chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 26-MAR-2021. This report was non-serious.
Mom describes large area of redness to shoulder midway down upper left arm.  Some swelling at site.
Initial Health Authority report (ref no. 34672) received on 20 Sep 2010: This adolescent was vaccinated with MENVEO (batch number not reported) 0.5 ml, intramuscularly on 17 Aug 2010. On 18 Aug 2010, the adolescent presented with fever (temperature of 38.7 degree Celsius) and on 19 Aug 2010 the adolescent experienced fatigue, arthralgia and headache. The outcome of the events was reported as completely recovered. The causality was reported as suspected and the seriousness criteria were reported as medically significant.
Same day of vaccination (9/24/2015), I started with some itching burning hives in both legs, started around 7:30pm, about 10:00pm, I went to the pharmacy and got some Benadryl capsules and anti-itching cream, I got better, when I got up in the morning 7:00am is started in my left arm, so I apply some more cream. I called my PCP and instructed me to keep taking Benadryl every 6 hours and if gets worse go to ER. Last night 09/27/2015 around 8:00pm, it started again in my left knee.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed  chickenpox consisting of several hundred lesions.
Vascular enlargement of the veins. Extreme headache, pain in hands, eyes excruciating pain. Uncontrollable bleeding  during menstruation.
Pt received all 4 Prevnar vaccinations and developed Strep pneumoniae bacteremia at 17 months old.  Prevnar was given 4 separate dates but the lot numbers are below.  Dates of 8/19/04, 12/16/04, 5/13/05, 8/15/05.  The vaccines were NOT given the same day.
Taking Shingrix depleted my shingles by about 99%/ suspected vaccination failure; Malaise; itchy; irritates skin; Taking Shingrix depleted my shingles by about 99%; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th November 2021, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), malaise, pruritus and skin irritation. On an unknown date, the outcome of the vaccination failure, shingles, malaise, pruritus and skin irritation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, malaise, pruritus and skin irritation to be related to Shingrix.  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 received Shingrix depleted her/his shingles by about 99 percent.   The patient stated he/she had malaise feeling (had to look up definition) so itchy, but he/she knew irritates skin, he/she stopped.  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.
B/P 100/50. C/O "head feels funny", like a headache after HPV given. C/O dizziness, pale after vaccines "I feel tired and weak". About 4p-4:30pm symptoms lessened then was sent home encouraged meal and increased fluids and rest, mother to observe closely.
19 yr old ADA biracial male who received a smallpox vaccine (primary 3 jabs in left arm), along with an influenza vaccine in his right arm on 11/9/05. Prior to Nov 2005, service member describes his health as being "very good". He denies any unusual local reactions at his influenza vaccine site. His smallpox vaccine site was assessed around day 7 as a take. Around day 7 or 8, he experienced fatigue, headaches, and body aches, as well as redness and swelling around his SPV site and left axillary lymphadenopathy. Around day 9 he began experiencing chest pain located substernally and on the left side of his sternum. The pain was sharp and intermittent. On Friday, 11/18/05, the pain subsided shortly after onset. It returned again on Sunday 11/20, and lasted all day. He went to work on Monday, 11/21, and ended up going to the hospital when the pain intensified. When the pain started, it was rated as a level 5/10, but on 11/21, it had increased to a level 10/10. The pain was brought on with activity. (Pain occurred with walking slowly on a flat surface for 1 or 2 blocks, 3 METS). The pain became worse when he took deep breaths and when he laid down, especially on his left side. The pain was accompanied by shortness of breath, an increased heart rate, and fatigue. At the hospital, his evaluation was consistent with myocarditis and he was admitted to the ICU. He was monitored and treated with anti inflammatories. He was discharged on 11/24/04 and reports he continued to have chest pain, shortness of breath, fatigue and the sensation of his heart racing with minimal exertion. He was evaluated by Cardiology at BAMC on 11/30/06. At that time, he would describe his health as poor. He took Motrin BID and was on limited duty until Jan 16th, when he was re-evaluated by Cardiology and his medication was changed. He currently reports he experiences a racing heart, shortness of breath and chest pain with minimal exertion and with excitement. (Sometimes he wakes up with symptoms following a vivid dream.) He remains on a profile for limited duty. Symptom: Chest pain. Comment: sharp, intermittent CP on day 9 after SPV and flu vaccine; onset with activity and worse with lying on left side and with deep breaths. Fatigue, malaise>60 days. Comment: fatigue started about 1 week after vaccines, but still present 2 months later. Lymphadenopathy, axillary. Comment: around day 7, left axillary (same side as SPV). Symptom: Tachycardia. Comment: heart racing. Symptom: Dyspnea (shortness of breath); Symptom: Headache, general; Symptom: muscle pain. Plan is to initiat a medical board-see enclosed reports.
2:52pm went to get a drink of water-came back feeling faint-sat down checked BP 64/40 pulse 84. Cold compresses applied-skin clammy. Gave water to drink. 3:03pm "feeling better" BP 86/50. 3:10pm "light-headed"-laid down on floor-ice to neck. 3:12pm "I'm okay now." -wants to sit. Advised to stay laying tx with feet up. 3:32pm sitting  BP 128/80 pule 96. Standing up "feels ok now." 3:38pm pt left ambulatory with friend driving.
Severe head pain, severe muscle pain, vomiting  Fever 101.8,  swollen right axillary lymph node
Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient's wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient  sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient's wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax 15MAY97 & 16MAY97 pt devel a delayed hypersensitivity rxn w/a bump on leg @ the site of inj;19MAY97 pt devel a rash on arms & legs w/redness & swelling lt thigh;DPH given to control itching;
Itchy, hot hive at injection site. Area felt swollen and hard. Hive approximately 3" across. Preceded by about 2 days of fatigue and muscle soreness (unsure if this is a side-effect or just general exhaustion)
pt recvd vax & became staring, druggy, glassy eyed; this lasted 5 mins, according to mom; fram 6PM-11PM when put pt down, would cry in a high pitch but would stop when picked up;
Left ear ache, ringing in left ear, diminished hearing in left ear, ear infection in left ear; ongoing since symptoms first presented.
Regular sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Regular sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Postmenopausal bleeding in 2019 and Endometriosis (had an intervention to remove a "polyp or something" in her uterus that ended up being endometriosis) in 2019. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Regular sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Mar-2021, VACCINATION SITE PAIN (Regular sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had pain in arm since 6 months.   This case was linked to MOD-2021-363265 (Patient Link).
PT denies any symptoms at this time he was  given high dose flu rather than flulaval, side effects/adverse reactions given; pt will contact PCP if any concerns.
Localized redness, muscle aching on side. Hotness, hard, itching, pain. Taking ZYRTEC and TYLENOL for rxn.
Hardness at vaccine site with 3X4 cm mild redness on LDT.
Information has been received from a nurse practitioner referring to an unspecified number of patients.  On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
Chills started at 12:20 am, followed by nausea and vomiting. This lasted for 5 hours. He also had a fever of 101.7 at the highest. This lasted for approximately 24 hours. He also had fatigue and lack of appetite.  He was given zofran for the nausea and tylenol for the fever.
Pt states she started feeling sick 3 days after the 2nd dose of the shingrix vaccination and ended up in the ER with tachycardia, cough and increased WBC. Pt states ER doctors did not believe this was due to the shingrix vaccination, but pt does think it is due to the vaccination. Pt got fluids in ER and felt better. She did not have a reaction with the first dose.
Last month on 03/2023 I started experiencing lightheadedness and my heart rate was low although, my blood pressure was normal. I've noticed on the machine I was having irregular heartbeat. I was so concerned that I scheduled an appointment with my doctor on 03/27/2023. Since my regular doctor wasn't available I was seen by her assistant. She did an examination. She also decreased my medication metoprolol to 20mg. I stopped taking tizanidine. I stated feeling better afterwards. Am going back to my doctor on 04/28/2023 again for a follow up. My doctor might take me off amlodipine. All the medications have the tendency to have irregular heartbeat so I am trying to avoid as much.
Dizziness, Headache, Myalgia, Fever, Diarrhea, chills, finger swelling, black out spell Narrative:
Patient had received the primary series for Moderna. She came to the clinic today to receive the Moderna booster. Vaccine was given by pharmacy technician  and given out of the bottle that had expired prior to vaccination. Patient was informed and the Moderna booster was given from a newly opened vaccine vial. Patient stayed in the clinic after vaccination for a few minutes and then left.
Left shoulder pain and reduced ROM due to pain after injection. On going for 1 month since injection.
I had itching, swelling in my hands and they got very cold. I was prescribed Zyrtec for the itching and the swelling. I felt tired and weak. I couldn't sleep and my Fibromyalgia was inflamed.
C/o injection site being very swollen (about the size of a baseball) very tender painful when moves arm.
Fever for 3 Days-as high as 103F Severe Aches Headache
Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted
PATIENT HAD A SEIZURE ABOUT 45 MINUTES AFTER GETTIN THE VACCINE. PATIENT'S EYES ROLLED BACK AND STARTED FOAMING AT THE MOUTH. PATIENT HAD BEEN SEIZURE-FREE FOR 3 YEARS PRIOR TO GETTING THE VACCINE.
Patient reported erythema, injection site soreness, inflammation, itching and swelling in her right deltoid.
Arm soreness, red, fever 102.8 degrees, face red and hot, arm pain from shoulder to elbow. Started about 4-5 pm the evening of injection. Took 2 APAP 325mg, used a cold pack, kept arm moving. Unable to lift arm.
Initial unsolicited report received from a nurse on 10-Jul-2018. This case involves a 12-year-old male patient who was inadvertently vaccinated with an expired first dose of 0.5 ml MENACTRA (batch number: not reported, expiration date: 28-Jun-2018, frequency once) via intramuscular in right deltoid on 09-Jul-2018. The patient's medical history was not reported. The patient's concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
S: from injection site red, swollen, warm to touch on right upper arm. Tx: Ice pack applied, Tylenol and Benadryl given PO.
chills, body aches, nasal congestion, sinus congestion, post nasal drainage, epistaxis, ear fullness. starting on 10/2/21. Husband recently tested positive. Received 3rd dose of Pfizer at grocery store, not at clinic
Pt states next day, numbness in forehead and side of face into neck, generalized weakness, "tingling" from mid-spine up.  States symptoms come and go.  Not any worse.
I had low blood pressure and I was very dizzy and faint. My muscles in my arms and legs were cramping or tingling. My tongue was swollen, and I was weak and nauseous. I went to the emergency room on 04/24/2023 and they gave me some fluids. They did not prescribe any medications. They did a CT scan, EKG, and blood glucose to check for a stroke. I got better that afternoon.
VACCINE REMAINED IN FREEZER BEYOND MANUFACTURER RECOMMENDATION. AFTER CONSULTATION WITH PFIZER AND AGENCY REVACCINATION WAS RECOMMENDED  TO ENSURE PROPER EFFECTIVENESS.
Injection site swelled up significantly over a couple days. Started getting concerned something was abnormal within 24 hours of getting the first shot. (5 pm shot, 3 pm took first documentation pictures). After it swelled significantly and caused any lifting / vertical movement in that arm or any motion of the deltoid/biceps I went to a walk in clinic. The nurse practitioner gave me a steroid cream to apply to the area and it went away within 3 days after applying it twice a day.
Information has been received from a licensed nurse practitioner referring to multiple patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported, lot # K021548, expiration date 06-MAY-2016). Concomitant drug was not reported. No adverse effect was reported. Additional information has been requested.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a male patient of an unknown age 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored ROTATEQ (lot# M007311, expiration date 30-NOV-2017; lot# M025572, expiration date 02-JAN-2018) (dose, frequency and route were unknown) for prophylaxis. The vaccines were exposure to 31.6 Fahrenheit for 16 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537:
feeling unwell; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:30 (at the age of 53 years) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation at Workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 (Batch/Lot Number: EL3247) for covid-19 immunisation. On 23Mar2021 22:00, 12 hrs after the second dose the patient experienced chills, fever, feeling unwell. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
dizziness lasts more than one month; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness lasts more than one month) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 DIZZINESS (dizziness lasts more than one month). At the time of the report, DIZZINESS (dizziness lasts more than one month) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact