chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/20 at 1015 Patient, a 46yo female born 05/13/1974, was sitting with the RN for a 2nd dose Pfizer. She reported to the  RN  that 2 weeks following her 1st dose Pfizer (Received: 3/30/2021, LOT # ER8737 Exp: 08/30/2021) she developed a rash at the site of her injection.  Client showed the RN a photo of the rash on her arm. The photo revealed a raised erythematous area surrounding the injection site. Client states the rash was warm to the touch and accompanying symptoms included flushing and shortness of breath. Client states the symptoms lasted a few days. She contacted her PCP who made a follow up appointment with the client for 4/22/2021. Client's arm on 4/20/21 revealed an indented, discolored scar at site of injection. She denied any signs and symptoms immediately following 1st dose vaccine and states the symptoms did not develop until 2 weeks status post first vaccine.
Hives all over body from head to feet (including torso, back, neck, arms and legs).
Sore arm for over a month constant pain could hardly use my arm. Just got Flu shot no problem getting injection initially the pain in my arm lasted for over a month. Never had a problem before usually get my Flu shots from my Pharmacy.
SEIZURE...APPROXIMATELY 30 SECONDS FAINTING....APPROXIMATELY 1-2 MINUTES
Swollen tonsils; Neck stiffness; Congestion; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced swollen tonsils, neck stiffness, and congestion on 15Jan2021. Event details: The patient got the shot yesterday and when she woke up this morning her tonsils were swollen. She had neck stiffness, her neck was stiff, forearms, a lot of congestion. The outcome of the events was unknown.
No additional AE; PROQUAD and VARlVAX instead of VARlVAX and MMR II.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-OCT-2021, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot# U010742, expiration date was reported as 03-OCT-2022, but upon internal validation established as 02-OCT-2022, 0.5 milliliter in the right thigh) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U002397, expiration date 22-JAN-2023, 0.5 ml into left thigh) (formulations, concentrations, dose numbers, frequencies and routes of administration were not reported) for prophylaxis. The measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered (instead of measles (+) mumps (+) rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II)) (overdose). Both of administered vaccines were dissolved in sterile diluent lot# T013004, expiration date 13-NOV-2022, 0.7 ml (formulation , strength, route of administration, frequency were not reported). No additional adverse event was reported (no adverse event).
15 mins after receiving yellow fever vaccine pt c/o shortness of breath and abdominal pain, generalized hives, leg cramps. Given Epi 1:1000 SQ .3mg IV MSO4 4mg, Benadryl 25mg po x 2, Solumedrol 40mg IV, Benadryl 25mg IM. Called 911 sent to hospital ER. Transferred to ER. Was treated in the emergency room and released.
It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; dizzy; irate; yelling; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 84-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started feeling bad and it may have nothing to do with a side effect of the vaccination. On an unspecified date, the patient felt pretty bad. He was coughing up phlegm. He was supposed to go back on 28Apr2021 but he was sick. It occurred to him that maybe he had COVID when he got the vaccine and it was just developing. He was pretty sick. He was coughing up a lot of grey mucous from his lungs. He felt terrible like he had a bad flu on an unspecified date. He might go to the hospital. He probably should have done that anyways. He was dizzy and terribly sick on an unspecified date. The patient was irate and yelling on an unspecified date. The outcome of events 'it occurred to him that maybe he had COVID when he got the vaccine and it was just developing', 'dizzy', 'irate' and 'yelling' was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
9/17 was doing fine until this am - now has red area of induration and heat where he got vaccinations - doesn't seem to hurt, maybe only itch a little - redness is not spreading. 9/19/16 Skin: Mildly erythematous patch on anterior left thigh 10x10cm without pustules or satellite lesions. Blanches. Minimal induration over injection site, no mass or fluctuance. Not seemingly tender. Not warm to touch.  9/23/16 Skin: No laceration, no lesion, no petechiae and no purpura noted. Rash is not papular, not pustular and not vesicular. He is not diaphoretic. There is erythema. Anterior left thigh erythema. Blanchable. No lesions. Skin not firm. Borders regular and not raised. Non-tender, not warm.
Warm to touch; sore arm and arm hurting; Joint pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (sore arm and arm hurting), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high, Obesity and Allergy. Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LABETALOL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (sore arm and arm hurting), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PAIN (sore arm and arm hurting) had not resolved and ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had resolved.            Patient was also taking Inhaler daily for asthma as concomitant medication  No treatment information was provided  Action taken with mRNA-1273 was not applicable
Rash; Muscle soreness; Red patch; Red marks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash), MYALGIA (Muscle soreness), RASH ERYTHEMATOUS (Red patch) and ERYTHEMA (Red marks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash), MYALGIA (Muscle soreness), RASH ERYTHEMATOUS (Red patch) and ERYTHEMA (Red marks). At the time of the report, VACCINATION SITE RASH (Rash), MYALGIA (Muscle soreness), RASH ERYTHEMATOUS (Red patch) and ERYTHEMA (Red marks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Patient c/o dizziness, blurred vision.  Skin hot to touch. Vital signs:  11:25am 130/76 81 18;  11:26am  120/82 80 18;  11:31am  130/79 75 18 O2 96% Temp. 97.2   11:41am 127/72 69 18 O2 97%;   11:48AM 130/90;   11:55am  132/84  70 18 O2 98%
Immediately after administering Hepatitis A noted rash around both of the patient's eyes. Vital signs were checked and stable. Steroids and BENADRYL was administered P.O.
stood up after meeting at work and went blind/greyed out, sight came back in right eye after a minute, left eye stayed out and gradually gained sections of vision over 3 day period. Still have vision dead spot Eye Stroke, after the 2nd injection- determined thru eye exam when getting new pair of glasses. performed extra tests to confirm. also after booster started experiencing syncopy/flushing when coughing or sneezing, that has been ongoing ever since, duration and intensity was worse at beginning.
Information has been received from a registered nurse (RN) concerning a 32-year-old male who in 1997 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck)., adult schedule. On 14-JUL-2005 the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 648297/0217R). About one day post vaccination (on 15-JUL-2005, the patient experienced a slight rash on her arm. Subsequently, the patient recovered. No further information was given. No product quality complaint was involved. Additional information has been requested.
Flushing, followed by scant ant clear mucoid emesis, followed by pallor. Child then presented with petechiae locaed bilateral temporal region extending down cheeks and chin. Noted scattered petechiae R axilla region. BP 90/42. No SOB/dyspnea, no diaphoresis, no LOC, no loss of muscle tone or strength.
Rash injection site edema  Narrative: Swollen arm, possible cellulitis, warm to touch- treated with antibiotics   Other Relevant History:
The patient received his Covid booster with Pfizer on 12/28/21 after completing the primary series with Pfizer. He received the regeneron infusion on 11/2/21 after testing positive for COVID-19 one day prior. Current CDC recommendations state to defer COVID-19 vaccination until at least 90 days after receiving a monoclonal antibody product for the treatment of COVID. The patient reports he was not asked if he had the infusion prior to getting his booster, but he was asked other questions. When he went with a family member to get their booster a few hours later, he heard them ask about the infusion - family member was turned away as they also had the infusion the same date as the patient did. The patient reports no concerns or symptoms at this time and will plan to monitor.
Left arm muscle sore at injection site, continued for several weeks, it has progressively worsened over time. I continued to expect it to improve, but it has now worsened and affects my range of motion with occasional tingling.
Upon arrival to observation room, just after vaccination, patient c/o decreased vision, feeling hot and as though she was going to pass out. Pt. appeared anxious stated she did not like needles.  Removed face mask to take slow deep breaths, sipped water.  BP 81/51, pulse 84, pulse ox 98%, skin mildly diaphoretic.  Did not lose consciousness, answered questions appropriately. Continued to drink water and take slow deep breaths, felt better after 4-5 minutes. Felt well enough to walk to the first aid room for additional observation (30 minutes).  Sitting in the first aid room she continued to drink water (16 oz) and ate several crackers; symptoms continued to improve and patient she felt much better, ready to leave the clinic.  Patient was calm, conversant, BP improved to 97/57, skin was warm and dry, pulse 74-78 and pulse ox 100%.
The patient was experiencing excessive hair loss /hair coming out in clumps; The patient was experiencing increased migraines; The patient was experiencing nose bleeds; The patient was experiencing injection site tender arm /arm tenderness; The patient was experiencing chills; The patient was experiencing right knee pain; The patient was experiencing stomach pain; The patient experienced injection site reactions; The patient reporting toxicity; The patient experienced tingling; The patient experienced injection site discomfort; The patient experienced minor headaches and over a month the headaches worsened; the patient feels convinced that that it triggered a autoimmune response; This spontaneous report was received from a physician and a nurse via a company representative regarding a 37 years old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not reported.     On 07-MAY-2019, the patient was vaccinated for prevention with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (lot number: R028651 and expiration date: 27-JUL-2021) (strength, dose and anatomical location were not reported). On an unspecified date in July 2019 (reported as "about one month after the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient experienced minor headaches (mild), tingling (paraesthesia) and injection site discomfort. It was reported that the headaches worsened over a month.   On 08-JUL-2019, the patient was vaccinated for prevention with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered IM (lot number: 1602284 and expiration date: 26-SEP-2021)(strength, dose and anatomical location were not reported). In addition, the patient did not mention any of the abovementioned side effects she was complaining until she went to the office the day after she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On 09-JUL-2019 (also reported as next day), the patient noticed she was experiencing excessive hair loss, her hair was coming out in clumps (alopecia), chills, injection site tender arm, right knee pain (arthralgia), nose bleeds (epistaxis), stomach pain (abdominal pain upper), increased migraines, injection site reactions and the patient reported toxicity (poisoning). It was reported that blood panel, lipids and hormones tests were performed to the patient, but no results were provided.  Additionally, the patient felt convinced that that it triggered a autoimmune response (immune system disorder). At the reporting time, the patient had not recovered from all the aforementioned events, except for the event injection site discomfort which outcome was unknown.   The causality between all the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of poisoning was determined to be medically significant.
The day after first dose was nauseous, fatigued and achy. Ended the next day. Irregular menstrual bleeding and painful cramps started at the same time but hasn't stopped since. Irregular menustrual bleeding and heavy cramps are still ongoing.
This spontaneous report was received from a medical assistant referring to an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecific date, the patients were vaccinated with improperly stored VARIVAX. Concentration, dose and route of administration were not reported (lots # M034586, expiration date 27-JUL-2018; M025871, expiration date 24-MAY-2018 and M014916, expiration date 25-MAR-2018) for prophylaxis. It was reported that the temperature excursion was for 1 hour and 42 minutes at 17.4 degrees F, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Skin has been sort of erupting/ the rash is gone on and off some for about 25 years, I guess or more probably years/ I don't always have it this bad; thought if she was allergic to polyethylene glycerol or polysorbate; exfoliate; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via an unspecified route of administration in upper left arm on 03May2021 (at the age of 63-years-old) at 1st dose, single dose for COVID-19 immunization. Medical history included dermatitis, asthma, and rash which has gone on and off for about 25 years or more. The patient's concomitant medications were not reported. The patient received the first Pfizer shot on 03May2021 at a pharmacy/ drug store. She has a long history of dermatitis issues and in January (unspecified), she had chemical testing done. She had quite a few chemicals that she reacted to and she have compared that with the list of chemicals that she received in print out when she received her first vaccination. She didn't see that there was a match, however she did speak with an allergist to ask her about any risk for her to get the vaccine due to chemical testing. The allergist stated to go ahead and recommended that the patient get the Johnson & Johnson if she could because there were just less chemicals or something. The allergist didn't explain that, but the patient did not find Johnson & Johnson vaccine available, so she went ahead and got the first Pfizer shot. The patient  waited until half an hour after her shot as suggested by the doctor and she did not have any reaction during that time, but ever since then, and it could be due to number of different things, her skin has been sort of erupting and exfoliating on May2021 and she really had a bad point today, she actually has an appointment with her dermatologist at 10:30 thinking they were going to have to put her on prednisone or something like that to stop it. This has just gotten really bad. The patient thought if she was allergic to polyethylene glycerol or polysorbate and she looked for those on the list of chemicals that she was tested for; she was not tested for either one of those chemicals, so she was actually unsure if she was linked to them or not. She was unsure if the first vaccine was the cause of this problem. The rash has gone on and off for about 25 years or more. She didn't always have it this bad, she does sometimes especially when summer season starts and ends. She was unsure if it was the vaccine that did this, if there was something in there which stayed in her body that reacted. When asked for the treatment, the patient stated that she took ZYRTEC and BENDARYL and added that she was seeing her doctor today at 10:30 so they might be treating her. The outcome of the events was not recovered.
Arm started bleeding; it was too fast to have the vaccine administered; This is a spontaneous report from a contactable nurse, the patient (retired registered nurse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for COVID-19 immunization and had no adverse event. On 27Apr2021, patient stated that when she received the second dose of the Pfizer BNT162B2, she believes that the vaccine was no administered as the person who did just "jabbed" the syringe in a second, her arm started bleeding and placed a band aid and stated that it was too fast to have the vaccine administered. She found suspicious that the vaccine provider did not write down his initials on the vaccination card as the lady who administered the first dose did. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; 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 vaccination site bleeding. 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
He got the vaccine, at first for about 6 hours he felt okay, did not feel anything, felt fine.  Then that day he started getting a headache, feverish, took Tylenol and felt better.  The next day he noticed his heart rate would not go down, it will not go down below 100, will shoot up to 130.  He went to the ER and at one point went to 150.  They prescribed him some medicine to lower his blood pressure and he has been taking that and it has not been helping.  He also went to his doctor and told him that it was probably anxiety, and his heart rate will still not go down.  He has not had any other reactions other than this and he's scared.
pt had reaction of mouth and  BIL cheek numbness, SOB, chest pain, sore throat irritated throat ,  chest pain approx 20 mins after vaccine was given. Pt was monitored and EMS called, pt was stable after 45 mins EMS directed her to return home.
arm has a ring around it; feels sluggish; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever). At the time of the report, VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This case is under data review.
Patient was given the second dose of Pediatric Pfizer after 13days rather than 21. We did not realize until we went in to chart it afterwards.  Spoke with supervisor and she instructed me to report it immediately.
Vaccine administered at approx 5:30 pm 12-5-07. Upon arising 12-6-07 patient noted arm (upper) at injection site erythemic-Patient called Dr and was instructed to call Dr. if condition did not improve. Condition became worse with erythema swelling and pain to "entire upper arm".-reported patient. Saw Dr. 12-7-07 and he dx Cellulitis. Tx: Cephalexin 250 mg one tablet QID x 10 days
I had something similar to a really bad diaper rash. It ran down to my anal area and my genital area. It was very inflamed. The doctor described it as a very bad case of Diaper rash. The rash cleared up in about 3 weeks. My doctor prescribed me Valacyclovir 500mg to treat the rash.