chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cough syrup), Penicillin allergy (PCN), Hypertension (HTN) since 27-Feb-2020 and Hepatitis C (Hep c) since 27-Feb-2020. Concomitant products included AMLODIPINE BESILATE (AMLOPINE) from 05-Aug-2021 to an unknown date for Blood pressure high, ATORVASTATIN from 28-Jul-2021 to an unknown date, MIRTAZAPINE from 05-Aug-2021 to an unknown date and PANTOPRAZOLE from 05-Aug-2021 to an unknown date for an unknown indication.   On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter states that they received 100 vials out of this one of the vials was taken out of the freezer on 26 Aug 2021 and thawed. Seven vaccination shots were given to patients on 26 Aug 2021. Some patients were given their first shots and some were given their 2nd shot and the remaining 90 vials were disposed  on 27 Aug 2021 along with the one used vial.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-Sep-2021 contains significant information includes Reporter's address, Patient demographics (Height, Weight, Race and age at vaccination), Medical history, Suspect product anatomical location, Concomitant products(Strength, route, start date and indication) and event outcome.
allergic reaction; swelling of the tongue; hives; itching; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program  support. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced allergic reaction, swelling of the tongue, hives, itching. Therapeutic measures were taken as a result of events. Events resulted in physician office visit. Pharmacist would like to know in the wake of the allergic reaction her patient had to the first dose of the Pfizer Covid 19 vaccine is there any information on interchangeability and could the patient get a dose of the Johnson and Johnson Covid 19 vaccine to complete the series? Patient actually ended up getting an Epi Pen. Patient got their first dose and afterwards ended up having allergic reaction. Is the patient able to get the Pfizer COVID-19 Vaccine again? Or can the patient receive a COVID-19 Vaccine from a different manufacturer? Patient got hives, itching, and swelling of the tongue right after the Pfizer COVID-19 vaccine. Patient's breathing was ok, just had the tongue swelling. Received treatment at an urgent care, not the ER. Patient went to see an allergist, who advised her she can get the Johnson and Johnson as a second dose. Patient received Benadryl at the Urgent Care. Is it ok for patient to receive the Johnson and Johnson COVID-19 Vaccine after the Pfizer COVID-19 Vaccine? Patient received the Pfizer COVID-19 Vaccine at a different facility. Patient wanted to receive the Johnson and Johnson COVID-19 vaccine at caller's facility. The outcome of events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Post vax the patient had a skin reaction with erythema at the injection site in an area 4x6cm.
Overall RIGHT side face swelling especially in the cheek, eye, both upper and lower lid and side of nose and mouth.  Coincidentally, shingle sores showed up around the eye, lip, side of the nose.  Being treated with Valtrex
My left arm because painful, swollen and fiery red around 8:00 am. Also began to feel very hot. By 7: 30 p.m. the redness had spread down toward the elbow.
Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had massive hard [painful swelling] for days/ Induration; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off/ Immune system disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Chronic fatigue; wiped out for a couple of days; wiped out for a month", "Knocked my immune system off", "Arm had massive hard [painful swelling] for days", "Cold", "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days", "Arm had a massive [hard painful] swelling for days", "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm had a massive [hard painful] swelling for days"; INDURATION (non-serious), outcome "unknown", described as "Arm had massive hard [painful swelling] for days/ Induration"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off/ Immune system disorder". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300137387 same patient/event, different vaccine dose (dose 2);
Pt came into pharmacy 2 days later to show me her arm had about a 3 inch diameter that was red and warm to touch. Pt did not report any pain. Pt was advised to continue to watch and contact her physician if symptoms did not improve or got worse. Pt went to the Dr. and was giving antibiotics.
Redness, swelling to right leg onset about 24 hours after 12 administration to right leg.  No fevers, no fluctuance.  Hot compresses for 2 days and over the counter prn.  No improvement.
Vaccine ADR; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a  and describes the occurrence of VACCINATION COMPLICATION (Vaccine ADR) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine ADR). At the time of the report, VACCINATION COMPLICATION (Vaccine ADR) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
When the shot was given it hurt like any normal Vaccine or shot that I have been given before.  But, the next day I woke up and my armpit was swollen and the underneath part of my arm was very tender to the touch.  These symptoms lasted a little over a week total.  I went back to the clinic on 5/25/21 just due to how long it was staying swollen and tender wanted to make sure that this was something that needed to be documented.  Doctor advised me to not take the second dose due to my reaction to the first dose.  I had Covid 19 back in October of 2020.
pt passed-out 10-15mins p/vaccines; may have had mild sz; BP low 68/48 30mins later vital signs nl temp 98.6; pt stood up & 10-15mins later started vomiting;
pt admitted to hospital with SOB, lethargy, altered mental state; found to be positive for COVID; hypoxic respiratory failure requiring intubation; bronchoscopy done with suspected cancerous lesions; transitioned to comfort care; palliatively extubated and pt passed away in the hospital
Patient has struggled with infertility for 2 plus years. She reported on the day of the vaccination that she was 3 months pregnant with twins. Patient stated that on the day following the vaccination, she was on an international flight when she miscarried the twins.
Adverse event, throat tightness at 3:10 pm 9-25-09. Administration of Fluvirin given at 2:40pm 9-25-09 Epi Pen 0.3mg IM deltoid given and transported to hospital at 3:30 pm 9-25-2009.
Right arm 3cm diameter red raised area, Left arm 3cm x 5cm area of diffuse redness, no induration.
Dx Stage 4  urothelial Bladder Cancer noted 4/1/22,  died 09/07/2022
Extreme weakness, fever (104.4F), altered mental status, dehydration. Happened at 1400 and released from hospital after receiving IV fluids and Motrin at 1930. Told to get rest and hydrate and call if any problems.
Pt received vaccine n clinic, apparently left clinic, went to store, had some popcorn and started feeling poorly.   came back to clinic and was found by an RN in the lobby-"pt was looking confused, very red in skin color and telling me she is not feeling right. I then learned that she had had a MMR vaccine. It appeared that she was having a reaction as she told me her face was feeling hot and lips were swelling".  We administered IM Benadryl and then approx. 24 min later gave IM epinephrine.  911 was called and pt was transported to local ER as was hypertensive and had received epi.
On 10/20/2022, I got what I thought was a heavy cold. I thought it was also possible that I had contracted COVID-19. I tested myself a few times and was negative. The cold ended up migrating into my chest, causing chest congestion and triggering my asthma. I ended up needing refills on my inhalers. That has all stayed with me to present with no change. I ended up with sinus congestion with severe sinus headaches. I treated that with Tylenol sinus severe. I am also still experiencing postnasal drip. I have an appointment with an E.N.T. this month and an appointment with a pulmonologist in May.
couldn''t sleep for months; had problems with his heart; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "couldn''t sleep for months"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "had problems with his heart".  Additional information: Is report related to a study or programme? No. Is the patient also the reporter? Yes. Is Pfizer Covid 19 Vaccine a Pfizer product? Yes. Caller reporting adverse event for family member and states he took it too, he has problems, he is getting better slowly, there is no way that this vaccine isn't terrible, he has problems too, he couldn't sleep for months, he had a problem with his heart, he went to a cardiologist, there is no way that he can get away with these issues with this vaccine, they are foreign bodies, its expected but its very severe reactions. Caller confirms the product he received is the Pfizer Covid 19 Vaccine. Caller declines to complete safety report, stating he doesn't care, he knew there has to be some side effects, its impossible to give him something like that and be okay, it has to do something, everybody he knows has affected them somehow. Everyone they have talked to has had problems, it's expected. His whole family, they all received the Pfizer and all had problems, had issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Aug2021 15:00 (Lot number: FC3183) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Vaccination history included: Bnt162b2 (Dose 1 (Lot No: FA6780), administered in left arm at 05:00 PM), when the patient was 23 years old, for Covid-19 immunization. The following information was reported: ACIDOSIS (hospitalization, life threatening) with onset 27Aug2021 13:00, outcome "recovered with sequelae" (2021), described as "Acidosis". The patient was hospitalized for acidosis (start date: 27Aug2021, discharge date: 28Aug2021, hospitalization duration: 1 day). The event "acidosis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (27Aug2021) had "acidosis", notes: which was 5 times higher than normal; electrocardiogram: (27Aug2021) had "acidosis", notes: which was 5 times higher than normal; (30Aug2021) everything was normal; heart rate: (27Aug2021) about 130-150 and wouldn't go below 100; (27Aug2021) still didn't go below 120; (27Aug2021) between 90-110; (30Aug2021) shot up to 170. Therapeutic measures were taken as a result of acidosis. Clinical course: On 27Aug2021 around 1-2 pm (as reported), patient heart rate was about 130-150 and wouldn't go below 100, patient had numbness all over face, both hands and arms, felt like she was going to pass out then her spouse took her to the ER. They said if patient went there a little late, her heart could've given out. They gave her some kind of calm medicine but her heart still didn't go below 120, she was sweating a lot and really hot. While resting at night it stayed between 90-110. They kept giving patient fluids throughout the night, also did EKG and blood test - they said patient had "Acidosis" which was 5 times higher than normal that caused all of that. Patient stayed there overnight and left the next day, two days later, patient heart shot up to 170 while laying down in the couch so she had to went to another ER, when she was there, they did another EKG and said everything was normal so they gave her beta blocker to take in case her heart rate went up again.  Follow-up attempts are completed. No follow-up attempts are needed. No further information is expected.
Pt collapsed immediately after administration. Pt woke up after 5 minutes, breathing improved, pulse came down to normal from high.
Pt had a well child physical in the office with immunizations on 9/1/2020 On 9/3 experienced cardiac arrest and taken to hospital ER - unable to resuscitate and pt expired. Suspected SIDS- no autopsy results at this time. Pt died on 9/3/2020
BODY SORENESS THE DAY OF AND DAY AFTER; CHILLS; KILLER HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-MAY-2021 11:18 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 04-MAY-2021, the subject experienced body soreness the day of and day after. On 04-MAY-2021, the subject experienced chills. On 04-MAY-2021, the subject experienced killer headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the killer headache, chills and body soreness the day of and day after was not reported. This report was non-serious.
Information has been received from a physician and a certified medical assistant concerning a 13 month old male patient who in September 2010 (reported as "last month") was vaccinated with a first dose of VAQTA. On 25-OCT-2010 the patient was scheduled to receive hepatitis B virus vaccine, inadvertently received the second dose of VAQTA inadvertently via intramuscular route (lot # 668912/1087Z, expiration date not available). The two doses were given to the patient "one month apart as opposed to 6-18 months apart". No adverse reaction was noted. Patient sought unspecified medical attention. Follow-up information has been received from the certified medical assistant concerning the male patient with murmur who on 25-OCT-2010, 4:00 PM was vaccinated IM with a second dose of VAQTA (in right thigh) and a first dose of unspecified vaccine (lot # U3720A, manufacturer: Sanofi Pasteur) (in left thigh). The patient did not require emergency room or doctor visit (previously reported as "sought unspecified medical attention"). Additional information is not expected.
Fatigue, significant, prevents daily activity  Headache, significant, any use of prescription pain reliver or prevents daily activity  Reaction Intervention: prescription medication
Per CDC guidelines, patient continued series with primary series shot. only adverse reaction was the patient being concerned of not being fully vaccinated to take a cruise trip
Tested positive for Covid the 18Feb2021 a day before his second vaccine.; Tested positive for Covid the 18Feb2021 a day before his second vaccine.; This is a spontaneous report from a contactable consumer (patients wife). This consumer (reporter's husband) reported for an unspecified age male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date: unknown) via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter husband got his first shot of vaccine on 30Jan2021 and patient underwent lab test and procedure which included Covid-19 test which result was tested positive for Covid on 18Feb2021 a day before his second vaccine. Patient went to hospital for IV of Bamlanivimab. The outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392105 same reporter/drug different patient/AE
On 5/15/09 patient returned to have a TST read.  PHN observed right arm triceps area reddened, firm and warm to touch in an area 3 1/2 by 2 inches.  Patient states this reaction began on 5/13/09 and has not worsened since then.  She has not taken any antihistamines, done any type of treatment or been seen by her PCP.  Dr. evaluated the right arm site and recommended Benadryl this evening and for patient to be seen by PCP on 5/16/09 if area worsens.  TC to Mom and discussed Dr. instructions and she will get Benadryl and take patient to the Clinic on 5/16/09 if necessary.  TC to mom on 5/18/09 and she states patient's right arm redness and swelling was decreased on 5/16/09 and she did not go to PCP.  Mom states redness and swelling completely gone and only a small bruise remains today.  Benadryl was not given as patient began with stomach flu later on 5/15/09.
-fever of 102.8 -body aches -pain under injected arm -chills -tired
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (lot# reported as H020254, EXP date 08-NOV-2013; lot#J000153, EXP date: 07-JAN-2015) exposed to 56 F for 8 hours. VARIVAX doses were evaluated and were supported. No adverse events were reported. At the time of report, the status of patient was unknown. Additional information has been requested.
I started having heart pain about two weeks after getting the vaccine, it escalated very quickly. I was soon having severe heart pain every 20 minutes, and I pushed through this for a few days before I became concerned and couldn't do my day to day actions with constant stabbing heart pain. I had no prior illnesses or health issues. I went in to my local PMC who gave me an EKG and got me a ultrasound on the area, they then said they say some fluid around my heart, I was diagnosed with pericarditis. They said this was very weird for a healthy 18 year old, and usually I would be seriously ill before this happened. A few months have passed, the treatment has not worked and now I'm going through more medication and testing.
A consumer report has been received. The report concerns a patient, Male consumer, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that consumer was administered FLUMIST quadrivalent and only received half the dose in one nostril on 02-Oct-2013. The outcome of the event of received half the dose is unknown. The report was considered to be non-serious.
Today at 850 am patient had his 1.5 yr old MD appointment - he has been healthy, well, happy boy with out any illness recently was scheduled for 4 vaccines, got two - Flu and Tdap. Was very fussy and cranky tonight when I got home around 6pm, did not want dinner, very very fussy, happy to go to bed, at 8:20pm he awoke with a cry that started to build, I went in to get him out of the crib and immediately noticed he was hot to touch, consoled him but he increased in the intensity of his crying, Called for wife, she came in and we got an axillary temp of 102.7, wife had him on the the changing table and I was in the hall way when I heard two grunts and wife yell he is having a seizure, she was picking him up to bring him outside, he was in extensor pattern, minimal breathing, left lateral gaze, unresponsive for 35-55 seconds - stop watch read 27 seconds but took me 10-20 seconds to get it started. Wife stayed out side, and I got ICE to place on femoral arteries, he regained consciousness, I called Dr as he was crying hysterically in the back ground. Advised for Motrin 100mg q 6 and APAP 160mg q4 if needed, keep dosing the Mortin for 48 hours any repeat seizure or decline of condition to call back asap. With APAP and Ibu in he was much improved, did not have IBU in the house so ran to store to get some, but administered first dose of APAP 160mg at approx 8:35, first dose of Motrin at 8:55, much cooler and less fussy by 9:20pm. Set up dosing schedule - Read on internet that Flu vaccine and Dtap together raises risk of Seizures.
the night of the vaccine I started feeling chills, had a fever of 100.9, headache, nausea, severe body aches.