chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), on 03Apr2021 as dose 2, single (Lot number: EW0151) and on 03Nov2021 as dose 3 (booster), single (Lot number: FF8028) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient received treatment with Paxlovid from 08Sep2022 to 13Sep2022 for Treatment of COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Left Supraclavicular lymphadenopathy 1.5 cm, painless. Presented 24 hours post injection
stated she notices some purple dots on her face and then knows that the rash is imminent,/ I had a rash in the back of my neck and on my face; it seem like it was from the head on the top of forehead; Itching; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533, age at vaccination: 72-years-old) via an unspecified route of administration on left side on 11Apr2021 as dose 2, single for COVID-19 immunization; tocopheryl acetate (EVION [TOCOPHERYL ACETATE], formulation cream), route of administration, start and stop date, batch/lot number and dose were not reported taken for an unspecified indication. Medical history included insulin-dependent diabetes and high blood pressure. Concomitant medications included insulin detemir (LEVEMIR) taken for diabetes mellitus; insulin aspart (NOVOLOG); atenolol (ATENOLOL); spironolactone (SPIRONOLACTONE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); amlodipine besilate (NORVASC); atorvastatin (LIPITOR [ATORVASTATIN]); olmesartan medoxomil (BENICAR) taken for hypertension. Previously, patient received first dose of bnt162b2 (Lot number EN6208, age at vaccination: 72-years-old), in left arm on 21Mar2021 for COVID-19 immunization and experienced a little hive on her hip, on the left side, the same side she received the needle and small rash on head yet same side on the arm that it was given on left side. On an unknown date in Apr2021, a couple of days later, the patient noticed some purple dots on her face and then knew that the rash was imminent, it came on the area of the purple dot, which was uncomfortable and concerning, and had a rash in the back of her neck and on face, it seemed like it was from the head on the top of forehead. Patient reported that the rash may got on face on both sides right and the left and the odd thing was when she brokeup in those rashes she got like a purple dark, when she saw the purple dark on her face, she knew that the rash was coming, that's why she was scared about it. She already called her doctor and he told her it seemed to be one of the side effects from the vaccine. On an unspecified date in Apr2021, the patient also experienced itching. But yesterday (14May2021), it was over a month that she received the shot and what occurred was the rash had reappeared and it was still there. On an unknown date in May2021, the patient underwent laboratory test which included urine test and many blood works at her doctor's office, result was unknown. For corrective therapy, patient did try putting some Evion cream on it, but that really did not help and made it worse, had Benadryl tablet 5mg by mouth, Xyzal tablet 5mg by mouth, and she took Xyzal last night (14May2021) as she thought that would help with her itching. She wanted to know if any information about how long these rashes will go and what she could use on it. The outcome of event itching was unknown while for the other event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Patient presented to the clinic for 1st dose of covid-19 vaccine. Patient is 13 years old and received the pediatric dose of Pfizer's covid-19 vaccine. Patient and family were informed of the event and were counseled on options. Patient will return in 21 days to receive adult formulation as second dose per CDC guidelines.
Large red, hot, swollen bump on arm (takes up most of upper arm). Heaviness and soreness on all arm. Feels like I have swollen lymph nodes under my arm. Stiff neck.  I feel down and tired.  Went to urgent care on 1/31 was given Bactrim and ibuprofen. Redness is spreading and bump is getting bigger. I have taken 6 doses of Bactrim and it seems to be getting worse. Arm is very sensitive and tender to the touch.
No adverse effects were reported.; 59 years old patient was inadvertently administered VARIVAX instead if Shingrix.; This spontaneous report was received from a nurse prescriber referring to a 59-year-old patient, of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 04-MAY-2020, the patient was "inadvertently" vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, vaccination scheme and anatomical site of vaccination were not reported; lot number S032353, expiration date 14-OCT-2021) as prophylaxis; instead of dose of Shingrix (wrong product administered). The nurse confirmed this was not a vaccine confusion. The use of a sterile diluent (MERCK STERILE DILUENT) to reconstituted the vaccine was reported. No adverse effect was reported.
No adverse effects reported; A patient received a dose of MMR II via intramuscular; This spontaneous report has been received from a pharmacist and referring to a patient of unknown age and gender.   The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not provided.  On 23-APR-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intramuscularly (Inappropriate route of vaccination)(dosing details, frequency, anatomical site, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Shingles - I received the Pfizer vaccine on a Wednesday afternoon and by Monday I developed a rash and throughout nthe week it was a burning sensation and turned into blisters and went to the Doctor and she diagnosed me with shingles / herpes zoster
Paralysis of arm/shoulder for 24-48 hours, limited movement after and pain, which persists to this day. Treatment with high-dosage ibuprofen and physical-therapy.
7 days after 1yr IZ (MMR, Varicella, Hep A#4, PREVNAR 4). Pt developed erythema multiforme rash.
rash on left upper arm, increasing in size over next days.  Saturday morning 1 1/2 " x 1 1/2", by Monday morning 3 1/2" x 4".  As of today about 4" x 6".  Rash was warm to the touch and itchy.  Told to take Benadryl and use cold compresses.
low grade temp approx 100;area @ inj is hard, swollen, red-is increasing in size;generalized joint pain, nausea-headache;
SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (INFLAMMATION, LIMITED MOBILITY); SHOWING IMPROVEMENT ON FOLLOW-UP WITH PATIENT. CONSULTING PHYSICIAN AS A PRECAUTION.
Red at injection site; Swelling at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Injection site, painful, red and swollen. Patient went to emergency room and was diagnosed with cellulitis. Patient was prescribed Cephalexin 500mg capsules.
Shortness of breath that start the day after 2nd dose of vaccine and has not gotten better with treatment
Information has been received from a physician concerning a 14 year old female patient who on 24-JAN-2012, was vaccinated with the first dose of GARDASIL (lot number, dose and route not reported). The physician reported that on 24-JAN-2012, the patient called the office later in the day with symptoms described as "mild clonus". On an unspecified date, the patient had an electrocardiogram which was normal. The patient was reported to be admitted to the hospital on 29-FEB-2012 because the she was still having symptoms. At the time of the report, the patient's mild clonus persisted. Additional information has been requested.
A patient was received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (Reference number- 00708509) and transmitted to Sanofi on 03-Aug-2021.  This case involves a patient (unknown demographics) who received an expired IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Jul-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot R1D972M and expiry date: 17-Jul-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "The caller did not have patient information or demographics but stated that there was no report of any adverse reaction or treatment required afterwards. Caller would like to know if the dose is valid and whether it should be repeated?"  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had mild soreness in my arm after receiving the vaccine for a couple of days. I was diagnosed with Non-Hodgkins Lymphoma in 11/2022.  I am receiving chemotherapy and I have completed radiation.
Case number PHEH2013US017531 is an initial spontaneous report received from a nurse on 15 AUG 2013, with a follow-up received on 30 SEP 2013. This report refers to a 12 year old male patient. Nurse reported that the patient received only Men CWY 135  liquid component of MENVEO (batch number: M11065) intramuscularly into right deltoid without being reconstituted with Men A lyophilized conjugate on 12 AUG 2013 (at 3:40 PM). No adverse event was experienced following this administration error.  Follow-up was received on 30 SEP 2013. Patient demographics, vaccination site and vaccination date were updated.
Patient felt like she was going to fait and her legs felt numb, could not walk that well.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, drug reactions/allergies or concomitant therapies provided. On 10-JUL-2015, the patient was vaccinated with the first dose of MMR II (lot # K018990, expiration date 15-OCT-2016, subcutaneously, dose and units were not reported), that was improperly stored. There was no adverse effect reported. Additional information has been requested.
This spontaneous report was received from a patient, refers to himself or herself of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were unknown. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) as prophylaxis (dose, lot number, expiration date, route of administration and anatomical location were not reported). The patient mentioned that, anyone could get shingles, even after the vaccination (vaccination failure). On an unknown date, the patient experienced shingles (herpes zoster) and at the time of the report, he/she was recovering from the first episode. The outcome of herpes zoster was reported as recovering. The reporter did not provide the causality assessment between zoster vaccine live(ZOSTAVAX) and herpes zoster.
Moderna COVID-19 Vaccine EUA 30 minutes after vaccination dizziness and lightheadedness approx 4 hours later dizziness returned accompanied by metallic taste in mouth
nauseous; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 06Jan2021 and is feeling nauseous on an unspecified date in Jan2021 up to now. They were asking how long this usually last. The outcome of the event was not recovered.     Information on the Lot/Batch number has been requested.
On Monday, April 12, I was diagnosed by Dr. as having the herpes zoster virus, or shingles.
Chest congestion; Sore arm; Body aches; Fever of 101-102°F; Fatigue; Headache; A spontaneous report was received from consumer, concerning himself, a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 101 to 102 F, chest congestion, body aches, fatigue, headache and sore arm.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the events, included atorvastatin, enalapril and travoprost. Patient took paracetamol for the symptoms.  On 13 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the same day post vaccination, the patient started having a fever of 101 to 102F, chest congestion, body aches, fatigue, headache and sore arm.  Action taken with mRNA-1273 in response to events were not applicable.  All events were resolved over a week.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
ARM HURT TERRIBLE; This spontaneous report received from a patient concerned a 57 year old female.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient experienced terrible headache when treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. (Dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination.(Dose number in series 2) No concomitant medications were reported.   On 11-NOV-2021, the patient experienced arm hurt terrible.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of arm hurt terrible was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211145104 (Dose number in series 1).  This case, from the same reporter is linked to 20211144980.
The patient was 5 days post cesarean section when she presented  to the ER with a pulmonary embolism.  She delivered preterm at 36 weeks and 6 days due to oligohydramnios and had a c-section due to an active herpes outbreak.  Her post-op course was unremarkable and was discharged home post op day #3.
fever 102-103, very irritable w/high pitched cry 4-6 hrs duration;
Circular area over L upper arm after Trumenba, redness developed 1 day after shot, then bumps came up 3 days later. As of today 08/12/16 still present.
got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid".  Clinical course: The report was not related to a study or programme. The patient was not the reporter. During report, caller mentions her fiance also got Covid and had gotten the Pfizer Covid 19 vaccine. Stated he is fine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Began covid-19 symptoms the day following the vaccination. Symptons were moderate fever, muscle aches, fatigue, headache, nasal dischage and cough. Treated with tylenol and sudaphed-pe. Symptoms resolved after 5 days.
Received Dtap lot U1857BA 3/2/08 in Left thigh, IM on 6/27/06, that same evening L thigh area, red, swollen size of 4" x 2" oval area, warm to touch on 6/29/06 at office. Subsequent OV on 6/30, size of area, 3x3 induration with9'x6" area of erythema (same from 6/29-6/30)
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
Woke up 10/23/09 at 0600 and could not get out of bed, legs locked up; arms and legs were weak; back pain was worse than on previous days and has continued to have > back pain and extremity weakness.
UNABLE TO MOVE LEFT ARM NORMALLY; MILD TO SEVERE/ LOT OF PAIN IN SIDE LEFT BREAST; MILD TO SEVERE/ LOT OF PAIN IN ARMPIT; PAIN FEELS LIKE MUSCLE STRAIN; MILD TO SEVERE/ LOT OF PAIN IN ELBOW; MILD TO SEVERE/ LOT OF PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication.  On an unspecified date, the subject experienced unable to move left arm normally, mild to severe/ lot of pain in side left breast, mild to severe/ lot of pain in armpit, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild to severe/ lot of pain in left arm, unable to move left arm normally, mild to severe/ lot of pain in side left breast, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in armpit. This report was non-serious.
Swollen area (possibly lymphnode) under left arm.  Area of swelling is about 4" high and 3" wide.  Skin is sensitive to the touch and somewhat painful if pressure is applied - like my arm hanging down.
Information has been received from a 58 year old male subject enrolled in a study. The subject's concurrent condition included allergic to penicillin manifested by rash, alcohol use (five mixed drinks per month), blood cholesterol increased, depression and herpes simplex. The subject's medical history included colitis ulcerative, chill, tremor, gastric disorder, clostridium difficile colitis and ex-tobacco user. The subject was previously on ENBREL for eight years and discontinued due to unspecified issues with ulcerative colitis; on REMICADE and discontinued due to rigors and sharp shaking; and also on SIMPONI from 2012 to 2013, experienced unspecified gastric issues and clostridium difficile. The subject was not on any biologics from August 2013 to July 2014. Concomitant therapies included VALTREX, citalopram, WELLBUTRIN, pravastatin, influenza virus vaccine (unspecified) and probiotics (unspecified). In July 2014 the subject started HUMIRA (Solution for injection in pre-filled syringe, 40 mg in 2 weeks, route unknown) for plaque psoriasis and psoriatic arthritis. In November 2014, the subject experienced ulcerative colitis flare. It was further described as abdominal pain, diarrhea and increased bowel movements. The events recovered without further treatment. In November 2014, the ulcerative colitis flare resolved. On unknown date in November 2014, he had a flu vaccine. Om 29-DEC-2014, he had PNEUMOVAX 23 (dose and route was not reported). On 29-DEC-2014, the subject experienced injection site pain on left arm. The event was resolved without further treatment. On the same date, the injection site pain on left arm was resolved. On 31-DEC-2014, the subject experienced nasal congestion, chest congestion, muscle aches, cold sweats and flu. On the same day, he experienced chills and general malaise. TYLENOL was taken as a treatment. On 10-JAN-2015, the nasal congestion, chest congestion, muscle aches, cold sweats and flu were resolved. On the same day chills and general malaise were also resolved. He felt that the flu was unrelated to HUMIRA. Action taken with PNEUMOVAX 23 regarding all events was not reported; action taken with HUMIRA regarding injection site pain on left arm, chest congestion, cold sweat and flu was reported as dose not change, regarding general malaise was not reported. The relationship between injection site pain on left arm with PNEUMOVAX 23 was reported as related, the relationship between chest congestion, general malaise, cold sweat and flu with PNEUMOVAX 23 was not reported. The relationship between injection site pain on left arm and general malaise with HUMIRA was not reported, the relationship between chest congestion, cold sweat and flu was reported as not related. Additional information is expected.