chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she developed the fluttering heart 2 weeks later; 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 72-year-old female patient received bnt162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EK4176), administration date: 15Jan2021, for COVID-19 immunisation, reaction(s): "allergic reaction of numbness and swelling of her lips", "allergic reaction of numbness and swelling of her lips", "allergic reaction of numbness and swelling of her lips"; bnt162b2 (DOSE 2, SINGLE), administration date: 10Feb2021, for COVID-19 immunisation, reaction(s): "no reaction"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: 301US8A), administration date: 29Sep2021, for COVID-19 immunisation, reaction(s): "she developed the fluttering heart". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Apr2022, outcome "unknown", described as "she developed the fluttering heart 2 weeks later". Therapeutic measures were not taken as a result of cardiac flutter. Clinical course: She said on her last three doses, she took an anti-histamine prior to getting those doses. Before her last three dose of this Pfizer COVID-19 vaccine, she took an anti-histamine prior to getting those doses and she did not have an allergic reaction. However, she develops fluttering of the heart two weeks later. She developed a fluttering heart two weeks later, on all of three of her last doses.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320687 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321099 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321098 same patient/vaccine, different dose number/event;
Severe nausea/vomiting, weakness, extreme dizziness, headache, fever 102.3, chills, talking delirious.
the Vial was Stored in Refrigerator for 5 day post first punctured; Received expired 2nd Booster more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture) and PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022 at 12:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022 at 12:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Booster more than 12 hours post puncture) and PRODUCT STORAGE ERROR (the Vial was Stored in Refrigerator for 5 day post first punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was received from the department of health and the  Expiry Date written on the box was 09JUN2022  The Vial initially was stored in refrigerator on 12MAY2022, vial was first punctured on 19MAY2022 at 10:30AM. The vial was stored post puncture in refrigerator. The vial did not undergo any temperature excursions. the vial was exposed to refrigerated Temperature range for 5 days. No treatment medications were reported.
injection site pain; headache; fever; chills; worsened joint pain; on and off fast heart beat; dizziness on and off/lightheaded; rash all over her body; her back and stomach are itchy; Fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "COPD" (ongoing); "type 2 diabetic" (ongoing), notes: She started to become diabetic around age 36 to 37; "bronchitis" (unspecified if ongoing); "million allergies" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "injection site pain"; HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "headache"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "fever"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "chills"; ARTHRALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "worsened joint pain"; HEART RATE IRREGULAR (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "on and off fast heart beat"; DIZZINESS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "dizziness on and off/lightheaded"; RASH (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "rash all over her body"; PRURITUS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "her back and stomach are itchy"; FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "Fatigue"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "sore arm".  Additional information: She was diagnosed with COPD maybe within a year or two ago. She was at the hospital for bronchitis and they claimed that she had COPD. She has a million allergies to who knows what. She has had her allergies since she was a kid so now she is allergic to who knows what. Maybe her side effects are from whatever. She is the type that if the doctor gives her a typical medicine for anything then she will have a bad reaction. Her doctors don't know what to do with her. She will have reactions, rash or a rapid heart beat or whatever to anything.  No follow-up attempts are possible. No further information is expected.
About 14 hrs after injection, I got really bad chills for a couple of hours, then got very hot and had a 3 timepoints of chest pains (I assume I had a fever at this time but didn?t verify). By 7am when I got out of bed, it felt like a truck hit me. I had a major headache, very fatigue, fever (checked at this point and it was 101), nausea, hotness/chills. By 12pm, I had an 100 degree fever, chills/hotness, and headache. By 6pm, I was only tired. Next day, I was back to normal with a little soreness in my injection arm.
Evening of shot developed red, sore, arm with lump size of orange. Was painful for 36 hrs. Did not take any meds, resolved on own. Also had "Montezumas revenge" first flu shot ever.
swelling at the injection site; pain at the injection site; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient asked that how long might have had pain and swelling at the injection site with the Shingrix vaccine. The follow-up could not be possible as no contact details were available.
Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital  and diagnosed with anemia, 4 negative fecal tests, neg EGD and colonoscopy.  Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse.  He died 1/23/2021.
Patient reports 7 days ago he received his second injection of Pfizer MRNA vaccine. The day following patient felt tired and fatigued. 2 days later he developed nausea and vomiting along with significant fatigue along with an intermittent headache. He did report a fever that developed yesterday and resolved on its own. He has a decreased appetite but has had intermittent fatigue. Patient reports no symptoms currently.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment information was not provided.
pt recvd vax & w/in 10 hrs pt devel severe vomiting which persisted x 4 wks; w/u incl endoscopy revealed only mild inflammation of duodenum; no specific dx, but clinical presumption of motility dis w/ probable gastric emptying abn;
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-OCT-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 0.5 ml (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28 F (-2.2 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 60 year old female patient with allergy to sulfa drugs, BACTRIM, EFFEXOR. On 14-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported, lot# reported as K010969) in her left triceps. Concomitant medications were not provided. The patient reported that her arm was red and tender at the injection site. The patient stated that the redness and tenderness started on 15-JAN-2015. The patient visited the physician on 16-JAN-2015. The nurse stated that there was erythema and tenderness at injection site. The redness was measured at 8 by 6 centimeters around the injection site. The patient had no fever. The physician treated the patient with cephalexin (500mgs, three times a day for 1 week), BENADRYL and ibuprofen (as needed). Outcome of the events was reported as not recovered. Additional information has been requested.
Starting at 1:00 am, I awoke with chills, body aches, headache and a 100.0 fever. This lasted until about 1am the next day, so about 24 hours. My fever got as high as 101.0. I took Advil every 4-6 hours but it did not help.
Patient had already received 2 doses of the Moderna Covid vaccine for this age group was inadvertently given a dose of Pfizer for this age group not aware had already received the Moderna series.
Approx. around 4/27 I notice a bump on my right cheek which I took as a bug bite.  On 5/1 I was feeling weird tingling going up the right side of my face from my ear to temple and had a headache which Tylenol helped.  On 5/2 I went the the  Urgent Care to make certain this was not something that was going to stop me from getting my 2nd dose of the Covid vaccine.  I tested positive for shingles and was put on an antiviral.  Continued to break out from Monday thru today.  On  Tuesday, 5/6 I went to see an eye doctor because of eye pain and scratchy feeling.  I was diagnosed with Shingles Pinkeye and was put on eye drops to reduce inflamation.  I go back to the eye doctor on the 14th of May for a follow up.
Felt dull chest pain in heart area on and off throughout the following day (12/22)  Have not felt today (12/23)
Hurts to lift arm day after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.
Three hours after receiving shot, complained of not feeling well, about 5 hours after shot, reported heart palpatations, chest heaviness and shortness of breath.  Called ambulance, was transported to hospital.  Admitted and was kept for three days, had new onset hypertension, headache, had complete cardiac work up which results were normal.  Was released to home, about 6 pm Thursday, by 10 pm she was writhing in pain in her head behind her right eye, right eye blindness, vomiting, diarrhea, severely hypertensive, unequal hand grips, was taken in again by ambulance to hospital.  facilitated transport to another hospital. Where they had to remove her right eye.  The nurses and er doctors did not record any information about the recent injection.  They just rolled their eyes.
The first instance was when I woke up the morning after I received the second shingles vaccination feeling dizzy.  I got out of bed to let my dogs out and was so dizzy I had to crawl on my hands and knees to the door. Even slight movement was debilitating and I ended up vomiting on the floor.  Symptoms lasted 24 hours and I had to lay in bed all day due to continued dizziness and nausea.    The second instance was the day after a holiday.  I again woke up feeling dizzy and vomited twice and this lasted 24 hours.  I then experienced underlying slight dizziness and nausea for a week.  The third instance was January 21.  I woke up feeling fine and about an hour later began feeling dizzy.  Dizziness lasted 24 hours and I had to lay down all day.  The fourth instance was last night (January 28) around 6:30pm.  I was eating dinner when I felt a rush of fluid in my left ear and then the dizziness hit.  I vomited twice.  I went to bed and woke up feeling a little better but still slightly off balance and slightly dizzy.
Swelling of lips and right side of the face. Patient went to emergency room for treatment. Patient was prescribed Prednisone 50mg once daily for 5 days
Patient previously had Fluzone HD administered on 9/23/2022 and received another dose of Fluzone HD inadvertently on 11/30/22. No adverse reaction reported.
Mom reported to staff on 5/5/06 that child's left arm swollen on 5/3/06 and began to run fever. She gave Motrin and rubbed arm with alcohol. On 5/4/06 mom noticed left arm of child more swollen and blistered and cont to run fever so took child to local ER and given antibiotic ointment to apply on left arm. Is improving.
Developing rash. Continued to grow ea day. Used cortisone cream at site. Went to doctor's. Was measured by other Dr. Lasted aprx. 12 - 14 days.
Pt recvd 2nd vax of Hep B & later exp itching w/ hives under arms & down sides.Pt tx w/ meds & sx abated slightly,w/ recurrences of hives & itching.
Headache, pain at injection site day after injection (Sat am). 24 hours later (Sun am) I had pain on my hip, as if from blunt trauma. I expected a large bruise which never developed.  24 hours after that (Mon am) I had rash that consisted of a cluster of red bumps 2" x 2" in the same place I had pain the day before. The rash did not (and does not currently) itch. The rash worsened and I had more pain - again as if I was bruised, but sometimes the pain was very sharp. This has continued for 10 days, with the rash and pain worsening every day. The rash has spread, as has the area in pain. I saw my doctor 1 week after I received the vaccine and she confirmed the rash appears to be shingles.  She has had shingles 5 times, so is personally familiar. The rash looks consistent with online photos, and my symptoms are consistent. In addition to the pain and rash, I have headaches and stomach problems.
itchy face; warm face; facial flushing; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable other hcp and a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, expiry date: Mar2021, via an unspecified route of administration on 04Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. An intern called to see if there was any cholesterol in the Covid vaccine or the amount of cholesterol in the vaccine. The patient had itchy face and warm face after receiving the vaccine. It was clarified that there was cholesterol in the vaccine, she would just like to know the source, she also clarified that the patient had facial flushing. The 1st Dose was on 04Jan2021, she reported facial flushing a few minutes later went away, the patient has already left. The patient states that she is vegan and wanted to know the source of cholesterol and if that could cause the facial flushing. The outcome of the event facial flushing was recovered while other events were unknown.
This spontaneous report as received from a pharmacist refers to an unspecified adult patient of unknown age and gender. On 07-JAN-2014 the patient was vaccinated with "less than a full dose" of VAQTA (lot# unspecified) (route, dose and location unspecified). No adverse effects reported. Follow-up information has been received from pharmacist and a health care professional regarding a 65 year old female patient. The patient do not have any illness at the time of vaccination. On 07-JAN-2014, the patient was vaccinated with VAQTA in the right deltoid. During administration the syringe malfunctioned and pushed the vaccine outward instead of into the patient arm. The patient received only half of vaccine during the administration. On 14-JAN-2014 (reported as 1 week after), the patient was readministered with VAQTA for the full dose. The outcome of the events were reported as recovered on the same day (07-JAN-2014). Additional information has been requested.
Patient reports feelings tiredness, body aches and chills within 24-38 hours of vaccination. Patient report just feeling very tired.
Headache, mild nausea, muscle aches, mild dizziness, soreness in left shoulder. Lasted all day on 4/10/2021. Felt all better on 4/11/2021, except shoulder soreness which still persists as of 4/13/2021.
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not reported
This spontaneous report as received from a pharmacist assistant refers to a patient of unknown age and gender. No medical history or current condition were reported. On 23-OCT-2014, the patient was vaccinated with a first dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 29-MAY-2014, the patient was vaccinated with a second dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 31-OCT-2014, the patient was vaccinated with a third dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 25-JAN-2015, the patient was vaccinated with a fourth dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
At facility, facility coordinator suggested that her mother also receive booster since we were on site. Moderna booster 0.25 mL administered. Upon completing vaccine card, noticed that 2nd dose was 8/4/2021 so booster dose was given 3 months and 2 weeks after 2nd dose rather than 6 months after.  Booster was given 2 months and 2 weeks earlier than recommended.