chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Armpit was warm to the touch; Armpit and top of arm hurts and bruised; Bruising underneath left arm and outside of the breast; Hurts to lift left arm; Slept all day; Did not feel well; Whole left arm, underneath the arm and pain in arm and soreness; Severe, severe, chills; Breast hurt to touch; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 045J21A, 044B21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Anxiety. Concomitant products included FLUOXETINE for Anxiety, LOSARTAN for Hypertension, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Routine health maintenance.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 16-Jul-2022, the patient experienced BREAST PAIN (Breast hurt to touch) and PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness). 16-Jul-2022, the patient experienced CHILLS (Severe, severe, chills). On 17-Jul-2022, the patient experienced MALAISE (Did not feel well) and SOMNOLENCE (Slept all day). On 18-Jul-2022, the patient experienced CONTUSION (Bruising underneath left arm and outside of the breast) and MOBILITY DECREASED (Hurts to lift left arm). On 19-Jul-2022, the patient experienced FEELING HOT (Armpit was warm to the touch) and AXILLARY PAIN (Armpit and top of arm hurts and bruised). On 17-Jul-2022, SOMNOLENCE (Slept all day) had resolved. At the time of the report, FEELING HOT (Armpit was warm to the touch), BREAST PAIN (Breast hurt to touch), MALAISE (Did not feel well), CONTUSION (Bruising underneath left arm and outside of the breast), MOBILITY DECREASED (Hurts to lift left arm), AXILLARY PAIN (Armpit and top of arm hurts and bruised), PAIN IN EXTREMITY (Whole left arm, underneath the arm and pain in arm and soreness) and CHILLS (Severe, severe, chills) had not resolved.            Patient had no known allergy. It was reported that patient has never been diagnosed or tested positive for COVID-19.   Patient was taking women's vitamin as concomitant product.  Patient received the second Moderna booster dose on16-Jul-2022.  Reaction did not cause patient to take medical care. Symptoms had not improved or worsened.
not eating well for a couple of days; loss of weight,; muscular weakness; felt tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not eating well for a couple of days), WEIGHT DECREASED (loss of weight,), MUSCULAR WEAKNESS (muscular weakness), FATIGUE (felt tired) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DECREASED APPETITE (not eating well for a couple of days), WEIGHT DECREASED (loss of weight,), MUSCULAR WEAKNESS (muscular weakness), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, DECREASED APPETITE (not eating well for a couple of days), WEIGHT DECREASED (loss of weight,), MUSCULAR WEAKNESS (muscular weakness), FATIGUE (felt tired) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment included plus protein.
Patient requested 2nd booster- only wanted Janssen - said Dr recommended and they were unwilling to get moderna/pfizer. Patient was administered 2nd booster (3 total Janssen doses). It had been 6 months since 1st Janssen booster. Patient was notified that it is not recommended to give 2nd booster Janssen and is only recommended pfizer/moderna.  The patient stated that their physician recommended the 2nd booster Janssen and they are having no adverse side effects.
1/10/03 elevated temp 102.4 and headache, left deltoid swollen and purple. 1/11/03 still elevated temp 103.5 came down with Tylenol and Motrin. 1/12/03 temp normal and arm normal by pm.
After being vaccinated I started having an asthma exacerbation within a couple days of vaccination. My peak flow meter readings dropped almost 100 points. I started taking flovent 2x a day instead of one time daily and started using my nebulizer 3-4  times per day. I was waking nightly having to use my inhaler. I figured the asthma would settle down but it didn't.  It continued to gradually get worse. I finally went to urgent care on January 4th. I've never had an asthma exacerbation last more than a day or two so this was getting scary after a month. At the clinic a lung x-ray was done and returned negative for disease. I was prescribed prednisone for 5 days and told to use my nebulizer every 4 hours.
Patient reports onset of injection site redness, swelling, itchiness and soreness onsetting approximately 24 hours after immunization received. Patient reports area of redness/swelling size of half dollar. Advised patient to call physician and gooly ice for discomfort.
heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided          No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M002268 with expiration date: 20-SEP-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-APR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
hives for 1 day p/flu shot, disappear p/DPH; pt vomited once or twice a day for 6 days;
Major joint pain.  No fever, but full body aches for 1 day.  Afterwards, most of pain  went away except lower back which has always been a problem.
1/23/21 day after vaccination pt noticed a rash starting around the injection site, next day rash had gotten larger, it went 2/3 around injection site, pt used triple antibiotic ointment, rash is mostly gone 2/3 pt stated she can still see redness, 2/2/21 pt noticed rash on arm, 2/3/21 rash is not size of dimes and a streak going downward toward hand, bumpy/red.
shingles; other zoster related injuries; Information has been received from a lawyer referring to a currently 83 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On un known date(reported as on or about 40118), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a healthcare facility and other healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries(Ill-defined disorder). The outcome of the events was unknown.
tiredness on Day 2 and Day 3, much of the day chills on Day 2 and Day 3, but only occasionally subnormal temp 97.5 F on day 3,  Possibly on day 2 as well but didn't check actual temp.
Pt exp h/a, vomiting, & weakness p/recvd flu vax;
Nov 1 received TD Tues AM felt lethargic, arm hurting. Wed AM HA, arm hurting. By late afternoon broke out in hives. By early Thurs AM hives from collarbone down. Given Medrol dose pak. Fri was given shot at urgent care. Prednisone and Antihistamine
received Pfizer covid-19 vaccine and Moderna covid-19 vaccine; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 18Jul2023 at 11:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in left leg, on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pneumonia", start date: 1967 (unspecified if ongoing), notes: Pneumonia around 1967, age 14. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "received Pfizer covid-19 vaccine and Moderna covid-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Still isolating for at least 3 more days, antigen testing & masking 8+ more days per guidelines. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 29Jul2023 to 03Aug2023. Additional information: the patient mentioned that finished Paxlovid 5-day treatment and felt fine though not 100% stamina due to recent Covid-19 bout. The patient mentioned that the patient remained isolated until Monday day 10 and that afternoon col-flu symptoms began. Next day (Tuesday), day 11 was worst day yet, other than original Day 1 when the patient first received diagnosis and began Paxlovid prescription. Still isolating for at least 3 more days, antigen testing & masking 8 plus more days per guidelines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Swollen and extremely painful lymphnodes; Swollen and extremely painful lymphnodes; This is a spontaneous report from a contactable other healthcare professional. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 10Aug2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. On 11Aug2021 at 17:30, the patient experienced swollen and extremely painful lymph nodes. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and extremely painful lymph nodes was not resolved at the time of this report.
NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 202A21A,expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. Treatment medications included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Began having eye pain and blurred vision on 10-8-21. Went to see optometrist on 10/20/21 who did a full eye exam and had no abnormal findings except need for an RX on the left eye. The optometrist advised me to see my primary care physician if the eye pain continued. Began having flashing in the left eye shortly thereafter and saw primary care physician on 10/25/21. He referred me to an ophthalmologist who I saw on 10/27/21. He sent me directly to the ER because of the flashing, headaches and eye pain where I had an MRI done. Optic neuritis was found on the left optic nerve that day and they started me on Methylprednisolone sodium succ 1,000mg injection for three days in a row. I saw a doctor (neurologist) on 10/28/21. Headaches dissipated following the injections. 11/24/21 I began having eye pain in the right eye and saw doctor again who ordered a second MRI to be done on 12/15/21. Optic neuritis was found on the right eye. Doctor  referred me to a specialized neurologist.
Patient stated that she had redness and swelling at the injection site and that it also felt hard. She stated that after approximately two weeks she developed a rash on her face and around her eye.  She said that she was seen at a local Urgent Treatment center where she was told that she had shingles and received a Toradol injection and  scripts for acyclovir and a prednisone pack. She said that she was also seen at Optical store where she was given a sample of a wetting drops to prevent dry eye. She also said that she had a constant headache which finally went away today December 6, 2017. She came in today to pick up a refill for another rx and that is when she told me about her reaction to the vaccination.
Patient requested Shingrix but received a Pfizer COVID-19 vaccine instead, this was discovered after administration. We did also administer her Shingrix after discovery, her primary doctor was notified, they did not seem concerned.
This spontaneous report was received from a nurse refers to a 4 month 3 days old patient. On 14-OCT-2013, the patient was inadvertently vaccinated with a dose of 0.5ml VARIVAX (Merck), (lot number, expiry date was not reported), subcutaneous. No adverse effect was reported. Additional information is not expected.
MMR was administered with known ear infection.  Antibiotics (amoxycillin) started same day as MMR.  Severe rash started on the 10th day.  Spread to entire body.  Lethargic.  Mild itching of face and eyes.  Doctor visit immediately after rash started; Benadryl (OTC) prescribed; 2nd day rash was worse; went to hospital for blood work to rule out measles.  5th day, doctor confirmed results that rash was due to an allergic reaction to the MMR vaccine.  Rash began to clear up the on 4th day, but took 4 weeks to completely fade away.  (note: also used baking soda during bath on 2 occasions)
Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 47-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Pt vaccinated with FLU/TD developed headache, itching throat, weak, tight chested & SOB.
Pt recvd 2 doses of Engerix-B 4-5 wks p/2nd dose had earache, dizziness, weakness, diarrhea, fainting, chills, fever; had 4 MD visits; recvd ATB;
Pt forgot he received this vaccine on  10-6-2022.  Pt has not experienced any adverse effects to the vaccination on 10-27-22.  Patient made aware
Patient received the Fluzone HD vaccination, however he had requested the shingles vaccination. He had already received the Flu Shot prior to the offsite clinic. Patient reported the following adverse reactions: chills, cold sweats and "not feeling well." These are normal adverse reactions from the flu vaccination.
Extreme headache, sore arm, nausea, lost my balance while walking, seizure 05/17/2021, seizure 06/18/2021, vertigo lasted for months until 3 weeks ago.
swelling, itching, and general inflammation in an approximately 2.5 diameter circle around injection site. Not sufficiently problematic enough to seek medical care.
I?m three weeks post vaccine #2.  During weeks 2 and 3 I have had vertigo off and on and almost fainted once.  It wasn?t clear that it was related to the vaccine until my husband started having the same symptom. I also had some leg tingling which may or may not be related. My blood pressure is normal. 70s / 120s.  I am still currently having these symptoms and have not contacted my doctor.
23 hrs after vaccination, onset of flu-like symptoms: headache, fever up to 100.8 even with acetomenaphen, (normal = 97.2), chills, muscles aches.Deltoid injection site was very red , swollen, and painful in an area about 5 inches wide and 7 inches long (almost entire upper arm) for 3 days. Symptoms lasted 3 days.
Stomach virus; Illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 10:15 (Lot number: ER8732, Expiration Date: Aug2021) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset 09May2021, outcome "recovered" (May2021), described as "Stomach virus"; ILLNESS (non-serious) with onset 09May2021, outcome "recovered" (May2021), described as "Illness". Therapeutic measures were taken as a result of gastroenteritis viral, illness.  Additional information: Reporter says her son got his first dose April 18th, and he is supposed to get his second dose today. She says she called because she was not sure if with the stomach flu he can get it or not. She says her son's first dose appointment was at 10:15 18Apr. She says that her son's stomach flu started last night because they had a family member who had it two days before then came over, and her son got it last night. AE Treatment: Caller says she gave him Imodium and some liquids like water. Caller clarified Imodium to being Imodium Multi-Symptom Relief. She says that the dosage given was Loperamide 2mg and antidiarrheal 125mg for this medication. Agent reports since callers son got first dose 18Apr2021 and since it is between doses that he is having an illness, he has transferred her to go ahead and report it.  No follow-up attempts are possible. No further information is expected.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 34 months old male patient who was vaccinated with a 0.5 ml dose of ADACEL (Batch number: U5533AA, expiration date: 18-Jan-2018, site of administration : right thigh and route was not reported) on 19-Nov-2018 and also was vaccinated with a dose of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. Concomitant medications included was HIB VACCINE (HAEMOPHILUS INFLUENZAE B [HIB VACCINE]) influenza vaccine  and HEPATITIS A VACCINE (HEPATITIS A) on same day of vaccination. The patients medical history medications were not reported. It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. A patient received ADACEL instead of DAPTACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC 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. List of documents held by sender: none.