chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced "very fast heart beat 8 hours after receiving the vaccine". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Moderate nausea without vomiting; Mild headache; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EW0158) at single dose on 19Apr2021 in right arm for COVID-19 immunization. The first dose was on 29Mar2021 11:00 AM in right arm (Lot Number: ER8730) and had increased volume of menstrual flow after 1st dose. Medical history included acid reflux; occasional nausea; heavy periods; penicillin allergies. Concomitant medication received within 2 weeks of vaccination included oral contraceptive ethinylestradiol/ferrous fumarate/norethisterone acetate (LOESTRIN FE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Patient experienced moderate nausea without vomiting on 19Apr2021, starting 11 hours after 2nd dose and tapering off by about 36 hours after. Patient also experienced mild headache in Apr2021. Both events considered non-serious, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of event nausea was recovered on 22Apr2021; outcome of event headache was recovered in Apr2021.  No follow-up attempts are needed. No further information is expected.
I first started having symptoms on 12/24. I had flashes of a headache a little bit of congestion and a slight fever. I was exposed to someone that was COVID-19 positive. After I tested positive all symptoms stayed moderate. I had a headache that was in and out. I can usually take something, and it goes away butalbital. The medication is for migraines, but these heads would go away quick once I take this medication. The fever was just an elevated temp always below 100. My energy levels are good no loss of taste and smell. I had a lingering cough from a cold, so I made an appoint and it lined up with my recovery of COVID-19. The cough went away when I tested positive and I kept my appointment, and she agreed it was a mild case. The appointment was already set for a cough that was lingering and I kept it to get clarity for my COVID-19 case.
I was awakened in the middle of the night with an asthma attack, and I treated it with an inhaler. I took a test in the AM the was positive for COVID-19 and then I did a PCR test that was required for work. I then reached out to the doctor, and he arranged for the anti-viral, but he said if I could manage skip if possible. It was a very mild case. I monitored my blood sugar, and they were elevated ever since. Glucose levels have been off since getting COVID-19 which is 20% higher than usual.
woke up at 3:25am with headache - didnt realize i was sweating profusly but was freezing, shortly and cold, had hot shower and sat infront of heater till house came up to 88 degrees then i got cold. went to bed - slept straight away foir 20 mins then woke up thinking it had been hours - lost all track of time - In the next 12 hours I was switching between hot and cold then tired and headache and went to sleep no exageration 20 seperate times) and actually slept - Drove my wife crazy because I was antsy as ever been. Unusually I dont get sick from much pretty much anything and the first shot I had no reaction whatsoever. I contacted my doctor who told me its perfectly normal - itll go in 24 hours max but the same constant hot / cold, tired / headache went on for 60 hours straight, by the end of it I didnt have a clue where I was with sleep because every time I slept it was only for 10 - 30 mins max at a time but I slept a lot. The headache felt like a hangover headache and that continued for another 3 days. My wife had no adverse reaction other than sore arm. Really would have appreciated knowing that it may have me off work for a few days - first time off work sick in 3 years lol - dont want to repeat that feeling again
03/30/2021 30 minutes post vaccination, I started noticing tongue swelling and throat twinging, noticed my throat feeling off and my tongue felt swollen and full, three hours later I noticed a foul taste in my mouth and a sore throat developing. About 5 hours after, my chest was very tight however I could still breath. Next day post vaccination, fever, chills, sweating came on and I slept all day. Took Tylenol that night and fell back asleep. I did experience any arm swelling. I did have arm soreness, headaches, body aches and pain that lasted 2-3 days.
I did not have an adverse reaction to the vaccine but I did contract COVID. I started having symptoms on May 20 and tested positive on May 23. I'm taking Tylenol and Sudafed. I have prescription for benzonatate for the cough.
G62.9 NEUROPATHY 4/18/2023 HYPERLIPIDEMIA
Mom called, stated pt left deltoid mild pain, where nurse gave Tdap. Pt stated left deltoid mild to moderately swollen, mild redness, hot to touch and fever. Pt stated will ice left deltoid, circle swollen site with pen and monitor it. Stated she will take pt to see MD if it gets worse.
pt recvd vax; urticaria type skin rashes epi; DPH & prednisone taken;
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
THE NIGHT OF THE 1ST DOSE ON (3/26), i EXPERIENCED SEVERE BONE PAIN IN BOTH OF MY LEGS.  I TOOK OVER SOME PRESCEIBED PAIN MEDICATION I HAD (VICODIN) AND IT DID ABSOLUTELY NOTHING TO RELIEVE THE PAIN.  i COULD NOT FALL ASLEEP FOR MORE THAN 30 MINUTE SPURTS.  i was in too much pain to eat and was just stuck in bed for 4 days.  upon getting the 2nd dosage, i experienced the same pain but the severity was worse.  Again, i could not fall asleep or eat.  Upon getting the 3rd dosage on top of the severe joint pain, inability to fall asleep, i began to experience neuropathy (fire and pin and needles on the bottom of my both feet all day every day).  as months went on, my symptoms have stayed and have increase in severity.  By september 2022, both my knees, both hips and finger joints in both hands are affected with pain and now I require medication to help me fall asleep.  I am constantly feeling fatigue and can't do most of the every day things I used to be able to do.  Running an errand now takes twice as long and actually must plan out which errand or chores i will choose to do each day since I'm only able to do 1 each day before I end up in extreme pain at night standing on my feet too long.
Pt called me 9/9 & told me arm was swollen, warm to the touch & had an indentation with a red line. I advised having adverse Rxn, pt went to ER. - around 8pm. ER said rxn to vaccine. Gave BENADRYL shot. Arm today (9/10) still swollen; has rash; not as warm but red indentation moved down arm. Pt put on steroids.
This report is submitted on behalf of my father, a previously robust and health older man. In my life I can only remember just once before COVID where he was sick. Since my father received his three COVID vaccines he has not been the same. He gets COVID nearly every time he travels to include every wedding, every plane flight, etc. As a result he can't enjoy his life, is more hesitant to visit family and has suffered from COVID multiple times and has had to take Paxlovid twice.
10 days after after my last period had ended, I had intense "spotting" (vaginal bleeding, about a tbsp of blood?) along with cramps, to the point where I thought I got my period again.  Lasted only a few hours. I've never had this kind of thing happen to before, spotting is extremely abnormal for me.
Rec'd DTP/OPV woke up from nap crying noted child to be "shaky" as if cold; Changed diaper & noted legs, feet were "blue" also hands;
Escalating crying post injection. Erythema @ site right thigh. * site of injection medial to desired area.  12/01/09 Pediatric visit notes for DOS 12/01/09.   Parent of Pt c/o crying all day, and pain. On physical examination physician noted erythema at the site of injection, R thigh.  All other systems were negative upon examination. Tx: Tylenol. Pt was consolable when crying. Pt scheduled for a follow up visit in 2 mos.
Felt fine this am but 3 hrs after awakening I had a severe lower back pain. It is almost impossible to get up or sit down, bend over, etc. I have not experienced back pain this severe before.
After 30 minutes, patient reports "tip of tongue feeling numb".  Respirations even and unlabored. Secretion controlled. Speech clear.
Accidental underdose; blood came out of the injection site/same thing happened; liquid and blood came out of the injection site/another Engerix-B dose/12April2021/same thing happened; . This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 1-month-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric (Received dose of Engerix B on 5th April 2021, for tolerance refer case US2021082203).   On 12th April 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th April 2021, immediately after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hemorrhage and injection site leaking. On an unknown date, the patient experienced accidental underdose. Rechallenge with Engerix B pediatric was positive. On an unknown date, the outcome of the injection site hemorrhage, injection site leaking and accidental underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage and injection site leaking to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: This case was reported by a nurse. As per the CDC (Center for Disease Control and Prevention) recommendation, the patient was revaccinated with a dose of Engerix B pediatric. During vaccination, a small amount of blood and liquid came out of injection site again. The reporter initially contacted CDC because they were concerned the patient did not receive the full dose of vaccine and the same thing happened again, which led to accidental underdose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082203:same reporter
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 45.41.  No concomitant medications were reported.  Batch number 031L20A administered on 12-Feb-2021 underwent temperature excursion with temperature of 35 degrees Fahrenheit from 10:00 AM to 11:00 AM. This vial was moved to fridge on 9-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. On 12-Feb-2021, 3 vials were moved to the clinic, on 13-Feb-2021 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 9-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. On 13-Jan-2021, 30 vials were moved to the clinic  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
2 days p/inj pt had maculopapular rash x 8-10 lesions on rt shoulder & buttocks while progressed to varicelliform lesions over the next 24hr;no fever;
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ER8734), on 30Mar2021 as dose 2, single (Lot number: EN625), on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) and on 21May2022 as dose 4, (booster) single (Lot number: 7553) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sjogrens disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Septra, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive and the next day started a 5 day course of Paxlovid; Negative, notes: I tested negative for four days; Positive, notes: tested positive Day 10 and Day 11; Positive, notes: tested positive Day 10 and Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had taken other medication in 2 weeks. COVID 19 Treatment, Brand: Paxlovid, Treatment start date was reported as 12Jul2022, Treatment stop date was reported as 16Jul2022, Indication was reported as treatment of COVID-19. Follow-up attempts are completed. No further information is expected.
pain, redness & swelling, mild fever, tiredness, sore joints, rash, hives, severe pain at injections site, weakness, lost of sleep, discomfort.
Hives appeared from my hips to my face 24 hours after the first dose.; This is a spontaneous report from a non-contactable consumer. This 25-year-old non-pregnant female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 04Jun2021 at 02:45 PM on right arm (at 25-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The past drug event included Nitrofurantoin allergy. No other vaccine was received in four weeks. The patient did not have Covid prior to vaccination and was not tested for covid tested post vaccination. On 05Jun2021 at 05:00 PM the patient experienced hives that appeared from my hips to my face 24 hours after the first dose. No additional symptoms were reported. No treatment was received. The patient was recovering.  No follow-up attempts were possible. No further information was expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included cholesterol (took medication for that condition), blood pressure abnormal (takes medications for the current condition) and seasonal allergy (takes medications for the current condition). Concomitant products included medication unknown (Other Medications). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site discoloration, injection site inflammation and injection site swelling. In April 2018, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the injection site inflammation was recovered/resolved. The reporter considered the injection site erythema, injection site discoloration and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient experienced redness and swelling at the injection site which lasted for 7 days. The patient then experienced discoloration at the injection site. The batch number for the suspect vaccine SHINGRIX was reported as C5237T, however it was changed to C523T as per latest sales data sheet.
it was a little itchy; rash on their left arm where they got the shot; it was pink; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (it was a little itchy), VACCINATION SITE RASH (rash on their left arm where they got the shot) and VACCINATION SITE ERYTHEMA (it was pink) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (it was a little itchy), VACCINATION SITE RASH (rash on their left arm where they got the shot) and VACCINATION SITE ERYTHEMA (it was pink). On 22-Mar-2021, VACCINATION SITE PRURITUS (it was a little itchy), VACCINATION SITE RASH (rash on their left arm where they got the shot) and VACCINATION SITE ERYTHEMA (it was pink) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medications for high blood pressure.  treatment medication included hydrocortisone cream for the itching and an ice pack.
It was given at vaccine site. I am at & have been treating her shingles that started on 4/3 after receiving her second Pfizer vaccine on 4/1/2021 & it is causing her a lot of pain & is hard to get rid of. she was not given information about V-safe to report it.  I know that having covid increases the risk of bad shingles so I thought I should report this.
During the prescribed waiting period the patient c/o nausea to his wife who is a Registered Nurse. She summoned staff who went to car to assess him. Pt was pale, skin cold "clammy and lips bluish. Patient was reclined in front seat of car. BP was 100/? Radial pulse not palpable. 0.1 mg Epinephrine IM in LD per RN @ 1355. EMS summoned per wife. Approximately 1357 BP 70/50, radial pulse faint & thready. EMS arrived & VS taken. O2 100% BP 108/70 Pt states he "feels a lot better" Pt transported to Medical Center per EMS.