chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on left upper arm where injection was given; developed 3/18/2020.  Red, itchy, painful.  Slightly raised.  Looks like hives.  Had fever the other day but feels fine today. Advised to contact PCP should rash worsen and ER if trouble breathing.  Advised to try Benadryl cream for itchiness & Ibuprofen or Tylenol for discomfort.
Rash around injection site, it is hot and painful to the touch, have not treated it with anything as it isn?t very bothersome.
Site reaction, large area of redness and swelling at site. (baseball size) + pain+ itch + fever 102-103 degrees, 5x within 6 hours of injection. Resolved over next 48 hours.
Client in for annual flu vaccine. Related to vaccinating nurse concerns that occurred following her 11/18/2016 vaccinations. Client states the next day from her 2016 vaccines, she developed a "red spot" and had "a lot of pain" with limited movement associated with elevation. (Client reported opposite sites for vaccine administration from EMR and 2016 vaccinating nurse's documentation of those vaccines). States she used warm compresses which help, but the pain lasted until after the holiday. States pain was constant but now "ebbs and flows". Described pain as aching, muscular pain with a red spot 2" in diameter at shot area. At 12/15/17 visit, states pain has gotten "tons and tons better". Now has full range of motion but has twinge type pain when she elevates her left arm half way; also states the aching continues.
The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around.  On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm.   On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it.   On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.
Patient died 3 days after receiving his first dose of the Covid vaccine. He saw his doctor 2 weeks prior to his death with absolutely no complaints, very healthy. He had no prior heart conditions and was pronounced dead of a heart attack.
36 hours after vaccination experienced nose bleed after sneezing .  I am not prone to them normally very rare . Thought I should report it as it took awhile to stop bleeding .
neck spasm; hyperacusis; pressure in upper mouth; Neck pain (with radiation); Tension headach; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headach), NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ALPRAZOLAM (XANAX) 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 22-Mar-2021, the patient experienced TENSION HEADACHE (Tension headach). On 30-Apr-2021, the patient experienced NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)). At the time of the report, TENSION HEADACHE (Tension headach), NECK PAIN (neck spasm), HYPERACUSIS (hyperacusis), ORAL PAIN (pressure in upper mouth) and NECK PAIN (Neck pain (with radiation)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: 125 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient reported experiencing pressure headaches on 22-Mar-2021. On 30-Apr-2021 patina started that pulsating and pounding in the back of her head when she does workouts that get her heart rate to 125. No treatment information was reported.
4 year old patient experienced severe swelling to left lower extremity; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; HCP reported that swelling was twice size of right extremity with hard, red, and hot skin; This spontaneous report was received from a physician via a company employee referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml/once, administered subcutaneously on left thigh for prophylaxis (strength was not provided, lot # and expiration date were unknown).  In approximately June 2022 (also reported as approximately 8 months ago), the patient experienced severe swelling to left lower extremity after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (peripheral swelling). The reporter reported that swelling was twice size of right extremity with hard, red, and hot skin (skin induration; erythema; skin warm), and that reaction lasted 2 weeks before resolving with treatment of diphenhydramine (BENADRYL), ibuprofen (MOTRIN), steroids and compression. The outcome of all events was reported as recovered and the recovery date was reported as unknown. The action taken with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) regarding all events was not applicable.   The causal relationship between all events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 83 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Developed hives and facial swelling 3 days after vaccination, worsened over the course of the next 24+ hours.
Suspected vaccination failure; Having it; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that had shot but it did not stop from having shingles now for 15 months and it was still painful. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Migraine, Fatigue, hot and cold chills and body sweats body sweats for no reason at all no energy I feel horrible
Patients mother received ZOSTAVAX vaccine on Friday 10/12/2007.  Patient developed flu like illness Sunday 10/14/2007 and developed lower left chest pain, burning and rash fairly classic for herpes zoster synday night. seen ny me ( her PMD ) on wed 10/17/2007 and started on valtrex 1000 mg q8h.  Patient herself had stem cell transplant/chemo/radiation 7 years ago and was reported to be cured of non hodgkin's lympoma.
Patient began to feel "itching to hands". This continued into the next day, and felt that the itching "moved around to her hands, backs, and legs".  She had a routine doctors appointment on that day where the Dr. reported no visible findings. Later that evening she called her daughter very worried and said the itching was much worse.  Her daughter advised her to go to the  ER.  She went to the ER where she was seen.  The ER physician reported as saying "you have hives in your mouth and on your tounge" she was given Benadryl, and an "IV steroid".  Patient was released.
felt weak & sore @ site that afternoon; noticed edema @ site that evening; noted rash around inj site w/papule @ center next day along w/fever & gen malaise; all sx cont 5-6 days; took DPH & Ibuprofen;
There was no immediate reaction but a day later the left arm felt like a pulled muscle. Chills and fevers followed. These lessened somewhat but about 6 days later ringing in the ears was moderate and as of this report has not subsided.  I have yet to schedule an office visit.
trouble with dry eyes; infection in her eye; blood sugar 54 mg/dl two hours after dinner with insulin, 147 mg/dl after candy, 85 mg/dl after oatmeal without insulin, 196 mg/dl after; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ6796), via an unspecified route of administration in the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus, bladder cancer from 2005 and ongoing (cleaned it out, but has to go for check ups every 6 months), stent in artery in neck on right side on 2011, atrial fibrillation (Afib), knee total replacement on 2010 and on 2015, and ablations on Jan2010 and on Jun2010. Ongoing concomitant medications included insulin lispro (HUMALOG) and insulin glargine (LANTUS) both for type 2 diabetes mellitus. She took her regular insulin last night (19Jan2021) at dinner time and her blood sugar went down to 54 mg/dl about 2 hours later. She ate some candy and it went back up to 147 mg/dl. This morning (20Jan2021), it was 85 mg/dl. She just had oatmeal without taking any insulin which is unusual for her. She just took her blood sugar again and it's 196 mg/dl, which after eating oatmeal is not really high. The patient want to know if anyone else had this response. She felt great afterward and didn't even felt it. She also had an incident with an infection in her eye yesterday (19Jan2021), but the doctor didn't think it was related to the vaccine. She just had one little tingle of it on an unspecified date and went right to the doctor and they gave her medication for the infection. She has plugs in both eyes so she has trouble with dry eyes on an unspecified date. Outcome of the eye infection was recovering while of the remaining events was unknown.  Information on lot number/batch number was requested.
Cellulitis in left arm. Cephalexin 500mg QID x10 days.
Fever 101.8 R - 103.0; 103 was reported by mom; 101.8 reported by nurse 1 hr p/APAP;
Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history or drug reactions/allergies who in January 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). On an unspecified date the patient was vaccinated with a second and third dose of GARDASIL. Concomitant therapy included hepatitis A virus vaccine (unspecified) and meningococcal vaccine (unspecified) with her second dose of GARDASIL. The mother is reporting that her daughter received all 3 doses of GARDASIL (on schedule) an developed neurological symptoms. Medical attention was sought. She does not remember when the symptoms began. Initially the daughter's left toes became swollen, red and tingly which lasted for 2 to 3 days. On 07-JUN-2007, the patient woke up with a tingly sensation of her left leg from her knee to her ankle. There was also a pimple-like bump on her leg which she thought was a spider bite. Since that day her leg has worsened. If the daughter gets generalized goosebumps on her body, they do not appear on that area of her leg. The patient cannot feel hot or cold sensations of that area and she cannot wear flip-flops because her toes cannot hold onto them. The bump was diagnosed as lymphomatoid papulosis. On 09-JAN-2008, the patient will also be going to a neurological center. At the time of reporting the patient had not recovered. No other details were given. On an unspecified date 3 magnetic resonance imaging test and a neurological examination was also performed. Additional information has been requested.  10/31/08 Reviewed dermatology, heme/onc & neuro clinic records of 12/12/07-7/14/2008. FINAL DX: LyP, lymphomotoid papulosis & cutaneous mononeuropathy LLE. Records reveal patient experienced skin lesions/eruptions since 6/2007 w/left LE swelling, numbness, pain, burning sensation, poor appetite & intermittent diplopia on meds w/15# weight loss.  Tx w/steroids w/o improvement then methotrexate which did provide relief but when tapered off, lesions recurred.  Exam in 12/07 revealed chickenpox-like skin lesions, papular & crusted. Biopsy done.  Began UVB phototherapy.
This spontaneous report was received from an immunization official referring to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot # L040458 with expiration date of 04-FEB-2018, for prophylaxis (dose, route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 13.5 hours. No previous temperature excursion was performed. The call was because of a "data logger". Additional information has been requested.
Pt. reports soreness in shoulder 2-3 days after vaccine. Soreness still present 30 days after vaccine. (Left arm same as vaccine).
Rash 6 days after immunization Flu for 4 days from 1-2 days after vaccine given.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patient was vaccinated with VAQTA (25/0.5) dose 1 (dose, lot number unknown) and the patient received a second dose of VAQTA 3 months after the initial dose of VAQTA. No adverse effects reported. No product quality complaint was involved. The outcome of the events was unknown. Additional information is not expected.
Increased ringing in ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 17Feb2021 (Lot number: EL9267) at the age of 77 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Cholesterol" (ongoing); "Verbatim: Allergies" (ongoing); "Verbatim: Sneezing" (ongoing); "Verbatim: Runny Nose" (ongoing), notes: Runny Nose due to time of year; "Rapid Heart Beat" (ongoing); "Tinnitus" (unspecified if ongoing), notes: The patient has had this problem before and has had tinnitus for many years. Concomitant medication(s) included: ATENOLOL taken for heart rate increased (ongoing).  The following information was reported: TINNITUS (non-serious) with onset 18Feb2021, outcome "not recovered", described as "Increased ringing in ear". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient reported that the right ear seems to be ringing worse than the left; she believes the ringing to be in both ears. The patient also said that at times it has gotten better, hasn't worsened, but remains steady. The event did not require a visit to emergency room and physician office. The patient did not receive vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 16 year old male who "sometime in the past" was vaccinated with varicella virus vaccine live. "Recently" the patient developed a mild case of chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Additional information has been requested.
fever, chills, light headed, slight nausea, Got out of bed at 2:30 AM to get a drink of water and passed out
Woke up the next morning feeling tired (physically tired, not sleepy tired) and a bit of a queasy stomach. Took it easy that morning, but by 1:00 pm was running a fever, which went up to 100.4 for the rest of the day and evening. Stomach was queasy all day and evening. I lay down the entire afternoon and evening. The next day, my fever was gone but I still felt weak, tired and had a queasy stomach. I took it easy all day and was not up to my usual routine. The following day (today), I still felt tired and queasy, but a bit better. I still did not resume my usual activities.
Fainting, fever, chills, nausea.  Had repeated fainting spells the morning after the day I was vaccinated.  Felt better the next day, still had slight fever.  By Wednesday (third day after vaccine day), felt fine.  The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.
This spontaneous report was received from a nurse and refers to a 12 year old female patient. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 02-OCT-2018, the patient was vaccinated with improperly stored second dose of GARDASIL 9 (dose and frequency were not reported) (lot # R011628, expiry date: 11-DEC-2020) intramuscularly in the left deltoid for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 02-OCT-2018. The outcome of event, vaccination site pain was reported as recovered/resolved. The relationship between the event, vaccination site pain and GARDASIL 9 was not provided. The vaccines were exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002051: Original Case: 1810USA002051.
17 hours later developed urinary frequency, urgency, and suprapublic and low back aching, multiple stools, exhaustion, and low grade fever.  Fever rose to 103 through rest of morning.  Saw Urgent-Care NP at 2:30 p.m.  (signed in 11:30 a.m.)  Urine only microscopic hematuria (not new finding) and no evidence bacterial infection.  Started on Macrodantin empirically while await culture. Fever resolved on antipyretics (tylenol).  Slept rest of day and through the night.  Much better in morning of August 20, with resolution GU symptoms and aching.  Urine culture negative/antibiotics discontinued.  Back to normal by August 20th evening.
I have suffered horrible auto-immune Sjogrens flares since I  received this vaccine. My eyes, my skin, my hair is falling out. My joints hurt. My medication I take for Sjogrens is now not even working anymore. I have had horrible symptoms for past 3 mos. I had Covid and recovered from covid  before getting vaccines. my auto immune never flared with covid like it has with vaccines. People who suffer from autoimmune diseases should never take these vaccines nor should we be mandated. I was fine before i took Moderna vaccines, my medications had my sjogrens under control. The covid infection was gone in 7 days. This has lasted two months of pure misery. How long will this last? Will my medications ever work again?
pt recv vax in rt arm & next day mild redness @ site & bruise;induration 10x14cm;no SOB , no itching;sl hurting;tx w/ice & antihistamine;
inflammation; Right neck pain; neck stiffness; body aches; severe chills; severe head ache; tinnitus; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 54-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 19Jan2021 (Batch/Lot Number: EK9231) as dose 2, single for covid-19 immunisation in Hospital. The patient medical history was not reported. patient was not pregnant. Concomitant medication in two weeks included vit d [vitamin d nos] and vitamin k [vitamin k nos]. no other vaccine in four weeks. The patient previously took iohexol and experienced drug hypersensitivity, first dose of bnt162b2 (Brand=Pfizer, lot number: EK9231) on 29Dec2020 into right arm for covid-19 immunisation. Patient experienced right neck pain, neck stiffness, body aches, severe chills, severe headache, tinnitus 2nd day after vaccine (20Jan2021, but also reported adverse event start date was 19Jan2021), inflammation on 20Jan2021. adverse event resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No if Covid tested post vaccination. Treatment received for the events included Magnesium and Curcumin to reduce inflammation. patient was not recovered from the events.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.