chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 15 developed a rash on left arm that traveled to the elbow over three days. At that time the Stills disease flared up, this has been under control of over 15 years. I developed a pain in the right calf and had a scan to make sure it wasn?t a blood clot. It was not a blood clot but continues to be a problem with undiagnosed pain. It was decided it would be better to hold off on the second shot. It feels like my body is now fighting itself again.
Nonstop sneezing and post nasal drip; swelling around eyes; fever; headache; extreme fatigue; coughing.
Rash on arms and legs after flu shot. I noticed rash a little more than a day after shot.
Second vaccination given on day 21; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccination given on day 21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccination given on day 21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccination given on day 21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Stroke; Fatigue flare up; Arthritis; Plaque psoriasis break out on left calf, left knee, and right knee; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4304137-00 (AbbVie).  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single, intramuscular, administration date 19May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke"; FATIGUE (non-serious), outcome "not recovered", described as "Fatigue flare up"; ARTHRITIS (non-serious), outcome "not recovered", described as "Arthritis"; PSORIASIS (non-serious), outcome "not recovered", described as "Plaque psoriasis break out on left calf, left knee, and right knee"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The action taken for adalimumab was dosage not changed. The reporter's causality for the event(s) of stroke and headache with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of fatigue flare up, arthritis, plaque psoriasis break out on left calf, left knee, and right knee with Humira (Adalimumab) was reasonable possibility. Unknown if the event abate after stopping drug. The reporter's causality for the event(s) of stroke, fatigue flare up, arthritis, plaque psoriasis break out on left calf, left knee, and right knee with Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was not Reported. The reporter's causality for the event(s) of Headache with Humira (Adalimumab) was Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  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.
4/3/21 Chief Complaint rash, itching,  Benadryl 50 mg IM administered in right arm at 4:01 PM, injection tolerated well, rash diminished, no tingliness remaining, patient states she feels fine, education provided on taking Benadryl 50 mg in 4-6 hours if necessary, to go to Emergency Room if symptoms increase.   4:11 PM B/P 140/90, Pulse 100, 94%, 4:23 PM B/P 140/90 Pulse 94.  Patient departed with significant other at 4:25 PM.
After his office visit with me on Tuesday 7/13, the patient went to get the Moderna COVID vaccine. He received the vaccine on Tuesday evening. On Wednesday, he developed new fevers as high as 104F (measured at home). Fevers improved with Tylenol. He did not report his symptoms, as per his wife, he assumed this was related to the COVID vaccine. By the following morning, his fevers had resolved. He took a nap midday, and shortly after waking, he reported to his wife that he was feeling short of breath. According to his wife, he appeared in respiratory distress and she heard wheezing. He asked to be helped to the ground, and she immediately called EMS. Unfortunately, before they could get him to a hospital, he died. At the hospital, his wife was told that because his death was outside the hospital, it was presumed to be due to "natural causes". She was told an autopsy would cost $5000, which she could not afford.
Widespread urticaria on inner thighs, arms, back of neck, stomach, chest. Onset ten days after booster shot of Moderna Covid vaccine.  No history of urticaria, no known allergies to medication, food, or cosmetic products. No new medication other than birth control, but that had been taken the previous month for an IVF cycle.
Throbbing deltoid pain about 7 hours after injection.  Iced and took ibuprofen.  Shoulder felt better for 24 hours and then started having more widespread pain the evening of 4/25 (including rotator cuff and tricep pain) and limited range of motion.   Increased pain last night and this morning . Have an appointment with an orthopedic tomorrow.
Pt given PREVNAR 13 - arm swelled large hematoma extending from deltoid to wrist with erythema. Patient on coumadin INR 3.3. Son reports 24-48 hrs post called 12/20/15. Hematoma extending down arm. Treated for large hematoma 24 hours post and prophylactic for cellulitis.
2 bivalent doses given within a day to a patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient).    No concomitant medications was reported. No treatment drug details was reported.
Severe sharp pain at injections site started 2 weeks after shot.  Shot site was very high in shoulder suspected SIRVA
The pt experienced flushing, dizziness, nausea 10 minutes post vax. Treated with epinephrine. Symptoms resolved within 15 minutes.
Started getting reduced hearing on both ears, worse on right hand side, shortly after 1st dose received on 4/2/2021. Hearing deteriorated even further after second dose received 5/4/2021. Right hand side ear worse than left.  No pain associated with hearing loss, but clouded mind, and extreme tiredness due to impaired hearing. Especially if in noisy locations like a grocery store.
diffuse arthralgias (especially knees rt & lt) & lt shoulder & wrists starting shortly p/2nd vax 24MAY95;
None COVID 19 EXPIRED 2/8/2023 GIVEN 3/3/2023
Shortness of breath - dizzy = Saturday clammy, shortness of breath - heart palpitations weak - Sunday, stayed home Monday DR's appt when back to emergency (was there Sunday), went to work Wed - was sent home. 11-15-13 = started Friday = no appetite - shortness of breath, dizzy = Sat. (went to work) clammy, heart palpitations - nausea 11-16-13 Sunday = 11-17-13 (went to work 1/2 day) clammy, dizzy, heart palpitations - nausea - dry heaves (at home in AM) also no appetite went to emergency room. Was given an EKG - blood tests, I.V. Was sent home everything was O.K. I wasn't! Monday called in made appointment to see doctor, she gave me a release to go back to work Wednesday 11-20. Was told to go home until I was 100% - whatever that is?? or whenever?? I have Addison's disease for which I take Prednisone - have been taking this for many years. I was told by my immunology - she told me to retake this Pneumonia vaccine because my immune system is in trouble. I did take this vaccine when I turned 60 - had no problems then. I have enclosed a list of my medications. Besides Addison disease, I have gastritis, gastric ulcer, hiatal hernia and diverticulitis. If this information needs more explanation call me before Dec. 16 - I'm going back to work Dec. 3. I have a DR's appointment and Dec. 6 I'm having a procedure done. So feel free to call before or after the 3rd and 6th. I'm still not feeling right - very tired - no energy?!!??!
Back pain, leg pin, arm pain(both arms) a headache and weakness and sleepiness
ERYTHEMA AND SWELLING NOTED ON POSTERIOR ARM FROM SHOULDER TO ELBOW BILATERALLY IMMEDIATELY FOLLOWING VARICELLA AND MMR INJECTIONS.
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Have had a splitting headache every single day since I received the first dose. It's been 12 days of having to take ibuprofen/tylenol in order to be able to function.
She had horrible intense itching to the booster for 6 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (ongoing), notes: Caller states she is immunocompromised and has an autoimmune disease; "autoimmune disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation, reaction(s): "No adverse event". The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "She had horrible intense itching to the booster for 6 weeks.". The event "she had horrible intense itching to the booster for 6 weeks." required physician office visit. Therapeutic measures were taken as a result of pruritus.  Additional information: Caller stated she was immunocompromised and had an autoimmune disease. She had a reaction a year and a half ago to the Pfizer BioNTech Covid 19 vaccine booster. She had horrible intense itching to the booster for 6 weeks. She stated it was internal from the inside out and she took 10 antihistamines a day. She had no reaction to the primary series. "It wasn't every time." She had boosters and the primary series and she was fine. She had doctor and immunologist. She had asked for a referral to a dermatologist.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357094 Same patient/product, different dose/events;US-PFIZER INC-202300357093 Same patient/product, different dose/events;
This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) reconstituted with sterile diluent (lot# and expiration date were not reported) and with other unspecified vaccines. On 22-OCT-2017, "shortly after" receiving ZOSTAVAX and the other vaccines, the patient went into renal failure and went to an unspecified hospital to receive dialysis. The patient was given treatment for the event. The outcome of the events was reported as "recovering". The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of renal failure was considered to be medically significant.
headaches, chills, fever 103.3,  100.2 (fever taken ever 4 hours) body aches, no appetite,  no energy,  from 11:30 am 4/9/21 until 4/11/21 about 6:30 am,  bed bound the entire time,  swollen injection site,
No additional AE; Patient, in combination with concomitantly administered MMRlI, was inadvertently administered PROQUAD instead of the intended VARIVAX; Patient, in combination with concomitantly administered MMRlI, was inadvertently administered PROQUAD instead of the intended VARIVAX; This spontaneous report was received from an other health professional referring to a 12 months old female patient. There was no pertinent medical history and drug reactions/allergies. Concomitant medication was not reported.   On 01-SEP-2021, the patient was in combination with concomitantly administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot# and expiration date were not reported) was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported, lot # T029102, expiration date: 23-FEB-2022) instead of the intended varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (accidental overdose and wrong product administered).  No additional adverse event was reported (no adverse event).
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history was reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot#, dose, route not reported). No concomitant medications were reported. On an unknown date, the patients experienced pain at injection site after receiving GARDASIL. The outcome of pain at injection site was unknown. The relatedness of the adverse event with GARDASIL was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Erythema, induration, warmth and tenderness. 8 x 9 cm area at inject site.
I had the Covid; I had the Covid; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266, expiration date: unknown) dose 1 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.On 09Mar2021, the patient reported that he got his Covid shot and got a call the same day, a message from the place where the patient got it, that they have cancelled his second shot and was supposed to go back for his second shot on the 07Apr2021 but now they changed it to 14 Apr2021 (which is five weeks from the first dose). The patient was concerned that it should be four weeks. On an unspecified, date the patient reported that the patient had the Covid. The patient had it (further clarification unknown) so wanted to make it sure that  he get the shot.The outcome of the events was unknown.
on Friday pt had extreme weakness, fever up to 102 and abdominal cramping and diarrhea.  Extreme Fatigue persisted through Sunday.
Patient was given two doses of the polio vaccine by receiving PEDIARIX and a separate polio vaccine on top of that. To my knowledge there has not been any adverse events.
Pt. had Redness about 3 inches, swelling, warmth and pain at site of injection. Also had headache, muscle pain, tiredness, fever, dizziness, and started at night of injection. Pt. took some ibuprofen, not helping.
Early afternoon, the day after immunizations, pt. noted "exquisite" tenderness, warmth and redness and slight swelling on front of R arm, below armpit. deltoid area where injection given slightly tender. No redness, warmth or swelling. 10/10/08, no nodes palpable. No fever. Decreased tenderness, redness and swelling unchanged. To MD, unknown cause. Started client on antibiotics and BENADRYL @ HS.
Throat swelling, itching on site and body, swelling in arm, and around ear in face
Arm around PNEUMOVAX is red, inflamed and warm. Raised area is approximately 10 x 15cm in size.  Went to doctor, was prescriped Amoxicillin 875mg bid for 10 days (in case of cellulitis).
Muscle pain, hotness and redness in upper arm, fatigue, muscle pain.  The fatigue and muscle pain lasted two days.  The upper arm symptoms were still present on the fourth day after the injection, but had lessened.
9AM pt recvd vax was cranky around 6PM; fever up to 103 brought down by APAP to 102; refused to eat & drink; diarrhea started 4-5AM-dark, black, runny stool x 6;
Not sure if she received or not the vaccine in the syringe, they do not know if there was vaccine or air on it; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine, and who is not sure if she received the vaccine in the syringe. They do not know if there was vaccine or air on it.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273  on an unspecified date intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, a patient was not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event "not sure if she received the vaccine in the syringe, they do not know if there was vaccine or air on it" is considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273  (Lot#: unknown) intramuscularly for prophylaxis of COVID-19 infection and patient was not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe.  There were no reported AEs associated with this case of not sure if she received the COVID-19 vaccine or if there was only air in the vaccine syringe.
day after booster started having chest pain.  came to ED EKG showed pericarditis indications, troponin was elevated 13.47 Will be transferred to hospital for admission.
6/1/05 11:30 AM Right upper arm at site of injection - 2 inches diameter, warm, slightly raised red/pink area. Client complained of generalized itching. Advised to take oral Benadryl and Ibuprofen. 6/1/05 Saw provider; received SC Epi; Complained of labored breathing per patient report. 6/2/05 To HD 2.5 diameter pink, warm area at injection site.
pt recv vax 15APR98 & 18APR98 pt exp frequent/cont episodes of irritability & sleepiness;pt also exp a few fevers & few episodes of emesis;pt was very tired;appeared to have a mild viral illness;
headache, nonproductive cough, chills, altered taste, loss of smell, diarrhea, sinus congestion, post nasal drainage, sneezing, itchy eyes. starting on  11/1/21
Numbness and Pain in Left Hand following Second Pfizer Shot.  Joints at Left Pointer and Middle Finger Red, "on fire".....Left Hand Swollen. I cannot lift, type, open doors, hold a coffee cup, tie my shoes, put earrings in, etc.