chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes; nausea; feverish; flu-like symptoms; numbness; tingling in right arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right  arm on 20Apr2021 at 15:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, fish allergy, fruit allergy (blueberries, cherries), food allergy (italian seasoning) and allergy to plants (flowers). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and methylphenidate hydrochloride (RITALIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norgestimate (MONO-LINYAH) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm  on 30Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 the patient experienced swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included Doctor visit, labs, and ultrasound. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes, nausea, feverish, flu-like symptoms, numbness and tingling in right arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Manufacture revised the expiration date to 8/31/2022 after the vaccine was administered.
First day after receiving my second vaccination at 12:30, I became very puky and threw up the rest of the day along with my arm that the vaccination was received went dead. The following day I regained feeling in my left arm off and on throughout the day and had body aches, chills, and had shortness of breath. Day three I began to feel better with occasional shortness of breath and I had feeling in my arm again.  I was completely back to normal by day four.
PAIN AT INJECTION SITE Narrative: THIS IS A 62 YEAR OLD WITH RECENT COVID 19 PFIZER VACCINES. PT HAD PAIN AT INJECTION SITE X 2 DAYS REPORTED AFTER SECOND VACCINE 2/19/2021.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection from lot # M022077 with expiry date of 10-MAR-2019 (dose and frequency not reported; route defaulted to parenteral) for prophylaxis (incorrect product storage). The vaccines were exposed to a temperature excursion ranging between 9 to 25 degree Celsius for a time frame of 12 hours. No adverse effects were reported. There was no previous temperature excursion. This report was because of data logger. Product quality complaint was not involved.
Approximately 2 minutes after receiving vaccine, patient passed out while standing and fell face down. Pt reported no signs or symptoms prior to falling. She exhibited no signs of allergic reaction, no swelling, regular rate & rhythm of pulse & breathing. EMS was called & pt taken to ER due to the fall. She was released after examination with a fractured nose but no other treatment.
3 hours post vaccine, pt started feeling achy and started to have a low grade fever. the next morning pt reports a fever of 103 degrees F, body aches, diarrhea, swollen arm (6 inches in diameter with heat and inflammation). The fever lasted 4 nights. temp has been normal since night of day 4. took advil ATC during rection.
At 6pm, he had a quarter sized hard, red spot on right arm that was hot to the touch, sore and hurting On 05/08/02, 7 am, arm swollen from shoulder to elbow-2X the size of the other arm, hot and red. Called dr, Was told to use ice pack and give Advil or Tylenol and watch for high temperature and discomfort. Took him to a nurse practitioner @ 4:00- after armpit was swollen
Developed fine pinpoint viral appearing rash a few weeks after receiving vaccines- no fever or other symptoms
softball size rash at the local site of administration, very itchy for 2 days once rash was noticed
This spontaneous report was received from a pharmacist refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX lot # L028282, expiration date: 28-OCT-2016 and lot # L032402, expiration date 26-NOV-2016, (strength, dosage and route were not reported). No adverse effects were reported. Concomitant therapy was not reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected because there is not permission to contact physician.
Red rash 4 inches x 3 inches. Raised a little, little warm to the touch. No soreness.
Patient reported experiencing extreme pain in her right arm approximately 4.5 hours after the injection which progressively became worse overnight.  Limited mobility of right arm.  Only with assistance and extreme pain can she move her arm above her head, in front of her outstretched, or behind her.   Resting pain 2 days later still high at 6 and 10 with motion.  Prickling sensations in her neck periodically as well.  Taking  440 mg of naproxen for pain.  7 days later still in significant pain but slightly better.  Migrating pain also now down the front of the arm, across the shoulder blade, and neck.
01/28/2021 inner ear infection slight adverse event 2/25/21  balance wasn't good get down and crawl to the bathroom I couldn't get around with out using a walker. went to see ENT they said it might be vertigo Physical therapist said it's not vertigo. Made appointment with neurologist. Checked me and didn't see anything wrong they can help me with. Sent me to see a balance specialist.  Sent back to physical therapist. In the morning it's not bad but i get very tired. I can't do 20% of the stuff I used to do. The doctors said it might be caused by the vaccine. I have trouble with my eyes and hearing aid. I have been taking my regular medicine and I have no side affects.
Reports mouth tingling sensation, denies any other symptoms, VSS, alert and oriented, speaking in full sentences, ambulating without difficulty, MD ordered PO Benadryl 25 mg, administered, patient recovered and ready for discharge
4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea.  Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP  3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis:  Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease
Information has been received from a pharmacist concerning a male with a history of "recent knee surgery" who on 03-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). The pharmacist reported that on 03-AUG-2009, the patient had an injection site reaction in the area where PNEUMOVAX 23 was given. At the time of reporting the patient had not recovered from the event. The patient sought medical attention by visiting his physician. Additional information has been requested.
Headache & NauseaVomiting Narrative: Got a severe headache about an hour after receiving injection with nausea, vomit.
8by7 cm area of erythema and slight induration in right thigh (large local reactions vs cellulitis)
This spontaneous prospective pregnancy report as received from a registered nurse refers to a now 17 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 16-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, GARDASIL, DTaP (unspecified), TDAP (manufacturer unknown) and MENACTRA (lot#, expiration date, dose, frequency were unknown). Concomitant medication included prenatal vitamins. The patient had a pregnancy test on 20-AUG-2014 that confirmed the patient was now pregnant. Patient became pregnant with last menstrual period (LMP) of 07-JUL-2014 and expected delivery of date (EDD) on 13-APR-2015. The pregnancy outcome was pending. Patient did not seek Medical Attention. Additional information has been requested.
Within 30 minutes of receiving vaccine patient reported feeling light headed, hot and heart palpitations.   BP increased to 158/110, Pulse 100.   Patient was CRNA working in ICU environment and was monitored by other staff present.   Signs and Symptoms resolved over the following hour.
Had difficulty breathing 4 hours after my scheduled vaccination, threw up at least 2x, my daughter worried about me and brought me to the closest Urgent Care and when we got there, they took my blood pressure, and it was 140/100 and was given an IV medication to help with it and was there for 2 hours for observation. I fell asleep and when I woke up, I was feeling normal again and my blood pressure went back to normal.
Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Nov2021 10:45 (Lot number: FE3590) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin for Allergy. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 19Nov2021 15:30, outcome "not recovered" and all described as "Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site mass, vaccination site erythema, feeling hot.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Pharmacy or Drug Store. Device Date was 20Nov2021.  No follow-up attempts are possible. No further information is expected.
Sore arm; Fatigue (minor); Tylenol 250 mg (prior to vaccine for migraine); Mild joint / aches; Mild / muscle aches; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis and paracetamol (Tylenol Tablet) tablet for migraine.   Concomitant products included levothyroxine sodium (Synthroid).   On 5th January 2021, the patient received the 2nd dose of Shingrix. On 11th February 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 21st January 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER and Tylenol Tablet 250 mg at an unknown frequency. In January 2021, less than a month after receiving Shingrix, the patient experienced migraine. On 21st January 2021, the patient experienced pain in arm and fatigue. On 11th February 2021, the patient experienced joint pain and muscle pain. The patient was treated with paracetamol (Tylenol Tablet). The action taken with Tylenol Tablet was unknown. In February 2021, the outcome of the joint pain and muscle pain were recovered/resolved. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the migraine was unknown.   It was unknown if the reporter considered the pain in arm, joint pain, muscle pain, fatigue and migraine to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for herself. The patient's concomitant products included Synthroid, which was ongoing since 1981. On 21st January 2021, prior to vaccination the patient received Tylenol 250 mg half tablet for migraine. The patient received Covid-19 vaccine Pfizer on an right arm. The patient had mild joint and muscle ache which was lasted for 36 hours and sore arm and minor fatigue. Less than a day after receiving 1st dose of Covid-19 vaccine Pfizer, the patient experienced sore arm and minor fatigue. Less than a day after receiving Tylenol tablet, the patient experienced minor fatigue. Less than a day after receiving 2nd dose of Covid-19 vaccine Pfizer, the patient experienced mild joint ache, muscle ache and minor fatigue. The patient experienced sore arm and minor fatigue, 16 days after receiving Shingrix, mild joint and muscle ache 37 days after receiving Shingrix and migraine, less than a month after receiving Shingrix. The patient did not receive any treatment for the adverse events and she was fine at the time of reporting. It was unknown if the reporter considered the pain in arm, joint pain, muscle pain, fatigue to be related to Covid-19 vaccine Pfizer. It was unknown if the reporter considered the fatigue to be related to Tylenol tablet. The permission to follow-up was denied. Note: The onset date for migraine was unknown, hence it was conservatively captured as an event.
PAIN IN ARM/ SORENESS ON ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis- psoriatic arthritis, and psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced pain in arm/ soreness on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of pain in arm/ soreness on arm was not reported. This report was non-serious.
My resting heart rate is normally 55 to 70.  Beginning 24 hrs after 2nd vaccination, my heart rate exceeded 100 and topped out at 125 for approx 16 hrs.  After that it calmed down and within a couple more days fully returned to normal.  All of this was tracked by my FitBit.
Headache, Fever, NauseaVomiting CHILLS, HEAVY ARM Narrative:  Other Relevant History:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing), notes: Graves Disease. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28May2022) Positive, notes: Tested positive for COVID for second time on 28May. Therapeutic measures were taken as a result of covid-19, drug ineffective. No other medications the patient received within 2 weeks of vaccination. No known allergies. Sick again after course of Paxlovid. Tested positive for COVID for second time on 28May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
This spontaneous report was received from a medical assistant and refers to a 26 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-SEP-2018, the patient was vaccinated with Oka-Merck PROQUAD, therapy type: recombinant human albumin (rHA), for prophylaxis, lot # R008196, expiration date on 16-SEP-2019 (dose, site and route of administration were not reported) and Oka/Merck VARIVAX for prophylaxis, lot # R009409, expiration date on 29-MAR-2020 (dose, site and route of administration were not reported). The vaccines were injected to the patient of inappropriate age as she was 26 year old. Also it was considered as inappropriate schedule of drug administration as both suspects were varicella-containing vaccines. No adverse reactions were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Shingrix (batch number 4492P, expiry date unknown) for prophylaxis. On 13th April 2018, the patient received the 1st dose of Shingrix. In April 2018, less than a day after receiving Shingrix, the patient experienced rash. In April 2018, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The patient experienced a rash on half of the face within 24 hours after vaccination that lasted one week. The healthcare professional would like to know if there were any reports of these reactions and if the patient should receive the 2nd dose. No additional information was provided. Escalation to vaccine specialist was done. The reported batch number 44929 for Shingrix did not exist and was updated as 4492P as per sales database.
Approximately 3-weeks after 2nd Pfizer covid shot I had a heart attack.  It was a 100% block of my LAD (widow maker).
Vaccine expired, Patient inform  information given by state and offer a new appointment 3 weeks after to revaccinate. No symptoms, adverse reactions or complains.
he had a bad reaction to the Shingrix vaccine 3-5 days after having it; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had a bad reaction to the Shingrix vaccine 3 to 5 days after having it. The reporter said she would not provide any additional details about the report and that her physician would have to be the one to do that.  The reporter did not consent to follow up. This case is 1 out of 5 cases reported by the same reporter.
101.3 Temperature, Chills Headache, Dizziness, Aching.
Patient reports feeling weak upon wakening the next morning after vaccine. Patient states she got in the shower, began to feel weaker and passed out. Daughter helped her get out of shower and she noticed L. arm was fire red, hot, swollen and fluid filled. She started taking Benadryl and Tylenol and went to the urgent care near her home.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Dec-3011, the patient inadvertently received expired FLUMIST. The product expired on 04-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality are not applicable, and the event is considered resolved.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 10/25/21, LOT #012F21A; pt had a positive COVID test on 7/14/22 and tried to recover at home; brought to ED a few days later with worsening cough and increase in SOB; hypoxia on RA; O2 supplementation; CXR showed COVID pneumonia; transferred to ICU; given IV steroids, Remdesivir, DVT Prophylaxis added; pt later passed away in the hospital