of the eye and some mouth tightening and loosening two days after vaccine.  He went in and was seen by the physician twice.  The first time was for a CT and other blood tests to ensure he didn't have a stroke.  The second appointment was to tell him that it wasn't a stroke and nothing else was wrong, so they assumed it was the vaccine.  He also went to the eye doctor during this time to ensure that it wasn't going to affect his stigmatism due to the fact that he couldn't wear his contacts only his glasses and his stigmatism is so bad he has to wear hard contacts.  Due to the twitching he couldn't wear the contacts.  It was reported to us on 04/08/2021 and he was still have some eye twitching, but not bad and his mouth symptoms had pretty much resolved.  The physician said that it should go away in 1-2 weeks and if not he was suppose to see her one more time.