chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION OF VACCINE FROM A PUNCTURED VIAL AFTER THREE HOURS AT ROOM TEMPERATURE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021, the patient experienced administration of vaccine from a punctured vial after three hours at room temperature. On 05-NOV-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from a punctured vial after three hours at room temperature and out of specification product use was not reported. This report was non-serious.
Full body hives 24 hours later; This is a spontaneous report from a contactable other healthcare professional (nurse). A 12-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, 24 hours later/the next day, patient experienced full body hives. Patient do not know if he should get the second dose. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Had slight headache and pain in back of neck on 26, assumed back of head was sinus, tool Sudafed, had taken acetaminophen about every 12 hours since evening of 25th,. Woke in the night of 26 which was early am of 27 with collarbone on right side hurting with a knot on it about the size of a nickel. Around 8 am on 27 th it seemed to spreading down and up into my neck, slight pain, more like an ache. Called Er in hospital told I could come to the emergency room if I thought I needed to, couldn?t give any advice on the phone but gave me this site.
Ongoing stomach cramps, gas and diarrhea that began on 3/9/21, one day after receiving the first vaccine.
This was not and event with adverse reaction.  This was an event due to the patient being under the age of 65.
Exactly one week after my arm was sore again all around the injection site. It was warm to the touch, red with very small bumps scattered, inflamed and sore only there. That lasted the whole day and about half of the next one, it was Friday Apr 2nd to the 3rd, 2021. Since them my arm is constantly sore, again around the injection site. Today, Apr 7th, 2021, the site is sore again, a clear red circle of about 2 inches around the site has appeared, and it's warm to the touch.
Left hand unable to spread fingers.  Atrophy of left hand. Numbness in both hands.  Surgery 10/18/2021.
Three to five minutes after receiving the shot, while sitting in a chair for post-vaccination observation, I got a sudden head rush and felt dizzy to the point where I could no longer sit upright and had to lay on the floor.  While positioning myself on the floor I lost hearing in my right ear for several seconds; my extremities also began feeling tingly.  The clinicians who were present brought a pad for me to lay on and a pillow.  I remained on the floor for about 15 minutes, during which time the dizziness subsided and I eventually I felt well enough to stand.  The clinicians gave me water to drink.  About 5 minutes later felt well enough to leave the clinic and go home.  For the next two days I felt intermittent tingling sensation in my extremities, and well as moderate pain in the vaccine injection site.  The abnormalities subsided by about the third day after vaccination.
Pt. stated arm was sore and itchy on Sat. Used Benadryl & ice. On Mon., Oct. 6th was seen by Nurse Practitioner at local clinic who measured site where Zostavax administered (Back of arm) 15-17 cm., area was red without blistering. No drainage noted. Keflex 500 mg ordered TID. (Shingles vaccine were public funds, Influenza was private funds)
Fast heart rates; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rates) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rates). At the time of the report, HEART RATE INCREASED (Fast heart rates) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
red papular lesions on bilateral arms and upper legs that itch badly.  Purpura rash on ankles and feet.  all non-blanching
Day 2 sore arm. by day 3 looked at side affects listed on info sheet.  I had headache, muscle and joint pain. felt like a vibration was coursing through me. unwell. decease appetite increase of tremor increase of bowel movements. today is day 8 headache gone, but at 3pm have been on the toilet 8x with very uncomfortable bowel movements. The vaccine also dried me out.  I have had to stay home, when I wanted to go out. I have experienced a significant inability to carry out daily life function. I hope this all ends soon, and does not stay on and become part of my state of health. I have a dr appt 10/18/2022. Will be informing her of my difficulty. I had no reaction to 3 prior Pfizer vaccinations against covid.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 2 (booster), single (Lot number: FH8020) at the age of 36 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 1808609) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: DULOXETINE, start date: 01Jul2019, stop date: 20May2022; BUPROPION, start date: 01Jul2019, stop date: 20May2022; AMPHETAMINE, start date: 01Jan2011, stop date: 20May2022; ACETAMINOPHEN, start date: 12May2022, stop date: 20May2022. 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: (unspecified date) Positive; (19May2022) negative; (22May2022) Positive; (23May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment medication included Paxlovid, treatment start date= 14May2022, treatment stop date= 19May2022, lot number= GA3990, indication= treatment of COVID-19. Adverse event: Relapse or rebound of Covid-19. The patient started testing negative after her 6th Paxlovid dose. Started testing positive again after my 9th Paxlovid dose. Still testing positive 24 hours after finishing 10th Paxlovid dose. No fever, other symptoms are still mild. Adverse event start date: 19May2022. Adverse event start time: 01:00pm, event recovering.
Pt sent me an email stating she had a sore upper arm, in the muscle, where she got the covid vaccine on 12-31-20 on the left deltoid.  It lasted about two days. She stated then that her lymph nodes under her arm on that side got really swollen and sore.  That started after the muscles soreness at the injection site dissipated. States it was fairly significant and that she could see swelling for a few days and feel it for several more, up to six more days.   States the lymph node swelling was probably the worst Jan 4 ? 6, and was still noticeable on Jan 9.  By Jan 10 is was basically gone.  States she has also noticed some very mild, intermittent itchiness on that shoulder near the injection site in the last few days. Pt states it used to be hard, warm and hot but has since decreased leaving her with some itchiness.
2nd dose of Pfizer vaccine was given on 16th day after first dose. Informed consent  questionnaire was reviewed by RPh.  Pt's guardian did not indicate that any prior COVID vaccine received when asked on the form. Pharmacy will implement strategies such as reviewing form verbally with parent and checking health agency website.
Developed Trigeminal Neuralgia on the right side of my face 3 days after shot that still persists today. Taste changed immediately following shot. Coffee, that I had drunk everyday prior to the vaccine tasted like dirt afterwards.  Brain fog and unable to think of words at times.
First vaccine I had injection site reaction that was very raised and was approx 3" wide and 5" long. Very rough to the touch with extreme itching.  I also had fatigue and headache the day after, This lasted approximately 2 week.  Second vaccine was on 2-5-21, I didn't have any side effects until 2-19-21. I broke out in hives from my head to my knee. The hives with thick, rough, and extremely itchy. I went to the doctor approx 7 times, but was told they couldn't do anything. I was told to take Singular and Hydroxyzine. I then seen a dermatologist and she told me that I was having a reaction to Polyethylene Glycol which is in Moderna and Pfizer. She advised me to take a different vaccine other than those two if I need a booster. She told me to take 2 Zyrtec, 2 Pepcid, and 2 Hydroxyzine a day. Finally, on March  16, the nurse gave me a steroid injection.  I began to feel better by that evening. By 3-18-21, most of the hives were gone. I went back to work on 3-18-21. On 3-23-21 I woke up covered in hives again. I even have hives in my ear and it's painful. When I break out, I have a severe headache.
No adverse effects reported; a patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.   On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026391 and expiration date 09-JUL-2020; strength, dose, frequency and route were unknown) for prophylaxis (product storage error). It was stated that the vaccine was stored with the temperature of 32.9 Fahrenheit for 3 hours and 40 minutes. There was a digital data logger involved, there was no previous temperature excursion. No adverse effect was reported.
Reaction started approximately at 10:30 AM, broke out with welts all over per patient. Reported being itchy but the welts had subsided quickly (before any medication was administered). No other new foods, detergents, soaps. No previous welts on her skin.
Patient experienced Muscle aches, Elbows ached and were swollen along with his knee's and thigh's.  Patient states his neck hurt so bad he could not turn his head from side to side.  Also states that his left eye would twitch.  Patient saw Primary Care doctor and was given Advil, Tramadol and steroid taper dose pack.
Did not yet received her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose) had resolved.            No concomitant drug information was provided by reporter.  No treatment drug information was provided by reporter
Information regarding PREVNAR was received from a healthcare professional regarding a 13 month old female patient who experienced vomiting, pneumococcal meningitis and fever. The patient received three doses in six months on unspecified dates. The patient experienced vomiting, pneumococcal meningitis and fever in Mar 2010 and was hospitalized for five days. The patient recovered. No additional information was available at the time of this report.
s/s:warmth and swelling at injection site, the left deltoid; pain in left arm and left shoulder.  treatment: prednisone taper, and ibuprofen, percocet, and exercises.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up was received included non significant information of secondary reporter was added.
This spontaneous report was received from a female patient of unknown age referring to herself. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date in the mid of August 2015, the patient was vaccinated with the first dose GARDASIL (formulation, strength, dose, frequency, route and lot number were not reported). Other suspect therapies included the second dose of GARDASIL 9 injection (strength, dose, frequency, route and lot number were not reported) (interchange of vaccine products) on an unknown date in October 2015 (reported as a couple of weeks ago). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of the event "patient received first dose of GARDASIL and second dose of GARDASIL 9" was unknown. The reporter did not provide the causal relationship between the event "patient received first dose of GARDASIL and second dose of GARDASIL 9" and suspect therapies. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt stated that the (L) arm where shot was  given was swollen from her shoulder to elbow and red and warm to touch - she stated she applied ice for 3 1/2 day and went to the drs on 9/13/10 at 3:30 pm. On 9/14/10 called pt and asked what dr did - pt was given a Cortisone shot and placed on BENADRYL. Arm feels better after shot will be on PO meds for 4 days.
I have severe itching, which started in my hands and feet, and now happens everywhere. After mild scratching I developed welts and they are hot to the touch.
Patient Developed Bullous Pemphigoid, 2 weeks after Vaccination; was given 5 day course of steroid Seen by Dermatologist Had Swelling at site same day, with Shoulder Edema applied Ice to site. Swelling went down to back of arm. Developed mild Rash that Progressed
pt recv vax 28JUN95 & 21MAR97 pt devel chickenpox;
Pentacel administered in Right deltoid. Three inch induration around injection site that is tender and warm to the touch.
This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Nov2021 at 20:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA; Lot Number: UNKNOWN) via an unspecified route of administration on 18Jan2021 (at the age of 27-years-old) and the second dose of COVID -19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA; Lot Number: UNKNOWN) via an unspecified route of administration on 17Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 24Nov2021 at 20:00, the patient experienced lymph node swelling in left under arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node swelling in left under arm was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Anal leakage - started on 4/17, still have as of 5/10 Lack of smell - started around 4/20, still have as of 5/10 Nausea when standing up- started around 4/17, ended around 5/5 Random feeling to puke (2-3 times daily)- started 4/20, still have as of 5/10
14 hours after vaccination, I woke feeling shaky and violent vomiting and diarrhea and muscle pain throughout body.  Thought was vaccine related and hoped within 3 days I would feel better. 4th day, Monday fell unconscious, hitting back of head somehow though I woke up facedown vomiting. Went to ER, they sent me home. Tuesday 5th day, went to my doc.  They tested me for tick-borne illness.  I am a trail runner and run in woods for training.  Had run 8 miles in woods just  a day or two before vaccine/illness. Could not get off couch Wed/Thursday, could not eat.  Did my best to stay hydrated and sleep. Friday, back to ER.  This time was admitted. They came up with aseptic meningitis though seemed confused and I tested negative to all normal things that lead to aseptic or viral meningitis. It now seems this vaccine may have caused a heart attack.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # M020071 with expiration date 18-JUL-2017 (dose, frequency and route of administration were unspecified) for prophylaxis. No adverse effects were reported. It was stated that the vaccines were exposure to a temperature greater than 14 but lower than 46 Fahrenheit degrees for a time frame of 2 hours and 30 minutes. It was also reported that there was a previous exposure to the same temperature for a time frame of 12 hours. The report was due to a data logger. This is one of two reports from the same reporter 1702USA010221. Additional information is not expected since the reported refused to be contacted.; Sender's Comments: US-009507513-1702USA010221:
MASSIVE STROKE(PARALYZED ON THE LEFT SIDE); This spontaneous report received from a consumer concerned a 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient had a massive stroke and got paralyzed on the left side (arm and leg). The patient was admitted to the hospital on the morning of 10-APR-2021 and was still in the hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive stroke(paralyzed on the left side). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422228-Covid-19 vaccine ad26.cov2.s -Massive Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Febrile with temperature of 101.1F, localized erythema, edema at injection site, pain and decreased ROM on left arm.
Tremor right hand and left hand.  11/09/2007 Lengthy MR received beginning with a psychiatric admission 1/10-21/2003 with DX:  Depressive Disorder NOS with suicidal ideation and gesture.  Panic Disorder with Agorophobia. Tremor-like involuntary movement of RUE noted on PE. Readmitted o/n 1/22-23/2007 for anxiety. Many PMD OVs, Consults, and Psych OVs for above symptoms as well as for R hand tremors.  No definitive DX for hand tremors. Most recent hospitalization 2/14-20/2007 for suicidal ideation, reporting feeling frustrated about lack of DX of hand tremors. D/C DX:  Mood disorder due to tremors, depressed.  Right hand tremor, R/O Extrapyramidal Disorder.  Problem list as of 10/2007:  Tremor NEC.  Depressive D/O NEC. Agorophobia with panic attacks.  Hyperthyroidism.  Thyroid nodule.  Essential HTN.  Pure hypercholesteremia. Duodenitis, non-specific.  Mood disorder due to a general medical condition.  Otitis. Dysphagia.