chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden facial discomfort on left side of face (pressure, numbness, tingling) and unexpected crying; 24 hours later mostly subsided but still decreased sensation in left side of face and feeling of pressure/tightness in left side of face.
Anaphylactic reaction; could not breathe; This is a spontaneous report from a contactable physician reported for 60-year-old female patient (cousin) received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via intramuscular route on an unspecified date at 16:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history included obesity. Family Medical History included Father passed away from heart disease and brother passed away from Leukemia. The patient experienced anaphylactic reaction and could not breathe on an unspecified date at 17:00. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccination received within four weeks prior to the first administration date of the suspect vaccine. The adverse events resulted in emergency room visit. No Adverse events following prior vaccinations. It was reported that she has a physician on the line regarding the Pfizer COVID 19 vaccine, Comirnaty. He is a doctor and reported that his cousin had an anaphylactic reaction to the vaccine a couple of months ago. He wants to ask if there is any kind of skin test to test for allergy to it like a polysorbate or peg test. She has an antigen level of 1.1. She was fine and said it occurred 5-6 months ago. He did not know exact date. They gave her a bunch of medicine and she was able to breathe. She was not hospitalized. She went to the ER and was treated and released. It was potentially very dangerous. They had to give her an Epi pen. This was after first dose. She wanted to get 2nd dose and her allergist said no way. Her endocrinologist said to be careful and maybe get J&J or Moderna. He thinks it was the Polysorbate carrier with Pfizer. It happened soon after the vaccine. It appeared an hour after. She could not breathe and went to local ER. She took a thyroid medication, not a Synthroid, but another one. She was given EPI and other medications. The clinical outcome of the event was recovered on unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Received doses from a vial first punctured the day before the date of administration; Received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Received doses from a vial first punctured the day before the date of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Patient received 4th dose. It was reported that 4 Patients received doses from a vial first punctured the day before the date of administration LOT 017b22a from the same vial. Date the vial was initially stored in the refrigerator was reported as 14Jul2022. Date and time of vial was first punctured was reported as 14 Jul 2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15Jul 2022 first administration 0:9 30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree Celcius to 25 degree Celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614374, US-MODERNATX, INC.-MOD-2022-614370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614374:Patient 4 US-MODERNATX, INC.-MOD-2022-614370:Patient 1
Chills, fever,  vomiting, headache, diarrhea, body aches, extreme fatigue.  Except for vomiting these symptoms lasted about a week.  The fatigue though it lessen is still prevalent.
1st dose...only right arm (shot spot) sore and it's still sore today, but no other side effects at all  2nd dose...arm not sore, BUT I was so out of it the next day 1. Major headache...no relief with acetaminophen & didn't try anything else 2. Minor temperature...99.8 most of the day 3. Every muscle, every joint and every bone in my body ached...perhaps my skin & hair also :-) 4. Nausea...without vomiting 5. Dizziness upon standing and intermittent lying down 6. Lethargic...probably due to all the above Stayed prone all day and night except to get water and go to the bathroom Drank lots of water and hot tea with saltines  Day 2: 1. Headache...gone 2. Temperature...back to normal 3. Aching...subsided, but not totally gone 4. Nausea...gone 5. Dizziness...subsided but not totally gone 6. Lethargy...hung in there, but not nearly as profound Made myself get up, eat and do minor household chores to gain better equilibrium and feel more productive plus work out the muscle tightness from being inactive
Vomited once on 3/15. Then had left upper chest burning radiated up to his left jaw for few days that started 3/15. Since 3/16 he has had generalized weakness, fatigue, difficulty walking, and chills. On 3/17, he had one episode of urinary urge incontinence. Fever on 3/18 and 3/21.  Imaging showed paraspinal myositis from suboccipital region to upper thoracic region. Main continued symptom now is generalized weakness and difficulty walking.
IT OPENED THE LUNGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced it opened the lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it opened the lungs was not reported. This report was non-serious.
I started having extremely high blood pressure; over 200. I also had dizzy spells like vertigo. Things got worst from there. I ended up seeing a cardiologist. They ran test and found that my aorta was enlarge. I had mitral regurgitation, and have rapid heart palpitations and ended on high blood pressure medication. Palpitations have now stopped. It took about two months for things to get back to semi normalcy.
On 7/19/02, had a seizure, lasting 10 minutes. Went to ER with a fever of 103.9F (Grand Mal). On 7/28/02, had a seizure lasting 27 minutes. Went to ER with fever of 100F (Grand Mal). Left arm with nickel-size lump on 7/19/02, down to pea-size by 7/30/02.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Shakiness-Mild, Systemic: Tinnitus-Medium, Additional Details: Patient stated that symptoms worsened after second dose on 6/23/2022. Her pcp encouraged her to get second dose despite having possible effects from first dose.  Patient is still receiving ongoing treatment from provider and is currently taking valium for her symptoms.
HE HAD VASOVAGAL SYNCOPE FOR LESS THAN A MINUTE (MORE OR LESS), REGAINED CONSCIOUSNESS AND WAS FINE AFTER.  HE WAS ALSO SWEATING A LOT. WE WERE ABOUT TO CALL 911 BUT WIFE REFUSED AND SAID THIS SOMETIMES HAPPEN TO HIM WHEN GETTING AN INJECTION OR GIVING BLOOD. WIFE WAS FANNING HIM AND SHE ASKED FOR ICE PACK WHICH WAS PROVIDED RIGHT AWAY.  PATIENT WAS FINE AFTER ABOUT 15 MINS AND LEFT PHARMACY.
20 cm X 19 cm erythema area, 4 cm diameter induration right leg.  Follow up: Diagnosis cellulitis vs allergic reaction.  prescribed ceflexin and prednisone.
approx 3 days p/vax lt arm painful down to elbow approx 1 wk later, pain down to fingers tips, vomited x 1-went to hosp, BP 235/56 @ hosp since then intermittent pain down to elbow, relieved by ASA; pt is beautician noted pain today @ work
At the very beginning of June I noticed my heart would skip a beat and I would feel it in my chest and I am familiar with that because sometimes medications trigger that and I couldn't figure out what I was doing differently, so I was a little perplexed why. For awhile I was nervous, so 3 weeks ago I seen my cardiologist and he did a heart monitor to capture the image of it to see what it is. He put in a stent about 3-4 years ago and I wanted to make sure I didn't have a blockage again but he didn't think it was and that it was a rhythm issue but wanted to make sure. It's very random and does it more in the evening than daytime, or I feel it anyways more in the evening. It causes me to to cough a lot when it happens and other than that I am waiting on results from EKG once he gets the report back and we will see what is going on.
Rash started behind ears on 15FEB91 moved to eyebrows, face, chest, back, abd, legs, & buttocks. Temp to 100 (forehead strep) was beet red & puffy; Enlarged glands behind ears. Cranky & slept a lot. Also ear infect & Conjunctivitis, coryza.
Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.
Mother advised child developed varicella rash 10 days post vaccine. Mother unable to relate if child had fever prior. Has generalized rash without infection (per mom). Child not seen.
pt states she developed covid arm after 1st covid vax and about a week later she developed a hard red raised area the size of a tennis ball around the injection site.  This lasted about a week. After getting the second vaccine she started having heart palpitations about a couple of weeks after getting second covid vaccine.  She would get nauseated and had shortness of breath.  It would come and go.  During the day and at night while she was sleeping.  At least 3 times a week.  She went to her PCP and was referred to a cardiologist.  She was given a heart monitor to wear for 2 weeks.  She was diagnosed w/ AFIB.  She had a heart ultra sound and was told there was no problem with her heart valves.   During this time she  developed a melanoma on her back.  She also developed lesions on her neck and nose.  She had to have surgery quickly and had to get clearance from her cardiologist to have surgery.  She had outpatient surgery.   Over time the palpitations have stopped.  She went to her cardiologist to confirm it was safe to get the covid booster shot.  Her doctor recommends she wears the heart monitor again before getting it.
soreness to arm injection site; might have lymph node swelling or something; a sharp pain/soreness right below her left ear; sharp pain below left ear that comes and goes; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; This is a spontaneous report from a contactable consumer for self. This 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 13:00 on left arm at single dose (Lot # EL1284) for COVID prevention. Medical history included ongoing arthritis in some form probably since 2011 (reported as ten years ago, as of 07Jan2021), ongoing Osteoporosis had it probably at least since five years ago, maybe longer, ongoing Barrett's esophagus had it probably since 2016 (reported as five years ago, as of 07Jan2021) High cholesterol this is managed or lowered with medication, and was diagnosed in 2001 (reported as probably 20 years ago, as  of 07Jan2021) her whole family has it. Concomitant medications were none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 10:00 AM at age of 64-year-old on right arm at single dose (Lot # EL0140) for COVID prevention. She says that the first time she got the injection in her right arm, but the second time her right arm was still hurting, which she has arthritis over there also, this time she got the injection in her left arm. She says that the soreness or sharp pain under her left ear could be or not be related. She experienced soreness to arm injection site. She says that the area below her left ear doesn't feel swollen, it just feels like not a sore throat, but every so often she has a sharp pain, and it could be that she slept on it wrong. She says she was wondering if that goes away fast or is connected, like a possible side effect. The patient received the 2nd dose of the vaccine 06Jan2020 13:00 and reported to have a sharp pain/soreness right below her left ear on 07Jan2021, sharp pain below left ear that comes and goes. She read that swollen lymph nodes were a side effect and is asking if that area is a lymph node and would that be considered a side effect and is asking how long it will it take before it goes away. She is wondering since side effects said might have lymph node swelling or something. She says in her arm where her shot was given is sore, and also kind of right below her left ear, which she thinks that is where a lymph node is. She says every so often she has a sharp pain there that goes away, and she wanted to know if this could be a part of it, since she is guessing that is where a lymph node is, or wondering it this is something even related that could be a side effect. Treatment included she took Tylenol Rapid Relief Extra Strength a while ago, dose queried but not provided. EXP: Jul2022, LOT: SJA072, this is not on the bottle, it must have been on an outer box which was discarded. Treatments received for the events pain, pain in ear, vaccination site pain and swollen lymph nodes. Outcome of the events were unknown.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received FLULAVAL 2014-2015 season (batch number 5AZ7H, expiry date 30th April 2015. On 26 September 2014, the patient received the 1st dose of FLULAVAL 2014-2014 season, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLULAVAL 2014-2015 season. Additional information received: 16 months patient who received inadvertently FLULAVAL Quadrivalent.  Child too young for indicated vaccine.
Chills.  Fever. Unsettled stomach. Headache.  Fatigue.  Time of effects was approximately 3 and a half days.
Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed). At the time of the report, PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  Company Comment: This is a case of Product storage error for this 71-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-381027, MOD-2021-381128, MOD-2021-381138, MOD-2021-381141, MOD-2021-381142, MOD-2021-381145, MOD-2021-381149, MOD-2021-381155, MOD-2021-381161, MOD-2021-381169 (Patient Link).; Sender's Comments: This is a case of Product storage error for this 71-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
about 10 minutes after vaccinated, he was feeling lightheaded and fainted. regained consciousness right after, and 911 was called and paramedics to the onsite and reviewed the patient status and was cleared by paramedic team and patient went home.
Patient was given a Moderna vaccine even though she is <18 y/o. Pt received her second Moderna vaccine on 4/27/21 to complete the series. Pt contacted on 5/17/21 and reports no adverse events.
Fever - Nausea x 2 days - vomiting - headache - oral rehydration and MOTRIN for treatment.
The patient presented to the clinic to receive a hep a-hep b (TWINRIX) vaccine. She received a flu (FLUARIX) vaccine instead. Then, when the error was discovered, the nurse called the patient and the patient returned to the clinic the same day and received a Twinrix vaccine. No injuries were sustained.
Like a little cold but no fever; fatigue/weakness; fatigue/weakness; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Apr2021, outcome "not recovered", described as "severe headache"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Like a little cold but no fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "fatigue/weakness". Clinical course: Patient stated that he got the Pfizer second dose 30Mar2021 and today (16Apr2021), the day of this report) has been one week patient has had a severe headache and thought it was a cold, but he had not runny nose or fever, nothing. Like a little cold but no fever. Patient was asking if this was a side effect of Pfizer. Caller was asking what Pfizer suggest for the headache as it was not going away after a few days, it has been more than 7 days, does Pfizer suggest a Covid test. Patient stated that he was fine on 30Mar2021 and Saturday (10Apr2021) he started getting the headache and thought about getting a Covid test, but he did not have a fever, not even 99-100 and it had been off and on and he was feeling good and sometimes it was severe. Stated it was like the cold is suppressed to his head and he had been doing hot water steam and whatever was coming out of his nose he gets out but it's not running. Since vaccination, he has experienced headaches and some fatigue/weakness that attributes to the headaches. He wanted to know if there was some over-the-counter pain medication that he could take that would not be detrimental and undermine the efficacy of the vaccine or the antibodies it should ultimately produce. Caller was asking what remedies Pfizer would suggest and stated it was the Pfizer Covid Vaccine. This report was not related to a study or program. Reason for no lot number of Covid vaccine stated as Caller unwilling to complete the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports 24 hours after receiving the covid vaccine hives developed on her face, lips, eyes & forehead.  Pt reports swelling ti eyes as well.  Pt states the hives resolved on there own w/ out using any OTC medication apprx 12 hrs after they appeared.   Pt reports an itchy scratchy throat as well.  Slightly swollen eyes & scratchy throat & muscle aches were still reported 3 days post vaccination
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with improperly stored doses of GARDASIL, 1 DF, lot # K011562, expiration date 08-APR-2017 (strength, dose number, route and anatomical location were not reported), and ROTATEQ, 1 DF, lot # L008996, expiration date 01-DEC-2016, (strength and dose number were not reported). No adverse effects reported. The reporter stated that the vaccines were exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm within hours of vaccine, at night started to get chilled, now a little over 24 ours out I'm getting chilled and achy, arm is still very sore.  Just started getting a HA around 11 am.
No adverse effect; Patient administered an improperly stored dose of VARIVAX; This spontaneous report was received from an other healthcare professional (medical assistant) regarding a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reaction and drug allergies were unknown. On 07-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # N035941 and expiry date: 18-DEC-2019 (strength, dose and route) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) for 26 hours. Previously vaccine underwent temperature excursion of 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for 5 hours. The call was due to digital data logger. No adverse symptoms reported (no adverse event). Product quality complaint was not involved.