chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Please note,  April 27th was my second first dose.  My first dose on April 7th at the Wellness Clinic is considered invalid by CDC. 1) Severe headache that was not relieved with Tylenol. After waiting about four hours with worsening headache, Advil provided some relief.  The severe headache persisted until my mild fever broke about 2AM.  Becoming a mild headache into the following week, which is mostly gone by May 7th. 2) Sever chills with shaking. 3) Blue arms to the elbows. 4) Minor fever of 1-2 F above my normal.
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # L043624, 3-NOV-2017, lot # M000761, 06-JAN-2018; lot # L005299, 17-FEB-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Left ankle rash and swelling.  Has persisted over a month. No known trauma/injury. No known contributing factors.
No adverse reactions reported; patient received one dose of expired vaccine; This spontaneous report was received from a nurse and refers to a 6-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JUN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not provided), one dose, intramuscularly, lot # R009953, expiration date 12-JUN-2019 (site of administration was not reported) for prophylaxis. Administered hepatitis a vaccine, inactivated (VAQTA) was expired. The administered vaccine had not any temperature excursions. No adverse reactions were reported.
fever; pain / body aches; nausea; fatigue; could not get out of bed; This case was reported by a physician via sales rep and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included methotrexate for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and methotrexate at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, nausea, fatigue and mobility decreased. The action taken with methotrexate was unknown. On an unknown date, the outcome of the fever, general body pain, nausea and fatigue were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, nausea, fatigue and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingrix at pharmacy, so the reporter did not knew the lot number, but patient only had 1 dose. The patient had pain, fever, body aches, nausea, fatigue that was 100 times the normal. For 4 days the patient could not get out of bed. The patient was on methotrexate and the reporter wondered if that drug caused the adverse event.
After receiving my vaccine I experienced a pinched nerve in my left shoulder that causes pain radiating down my left arm and to my elbow
This case was reported by a nurse via sales rep and described the occurrence of burning sensation in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster. In November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 7 days after receiving SHINGRIX, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was recovered/resolved. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced burning sensation one week after vaccination end of November, in the area where previously had zoster episodes. The event gone in about a week. The reporter agreed to be followed up.
Day #3 post vaccine 12/2/03: headache/sore throat. Day #4 12/3/03: body aches/fever (102 degrees). Day #5 nasal discharge/chest congestion.
Off label use; Interchange of vaccine products; Drug ineffective; suspected covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220133895(0) (JANSSEN).  A female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 2 ( booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, Single; Lot number 1805020), for Prophylactic vaccination. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant) with onset 18Jan2022, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Jan2022, outcome "not recovered", described as "suspected covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: (NR: Not provided).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient felt dizzy and hot; needed to lie down. Skin was clammy and BP was low.
ALLERGIES; HEADACHE; GREEN VEIN UNDER ARM; SORE ARM; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced green vein under arm. On 09-MAY-2021, the subject experienced sore arm. Treatment medications included: paracetamol. On 09-MAY-2021 20:00, the subject experienced headache. On 10-MAY-2021, treatment medications included: cetirizine hydrochloride, and paracetamol. On an unspecified date, the subject experienced allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, headache, and green vein under arm, and the outcome of allergies was not reported. This report was non-serious.
Pt received Moderna at 7:33 PM. Started complaining of dizziness around 7:40 PM. Benadryl 25 mg liqd po given.  8:05 PM complained of difficulty of breathing gave Epi 0.3 mg IM on R thigh, 911 called and arrived at  8:20 PM. VS stable. Pt transported to hosp.
Around 9:00pm, pt started whimpering in her sleep. When my husband picked her up she started vomiting profusely. She would cry for about 10 seconds and then go completely limp. She was very pale and cold to the touch. She continued vomiting after which she would cry for about 10 seconds and then go limp again. At about 9:20pm her vomit was very little and bright yellow in color. She would, at this point, quit breathing, start choking, vomit, cry for 10 seconds, and then go limp again. I called her physician and after talking to him called 911, She got to the hospital around 10:30pm and she continued experiencing the same symptoms until around 12:00am, 8/22/06 and she was discharged. She slept until around 6am when she woke up, drank some of her bottle, and went right back to sleep. She slept like this all day, only waking to eat. She seemed as if in a deep sleep. When she was awake eating, she seemed extremely groggy. The next day, 8/23/06, she was awake more and acting more like herself. She still slept more than her normal regimen though. By the third day, 8/24/06, she seemed normal. She seems to be healthy now although we wonder what her future holds her physician said he thought it was the flu or a different formula we tried. He seemed very unconcerned but I only talked to him on the phone. My husband and I thought our daughter was going to die. From the research I have done, I now know my daughter experienced shock/collapse after receiving her vaccines.
May not get the second dose on time (may be greater than 36 days) for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May not get the second dose on time (may be greater than 36 days) for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
After vaccination in R arm, pt c/o pain, numbness in R arm & leg. Also, a rapid heartache. VS WNL. Sprite given. No respiratory distress noted. Pt. ambulated in gym with difficulty. Oxygen via nasal canula given x 20 minutes. Parent notified, child sent back to class per mom's wishes. Improved condition, only some c/o of numbness in R arm.
She got her 3rd vaccine, an hour after she came home she felt light headed.  She drank something and felt OK.  After that she had an allergic reaction, she started itching, and felt flushing of her face.  She took Tylenol and went to sleep.  She gets the normal reaction to all vaccines, and after 2-3 days she's fine.  She got it one day and then she was Friday.  After that she has noticed that her memory is getting foggy, her long term memory is not very good.  She figured out that she a book that she has memorized and recite it and she cannot remember the words, but that still continues and can't recall things and she is concerned about that.  She wants to know if there is anything that she can do and if it's going to be long-lasting.    She does has an appointment with her doctor and also with a neurologist next week.
Numbness on legs, tenderness on abdemen, then, breathing difficulty, can't urinate and no bowel movement.
Symptoms:   Tongue itching, denies swelling, airway constriction, shortness of breath. this is dose #2, no issues with first dose  Assessment: Chest clear, no visible facial or oropharyngeal edema, vital signs are WNL    Treatment:   25mg IM benadryl x1 with resolution after 5 min and released after 30 min observation and felt alert enough to drive
Pt experienced increased soreness, redness and warmth to the touch. This was her 2nd dose and she stated not experiencing any of this with her first dose.
Breakthrough case admission after three vaccines Moderna 2/1/21 Lot# 027L20A ; Moderna 3/1/21 Lot# 043L20A;  Moderna 12/10/21 Lot# 030H21B
Dry cough; Fatigued; Bitemporal headache 4/10 with 10 being the worst; Fever started within 6 hours after the vaccine/The next day temp increased to 100.3; This is a spontaneous report from a contactable physician. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 29Jan2021 09:45 at a single dose for covid-19 immunization. Medical history included Rheumatoid Arthritis, Menieres disease and history of 6 pneumonia episodes 4 during childhood 2 as an adult. The patient previously took bactrim, augmentin and malarone; all of which the patient had allergies to. It was reported that Fever started within 6 hours after the vaccine. Initially 99.8 in the evening of the day I was vaccinated. Also, dry cough which lasted about 5 hours and was gone after that. The next day temp increased to 100.3. This lasted until 24 hours after vaccination when it abruptly ended. However, patient continued to be very fatigued. Also, several hours after vaccination, bitemporal headache 4/10 with 10 being the worst which ended approximately 24 hrs after vaccination; all on 29Jan2021 at 3:00PM. The patient receive acetaminophen for the events. The outcome of the event dry cough recovered in 29Jan2021, headache recovered on 30Jan2021, not recovered for event fatigue, while recovering for fever.  Information on lot/batch number has been requested.
pt recv vax 17APR96 & 21APR96 pt devel 2-3 lesions & presented to MD;23APR96 pt had 20 lesions w/extensions;24APR96 pt had devel full-blown chicken pox w/numerous lesions all over body;
Patient complained that injection site was warm to the touch.   There was no visible redness or swelling at the injection site when she came in this afternoon.  I suggested that she apply ice for 15-20 minutes several times a day.  If no better or it gets worse, she should call her doctor.
I had fever - got up to a 102. Couldn't get warm - chills; Sore arm; severe headache; fatigue - slept the whole day after the vaccine. Lasted about 72 hours. Fever lasted a little less than 72 but the rest stayed for the whole 72 hour time period. Tylenol - took that around the clock.
The patient had a reaction on the arm the injection was given, this reaction was not at the injection site, but lower. It was red, raised, hot, and she said painful at first. It is currently getting better than it was, but she is still recovering.
significant swelling in 6 inches, pain erythema induration, Tx: Keflex 250 tid X 10 d
Patient's mother reported that beginning the day after vaccination patient had some pain and developed an itchy rash at the injection site. She took the patient to the doctor who told the mother it was some form of cellulitis. As of last contact patient's condition was slowly improving.
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix 1440) (batch number B4JL4, expiry date 21st February 2022) for prophylaxis.   On 5th May 2022, the patient received Havrix 1440. On 5th May 2022, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 6-MAY-2022 Reporter's Comment: The patient received an expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix, which was already expired on 21st February 2022, which led to expired vaccine used.
One week after shots pt began to run 102-103 F fever. One week and 3 days later small pinpoint rash began to develop all over her body.
Sepsis, present on admission, due to COVID pneumonia Pancytopenia, suspect due to COVID infection On dexamethasone and remdesevir, added rocephin and doxycycline for possible bacterial pneumonia Discussed with family at bedside on admission, they prefer that Pt receive care at alternate hospital and transfer center contacted, on list for transfer. Stable for transfer to alternate hospital on 1/18
A serious report of trauma has been received from a study investigator concerning a 36-month-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 20-Oct-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 21-Oct-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
On 06/09/2001 the patient developed a rash on her legs, arms and face. Then over the next few days she had blisters the size of nickels all over her face, legs and arms. The patient was treated with Acyclovir, topical steroid, Claritin and Benadryl. On 06/20/2001 the patient was recovering, but still had some rash.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates in 2017, reported as since 11-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot number: M017337, expiry date: 05-OCT-2017; albumin status: recombinant human albumin (rHA); dose and route of administration were not provided). Other suspected therapy included sterile diluent (also reported as "diluent that was used to reconstitute the doses") injection (manufacturer unknown) (strength, dose, route of administartion, lot number and expiration date were not provided). The nurse reported that there were multiple unspecified temperature excursions on unspecified dates. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006353.
No additional adverse effects reported; The patient received a pediatric dose of VAQTA; This spontaneous report has been received from a medical assistant referring to a 23-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 24-AUG-2020, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) injection 25/0.5 (units not provided), at a dose of 0.5 milliliters (ml), as prophylaxis (route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported).   It was reported that this was a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (incorrect dose administered). No additional adverse effects were reported.
Rash on lower arm (inside) Pain in lower abdominal and on the side (right & left) I felt as if I has appendicitis, finally I took 2 advil gel two consective nights and it help I went back to the doctor to be examined I still feel like it is in my side on both sides., in adominal area. I also experience dizziness at night and when I got up in the morning.
Pt developed encephalopathy of unclear etiology, and was hospitalized.  Found to have low grade UTI, possible old stroke findings on head Ct VS new small infarcts, h/o alcoholism confounding the picture as well. Hospitalized 2/28/2017 through 3/3/2017, still requires cane, still confused, needs PT and also cognitive and speech therapy.
Pt. reported that 2 hours after injection arm felt almost paralyzed and extremely painful, more than regular injection site RXN.
Slightly swollen, warm, red area approximately 3" X 1/2" @ injection site over the weekend is improving without Rx.
Information has been received from a 64 year old female patient (also a nurse) referring to herself. The patient had no medical history and was allergic to ibuprofen. Concomitant medication included blood pressure medicine. On 22-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot #, expiration date and dose were not reported, subcutaneous). On 23-AUG-2016, the patient experienced a reaction described as "a slight pink area at the injection site". The patient didn't sought medical attention and no treatment was given for the event. No lab diagnostics studies were performed. On 25-AUG-2016, the patient recovered. The causality was not reported. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/13, Pfizer, dose #1 02/11, Pfizer, dose #2 08/02 pt cc: cough, diarrhea exposure: unknown 08/18 COVID swab, result: detected 08/18 SARS-COV-2 Variant Sequencing result: pending 08/28 CXR impression: No acute intrathoracic disease. 2. No radiopaque foreign body is identified. 08/31 CXR IMPRESSION: No significant change. 08/31 pt admit to ED cc covid and anxiety dx covid-pna los: 1 day
DEVELOPED ONE ITCHY LARGE HIVE OVER INJECTION SITE ABOUT 24 HOURS AFTER INJECTION. ABOUT THE SIZE OF A QUARTER.
Developed pityriasis rosea one week after small pox vaccination. Diagnosis made by dermatology.
patient experienced an episode of a-fib which brought her to the emergency department 4 days after her first injection.  Her doctor increased her metoprolol as a result.
Fatigue - rapid heart rate when standing up, exceeds 120bpm when walking or standing and then goes down when lying, chest pain, severe headache, shortness of breath. All tests to rule out other causes negative
expired product (VAQTA) administered with previous temperature excursion; expired product (VAQTA) administered with previous temperature excursion; This spontaneous report as received from a medical assistant refers to a 24-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2021, the patient was vaccinated with an expired of hepatitis a vaccine, inactivated (VAQTA) 1.0 ml, lot # S034296, expiration date 09-JAN-2021 (route of administration and anatomical location was not reported) for prophylaxis. The administered dose of hepatitis a vaccine, inactivated (VAQTA) experienced previous temperature excursion.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034296; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001667: