chrisvoncsefalvay/vaers-outcomes huggingface dataset:
premature ventricular contractions; a sharp pain in her chest; her heart started slowing down and then began hurting to beat; It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 06Apr2021 09:30 (Batch/Lot number was not reported) (at age 31 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received within 4 weeks prior to COVID vaccine and no other medications received within 2 weeks of vaccination. On 06Apr2021 21:30, 12 hours after getting vaccine, the patient felt a sharp pain in her chest and her heart started slowing down and then began hurting to beat. It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest. She went in and was hooked up to a holter monitor where they found 251 PVC (premature ventricular contractions) in 24 hours. It took 3 weeks for her heart to go back into normal sinus rhythm. She was given beta blockers as treatment. COVID test post vaccination (nasal swab/NBATT) on 10May2021 was negative. The patient was recovering from the event. She had not received the second dose and won't because of the first dose side effects.    Information on the batch number has been requested.
administered Kinrix to a 9 month old male patient; administered Kinrix / instead of D-Tap & and Polio (3rd dose); This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The  9 month old patient inadvertently administered with Kinrix instead of D-Tap & and Polio (3rd dose), which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details provided. The reporter consent to follow up.
started presenting pain on her hands/pain on feet; numbness on hands; headache; regular nose allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (regular nose allergies), PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet), HYPOAESTHESIA (numbness on hands) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (regular nose allergies). Concomitant products included OMEPRAZOLE for Gastritis, VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERSENSITIVITY (regular nose allergies) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet) and HYPOAESTHESIA (numbness on hands). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERSENSITIVITY (regular nose allergies), PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet), HYPOAESTHESIA (numbness on hands) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additionally, patient received two other unspecified concomitant medications for gastritis.
Moderna COVID-19 Vaccine EUA.  Around 7pm on 06Jan21, symptoms began with a headache, increased heart rate, inability to sleep/relax. On 07Jan21, Migraine headache, inability to sleep/relax, increased heart rate, passed out, lightheaded, back pain, neck pain, weak, fever, chills, hot, dehydrated (even with large consumption of water). Took two motrin and an hour nap, which severely decreased above symptoms but still experienced them.
9:00 p.m extremely tired, no energy, head ache body aches. Cold  chills then hot. Weak thru Monday 3/15/2021 feeling better , just still feeling tired.
Breakthrough case admission after 5 vaccines 1/25/21 Moderna Lot# 029L20A;  Moderna 2/25/21 Lot# 010A21A;  Moderna 10/21/21 Lot# 076C21A;  MOderna 4/8/22 Lot# 066K21A;  Pfizer 9/27/22 Lot# GH9703
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown.
09/16/22 presents to EC ED for "fall, leg pain". PMHx of "Alzheimer's, glaucoma, prior pubic rami fractures"
18 days after vaccination in which I only had soreness at the injection site.  Anxiousness, followed by dizziness and later nausea.
Patient describes intermittent pain at injection site in arm. She received dose of FLUZONE in November 2014 and is still having dull pain in arm. She has not had to seek treatment.
left arm redness and swelling, treated initially for cellulitis but not responding to antibiotics, more likely local injection reaction
Patient consent form shows no allergies to medications or vaccines and was given Pfizer covid shot. She was not on any medications, and no known allergies to food. After roughly 10 mins she said she felt tired, her head was feeling heavy, her heart rate increased. Patient stated she was able to breath fine, alert of surroundings. Alert x 4. Felt cold and shivering.  Heart rate was 110, came down to 90, and then increased to 99. 02 level was 99. Temp 97.3. BP 134/72.  Ambulance was called out of caution and patient transported to hospital.
serious neurological reaction; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological reaction". The event "serious neurological reaction" required physician office visit. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012028 same patient, different dose/events;US-PFIZER INC-202300012027 same patient, different dose/events;US-PFIZER INC-PV202300005067 same patient, different dose/events;
2 mo old (ex 29 wk) received ROTATEQ vaccine on 5/6/11, presented to PMD on 5/9/11 with complains of watery stools for 2 days, next day developed vomiting.
painful left medial knee. Known arthritis site but pain suddenly escalated and was unable to weight bear. This subsided after two weeks.
10 cm by 6 cm localized reaction with raised border occurring 1 wk post injection.
Polyarthralgias (shoulders, elbows, knees, hands) following administration of vaccines below. Elevated ESR and CRP, normal CBC & Rheumatoid factor. NSAID treatment resulted in symptom resolution.
Couldn't get warm; Aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Couldn't get warm), PAIN (Aching) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING COLD (Couldn't get warm), PAIN (Aching) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Couldn't get warm), PAIN (Aching) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was received from a consumer (Patient's husband) concerning a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, high blood pressure, pain in hip and shortness of breath.  The patient's medical history included three by-pass (open) heart surgery in 2020. No relevant concomitant medications were reported.  On 25 Feb 2021 Thursday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, Thursday night, the patient experienced high blood pressure of 189/101 and got a heart attack followed by shortness of breath and the patient hospitalized on 25 Feb 2021 Thursday night. On 26 Feb 2021, Friday at 04:00 PM, the patient was discharged from hospital. The patient experienced hip pain and little high blood pressure than normal.  Laboratory details included blood work normal and high blood pressure, 189/101.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, heart attack pain in hip and shortness of breath was not reported. The outcome for event high blood pressure was considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments:  MOD21-043135:Same reporter
Lethargy persistent; Joint pain and swelling sudden extreme. Fingers, knees, wrists and ankles.
I had a dry cough, scratchy throat, my wife had tested positive the day before, so I tested using a home COVID-19 test. Once it came back positive, I made an appointment to go into a local clinic. They verified my home test, I was prescribed the LAGEVRIO because I am on a blood thinner. Once I started taking the antiviral I was feeling better within a day.
Redness, tenderness, swelling 13 x 15 1/2 cm. Augmentin 875 mg, twice a day for 10 days
Felt dizzy as we were leaving the facility where I received the shot. Extremely dizzy and light headed for 5 days after that. Called to report the dizzyiness and they sent me to Urgent Care
1st dose no side effects 2nd dose side effects consist of  muscle pain, temperature, fatigue and fever over 2 days 3rd dose side effects consist of extreme muscle pain, temperature, fatigue, headache, sleep apena, runny nose still existing over 4 days now.
heart palpitations, light headed, feeling hot, chest tightness, headache, elevated heart rate.
About 6 day later, she developed a low grade fever (99.6), headache,  her chest was feeling heavy and tight, she was achy all over, she had chills. She had a horrible cough (deep, barky cough, non productive cough) Her symptoms continually got worse. She also had an earache. She was having trouble breathing so we went to the ER on 02/16/2021. They diagnosed her with bilateral pneumonia and fluid on both of her lungs. She was discharged from the ER same day under my care, I am an RN. The prescribed her a Zpack (Azithromycin) 500 MG for 1 day, the next 4 days 250 MG, Naproxen 500 MG every 12 hours, Albuterol nebulizer treatments every 4 hours. ER doctor believes that the vaccine may of effected her immune system.  She does have a follow up  with Dr. on March 2nd. She is improving. She still has a mellitic/bitter taste in her mouth from the first vaccine.  She is doing better but not completely over it.
Staring 5 hours after the vaccine a tightness in the chest started. It was difficult to breathe. By the next day it was difficult to move because of what felt like a band around my chest. It feels like I am running out of air doing my normal routine. I have started moving excessively slowly as I can't get a deep breath. It is four days after the vaccine and I am considering going to the er because it is not clearing up. I started taking Benadryl and Claritin yesterday which has greatly relieved the symptoms (not gone but brought to a manageable level), but everytime the medication wears off it comes back in full force.
Choking spell (choking), aspiration spell (aspiration), not breathing well (dyspnoea, NOS), pale (pallor), perioral cyanosis (cyanosis NOS). F/U states: Country of origin; United States. A 3 month old female received her 2nd doses of Prevnar, Menomune, Havrix and Rabies vaccine (the given batch no. UA598AB is unknown for RabAvert) on 8/23/01. Approx. 5-6 hours, post vax, the infant experienced a "choking/aspiration spell". She also was "not breathing well" and turned pale with perioral cyanosis. EMS were called and the child was seen in an ER. The reporter noted that the infant recovered before reaching the ER. She was hospitalized where a result of a CBC, UA and "basic metabolic panel" were normal. Seriousness criteria: hospitalization, life-threatening. Causality: possible (for possible allergic reaction). No change is risk-benefit-ratio. No measures necessary. Addendum 11/15/01: According to information received, no rabies vaccine was administered to the child. The vaccines administered on 8/23/01 were Infanrix, Prevnar, Act-Hib and IPOL, rather than Havrix, Prevnar, Menomune and Rabies vaccine, as originally reported. Consequently, for RabAvert, this case is reclassified as non-company-drug. Causality unrelated (rabies was not administered.
no adverse events; an improper stored dose  of PNEUMOVAX23 was administered today / the product was frozen upon removal from the refrigerator; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-JUN-2021, the patient was vaccinated with an improper stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, intramuscularly, lot# T034630, expiration date 22-JUN-2022, for prophylaxis (strength and frequency were not reported). Temperature excursion details were not provided; however, the product was frozen upon removal from the refrigerator. A digital data logger was not involved. No additional adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Approximately 3 weeks post first MMR vaccine.  Patient had left parotid swelling, positive mumps IgM - no fever, no rash - parotid swelling resolved over 48 - 72 hours.
About 11 hours after receiving the COVID-19 Moderena first injection (2 a.m. Friday), I began to have body pains, insomnia, lethargy and general cold/flu symptoms. These symptoms worsened over the course of the day, worsened at times and lasted until late in the evening on Saturday. The worse points included fevers of 101.5 at about 3:30 p.m. Saturday (48 hours after injection) and 100.9 at 7 p.m. (51.5 hours after injection). My fever seemed to break in the middle of the night between Saturday and Sunday. On Sunday morning, I woke up feeling nearly 100%.
screaming for 1hr, high pitch scream, pain in local area;tx ice-APAP, no more pertussis;
Around three hours after the shot, I started feeling numbness in my left arm around 2:00 pm and didn?t get feeling back until around 4:30 pm.
I contracted chicken pox. Had one in my right eye, and now I have a visual impairment.
Fever, headache, flushing, earache took 1000mg acetaminophen for symptoms.
sneezing; Pressure headaches; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old non pregnant female patient received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 20Mar2021 at 18:45 (at the age of 25-years-old), as a single dose for COVID-19 immunization. Medical history included known allergies to keflax, lavender and nitrile non latex material. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 20Mar2021 at 21:00, the patient experienced sneezing and pressure headaches. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events sneezing and pressure headaches was recovering, at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's initial captured in First name field of the patient tab. Removed name from last name field 2. Relevant Med History#1, verbatim updated to Allergy to nitrile non-latex material; Relevant Med History#2, verbatim updated to Allergy to Lavender 3. Past Drug Event#3, drug Keflax coded to Keflex 4. Event Pressure headaches was recoded to head pressure 5. Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient c/o SOB following 1st Doese of Pfizer-Covid-19 vaccination. L/S clear. Patient being assessd by EMS. Vitals assessed. 0 dizziness 0 n/v
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, (Oka-Merck) PROQUAD underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
Child started crying 45 minutes after vaccine administration. Screamed unconsolably for 3 hours. Mother gave motrin which didn't help. Child finally cried himself to sleep.
This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced herpes zoster (shingles). At the time of the report, herpes zoster (shingles) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Developed shingles 48 hours later. Concomitant product use and treatment information not provided by the reporter.
Pt to ED w/ fatigue and dizziness. Patient had missed dialysis session due to COVID diagnosis. Pt also reported episodes of black stools and emesis. On arrival, VSS, EKG revealed Afib. Labs showed hyperkalemia (6.2) which was treated with calcium gluconate, insulin, and bicarbonate. Cr was elevated to 13.74. CBC demonstrated Hgb 3.7. Patient was started on protonix gtt, given 4U pRBC transfusion and hemoglobin was monitored. During this time, his anticoagulation was held.  He was evaluated by GI and small bowel enteroscopy was performed with cautery of actively bleeding lesion in gastric fundus. GI recommended ...
Patient stated that her arm was swollen and had a large, orange shaped swollen lump the size of a baseball. The swollen lump had shrunk to the size of a plum but was still bruised. She also reported fevers since vaccination and pain and itchiness and tingling running up and down her entire arm since vaccination. She reported her arm being very painful and being unable to move it after vaccination.
Six days after administration of MMR client noticed reddness the size of 50 cent coin. The following day (5/1/09) swelling had increased to 50mm in size, warm to touch with erythema. Client states it itched 4/30 and she scratched it. Ice placed today with improvement per client. T 98.4, P 60, R 18, BP 118/70. Given Cephalexin 500 mg po tid x 7 days.
GARDASIL 9 was stored improperly and administered; No Adverse event; This spontaneous report as received from a license practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with an improperly stored does of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651, expiration date 09-JUN-2022, for prophylaxis (strength, dose, route, anatomical site and vaccination schedule were not reported), which had a temperature excursion of 50 F for 1 hour and 46 minutes. The temperature excursion was detected by a data logger and had no previous temperature excursion.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307:
Chills in the evening and headache.  Poor sleep.  Headache the next day and fatigue.
No adverse event occurred. Incorrect vaccine administered by nursing. Order for Hep B, but Pedvax Hib administered.
Can the vaccine cause weight gain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Can the vaccine cause weight gain) 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 WEIGHT INCREASED (Can the vaccine cause weight gain). At the time of the report, WEIGHT INCREASED (Can the vaccine cause weight gain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided