chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PASSED OUT; TERRIBLE FEVER; SMALL ANEURYSM IN BRAIN; 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 past medical history included hormone therapy, and IVF (In-Vitro Fertilization). 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included hormone therapy. On 03-APR-2021, the patient experienced terrible fever and headache after vaccination at night. On 04-APR-2021, the patient passed out which had never happened to her before. She was taken to the emergency room and was diagnosed with a small aneurysm in her brain. The patient was very fearful, this was new and would be getting larger/rupture sooner. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible fever, passed out and small aneurysm in brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210412164-covid-19 vaccine ad26.cov2.s -Small aneurysm in brain, Passed out. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
This spontaneous report as received from a pharmacist refers to a 54 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Rash/hives began per mom's report 5 days following vaccination. 6 days after vaccination his entire thigh was red, swollen and hot to touch (baseball sized) with raised welts inside that were itchy. Mom gave Benedryl and ice applied locally.
Irritation on opposite arm than injection. Increased in discomfort and pain over next 4 days. Patient when to ER on Sunday 12/19/10 and was told she had Active Shingles outbreak. Given Acyclovir to treat.
004M20A] intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The vial was used on 13 Feb 2021, then, the next day, the pharmacist noticed that the vail has greenish hue at the top and bottom.  He was not sure if it is just the glass of the vial because the product looked normal it's off white suspension and clear and the glass looked thicker. No adverse event was reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, product quality issue, was considered resolved on 13 Feb 2021.; Reporter's Comments: This report refers to a Product quality issue for mRNA-1273, lot # 004M20A with no associated AEs.
Pt given pneumovax on 7/13/06 for routine preventive care. She returned next day for upper arm swelling, pain, redness, seen by me, diagnosed cellulitis, resolved promptly with Keflex.
This 81 year old  received the Covid shot on  2/2/21    and went to the ED on  3/2/21    with the following diagnoses listed below. U07.1 - COVID-19 DIARRHEA FEVER
This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (10 of 10) concerns a 77-year-old male patient, who had a medical history of lung cancer, atrial fibrillation, recurrent deep venous thrombosis, hypertension and hyperlipidemia. The patient died of suspected myocardial infarction, two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine: manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
One day post vax, pt refused to walk on his right leg, complaining that it hurt. Pt is a twin. His sibling also received Prevnar and refused to walk on her leg that day.
Started 1-2 weeks after 1st shot vascular rash on arms and legs; Red splotches; Some tingling; Vaccine location: Left leg; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left leg on 25Mar2021 at 00:00 (at the age of 56-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 56-years-old), as a single dose for COVID-19 immunization. Medical history included rosacea, cured stage 1 melanoma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included nabumetone (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D), from an unknown date for unknown indication and unknown if ongoing. The patient previously took pseudoephedrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021 at 16:00, 1-2 weeks after 1st shot, the patient had vascular rash on arms and legs and some red splotches, some tingling, no hives, no itching and was still present on day 29 for 2nd vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events vascular rash on arms and legs and some red splotches, some tingling were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
13APR95 8AM awoke w/localized erythema & edema @ lt deltoid inj site; mom gave APAP & used ice packs alternating w/heat throughout day; 14APR95 awoke w/edema, erythema worsening; consulted MD on 13APR & again 14APR;  edema, cellulitis
After 3-4 days after the vaccine in my left arm I had a lot of shoulder pain. It got worse and worse to where I could not even use my arm, I could not sleep at night it was so painful. It was not at the injection site, it was actually at my shoulder. It hurt to touch it and it hurt to move it. I waited it out to see if it would get better. I could not use my arm to even hold my coffee cup or anything. I kept thinking it was going to get better and it would get better but it didn't. I went to my PCD on 4/8/2021  and saw a PA, not the DR. She prescribed anti-inflammatory and gave me a prescription for physical therapy. She said it was probably my rotator cuff, which I never had any trouble with at all before. The anti-inflammatory worked while I was taking it, it took the edge off but after I stopped taking it, the pain returned. I called the DR back in May and asked to see the DR but I cannot get an appointment until July 19, 2021. I am also doing physical therapy right now for my right shoulder.
Chills, fevers, stomach upset, weakness for last 3 days. Still not well.
Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that one-half hour after the shot was given, a pain went up her neck and then the left side of her face swelled up. The swelling and pain was gone by the following day.
8 month old was given Kinrix instead of the separate Dtap and IPV vaccines; 8 month old was given Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 19-OCT-2023, the patient received Kinrix. On 19-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 8 month old was given Kinrix instead of the separate Dtap and IPV vaccines) and inappropriate age at vaccine administration (Verbatim: 8 month old was given Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Oct-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received a dose of Kinrix instead of the separate Dtap and IPV vaccines at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L050909, expiration date: 14-JUN-2017 (dose and route of administration were not reported). No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of 6.1 degrees Fahrenheit 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Medic did not dilute the vial of Pfizer and patient received a full vial of Pfizer vaccine undiluted
1/28 (1 day post vaccine) Weakness, lethargy, lightheaded, severe headache, chills, body aches (treated with rest, sleep, and ibuprofen). Started approximately 12 hours post vaccine and lasted until 24 hours post vaccine. Headache remained but tapered off at 36 hours post vaccine. 1/29 (2 days post vaccine) red rash developed at injection site. Mildly itchy, very red, tender, slight lump under skin. Approximately 2 inches in diameter at 0800, spread to approximately  5 inches in diameter by 2100.
Approximately 5 minutes after vaccine , patient "felt faint" and "could not walk" >fainted Blood Pressure - 74/44 pulse 47! Within 5 minutes patient BP increased to 102/68 pulse 74. Still pale. Complete recovery 15 minutes 115/72 pulse 85.
Pt recv vax on 10/29/98; on 10/30/98 pt exp red/rash/sore of LA x 1 wk
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Positive, notes: On the sixth day after treatment, I tested positive for covid again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: During the treatment, covid symptoms resolved. Four days after finishing the treatment, symptoms began returning. On the sixth day after treatment, patient tested positive for covid again. During this entire time, she did not leave the house so could not have been re-exposed. Paxlovid taken as a treatment of Covid-19, started on 29Nov2022 till 04Dec2022. Adverse events noted from 08Dec2022, 08:00 PM. Prednisone taken from 05Nov2022 till 30Nov2022. Methotrexate taken on 05Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe swelling, redness, tenderness at site and extending over entire upper arm. Very hot and hard. Ibuprofen administered 11/9/2012 8:00 PM.
This spontaneous report as received from a physician refers to a patient of unknown age. On 15-JUL-2011 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscular. The physician reported that the patient was administered the second dose of GARDASIL (0.5 ml, intramuscular) on 25-JUN-2013 and the third dose (0.5 ml, intramuscular) was administered on 21-AUG-2013. No adverse effects reported. Additional information has been requested.
He had originally received a J&J vaccine at another pharmacy.  We submitted a VAERS report when he got the first Pfizer dose.  The patient was called and informed of the two vaccines and he said he had no side effects at all and felt fine.   He then proceeded to get the second shot for some reason.  He has no side effects from this dose either.
4:18 Child became pale & lost consciousness. While transferring to bed extremities began to stiffen while back & neck arching. Upper extremities with posturing, pupils dialated & color pale & ashy. Seizure-like episode lasted approx 20 sec. Placed on R side. 4:20 O2 via mask @4L. Color improvement immediate. Dr in for evaluation.  4:22 RR 26, HR 68, BP 110/60, O2 Sat 98%, Conscious 4:30 RR 30, HR 70, BP 110/68, O2 Sat 98%  Conscious & tearful 4:50 RR 32, HR 100, BP 112/68, O2 Sat 98% Conscious & Calm 4:55 C/O Feeling Sleepy 4:57 911 contacted  4:59 Up to B/R to void with nurse & Grand mother's help 5:10 EMS Arrived & report given
Severe headache, fever as high as 104,  no appetite--just drank water and ginger ale all day that Sunday.
Confluent maculopapular erythematous exanthem over entire face/neck/trunk/diaper area/extremities. w/o fever, fussiness, or abnl of exam
Rigors; Fever; Myalgia; Headache; Fatigue; This non-serious case was reported by a physician and described the occurrence of rigors in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised and adrenal cortex insufficiency.   On 25-MAY-2023, the patient received Shingrix. On 26-MAY-2023, 1 days after receiving Shingrix, the patient experienced rigors (Verbatim: Rigors), fever (Verbatim: Fever), myalgia (Verbatim: Myalgia), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). The patient was treated with prednisone. On 27-MAY-2023, the outcome of the rigors, fever, myalgia, headache and fatigue were resolved (duration 1 day).   The reporter considered the rigors, fever, myalgia, headache and fatigue to be related to Shingrix.     The company considered the rigors, fever, myalgia, headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The reporter stated this was a subsequent dose. The reporter did consent to follow up.
The patient was given the second dose of the Pfizer vaccine; the vaccine's beyond use date was 10/5/22, and the vaccine was given 10/11/22. The vaccine's expiration date was 11/30/22. As of now, the patient has not reported any adverse effects.
This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L002422, expiry date: 23-APR-2016, route of administration was not reported). Concomitant therapy was not reported. No adverse effect was reported. It was also reported that, expired dose of ZOSTAVAX was supported as per the post expiry memo. Additional information has been requested.
Initial report was received from a patient on 26 September 2011. A 23-year-old female patient had received an Intramuscular (IM) injection of ADACEL (lot number not reported) in right arm on 19 September 2011. On an unspecified date, the patient right arm was aching and felt heavy when trying to lift it. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
1) 2-3 weeks after my second Pfizer shot I had irregular menstrual bleeding.  It was light but almost constant for a month. Got my period, and then started spotting again. Most recently 1-2 weeks ago I had heavy and dark bleeding that lasted around 5 days. I?m not currently bleeding; 2) Not sure if this is related, but I?m thinking it is because I?ve had no lifestyle changes since I got the vaccine. I have an alcohol problem  that I?ve had for 5 years. I have times where I will be drinking daily for weeks at a time (approximately 4-5 drinks a night). I have NEVER experienced this in my 5 years of drinking, and it?s happened twice after the vaccine. Once in August and again last night/this morning.  Both days I was drinking. Late at night I started shaking uncontrollably.  I couldn?t walk without falling, and it was even hard to get up. This morning I was still shaking as bad (maybe worse) than last night. This happened both times.  The first time I had severe  hand tremors along with the balance issue.  This time I did not have hand tremors, but my whole body was still shaking every time I got up. Please look into this, I?m starting to worry.
Information has been received from a consumer concerning her 11-year-old nephew who was previously vaccinated with a dose of Varivax (Oka/Merck) on 22-APR-1996. subsequently, it was reported that the patient experienced varicella. It was unspecified if medical attention was sought. No further information was available at the time of the report. Follow-up information received from a healthcare facility stated that no reaction was documented following vaccination. Additional information is not expected.
C/o pain that wakes patient up at night taking 800 mgs motrin - using heat but not helping
4-18-15 10 am pain at site, pain under arm (worsening as day progressed). 4-19-15 2 am woke up with chills, trembling, headache and nausea. Temp 99.9. 4-19-15 2pm Temp 102.2 arm extremely painful at site. Not able to left arm at all.
The same night of vaccination I had chills and Slight fever, My platelet went down to a 13, My doctor advise for me to take Steroid in order to get my immune system back up,  I am taking 40MG of prednisone  once a day.
HEART FELT REALLY STRANGE; This spontaneous report received from a patient via a company representative concerned a 28 year old of unspecified 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced heart felt really strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart felt really strange. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
weakness; fatigued; body pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), FATIGUE (fatigued) and MYALGIA (body pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CICLOSPORIN (RESTASIS) for Eye dryness, PANTOPRAZOLE for GERD, MAGNESIUM OXIDE, ORYZANOL, PYRIDOXINE HYDROCHLORIDE, THIAMINE MONONITRATE, TOCOPHERYL ACETATE (MAGWELL) for Magnesium supplementation, ZOLPIDEM for Sleep disorder NOS, AMYLASE, ASCORBIC ACID, CELLULASE, FOLIC ACID, LIPASE, PROTEASE NOS (JUICE PLUS) for Supplementation therapy.    On 02-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 3:00 PM, the patient experienced FATIGUE (fatigued) and MYALGIA (body pain). On 03-Mar-2021, the patient experienced ASTHENIA (weakness). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Fatigue, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), FATIGUE (fatigued) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt received 1st dose Shingrix on 10/30/19.  Pt reports soreness/inj site rxn x 3 days, then pain began to spread from inj site, down the arm and to his back around day 6 (~11/4/19). Currently, still has rash and blisters present as of 11/18/19.
Friday 7-24-2020, 0800 in AM, client would not bend leg and c/o pain with touch. no redness, no lumps, no swelling, no radiant heat emanating from leg, no fever and is playing with other children.
SOB, digestive issues stomach ache, nausea, no fever, 01/21/21 still with SOB and digestive issues
This spontaneous report has been received from a registered nurse and referred to six patients of unknown ages and genders. The patient's relevant medical history, concurrent conditions, and concomitant therapies were unknown. It was reported by the nurse that on unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route, and route of administration were not reported; lot # M044347 with an expiration date 04-NOV-2018) for prophylaxis. The data logger reported that the vaccines were exposed to a temperature excursion of -6°C for a total time frame of 1 hour and 19 minutes. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.