chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hurt. Large red circle days later; Hurt. Large red circle days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraine in past; "preeclampsia" (unspecified if ongoing), notes: Had preeclampsia. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Hurt. Large red circle days later". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in the arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and MYALGIA (Body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Pain in the arm) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and MYALGIA (Body aches) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-074984 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074984:Mother case
Rash from 09/18/2005 - 09/19/2005. On 09/20/2005 Lump in left upper arm 2-3 cm.
Information has been received from a 32 year old female RN with a negative titer for rubella and subsequently experienced a lack of response. The nurse reported that she was unsure if she was vaccinated as a child and was also unsure if she was again vaccinated while in National Guard. In approx. 9/01, the pt was vaccinated with a dose of MMRII. The pt had a repeat titer drawn "at 90 days". The pt's titer was now borderline for the rubella titer. Additional information has been requested.
Pain and tenderness in left deltoid area, increasing in severity on day 5. Very uncomfortable to lift left arm.
Pt. has history of having reactions when given shots. Pt. walked to a chair outside about 20 feet outside of the injection room after receiving his shot.  He sat down in the chair and within 1-2 minutes the patient fell face down on the floor.  A customer yelled for help and pharmacy staff and the nurse practitioner responded to help. Pt. was passed out but breathing heavily.  We rolled patient to his back and he came to and tried to get up.  We told him to stay flat and assured him he was being taken care of.  The nurse practitioner stated it was a vagal nerve response.  The patient sat up and talked with us and stated this has happened before.   The ambulance response was called and checked patient out and he was released about 30 minutes later.  His blood pressure was normal and patient stated he felt fine.
mild numbness left side of face, starting day of vaccination; no f/u info available at this time. discussed with local health office.
Area of 10cm macular lesions, warm to touch, splotchy no fluctuance - likely reaction treated with ice pack & MOTRIN. Will return to clinic if worsening.
Severe Joint and muscle pain. Lethargy. Headache. Pain and swelling at injection site. Symptoms lasted around 36 hours. The vaccine was the currrent Shingles shot. Will take the second vaccine with 2-6 months.
Patient received rotavirus at 12 month wcc, along with 1 yr vaccines.  There was no treatment for it but did advice parents to check for blood in stool and or severe abdominal pain.  As of today 12/30/2022 pt is doing fine and neither one of those symptoms have been present.
~5am 5/6/21 woke with vomiting, nausea, headache, chills, exhaustion (this happened off and on for ~ 6 hours). . . Around 11am 5/6/21, I took Goody's headache powder and Zofran (this was after a telemedicine appointment with my PCP to ensure this all fell within the range of normal side effects and to confirm what medicine I could take).  I could finally eat around 1pm on 5/6/21 (didn't try before that).  I was still pretty tired/exhausted the rest of the day and went to sleep early that evening.  The following day (5/7/21), I generally felt okay but was a little foggy/tired.
FLU LIKE SYMPTOMS/ FEVER/CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, 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 subject experienced flu like symptoms/ fever/chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms/ fever/chills was not reported. This report was non-serious.
Child had previously received flu vaccine on 10/05/2021 and today received another dose of flu vaccine.
This spontaneous report received from the medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient missed dose of M-M-R II 0.5 ml subcutaneously (lot number not reported, expiry date: 06-APR-2018 and 18-MAY-2018) because the reconstituted product did not have the normal color. No adverse effects reported. PQC has been filed. The patient had been rescheduled for vaccination. Additional information has been requested.
Patient was to get Pfizer Bivalent vaccine the Medical Assistant accidently gave Pfizer monovalent vaccine.
As soon as we got home, he was extremely sleepy and had developed a fever just above 101. He would "Scream" cry, which he NEVER EVER did, and hasn't since.  He developed a severe runny, then congested nose which actually scared me because it seemed like he was going to choke on his own mucus.  He had troubles nursing due to this excessive mucus. He was unable to properly breathe while nursing.  I barely slept those three days.  This went on for 3 days after the vaccination, beginning the day of the vaccination.  Then after the 3 days, everything including scream crying, fever, fatigue, and excessive mucus stopped all at the same time.  Coincidence?  I don't think so... For treatment, I gave Tylenol the first day because he was red from screaming so hard and to hopefully calm the fever.  I tried not to give any more Tylenol, but the next day he kept screaming and turning red, even when nursing, so I gave him one more dose. Doseage of Tylenol given was according to guide provided by doctors office, which was only half of the smallest dose for infant tylenol. I now know Tylenol is the worst thing to give an infant...  Thankfully he did not choke in his sleep on his mucus.
Patient was nervous about getting the vaccine and was experiencing anxiety even before the shot. After receiving the shot she remained seated and coherent for a few minutes, then became non responsive and slumped in her chair. I elevated her legs and after about 30 seconds came around.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 23-moths-old patient of unknown gender. Concurrent conditions, medical history and concomitant therapies were not provided.  On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Red circle rash at injection site. Painful and itchy to touch. About 3 inches wide. Painful, extemely hard, and inflamed.
Patient developed lightheadedness/presyncope. Given water. Vital signs taken. Patient monitored for additional 15 minutes.
The following reaction occurred after the 2nd dose of the Covid-19 (3/39/2021) and after the Booster in Nov. (date listed above). Two to three days after receiving the vaccine, I noticed redness under both breasts and between my breasts. The redness extended over an inch below my breast. It didn't itch. The first time it happened after shot #2, I took Benadryl. With shot #3, I did not treat it. The redness by my breasts went away on it's own by the next day. I also had redness at the injection site after all 3 vaccines. That took longer to clear up. The redness remained for over a week with shot #1 and a few days with the booster. I am wondering if it is safe to continue with additional Covid-19 vaccines.
CLIENT RECEIVED MODERNA VACCINE AT 17YO. MODERNA IS APPROVES FOR AGES 18YO AND ABOVE.
fever of 102°F; severe headache; nausea; body pain; cough; weird taste and smell; weird taste and smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 23Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 03Mar2021 (at the age of 39-years-old) as dose 1, single for COVID-19 immunization and experienced headache for 12 hours after that dose. Patient reported that, she received her second Pfizer Covid vaccine dose on 23Mar2021 and developed a fever of 102 degrees fahrenheit at 10-10:30 pm that same day. Patient also developed a severe headache, nausea, and body pain, she was still having a headache and reported that she then had a cough and a weird taste and smell. She wanted to know how long that could last. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 23Mar2021. The clinical outcome for the events was unknown, except not recovered for severe headache.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Started getting red rash, raised hives all over back, torso with significant itching. Hives moved across body over time (1 week) . I started scratching heavily at night and skin condition worsened especially around legs (knee, calves). Skin appears very red, bumpy (looks like third degree burn). Started taking 50 mg of Benadryl nightly, with no relief. Went to doctor by 2nd week of November, prescribed MethylPrednisolone 4 MG for 6 days. Had no effect and no relief from hives and itching.
Three days after my Moderna vaccine, I experienced tiredness and felt very exhausted. I also had SOB with chest pain and I thought it was due to anxiety. I also had body aches and when I would inhale my chest would hurt and felt a pressure sensation in my chest. I took Ibuprofen and Tylenol for pain medication. I went to health care but they did not do anything and just kept me waiting. I then went to Medical Clinic where a doctor examined me. I told him I was having SOB with pressure sensation to my chest and exams were ordered. He told me that my muscles in my chest and lungs were inflamed. He game me an injection, gave me medications and told me to relax and to take two days off of work.  When I went home, I was in bed for three days due to my SOB and weakness to my body.   I know for a fact this was not an anxiety attack or my anxiety and this was I feel was related to the Moderna vaccine. To this day I still have SOB that comes and goes and I continue to feel agitated when taking walks,  bending down and performing my daily activities.
Child received MMR and VARIVAX on 8-5-09. 8-11-09. Child started with a rash on 8-12-09 child was brought into Health Dept with rash on face, head, arms, chest. He had fever Friday, Saturday, Sunday - 99-103.
Information has been received from an unspecified person at a medical facility concerning a 9-year-old white female with a penicillin allergy who on 16-MAR-1998 was vaccinated in the left thigh with a first dose of Varivax (lot# 623510/0694E). There was no illness at the time of vaccination. On 17-JUL-2006 the patient developed shingles. She was seen at a physician's office. On 22-JUL-2006, she was rechecked in the office and was fully recovered. Additional information is not expected.
pt adm to hosp 10 days p/vax;rash & fever had worsened over 1-2 days;had also been on Augmentin for OM
I had symptoms of cellulitis after I got the Pneumococcal shot. Started Itching around 4:30 pm. Had shot around 9:45 am on 10/31/05. No redness where the shot was given. All occurred on the inside of arm, especially elbow which was swollen at least 3 times the size of my arm. I have psoriasis on both upper arms. I believe the nurse went into far and hit a node. It was very busy at the clinic and I also didn't see her use an alcohol swab before sticking me.
Had vaccine on 4/6/11. On 4/7/11 area red & warm. 50 mm x 30 mm (R) outer arm. No other symptoms.
It was discovered that this Pt received 3ml of the vaccine instead of the recommended 0.5 ml dose after an incident from 10/08/2021 where the same EMT administered the same dose to two other Pts.  Called Pt to notify of the event.  She denies having any local/systemic side-effects or any adverse reactions following vaccination.
blacked out for a number of seconds; fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 90-year-old female patient received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Just to my thyroid gets little slow" (unspecified if ongoing); "my cholesterol just a little high" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; LEVOTHYROXINE taken for thyroid disorder; LATANOPROST ophthalmic taken for glaucoma; TYLENOL. Vaccination history included: bnt162b2 (Dose 2, 6208), administration date: 12Mar2021, when the patient was 90-year-old, for COVID-19 Immunization; Bnt162b2 (Dose 1, EM9809), administration date: Feb2021, when the patient was 90 years old, for COVID-19 Immunization. Concomitant medication also included unspecified Vitamins. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 12Nov2021, outcome "unknown", described as "blacked out for a number of seconds"; SYNCOPE (medically significant) with onset 12Nov2021, outcome "unknown", described as "fainted".  Clinical course: The patient took the COVID-19 vaccine booster shot yesterday and she forgot to sit down and rest for 15 minutes. Caller was wondering if that would cause a problem. Caller also stated that she had a usual bit of a sore arm. She also had the flu shot on the other arm. Last time she had the Pfizer COVID vaccine booster she did have a blackout about 35 minutes after. She received that shot on Nov2021. The shot she had yesterday was the 4th Pfizer COVID vaccine that she had had. The patient had the shot and waited for 15 minutes then she had to go, she headed to (Name: Withheld) and then she had to (Name: Withheld) and then had to go to the checkout one, so that was another 15-20 minutes getting home, so she was trying it occurred maybe about an hour and a half after she had shot, she had never fainted in her life like this and lived in a retirement village her husband and her at that time and she was not on a city street she was inside of retirement complex then all of a sudden she was driving on the wrong side of the road she had just blacked out for a number of seconds, she did not know 10, 15, 20 and that was all, that was a little frightening so she decided that she would not drive alone to have an injection again she would have to have somebody just for safety sake. That was all happened.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300342163 same patient, different dose number/event;
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; Lot# L037339, expiration date: 09-FEB-2018) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Nauseated but no vomiting Narrative:  44- yr old female with history of chronic pain presented to the medical facility with a headache 2 days after receiving her first COVID-19 vaccine. Patient received 1L of lactated ringer, IV prochlorperazine (10mg/2ml IVP), IV diphenhydramine (50mg/1ml IM), IV Ketorolac x2 (15mg/0.5ml), magnesium 2g IV and valproic acid 500mg IV. Patient still complained of headache but was anxious to be discharged. Since all of the above medication failed, patient received Dilaudid 0.5mg IV after assuming she was not driving home. ED diagnosis was acute cephalgia.
Temperature increased around 11AM to 99.4, 1pm 100.5, 4pm 103.8. Severe chills, uncontrollable convulsing, weeping, fire like pain in all muscles, loss of consciousness (black out), extreme discomfort at injection site, entire arm swelling, low blood circulation in entire body (turned purple), pale, extreme headache.
Afib episode 8 hours later  Episode lasted 12 hours  Second episode 14 days later (Patient has chronic afib, does not normally have isolayed episodes )
She developed a red are on her left deltoid region  last evening .The redness is about the size of a half dollar .The surrounding area on her deltoid is  warm to the touch .Denies any itching or pain at the site. .She was seen by NP  no treatment needed at this point .Her vaccine was done on 12/29/2020.
I felt fine after the vaccine. That night, I had a sore injection site, but no other symptoms. I woke up at 1:15 a.m., felt okay, walked to the bathroom, and suddenly felt extremely nauseous and thought I might vomit. After walking a few steps, I fainted unexpectedly and got a concussion from the fall. Note: I had hit my head earlier that day on something while standing up, but that had not caused any symptoms.
After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
lymph nodes under her arm and the side of her neck were swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) was resolving.      No relevant concomitant medications were reported.   It was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine as a booster for COVID-19 immunisation. The patient reported her lymph nodes under her arm and the side of her neck were swelling and it took 6 weeks to go down. No further follow-up is anticipated.  No treatment information was provided. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes under her arm and the side of her neck were swelling) was resolving.      No relevant concomitant medications were reported.   It was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine as a booster for COVID-19 immunisation. The patient reported her lymph nodes under her arm and the side of her neck were swelling and it took 6 weeks to go down. No further follow-up is anticipated.  No treatment information was provided.
Dizziness 5 mins after receiving injection, nausea at about 20 mins post vaccine, vomiting, about 30-35 mins post vaccine, chills about 1 hr post vaccine, body aches about 4-5 hrs post vaccine, soreness at injection site about 24 hrs post vaccine, swelling of lips about 2-3 hr post vaccine.
I woke up the morning of February 16, 2021 with my heart beat racing (resting rate 130+ bpm's).  So I went ahead and did several readings with a Kardia device which showed AFIB, Tachycardia, and PVCs. I have those readings available upon request. The cause is likely from my second Covid 19 shot that was given to me Saturday, February 13, 2021. I cannot think of any other variables that would have caused this irregular hear beat. Since this event occurred, I have been in regular contact with my Cardiologist. My daily ekg's are showing frequent arrhythmias, mostly PVCs.  I'm currently going through a series of tests to determine a course of action going forward (CT Cardiac Scoring, EKG's, Echocardiogram, etc.)