chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment/COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19 Treatment/COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LOSARTANUM KALIUM, MELATONIN and FISH OIL for an unknown indication.   On 20-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19 Treatment/COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 24-May-2022, COVID-19 (COVID 19 Treatment/COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.         Device Date was reported as 05-Jun-2022.  Patient had the disgusting taste in my mouth for the entire five days.  Company comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 19-May to 24-May. Patient tested negative for COVID 19 on 23-May and then tested positive on 03-Jun with mild symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 19-May to 24-May. Patient tested negative for COVID 19 on 23-May and then tested positive on 03-Jun with mild symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Temperature to 104 degrees (ax) at home <24 hrs after vaccine. vomiting lacy reticular rash on extremities.
Pt developed fever within 3-4 hours after immunizations were given. Later in the evening child became unresponsive and presented to ER in status epilepticus.  Child was given Lorazepam, Valium, Phenobarbital, Rocephin and Vancomycin. Intubated and placed on ventilator. Was given oxygen. Child transferred to another hospital. Hospitalized x 1 day.
Patient was 3 years old at the time of the vaccine and the Pfizer vaccine was not approved for this age
Not a terrible adverse reaction (for me) but just reporting in case the info is of use.   Swelling of hands and redness in hands and very itchy skin all over - this started about 4.5 hours after receiving the vaccination.  I immediately took 50mg Benadryl and 2x my normal cromolyn dose as soon as swelling started in my hands and itchiness was noticeable. Within 30 min the swelling came down. I did NOT feel my throat swelling or closing. My breathing was slightly more labored, so I also took a dose of prescribed inhaler about 5 hours after vaccination. Next few nights after vaccination I had a lot of itchy skin and burning skin sensations, all managed with extra doses of Benadryl.  I plan to get the second dose, but just wanted to report as I have no idea what types of adverse reactions y'all are looking for. I have no idea if my reaction would or would not have escalated further to needing an epic-pen use/urgent care trip had I not taken Benadryl and cromolyn promptly.   *(I had pre medicated with some Benadryl before vaccine at 9am if that is useful info)  Thanks for your time and for all y'all are doing to keep us all safe.
pt recv vax 22MAY97 & 36hr post vax pt suffered itchy hives which subsequently resolved;
Chest pain DOE (dyspnea on exertion) Pneumonia of both lungs due to infectious organism, unspecified part of lung Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present  Death
VACCINE ADMINISTERED AFTER 48 HOURS FROM PUNCTURED VIAL; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 17-AUG-2021, the patient experienced vaccine administered after 48 hours from punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 48 hours from punctured vial and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210837503.
A nurse reported that a 2 year old female received a dose of Prevnar on 11/12/02. On 11/13/02, the child's mother called to report that there was a "red, hard and sore area" around her child's injection site. On 11/14/02, the mother reported that the area was slightly larger "4 inches in diameter," and the child was "fussy." *The child recovered.* This is one of two children from this facility who experienced a similar reaction following receipt of Prevnar lot 485-989 on the same day.
Left arm injection site became red, warm, itchy and firm to the touch. Redness and itchyness persisted for 8 days then resolved.
Client received his Pfizer COVID booster vaccine on his break lot # FF8841 exp. 12/31/21 at 1:40 PM. At 2:08 PM, client reported he felt dizzy to EMT. Client reported this also happened after he received his second Pfizer COVID vaccine. Client reported he ate breakfast this morning. Client was sitting and eating a snack in the observation room after receiving the booster. Client had an energy bar and an orange for lunch today. Client reported to EMT that " I still feel dizzy.? Client was moved from regular chair to anti-gravity chair in a high fowler position for observation by EMT and PHN. At 2:08 PM, EMT took client?s vital signs: B/P 164/102, P 90, 02 Sat. 98%. Client c/o feeling "hot". Client denies any c/o chest pain, high blood pressure, diabetes, or any other underlying medical conditions. At 2:14 PM, EMT took client?s vitals: B/P 168/100, P 90, 02 Sat. 98%. Client continues to feel lightheaded. EMT provided client some graham crackers and water which client consumed them without any issues. Client is not currently taking any medications. Client continued to be monitored per protocol. At 2:30 PM, EMT took client?s vital signs: B/P 162/104, P 95, 02 Sat. 94%. Client states "I'm feeling better, and my dizziness is improved.? At 2:40 PM, EMT took client?s vital signs: B/P 150/96, P 89, 02 Sat. 94%. Client states "I'm feeling more relaxed.? At 2:50 PM, EMT took client?s vital signs: B/P 156/110, P 83, 02 Sat. 95%. Client states "I'm feeling better" with no additional symptoms, complaints or new symptoms and denies any c/o pain, chest pain or SOB. At 3:00 PM, EMT took client?s vital signs: B/P 160/110, P 85, O2 Sat. 96%. Client states, "I feel good now" and denies any new symptoms. At 3:08 PM, client was monitored for a total of one hour. PHN educated client to f/u with his medical doctor for his elevated blood pressure and if he experiences any adverse reactions to call 911 after he leaves. Client stands up independently and ambulates without difficulty and he states, "dizziness has gone away.? Client left observation area with a steady gait without any s/s of distress noted and returned to work.
Allergies - seasonal sneezing, itchy watery eyes has Continued All year; affects bronchial problems, seem to be much more susceptible to upper lung congestions /concerns big uptick in PSA test results relating to Prostrate cancer;  strange blood clotting with hair follicles;
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 4 years old male patient who was vaccinated with an expired vaccine, PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included Prevenar 13 in left thigh. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C4976AA (expiry date: 4Jun2018) in the right thigh. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Noticed pimple rash on L arm at injection site. Small cluster few red pimple areas on face and stomach and back couple on legs.
Nausea, fever, bodyaches, chills, ringing ears, lightheadedness, dizziness, fatigue
Pt developed fever, chills, achey, n,v, malaise, diarrhea, t99.8-100.4; rt knee joint severe pain; Has reddened spots on joints of wrists & fingers; BP dropped to 80/60;
Client presented for flu vaccination at her worksite on 9/19/2019. On 10/7/2019 email received from HR at client's company asking for someone to call client regarding symptoms she was still having from her flu shot. TC to client and she stated that she had "normal" pain at the injection site for two days but then the pain spread into her shoulder, armpit and back side of her shoulder. Her shoulder has become increasingly difficult to move. She had not sought medical attention but agreed after talking with us.
Within 24 hours post vax, the pt developed an injection site reaction characterized by an area of redness and swelling the size of a baseball.
Arm where she received Tdap is red, swollen and warm to touch on Wed 6-17-09.
About 12 hours later skin turned bright red (like severe sunburn) all over chest, stomach, back, inside arms, up neck, sides of face (not legs). Hot to the touch, no glands swelling - peaked at 2 days post vaccine then started subsiding on day 3.
area w/generalized swelling w/some tenderness;not red, not hot;it taking Ibuprofen;declines medical eval;hx of some erythema p/PPD;
Report reaction; Arm turn yellow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report reaction) and VACCINATION SITE DISCOLOURATION (Arm turn yellow) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Arm turn yellow). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Report reaction) and VACCINATION SITE DISCOLOURATION (Arm turn yellow) outcome was unknown.            No concomitant medication was provided.   This case was linked to MOD-2021-368986 (Parent-Child Link).   See case MOD-2021-368986 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2021: Follow up document received on 31 OCT 2021 contains report contact information added, Patient demographic details added, additional events added.
Heavy menstrual periods. The durant is still 5 days but I could no longer use sanitary pads or tampons. I had to switch to a menstrual cup.
Initial and follow-up Information has been received through the Merck pregnancy registry from a physician concerning a 17 year old female with no pertinent medical history, no known allergies or adverse drug reactions and one prior pregnancy and child with no complication or problems.  On 14-FEB-2007, the patient was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot# 655619/1427F).  There were no concomitant medications reported.  The physician reported that after the administration, the patient reported that she was pregnant.  It was reported that the patient had a prenatal mid trimester sonogram performed and "slanted eyes" were noted.  At that time it was suggested to the patient that the baby might have Down's syndrome.  On 24-JUL-2007 the patient had a full term vaginal delivery.  Her baby was diagnosed with Down's syndrome confirmed by chromosome analysis.  The baby had been evaluated by a cardiologist for a patent ductus arteriosis  which has closed and a "tiny" patent foramen ovale.  The baby had an unspecified thyroid problem for which an endocrine follow-up was scheduled.  At the time of the report, the outcome of the atrial septal defect, thyroid disorder and trisomy 21 were unknown.  Additional information has been requested.
On 8th day after Moderna Covid 19 injection, there was a very raised, red area on left arm - felt very warm.  By the next day  the area had increased in size and some of the swelling had subsided.  Today, the third day after the reaction appeared, the redness has spread to  a large part of the outside of my upper arm - still feels warm -slight pain.  Previous to this side effect, I felt a loss of strength in my left arm during a workout. ( My concern is that this occurred so late after the injection and what it means going forward with second injection.) I have called my doctor but have not talked to him.
Patient presented to ED on 9/13/21 with progressive cough, SOB and fatigue with a positive covid 19 test as well as yellow tinged sputum concerning for a superimposed bacterial infection. Patient additionally had uptrending troponins prompting question of decreased cardiac function and cardiogenic shock in setting of CAD and increased metabolic demand. Patient's respiratory status and overall condition progressively worsened and the family made the decision to transition to CMO only. Patient passed away on 9/26/21.
Initial within the first few hours, had a sore right arm and then began to chills.  Lager on that evening had a fever.  Fever and chills persisted through the night.  Took Advil multiple times to combat the symptoms.  In the morning, by around 8 am felt my upper lip becoming a bit numb and growing in size.  Began taking benadryl. within the hour.  and took every 4 hours the rest of Sunday.  My lip size did grow a bit larger ad was somewhat numb, like the dentist after an anesthetic,  By the afternoon, my lip size began to recede and continued until was about normal by 9 pm. Fever and chills were gone by that time. And all normal on Monday 10/02/23.
Patient received I.M.( covid vaccine)  in left deltoid he became pale and diaphoretic felt weak. NP immediately assessed him as he lost consciousness for maybe 10-15 seconds was easily aroused with sternal rub and alcohol inhalant . BP 116/62, O2 sat 100%, HR was 50. Given 3 cups of water candy and ice pack , color returned completely oriented and sat for observation for 30 min. He has had this occur with tattoos, phlebotomy and other shots. He admits to having syncopal episodes in the past, told to f/u with PCP but left clinic completely stable.
p/vax pt had diffuse hives;seen in ER & concern of anaphylaxis; given SC epi twice & adm to hosp overnoc for observation 9/23/99;
Pt did not devel "protective titers" p/3 injects of Engerix-B; "plan to revax pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if person contracts Hepatitis";
Patient passed  out and started seizing for <1 minute.  I held on to her to prevent her from falling down.  Once she was conscious, I went to grab her mom (and an RN passerby available).    Mom got her water and we provided her a cold compress.  She was very sweaty and a little bit of low heart rate (per RN).   She refused an ambulance.  She sat down for at least 30 minutes after using the bathroom (with mom helping).   Patient says she she has a history of passing out when she got tattoed or got her dermal filler.
115PM 29SPE93 pt cried all night off & on in sleep, flailed around in sleep is hot to touch-dont have thermometer; doesn't want to walk or eat; lt thigh sore, kinda puffy but not red, feels warm; peeing more than usual;
Experienced a prickly sensation in many areas, as a severe rash developed on hands and feet. Was extremely itchy and red. Treated at home with ice, hydrocortisone. Had a virtual doctor visit and they prescribed betamethasone, which maybe helped some, but it seemed as if the rash resolved on its own over time. It took about 3-4 weeks to do so.
Heart palpitations and Atrial fibrillation..pain swelling, fatigue, and sleeplessness
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old male patient who received Shingrix (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 26th May 2018, the patient received the 1st dose of Shingrix (intramuscular) 1 dosage form(s). On 31st May 2018, 5 days after receiving Shingrix, the patient experienced rash (serious criteria other: as per reporter). The patient was treated with Antihistamines and Steroids. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be possibly related to Shingrix. Additional details were updated as follows: At 13:25, the patient received Shingrix. The patient had a rash all over his body except for his face. He visited the physician on 6th April 2018 and was prescribed an antihistamine and a steroid. Unrelated QA report was completed.
Approximately 17 hours after receiving the vaccine 05/08/2018 at 11:30 am, developed flu-like symptoms: Chills, over-all body aches, fever (101.1), lethargy. Began taking TYLENOL 500 mg every 4-6 hours until symptoms resolved the next morning, approx. 6:00 am. On 05/09/2018, at 6:00 am, approximately 36 hours after the injection, a localized reaction at the injection site was noted(redness and itching that began as approximately 1 inch in diameter and spread to about 3-4 inches in diameter). Began BENADRYL 25 - 50 mg every 6 hours until redness and itching resolved on 05/12/2018.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had none pertinent medical history and none drug reactions and allergies. On 16-MAR-2015, the patient was vaccinated with ZOSTAVAX, lot # reported as K016318, expiration date: 24-DEC-2015, 0.65 ml, subcutaneous. No information regarding concomitant medications was reported. The pharmacist reported that, in March 2015, a couple of days after receiving ZOSTAVAX, the patient developed a lump the size of a baseball under the injection site that was red, inflamed and itched. The patient sought medical attention by visiting an unspecified physician, who prescribed her BENADRYL for treatment. The outcome of the events was reported as recovered/resolved on an unspecified date in March 2015. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath, febrile, chills, hives & swelling over 100% of body
No adverse reaction. Vaccine was expired by 5 days at the time of vaccination. Our office has contacted the manufacture GSK in regards to possible adverse reactions and need for re-vaccination. Documentation provided from GSK states the vaccine is stable and potent for up to 30 days after expiration date on box, although not recommended to give an expired vaccine, the patient would not need to be re-vaccinated and can continue on the recommended vaccine schedule for Menveo. Patient is not having any adverse reactions.
99 degree fever and body aches; 99 degree fever and body aches; This spontaneous report as received from a veterinary professional via a company representative refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-OCT-2021, reported as on Monday, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.         On 25-OCT-2021, reported as for the past 3 days, the patient experienced 99 degree fever and body aches. It was unknown if the patient received tretament.  The outcome of the events was not reported. Causality assessment was not provided.
On 11/10/99, the pt developed varicella and sought unspecified medical attention. No further information is available.
really big sharp headache; lots of vowel movements (Diarrhea); Chills; dizziness; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (right arm, second dose) from 12Jan2021 17:00 to 12Jan2021 17:00 at a single dose for COVID-19 vaccination. Medical history included UTI. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 (first dose). It was reported by the patient that she was awaken in the middle of the night because of a really big sharp headache also with lots of bowel movements (Diarrhea). The patient also had Chills and dizziness; all on 13Jan2021. There was no treatment for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
Within 5 min of vaccine (GARDASIL) pt passed out onto the floor. Bruise to bridge of nose lower lip cut, scant bleeding, mild swelling.