chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness on the injection site; blister on the injection site; This is a spontaneous report from a contactable consumer (reporting for his wife). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got redness and blister on the injection site yesterday (18Mar2021). The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Rash on neck appeared 2nd morning after 2nd Pfizer vaccine given.  She noted it really didn't itch unless the area was touched or rubbed.  Reported redness, "welps."  Improved on its own after 1 week
Upon initial vaccination, my arm of injection site was sore and swollen for about 3 days and then was fine. Exactly one week after vaccine, the injection site began to itch. The next day and following days, I have developed itchy hives on many parts of my body. They are continuing to multiply and remain very itchy.
Ct received her first rabies vaccine on 3/25/09 and 2 days later had flu-like symptoms, sore throat, "bad" cough, fever, chills, excessive tiredness and congestion.  The s/s persisted until 1 week before second vaccination.  The health dept told ct to postpone the 2nd vaccination until she felt better.  Ct also saw her general practitioner after 1st vaccine and was given a Z-pack.  Ct states she improved "a little bit".  Ct came in for 2nd vaccine on 4/15/09.  A couple of days after vaccination she had the same symptoms, swollen tonsils, cough and fatigue, but they were not as severe.  Ct came in for her 3rd dose on 5/6/09.  A couple of days after the 3rd dose she had swollen tonsils/glands and her cough is back and is producing phlegm this time.  Ct is planning to see a Dr again today to follow-up.
wife got shot, got shingles anyway/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: wife got shot, got shingles anyway/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient's husband via interactive digital media. The patient and her husband both got their shots but the patient got shingles anyway, sounds like covid shots. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR050173, reported by same reporter for himself.; Sender's Comments:  US-GSK-US2023AMR050173:Same reporter.
Mom called office on 5/22/2019 and reported that on Monday evening 5/20/19 patient started to not feel well, arm pain, fatigue, shivers, headache, and chest pain. Fever started 5/21/2019 of 101.  Motrin was given and patient was told to call if not better in two days or if worse to call sooner to be seen
PATIENT HAD SWOLLEN, RED, AND HOT INJECTION SITE 4 INCHES IN DIAMETER.
Day 1 and 2 - expected lethargy, sore arm, muscle aches  Day 3-present - dizziness and (sometimes) nausea.  It's been 4 days of dizziness to the point that I can only be up for 10-15 minutes at a time, can't drive.  Any exercise at all (even going up a single flight of stairs) makes me dizzy. There is also a general feeling of "unwell", but it's hard to describe, like a brain fog.
Extreme pain in right arm the night following injection. It hurt to even move my arm for 15 days. Had to take 600mg ibuprofen during this time. I am still experiencing frequent muscle pain  during the day and it wakes me up at night. I was told that I may have pain for a few days but it is now close to 3 months. I was reminded that it is time for my second dose of Shingrix but I will not be getting another injection of this drug. After the first few days I called my doctors office and the pharmacy neither of which were much help. They told me to continue Ibuprofen which I now take daily.
Patient received the Moderna booster after 2 doses of Pfizer. Hives appeared on arms, legs and torso about 13 hours after getting Moderna.
Information has been received from a medical assistant concerning a 13 month old female patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659155/1366U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Follow up information has been received on 24-MAR-2008 from a medical assistant concerning a white 13 month old female patient who on 23-JAN-2008 was vaccinated with a second dose of VARIVAX (lot # 659155/1366U), dose unknown. Subcutaneously in the right thigh. Other vaccination received on 23-JAN-2008 included hepatitis A virus vaccine inactivated (MSD) ( lot number 657307/0440U) intramuscularly, left thigh and MMR II (lot number 656544/0700F) subcutaneously, left thigh. On an unspecified date, the patient experienced a red raised are on right thigh around VARIVAX site. It was also reported that in an unspecified date, the patient experienced swelling and itching afte receiving VARIVAX. On an unknown date, the patient recovered. No further information is available.
Immediate "space cadet" type feeling. Maybe feeling like getting the flu. Very sore left arm for over a week. Lived on ice and ibuprofen for 10 days.
PATIENT RECEIVED A FLU VACCINE ON MONDAY (10/28) AND TOWARD THE END OF THE DAY, AND NEXT DAY, SHE STARTED TO DEVELOP SOME SHORTNESS OF BREATH, COUGH, CHILLS, AND SWEATS. PATIENT WAS GIVEN A SOLU-MEDROL INJECTION, COMBIVENT NEBULIZER, PREDNISONE, AND AZITHROMYCIN. UPON DISCHARGE PATIENT REMAINED ON PREDNISONE X 10 DAYS AND WAS PRESCRIBED ADVAIR.
Her arm was very sore, much more sore than after the first vaccination; This is a spontaneous report from contactable nurse (patient herself) via Pfizer Sales Representa-tive. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. The afternoon after receiving the second dose of BNT162b2 in her left arm she felt "off" as if she was get-ting sick. She felt very fatigued and weak. Her arm was very sore, much more sore than after the first vaccination. She reported that her daughter also had the same reaction as she did, with severe fatigue and feelings of being ill but with no fever and a very sore arm. The next day she had pain in her neck and upper back and a sharp pain in her left axilla. She described the pain as if "someone injected the axilla with a long needle." When she examined the axilla, pressing into her arm pit she reported a sharp pain that radiated down her left arm and wrapped around her thumb. She also reported tingling in her fingers when she explores the axilla. The discomfort has lasted 72 hours after her vaccination. She cannot feel a lump on her axilla, just localized tenderness. The outcome of event for "much more sore than after the first vaccination" was unknown.   Follow-up attempts completed. No further information expected.
Narrative: 66 yo female with PMH: HLP, dry eyes, GAD, panic disorder, PTSD, chronic pain, HTN, GERD, and asthma reported headache, tickle sensation in throat and anxiety during the observation period post covid19 vaccine injection. Pt received covid19 vaccine (Pfizer) on 1/20/2021. Pt has hx of swelling of throat with contrast media (which she carried an Epipen for). Symptoms improved after 45 minutes. Anxiety could be from patient's hx of anxiety/PTSD. Headaches/tickled sensation of throat could be from vaccine. Pt denied breathing/SOB. Headache & anxiety, throat tickles
In the evening after getting the shot, I started getting chills and became more sensitive to cold temperatures.  Many of joints became stiff, some of which made a cracking sound when I flexed them.  Several muscles in my arms, legs and back felt sore and weak.  After a restless night of sleep, the cold sensitivity is all but gone.  Some of my joints and muscles are still a little stiff and sore, but I'm sure they'll be better by the next morning.
Swelling to left shoulder and especially upper arm on second day when awoke. Patient has been allergic to PNC in past. No previous problems with immunizations or eggs.
It started out with a burn feeling and itches. It spread all over my body. When they dry out the leave black marks. I still have the spots on my body. I felt like something is crawling on me. Next day my skin look like someone burnt me. I went to the doctor and they prescribe me some cream and Z-Pak. It difficult to sleep at night. The marks look like ring worms.
03/31 - Sharp pain in right eye, followed by bad headache.  Lasted one day. 04/14 - Woke up  and could not walk. My right leg up to my kidney was inflamed and spasmodic.  Right calf and behind right thigh was very bad.  04 /18-  I took 2 Ibuprofen  every 6 hrs by Monday I could take a few steps and today I can walk a short distance.
pulmonary embolism/blood clots; heart problems; blood clots; mild immune response; Headache; Little chillls; Really bad fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism/blood clots) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, POTASSIUM CITRATE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism/blood clots) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism/blood clots), CARDIAC DISORDER (heart problems), DYSPNOEA (blood clots), HYPERSENSITIVITY (mild immune response), HEADACHE (Headache), CHILLS (Little chillls) and FATIGUE (Really bad fatigue) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow-up case booked in; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Three days after receiving Vaccine in my right arm, I started feeling pain in left side of chest accompanied by swelling. Its still the same days later. The pain feels like how a bruise would feel. It feels like a woman who has breast cancer would feel in the chest area.
Pt states she had side effects of Adacel immunization. She said she had body aches, headaches, fever, chills, lose of appetite. Pt has no primary doctor.
Patient called to report hives on back of neck and right arm appearing 2 days after vaccination. First time receiving high dose. Treated with diphenhydramine with no improvement. No fever but itching reported. Recommended calling MD on Monday if no improvement and going to ER or clinic if symptoms worsen.
Information has been received from a nurse concerning a 14 year old female with no known drug allergies and sickle cell trait, who on 05-AUG-1998, received her initial 0.5 mL subcutaneous dose, and on 21-SEP-2007, she received her second 0.5 mL subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck). There was no reported illness at the time of vaccination. On 24-SEP-2007, she was evaluated in the physicians office after she experienced a 3 inch X 3.5 inch area of erythema at injection site. Treatment included the "recommendation of Benadryl". On 26-SEP-2007, she was re-evaluated in follow up and "the symptoms had improved". There were no laboratory or diagnostic tests performed. No product quality complaint was reported. No further information was available. Follow up information from the physicians office reported that the patient was treated with clindamycin 300 mg every eight hours and Benadryl 25 mg every eight hours as needed (duration not reported). At the time of this report it was reported that the patient had recovered. Upon follow up, a caller (unidentified) stated there was no additional adverse event information and does not wish to receive any further letters. Additional information has been requested.
pt recv vax 1997 & pt exp stinging @ the inj site;pt recovered;
Headache, fatigue, joint ache Rest, acetaminophen, fluids Slowly recovering
Injection site - red, swollen and extremely itchy - size of affected area about 8 x 6 inches.
Left Arm swelled up, Painfull and Rash.  Numbness on Left side of body with left side of face and left hand and fingers continuing to remain numb
Patient has had no adverse events from receiving these vaccines. MMRV was given instead of MMR. He is 27 and this was the incorrect vaccine. Pt also received Varicella on same day which is in the MMRV combination.
Right upper arm swollen, red, and hot to touch, red raised rash on torso and legs.  The rash was itching and bothered her.
Per parent waking up screaming and inconsolable for an hour. Self calms and is at baseline until next awakening. May be ok now 1/14/22
p/vax pt arm swollen up 3PM;the next day arm began to be blotchy w/many red sore areas;
This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th March 2019, less than a day after receiving SHINGRIX, the patient experienced smell alteration, nasal sinus discharge and taste metallic. On 17th March 2019, the patient experienced fever, pain, chills, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fever, pain, chills and pain in arm were recovered/resolved and the outcome of the smell alteration, nasal sinus discharge and taste metallic were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the fever, pain, chills, pain in arm, smell alteration, nasal sinus discharge, taste metallic and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. Later that evening, the patient developed a metallic taste in mouth, medicinal smell in nose and sinus drainage in throat. The next day of vaccination, the patient could barely raise her left arm because it was sore. The day after vaccination, the patient also experienced a low grade fever, aching and chills. The reporter did not consent to follow-up. This case has been linked with case US2019052653, reported by the same reporter.
It was reported that a 42 year old female patient received a JE-VAX vaccination on 03/21/01. Reportedly within 24 hours the patient developed a local reaction - redness at the injection site and soreness also generalized itching which lasted 24-30 hours. Reportedly these symptoms completely resolved. From additional correspondence received on 05/03/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. This case is closed.
chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).
Two weeks after receiving a rputine Tdap vaccine, i had mild tingling in feet for a few days, then progressed to calf muscles leading to weakness and tingling, then was followed by tingling in hands and ascending weakness and weird tingling sensation ascending on legs and arms. Goose bumps on legs and arms without being cold would preceed weakness. Very strange sensation of having weak heavy limbs that were slow to move. Walking was more like sliding my feet along the ground. I could not go up and down the stairs hardly at all, but when i did I would get severe muscle twitching and it took all my energy. It took about 2 weeks to get to the worst of the symptoms, landing me in the ER three times because paralysis was creeping up my hips through stomach and lower back. My primary saw me amd ordered a MRI and got the results sent to neuro. The day I went to the neurologist was the worst day of symptoms with shortness of breath. Neurologist said most likely not Guillian Barre but might be a mild case. He said my reflexes were not absent but they were very slow. He honestly was stumped as to what was going on. He said most likely a polio type virus with neurological symptoms. He said it could have been caused by Tdap vaccine but not likely since it was over two weeks after vaccine to the onset of symptoms. MRI was unremarkable. He told me to not get any more vaccines. My primary doctor told me not to get any more vaccines. My functional medicine doctor said to never get anymore vaccines.
body aches; swelling; elevated heart rate; elevated blood pressure; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan and rosuvastatin calcium (Crestor).   On 12th August 2019, the patient received the 1st dose of Shingrix .5 ml. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, heart rate increased and increased blood pressure. On an unknown date, the outcome of the injection site pain and injection site swelling were resolved with sequelae and the outcome of the heart rate increased and increased blood pressure were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, heart rate increased and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced all of the most common symptoms. The patient had pain, swelling and tenderness at the injection site. The patient's blood pressure and heart rate also elevated.
pediatric patient received adult dose; pediatric patient received adult Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. Nurse reported that the pediatric patient received an adult Engerix-B dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
Bad headache; Body aches ribs sore; Very tired; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot Number:EL3247), via an unspecified route of administration, administered in right arm on 02Feb2021 15:30 at a single dose (1st DOSE, SINGLE) for covid-19 immunization.Medical history included diabetic, hypertension and allergies. Allergies to medications, food, or other products included penicillin and vankomyicin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has been not tested for COVID-19, since the vaccination. The patient experienced within 12 hours started bad headache, body aches ribs sore, very tired on 02Feb2021 at 12:00. No treatment was given for the events.  Follow-up attempts completed. No further information expected.