chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received on 18 June 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3616AA received on 02 August 2011, lot number not reported received on 06 September 2011 and lot number not reported received on 27 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 12 May 2012, approximately 6 months after the last dose. On 13 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and apnea. Laboratory testing included positive PCR on 29 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Approximately 24 hours after receiving the vaccine, began to have chills, severe joint aches, fever reached 100.4.  Took Aleve in the evening so could sleep.  Next day some fatigue.  Third day following receipt of vaccine, no issues.
Symptoms: Arthralgia, severe body aches, stiffness in neck, severe joint pain. Fatigue and rash on torso (hives) developed. Began early in February, increased in intensity after 2nd dose. Rash appeared in March. Notified Doctor. I declined final dose of vaccination.
still experiencing a low grade fever; This is a spontaneous report from a contactable nurse (patient herself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 31Dec2020, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated he received the vaccine on 31Dec2020, and he is still experiencing a low-grade fever. He wanted to know if this is expected. He would also like to know how long this side effect usually last. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
VOMITING; COVID-19 VIRUS TEST POSITIVE; BODY ACHES; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any symptoms related to covid, only the secondary symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vomiting, covid-19 virus test positive, body aches, fever, and nausea. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, fever, and nausea, and the outcome of covid-19 virus test positive was not reported. This report was non-serious.
Caused blisters on the chest the night of the injection; Developed bumps along the abdomen; Feverish (red & warm); Feverish; Feverish (red & warm); patient had arm swelling; had swelling at the spot of the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm) and RASH (Developed bumps along the abdomen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In October 2021, the patient experienced VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish). On 18-Oct-2021, the patient experienced BLISTER (Caused blisters on the chest the night of the injection) and RASH (Developed bumps along the abdomen). At the time of the report, BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), RASH (Developed bumps along the abdomen), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Patient's second dose was scheduled on 15-NOV-2021. However the patient did not receive second dose.  The pharmacist stated that some people term it "feverish" and by that mean red and warm.  No treatment medication was reported by the reporter.
No adverse event reported. Only air was administered. Patient was contacted to get second dose but decided to get elsewhere.
Moderna vaccine given to patient below 18 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old). On 25-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to patient below 18 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered 25 Jan 2021 morning and patient did not experienced any adverse events.  No concomitant medications were reported.  No treatment medications were reported.
Swelling under right eye.  Pharmacist said to try allergy eye drops or Benadryl.  Neither has done anything.
MENVEO diluent only admin on 7/5/17. No ADR reported. Called Glaxo - revaccination not necessary.
Pt c/o chest tightness and 9 mins after receiving vaccine. She denies any past medical Hx. Husband with pt and verified that she has no PMH. Pt assessed and evaluated by NP and EMTs. BP - 152/110, 165/115 with automatic cuff, 158/110 manually. O2 sat 99%
Patient reports: left shoulder ache since receiving flu vaccine on 11/30/22. Patient contacted office and seen on 12/10/22. Patient has been using warm compresses for relief .
48 hours of body aches, fatigue and temp 100.0 F  starting 2/28 @ 630 pm
Patient developed "extensive pulmonary embolism" and "acute common femoral artery DVT" seven days after receiving the covid vaccine requiring ICU. He was on prophylactic heparin during hospitalization for leg cellulitis w/ abscess (no sepsis) prior to this event.
Pt exp a h/a 2 hrs p/recvd an inject of Typhoid vax; 1 hr later, pt blacked out; pt also devel chills, BP dropped, had a rapid pulse; pt tx w/adrenalin for this rxn;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 64 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EP7534), in left arm and as dose 2, single (Lot number: EW0151), in left arm for covid-19 immunization. The patient's relevant medical history included: "Adhesives, some fruits" (unspecified if ongoing), notes: Adhesives, some fruits; "Adhesives, some fruits" (unspecified if ongoing), notes: Adhesives, some fruits. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 21Jan2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid taken as treatment for covid 19 from 14Mar2023 to 18Mar2023.
Numbness in right cheek within an hour of the vaccination. Subsided in approximately three hours.
Patient was given her first flu shot with Fluvirin on October 29, 2008.  To date she still has muscle tenderness at the injection site.
Pt was given influenza vaccine PF on 2/16/16. Pt reports on the morning of 2/18 he discovered a red area on left bicep that wrapped around both sides. Pt reported pain in bicep that extended to left chest muscles, axilla and shoulder. Pt also given TWINRIX to left deltoid on 2/16/16. Also reported fever, body aches x 2-3 days.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 18-year-old male patient received, on 08Jun2016, the first dose of TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced persistent cough. Clinical outcome was unknown at time of this report. Follow-up (30OCT2016): Follow-up attempts are completed. No further information is expected.
Uticaria - noted on face and hands. Lasted about  3-4 days then resolved with steroid cream and extra antihistamines.
I got the vaccine booster about 12:30 in the afternoon on 11/17/21. Around 1:00 or so in the morning I woke up with chills and a migraine. The migraine continued into the next two days accompanied by nausea and vomiting. I also had stomach pains in my lower abdomen about the time the chills started, sharp stabbing pains. The severe migraine finally let up about the second day but then for the next two weeks I had a headache that would not go away, no matter what I took to relieve the pain. The headaches finally stopped on Tuesday, November 30, 2021. Also for about a week after the vaccine I was nauseated off and on.
barely move her arm / lot of difficulty moving normally; reaction that was hot and red; reaction that was hot and red; got shoulder pain; right thumb is clicking and moving out of its position; is painful; neck pain; neck pain and its stiff; This case was reported by a consumer via patient support programs and described the occurrence of mobility decreased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck. On an unknown date, the outcome of the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot a month after the Shingrix shot. The patient experienced hot and red. Then she got shoulder pain and she can barely move her arm.  The patient had been treating with heat and creams. Her right thumb was clicking and moving out of position and she has to put it back in place and is painful and not feeling right. She was having neck pain and it is stiff. The patient was having a lot of difficulty moving normally.
skin asthma; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included hypertension and diabetes, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced skin asthma on an unspecified date with outcome of unknown. Clinical course reported as follow: patient received his first dose of the vaccine 2 weeks ago and he was scheduled for his second dose on 11Mar2021. He was taking medication for his hypertension and diabetes. As per him, he didn't stop taking these medications even though he received the 1st dose of the vaccine. Aside from this, he experienced skin asthma from the past two weeks after taking the 1st dose of the vaccine and he took medication for his skin asthma yesterday (08Mar2021).  Information on the lot/batch number has been requested.
Injection Site Soreness, Jaw jumped 2 times on day 1 Narrative:  Other Relevant History:
Day following injection, patient developed redness and swelling around injection site, spreading to upper arm and bicep. Came to pharmacy a day later, and said it was improving. Told her to continue to monitor it, and if it gets worse or doesn't continue improving, to seek medical attention.
Had an SVT 3/13/21. Ambulance gave dose of adenosine and transported to the hospital. I also had an SVT after my booster shot on 10/24/21. SVT was on 10/28/21 at 4:30 a.m.  I have been having intermittent SVTs since my first vaccine.
EMPLOYEE TESTED POSITIVE FOR COVID 19 AFTER RECEIVING BOTH PFIZER VACCINES GREATER THAN 3 MONTHS AGO
Passed out a month after vaccine due to heart output insufficiency; Flu like symptoms 48 hrs; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms 48 hrs). On 28-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) and INFLUENZA LIKE ILLNESS (Flu like symptoms 48 hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Cardiac output: insufficient (Low) Heart output insufficiency.         No concomitant medication reported. No treatment information was provided. The patient reported that the immune response to the second dose caused the adverse events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s age (69 years) is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s age (69 years) is a confounder.
Patient states she received the pneumonia vaccine on Friday to the left upper arm. The next day, she noted redness and swelling at the injection site. She outlined the redness with a pen, believing it could be infectious. She otherwise feels well, she is concerned about the mild swelling and discomfort. She is currently about 23 weeks pregnant. She does mention 3 episodes of emesis today associated with lunch. She has had some similar episodes throughout her pregnancy associated with eating. She reports T-max at 99.0.
Got bells palsy; This is a spontaneous report from a contactable consumer.  A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot Number: Ew0168), dose 2 via an unspecified route of administration, administered in left arm on 12Jun2021 14:30 PM (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Ewo182) via an unspecified route of administration, administered in left arm on 22May2021 14:30 PM as DOSE 2, SINGLE for covid-19 immunization. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Jul2021 17:30 PM patient experienced got bells palsy. The adverse event result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The patient received treatment with steroids physical therapy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Event seriousness considered as disabling/incapacitating as per the reporter. The outcome of the event was not recovered.
One week following my booster (3rd shot) of Moderna vaccine, I experienced a TIA resulting in inability to speak or form words for approximately 30 seconds. 7 months later, in November 2022, I experienced a second, more serious TIA comprised on left-sided paralysis lasting approximately 15 minutes, with current residual neurological and physical deficits.
The morning after having the shot I woke up achy and tired. I noticed my neck was especially painful. Within a couple of hours I knew I couldn't go to work, as I became feverish and extremely fatigued. I spent the day in bed, lacking the energy to do anything. Around 7:30 pm I felt well enough to get up and eat something but still weak and feverish. By the next morning I was able to go to work, but only felt about 80% back to normal. I have never responded to a vaccine this way, and it's making me reconsider getting the second shot.
Pain, redness, swelling at injection site started after injection and continued. Seen on 5/16/18. Diagnosed with Cellulitis of Rt. upper arm. Started on Cefdinir 300mg, 2 caps daily x 10 days.
Approximately 12 hours post 2nd injection systemic rigors, uncontrollable tremors, tachycardia, severe tachypnea, nausea, fever >103F, severe diaphoresis. Most acute reaction lasted 8-12 hours. Sub-acute reaction of mild fever, generalized ache,  and malaise 48 hours post.       I am a health care provider, Certified Registered Nurse Anesthetist (CRNA).
No adverse affects reported; Nurse called reporting improperly stored VARIV AX was administered to patient on 01-MAY-2020; This spontaneous report was received from a registered nurse refering to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 01-MAY-2020 the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot number S012036 , which has been verified to be valid, expiration date reported and validated as 17-APR-2021) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis (Product storage error).  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 48.2 (no units reported) for 4 hours as recorded by the data logger. There were no previous tempeture excursions. There was no adverse effect reported.
blood clot in the brain; This is a spontaneous report from a contactable consumer, the patient.  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 07May2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunisation. The patient experienced a blood clot in the brain on an unspecified date in Aug2021. The patient was hospitalized for having blood clot in the brain for 1 day. Therapeutic measures were taken as a result of blood clot in the brain with Lovenox. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt recvd MMR/HIBTITTER on 4JAN92 & had fever of 101 R x 24 hrs later; died 5JAN92;
Delayed local injection site reaction. Raised rash, hot, swollen, itching.  Took Benadryl, applied cortisone cream and ice pack.
Pt called call center on 4/21/21 at 1:59pm complaining of body ache, headache, fatigue, dizziness and trouble breathing sometimes and onset of symptoms is midnight of 4/19/21. Pt stated she got her Moderna vaccine on 4/19/21. Advised pt to go to nearest ED and pt states she will go right away
pt got vax immed became lightheaded & confused p/ vax; remained @ clinic 1/2 hr; appeared to recover sent home;similar episode /w T 38.9 C;to ER,suspect of FLU developing;improving in am;MD feels pt had vasovagal episode & underlying illnes