chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been experiencing heart palpitations ever since my second Modera shot. On the day of the vaccine, it happened roughly 10 times, the second and third days were similar. Slowly the palpitations became fewer and fewer, but now, 10 days after my shot, they seem to be increasing again.  I am currently 20 weeks pregnant, due October 12.
This spontaneous report was received from a pediatrician and refers to a 15-year-old male patient. The patient did not have any concurrent conditions, medical history, allergies or known drug reactions and did not take any concomitant medications. On 19-MAY-2017, the patient was vaccinated with GARDASIL 9 injection, intramuscularly, lot # N003703, expiration date: 29-OCT-2019. On an unknown date in approximately 2017, the patient had minimal injection site tenderness. On an unknown date in 2017 (reported as "an unspecified time after receiving GARDASIL 9), the patient developed a sinus infection and was prescribed amoxicillin (dates unspecified). On 12-JUN-2017, the patient experienced injection site pain rated as "2" and increased swelling. The physician prescribed heat on the injection site and ADVIL as a treatment, on 12-JUN-2017. The physician saw the patient at the office on 16-JUN-2017 due to the patient experiencing injection site swelling and tenderness about 2 inches diameter and induration about 3/4 inches diameter which felt like a knot (developed on unknown date). On 16-JUN-2017, the patient was afebrile. The outcome of the events was unknown. The causality assessment between the events and GARDASIL 9 was not provided. Additional information has been requested.
Patient was given a Moderna Bivalent at his second dose instead on the Monovalent Moderna.
Bacteremia - strep epidermidis, developed respiratory distress required intubation for hypercapnic respiratory failure. Developed PEA on 3/28 died.
Patient received an expired Pfizer booster dose, but did not report any side effects. Patient will come by for revaccination.
becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate; any new supplement or drug she tries he has a reaction dermatologically; arms burn like sunburn; rash under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol), Drug allergy and Food allergy (Sensitive to food that contained salicylate).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin). At the time of the report, HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-239094 (Patient Link).
Baby was coughing & gurgling (choking on excess saliva). Covered in hives. O2 levels were o.k., so paramedics allowed us to transport him to hospital. He was treated with antihistamines & released. He began to fall behind developmentally & has autism, epilepsy & tremors now.   12/15/08 MR received from PCP including allergy consult.  Pt developed cough, choking, facial redness and hives shortly after receiving vax. Resolved in ER with benadryl. Developmentall well at 6/16/06 WCC. Sleep issues noted 9/06. Febrile seizure 5/07.  By 6/18/07 more seizures noted as well as loss of speech. and spinning behaviors. Assessment: Well check. Speech delay. Placed on Keppra for grand mal seizures.  Tremors noted 11/07.  Multiple episodes of croup. ? asthma.
- presents with a cc of heavy menstrual bleeding - for the past year she has only had light spotting with menstrual cycles; today she went through 4-5 of the largest available commercial tampon (dark purple) every 1-3 hours - in the drive in to the ER she reports feeling wozzy and had pressure in the front of her head, now resolved - denies abd pain
atopic dermatitis; psoriatic dermatitis; skin parasthesia; my skin is disfigured with itchy/painful scales; 2 skin infections; Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 10:30 as dose 1, single (Lot number: PAA156052) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "GAD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Mild excema" (unspecified if ongoing); "Penicillin: Allergy" (unspecified if ongoing); "Allergy:Sulfa" (unspecified if ongoing). Concomitant medication(s) included: RALOXIFENE; SIMVASTATIN; AMBIEN; MELATONIN. Past drug history included: Ciproloxacin, reaction(s): "Allergy:ciproloxacin"; Zolpidem, reaction(s): "Allergy: zolpidem".  The following information was reported: RASH (medically significant) with onset 12Feb2021 at 21:30, outcome "unknown", described as "Broke out in a rash all over my legs/The rash never subsided and, since then, gradually worsened and spread to my arms, trunk, and neck, and jawline"; SKIN INFECTION (medically significant), outcome "unknown", described as "2 skin infections"; DERMATITIS ATOPIC (medically significant), outcome "unknown", described as "atopic dermatitis"; DERMATITIS PSORIASIFORM (medically significant), outcome "unknown", described as "psoriatic dermatitis"; PARAESTHESIA (non-serious), outcome "unknown", described as "skin parasthesia"; SKIN EXFOLIATION (non-serious), outcome "unknown", described as "my skin is disfigured with itchy/painful scales". Therapeutic measures were taken as a result of skin infection, rash.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Irritability, inconsolable, legs red and swollen, right more than left, hot to the touch.
swollen right foot; infection in the toe or foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot) in a female 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot). At the time of the report, PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  Patient was scheduled to receive a Moderna booster shot on 27-Dec-2021. The patient asked whether the possible infection would have any effect on the booster dose of the vaccine or not.
2/13/21 Headache,  Left upper arm at injection site. 3 inches in diameter, Site hot, red, swollen, intense itch,  4-5 tiny raised rash, tender to touch. Treated with ice on and off, Hydrocortisone cream and Ibuprofen to help sleep at night.  2/14-21 Headache improved. Let upper arm still basically the same but less intense itch.
5 min. after flu shot: paleness, weakness, dizziness and nausea; later: very fast heart beat that woke me up - called Hosp. for info. they sent ambulance to ER. nex day: some swelling, redness and pain at site of shot.
patient received doses more than 12 hours post-puncture and stored in room temperature; 4 patients received doses >12 hours post-puncture; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) in an 80-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received doses >12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown when the vial was initially stored in the refrigerator. Moderna vial set to the counter on 31 Mar 2022 at 12:10 PM. The vial was first punctured on 31 Mar 2022 at 12:25 PM and it was administered on 01 Apr 2022 at 1:30 PM, 2:15 PM, 2:30 PM and 3:30 PM to 4 patients.  Post puncture the vial was stored in room temperature and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was a little over 25 hours and 20 minutes before the first dose was administered.  No treatment information was provided.
Headache morning of 4/2 progressively got worse throughout the day. Chills, body aches all over, could not work or function. Had to sleep. Lasted 12 hours and then feel fine come 9pm 4/2.
Patient reported by phone and email red bump at site of flu vaccine and sore arm/shoulder joint four days post-injection. She denied limited mobility. She was encouraged to apply warm packs but stated she could not do so during work hours. At her pre-arranged PCP visit on October 12, she stated most of the redness was gone except the one small red spot. She stated that her PCP did not feel it looked bad enough to send a report to the Clinic. Patient remained concerned and consequently a VAERS report was offered by the Clinic.
The reaction started on 04/07 and woke up on 04/08 completely deaf in both ears. As of today, I have 40% in my right ear, but still completely deaf in my left ear. I went to my primary doctor who referred me to a specialist. The only thing that may have helped is they did steroid injections into my ear drum. I have been told there is no saving the hearing in my left ear. I have severe fatigue and breathing issues and Tinnitus. It seems like all the pain I had before has increased. I am seeing a Rheumatologist because they believe my immune system is now overactive and attacking my joints.
The patient was given Modern instead of Pfizer for their second dose. 4 hours after injection (6pm), patient complained of and was admitted to a hospital ICU floor with high fever, rapid heart rate, and arrhythmia.
Extreme Dizziness/Vertigo. Sudden onset Sunday night, felt like bed was rocking and room was spinning. Motion sickness, vomiting, exhibited sings of stroke. Called 911 EMTs felt like it was not a stroke, but cautioned me to watch for symptoms. In New York at time of event, returned home in wheelchair Monday. Met with primary care doctor's office Tuesday, given Meclizine 25mg and a steroid. Otherwise healthy, no case of COVID or any other sickness in several years. Currently still dizzy 7 weeks later although much better than before.
April 5/6 evening +Fever of 100.4, red cheeks, weakness, fatigue, muscle and joint pain, feel of pressure at upper chest bone area, (not like pneumonia or racing  heart), discomfort in arm area. April 7th a pink area on arm appeared. April 8.  feeling better.  Still discomfort in arm and tired.
Stomach discomfort/nausea/vomiting Headaches/Migraines Muscle aches Cold sweats Hot flashes Fever Diarrhea Loss of appetite Sore/stiff arm Fatigue
Headache, Myalgia, Fever, NauseaVomiting,  Localized pain; chills, fatigue Narrative:
7 days post vaccination, redness, soreness and swelling at vaccination site. 8-10 days post vax, local pain with chest pain, pain scale (6), no breathing difficulty. Resolved with Tylenol.
This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was captured as adult as per the vaccine indication. The sales representative stated the reporting physician was very vague. The physician stated that she believed that SHINGRIX was responsible for several shingles outbreaks in her patients over the past several months. The physician stated that there had been two or three patients who experienced adverse event that looked like a shingles outbreak shortly after vaccination with SHINGRIX, the time frame for the same was over the past several months. The physician was asked if she was sure that the patients experienced shingles, she stated that the symptoms presented as shingles. No single patient was identified. The physician did not agree to follow up. The case was considered for suspected vaccination failure as the time to onset and the vaccination schedule completed by the patient were unknown.
This spontaneous report as received from a nurse via company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the booster of VAQTA (lot # not reported) (25/0.5 U/ml, intramuscular, 0/5 ml). It was reported that the patient received the booster dose 15 days prior to the minimum interval of 6 months from the first dose. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Im Vaccinated and I got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she in April the patient went to get his/her Shingles shot.  The patient stated he/she in the past got shingles in February 2021. The patient stated 10 months after he/she thought all would be ok. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-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 TREMOR (Tremors). At the time of the report, TREMOR (Tremors) had not resolved.            Patient saw his doctor but was not diagnosed with anything yet. He takes concomitant medication that did not want to disclose. No treatment information was provided. Patient would like to have a face to face meeting with someone.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On 15-JUN-2016, the patient received an expired dose of VARIVAX (lot # K003414, expiration date 06-MAR-2016, dose was unknown), subcutaneously. No known adverse effects was reported. Additional information has been requested.
He came into clinic for 2nd dose in series, told us he had reaction 10-14 days after first dose. Had pictures of rash that extended over his chest back, bottoms of feet, itchy, red raised with irregular borders. Had tried doing sauna which made it worse. Had nausea/vomiting, fever/chills/body aches/headaches. Missed 4 days of work. We advised not to do 2nd dose, but he said he had consulted with a relative who is a MD, and he said go ahead with it. He stayed in our clinic for 30 min with no reaction. Asked him to notify us if he has reaction this time. Advised him to have antihistamine on hand in case he starts having another reaction, and to seek medical care if any trouble breathing.
I received my shot and had a slight dizzy spell after my 15 minutes were up to leave which lasted approximately 45 minutes to an hour. I experienced a change in my taste. Food was really salty. That lasted for about 6 months. I noticed that I had a rash that appeared on the back side of my right lower calf. It was the size of a grapefruit. It started out light and got noticeably darker with time. There was no itching, no swelling. Just discoloration. So, I contacted my doctor and explained what was going on and he wanted to see me. When I saw my primary doctor, he couldn't explain the discoloration so he referred me to a dermatologist. The dermatologist could not explain why I had discoloration. He said he normally sees this kind of thing on a diabetic but i''m not a diabetic. He treated me with a salve and, after a period of time, it faded and it's still noticeable but not as prominent as it was before. I will be having a follow up appointment in a year.
Within 3 hours of vaccination, the patient developed severe diarrhea and has continued with diarrhea, now 5 days.
Vaccine recipient received vaccine on 1/8/2021. She reported that on 1/15/2021 around 3-4 pm noticed that she had left eye weakness. Over the weekend 1/16/2021 ? 1/17/2021, she noticed that the left eye weakness/droop was more pronounced when she was tired. On 1/18/2021 she went to see a neurology specialist and had an MRI done. Vaccine recipient reported that the MRI findings were normal. On 1/18/2021 she developed a migraine and took propranolol and Aleve. She is waiting on pending blood work and results.
Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (fatigue) in a 71-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 an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-004679 (Patient Link).
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route were unknown) and/or sterile diluent (lot # K0121917, exp date 09-SEP-2017). No adverse effects reported. Additional information has been requested.
Moderna on 2/5 and 3/9. Positive on around Aug 1 admitted 8/6-8/13
c/o facial flushing and feeling hot 5 minutes after vaccine. Refuses transport to ED.139/81,76,97% RA 134/90
Fever, rashes  from face to body and legs and red eyes over the course of 3 days
pt states she developed a headache about an hour after taking the vax.  She got very hot and started pouring sweat.  It has made her extremely tired and is requiring a lot more sleep than usual.  Her left arm is sore to touch,  she is having body aches and pains.  States she is having pain and pressure in both shoulders.  She is taking Motrin but has not helped.  She is having to miss work due to the pain.  She says she is suffering from the pain and will have to contact her PCP.