chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-JUL-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-SEP-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed Lidocaine, Tramadol and Valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
MY FACE STARTED ITCHING AND RED AND MY THOAT WAS SORE TO SWALLOW AND SEWLLED I TOOK BENADRLY AND WENT TO THE ER AT the HOSPTIAL THEY WATCHED ME FROM ABOUT 12:00 PM TO 1:30 PM AND SENT ME HOME TO REST
Breakthrough COVID infection. Covid test result Positive; Breakthrough COVID infection. Covid test result Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 24-year-old non pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch/Lot number: not reported) via intramuscularly in left arm on 20Feb2021 10:00 AM (age at the vaccination: 24-year-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch/Lot number: not reported) via intramuscularly in right arm on 30Jan2021 05:00 PM (Age at vaccination: 24-year-old) as dose 1, single for COVID-19 immunization at public health clinic/veterans administration facility. The patient had no other medical history and concomitant medications was not reported. patient had known allergies to mushrooms, olives, olive oil, seasonal/environmental. Patient did not receive any other vaccine within 4 weeks prior COVID 19. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. On 15Nov2021 07:00 AM, patient experienced breakthrough COVID infection. The adverse event result in emergency room/department or urgent care. Events considered as non-serious as per the reporter. On 17Nov2021, patient underwent lab tests and procedure which included Antigen Rapid test with Nasal Swab results positive for Sars-Cov2 infection. Patient did not receive any treatment for event reported. The outcome of the event breakthrough COVID infection was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
gullian barre syndrome; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "gullian barre syndrome". Clinical course: the patient got gullian barre syndrome after getting Covid shot and then got the syndrome again a year later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and considering the possible temporal relationship based on the description of the reporter, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event "gullian barre syndrome" conservatively. This case will be reassessed once additional 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.
tingling and numbness left side of face and tongue symptoms resolved by 10/11/2010
Extreme itching on the back of the left hand accompanied by moderate swelling of the left hand. This was followed by numerous (over 100) very small blisters on the back of the left hand. This has continued for a week although the symptoms appear to be subsiding. As of yesterday (July 14, 2018) the back of the left hand is still warm to the touch and still has some slight swelling.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 09:00 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "IV contrast allergy" (unspecified if ongoing), notes: Known allergies: IV contrast; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: STELARA taken for Crohn's disease. The patient also took multiple unspecified medications as concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Positive; (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19: complete 10 doses of PAXLOVID from 18Dec2022 to 23Dec2022.
Became light headed and dizzy Blood Pressure taken in 5 min intervals and steadily climbed to triple digits for diastolic and systolic readings. Individual has no prior history of hypertension. Heart rate and oxygen were good. BP was 161/101 paramedics stayed until BP started going down after roughly 45-60min.
Got shot in left arm  .Came home, looked in mirror left eye normal,  went for walk, started feeling like something was stabbing me in eye. Came home looked in mirror and left eye tomato red.  Thought I had pink eye.  Went to Opthamologist  next day and it was Intraoccular Pressure.  Had pain in eye, left side headache, left nostril dripped for about 3 days, extreme light sensitivity.  Have been on Prednisolne Acetate for 2 weeks>  Have been to Opthomologist 3x so can monitor eye pressure.  He believes it was from RSV Vaccinee
100 degree fever & body aches started 26 hrs after injection (injection on 9/24/21 @ 3 PM, adverse event on 9/25/21 @ 5 PM). Fever ended 5 AM on 9/26/21. Felt fatigued the rest of the day, then totally fine on 9/27/21.
Patient said vaccine hurt more than usual during administration but he didn't think anything of it. The next day his arm started hurting more. It got better in a few days, but then got worse. Still hurting a month later.
No adverse event; Patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) 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 UNDERDOSE (Patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose The patients have not reported any adverse reactions at this time.  No treatment medication was provided. This case contains information for the 9th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666251, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666279, US-MODERNATX, INC.-MOD-2022-666281, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666283, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666295 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277:Patient 7 US-MODERNATX, INC.-MOD-2022-666063: US-MODERNATX, INC.-MOD-2022-666248: US-MODERNATX, INC.-MOD-2022-666249: US-MODERNATX, INC.-MOD-2022-666250: US-MODERNATX, INC.-MOD-2022-666251: US-MODERNATX, INC.-MOD-2022-666252: US-MODERNATX, INC.-MOD-2022-666278: US-MODERNATX, INC.-MOD-2022-666279: US-MODERNATX, INC.-MOD-2022-666281: US-MODERNATX, INC.-MOD-2022-666282: US-MODERNATX, INC.-MOD-2022-666283: US-MODERNATX, INC.-MOD-2022-666286: US-MODERNATX, INC.-MOD-2022-666290: US-MODERNATX, INC.-MOD-2022-666295:
Bell's Palsy, progression to complete right sided facial paralysis over 3-4 days, started prednisone treatment within 72 hours of onset.
Pt. called 12/7/11 per pt. telephone statement. Day after vaccines given left shoulder swollen and red. Pt. stated cool compress was applied. Pt states shoulder painful. Pt. took TYLENOL and BENADRYL. 12/12/11 per pt telephone statement, soreness is better. Pt. states took ibuprofen and has two "knots" on left shoulder.
Mom states that 2 days after recieving the HPV vaccine patient had discomfort in the arm that the vaccine was given. Patient's mom never called the office to report such events. Patient saw Orthopedic doctor Dr and Physiatrist Dr. Dates of evaluations are unavailable at this time. On December 9, 2019 mom came into the office to report that the Orthopedic doctor diagnosed SIRVA or shoulder injury resulting from vaccine administration. Merck Rep notified of such events on January 8, 2020 at 10:30 AM.
Rash raised hive size of an orange at injection site. Now toward inside of upper arm and swelling gone, flatter light pink. Covid Arm  Recovering
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, route and site not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that "several years ago" on an unknown date, the patient experienced anaphylactic reaction along with swelling of the arm after receiving a dose of PNEUMOVAX 23. The patient went to a hospital. At the time of the report, the patient had recovered. Additional information has been requested.
Pt developed what appears to be an abscess to the injection site 1 day post injection. Pt states initially the site was approx., 'golf ball sized', swollen, red, hot to touch. It slowly decreased in size over time. Today is approx. olive sized, semi-firm, tender w/white head to center, warm to touch.
Patient reports that when her second booster dose was administered that the majority of the vaccine sprayed out and did not go into her arm.
Patient had VARIVAX in the right arm. She had one varicella vaccination previously in her lifetime. 3 days after present vaccination, she developed blistered lesions in a circle around the site of vaccination. These worsened and she went to emergency room on Jan 2, 2011 and was treated for cellulitis with ROCEPHIN and KEFLEX. The area continued to worsen with increasing vesicles and more redness and swelling and some pruritis. She returned to the emergency room on Jan 5, 2011 and was admitted. Infectious disease consult was done and diagnosed with attenuated varicella virus localized infection after vaccination.
Severe weakness in both legs, but worse in the left leg. "When I walked my legs got so weak I would have to stop walking and stand in place for a while, then resume walking." Pitting edema in both feet Muscles in right and left buttocks extremely painful Severe leg cramps in both feet that went up to the sides of my legs Neck muscles on the right side from the bottom of face to top of shoulder sensitive
A report was received from a healthcare professional on 10/02/2003 concerning a 55 year old female vaccinee who experienced redness at the injection site an unspecified length of time after inadvertently receiving expired Fluvirin vaccine on 09/30/2003. On 09/30/2003 the vaccinee inadvertently received expired Fluvirin vaccine and an unspecified time later the vaccinee experienced redness at the injection site.  The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Onset of itchy, red palms of hands 9/22/03. 9/23/03 some itching of palms, soles of feet, torso and arms. Some small welts on arms for short period-resolved. 9/24/03 mild itching on arms - resolved same day. No further symptoms.
patient received dose from an expire vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from an expire vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
huge red bump that came up on her arm; huge red bump that came up on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm). At the time of the report, VACCINATION SITE ERYTHEMA (huge red bump that came up on her arm) and VACCINATION SITE SWELLING (huge red bump that came up on her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-580246, MOD-2022-580248 (Patient Link).
Patient stated severe immobility in her arm for about 5 hours from pneumonia vaccine. took medicine and had some relief.
PATIENT REC'D ANTHRAX # 2 ON DEC 16, 2003. WITHIN 48 HOURS, HE DEVELOPED PAIN IN JOINTS OF SHOULDER,ELBOW,AND THUMB. REDNESS AND ERYTHEMA RESOLVED WITHIN ONE DAY, HOWEVER, JOINT PAIN PERSIST GREATER THAN 4 WEEKS. PAIN INCREASES WITH MOVEMENT AND ATTEMPTING TO LIFT OBJECTS.
severe bilat hip/waist low back pain; difficulty dressing from exam table.  CMP, CPK, UDIP, Uni Acid, SULINDAL Rx given today.  (exam:  non tender, from hip, & rash) (4- d out still after Sx)
1) Left arm swelling - Left deltoid, vaccine given 8/10/10. Noted swelling on 8/11/10. She was seen by PCP treat Rx BACTRIM. LA swelling improved, no erythema, (+) warmth. 2) Lips swollen and puffy eyes. She's to take BENADRYL 25mg every 4-6hrs x 24 hours.
Patient complains of loss of vision in right eye approximately 1 week after receiving flu vaccine (AFLURIA 2014-2015). On the date of reporting (10/10/14) patient states that the only improvement is a little brightness in peripheral vision.
Insomnia for about 36 hours; fever (101.5 @ highest); body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 17-years-old male patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 19May2021 at 13:30 at the age of 17 years (Batch/Lot Number: EW0173) as 2nd dose, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. The patient did not diagnose with COVID-19, prior to vaccination. Medical history included allergies bee Stings. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 28Apr2021 at 12:30 PM at the age of 17 years (Batch/Lot Number: ER8736) for covid-19 immunisation. On 19May2021 at 11:00 PM, the patient experienced insomnia for about 36 hours, fever (101.5 at highest), body aches and headache. The patient has not been tested for COVID-19 since the vaccination. No treatment was given for the events. The outcome of the events was reported as recovered on an unspecified date.
Full anaphylactic shock; Hives; Low blood pressure; Dizziness; Stuffy nose; Bad headache; Nausea; A spontaneous report was received from a healthcare facility staff member who was a 36-year-old, female patient who received Moderna's COVID-19 Vaccine, and who developed full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose.  The patient's medical history included a latex allergy and pregnancy.  Concomitant product use was not provided by the reporter.   On 06-Jan-2021, approximately 30 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 01122019) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received her Moderna vaccine on 06 Jan 2021 at noon.  She reported that approximately 30 minutes after receiving the vaccine, she went into full anaphylactic shock.  She stated that the reaction began with nausea.  She then developed hives, got low blood pressure, and was dizzy.  She was taken to the hospital.  There, she received two rounds of epinephrine along with diphenhydramine and famotidine.  She was released that same day from the hospital once she stabilized.   On 07-Jan-2021, a full 24 hours after receiving her vaccine, she experienced another anaphylactic reaction.  She stated that the reaction happened exactly like it did on 06 Jan 2021 and presented with all the same symptoms.  Patient injected herself with the epinephrine pen that she had at home as soon as the symptoms started.     In addition to the anaphylactic reactions she experienced, patient reported that she had a bad headache since receiving the vaccine as well as a stuffy nose that comes and goes and coincides with hives.  As of 10 Jan 2021, she stated that the flare ups had finally subsided, however, she continued taking diphenhydramine and famotidine as prophylaxis for anaphylactic reaction.   Treatment for the event included epinephrine, diphenhydramine, and famotidine.  Action taken with mRNA-1273 in response to the events, full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose, was not provided.   The events, full anaphylactic shock and low blood pressure were considered resolved on 07 Jan 2021. The events, nausea, hives, and dizziness were considered recovered/resolved on 10 Jan 2021.  The outcome of the events, bad headache and stuffy nose, were not reported.; Reporter's Comments: This case concerns a 36-year-old female patient with medical history of latex allergy, who received their first of two planned doses of mRNA-1273 (Lot 01122019), and who experienced the serious unlisted event of Anaphylactic shock, the non-serious listed events of Headache and Nausea, and the non-serious unlisted events of Urticaria, Hypotension, Dizziness, and Nasal congestion.  Based on the current available information and temporal associon between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
One hour after vaccination I began to experience mild vertigo. This continued throughout the evening. The next morning I woke up and it was more severe. Every time I moved, walked it felt like the room was spinning. I went to the pharmacy and bought some meclizine which helped. The next morning I woke up, got out of bed and began to fall. I caught myself on my nightstand but could not "shake" the feeling so I had to sit back down. Since then I have to hold onto the walls etc in order to walk. Turning my head and any movement causes everything to spin. I have never experienced this type  of feeling before.
Felt cold with chills, shaking uncontrollably, face flushed, achy, heart racing, could not breathe- thought it was due to being anxious (asthma), Temp 101.2.  Still not feeling well as of 10-22-10 3:45 PM- has a fever, feels achy. Tylenol taken, just resting- did not go to work today.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient state that he felt hot, and he had perspiration on his head. I gave him cold water, I was repeatedly asking if he was ok every few minutes and at first, he in a few minutes he had fainted and was unresponsive. I splashed cold water on head and neck, and he became responsive again. I made him lie down and elevate his legs. when he came too, he said that everything just went black. in about 15 minutes he stated he felt more back to normal.