chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had migraine from 10/26/2021 to 11/1/21, and experienced an ocular migraine with loss of vision on 10/28/21
Received vaccine at 11:15, by 6 pm arm red, hot swollen from shoulder down to elbow.
RANDOM NOSE BLEED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergy no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and  expiry: unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced random nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from random nose bleed on 28-MAY-2021. This report was non-serious.
Swelling and pain in (L) upper arm x 2 weeks, then swelling resolved but pain never went away. It is unchanged. PT attempted - 7 sessions, ROM of LUE improved but the pain is unchanged.
Bruise at injection site.  Redness , hotness on lower portion of arm.  Not in the area of administration.
mom called into clinic describing irritable behavior & knot on legs size of egg;d/t p/hr pt sent to ER where dx w/post inj swelling probable hematoma;site assessed as mild edema-half dollar size;
This spontaneous report as received from a physician assistant and a nurse refers to a 22 year old female patient. On an unknown date the patient was vaccinated with series of doses of GARDASIL (dose, route and lot # unknown). Physician assistant reported the patient experienced a positive HPV test with a PAP test, two years after completing the GARDASIL vaccination series. Nurse resumed the call, stated patient was in office to receive results of PAP test. The outcome of the event was unknown. Additional information has been requested.
Very severe chest pain for 3 hours. I was in to much pain to move around so I stayed laying down. The symptoms then deceased but did not entirely go away.   Note: I experienced similar symptoms once when I had a cold or flu
Shaking; Very week; Lethargy; Did not feel well; Pain in injection site; Fever of 102.00 Degree F; Severe chills; Tired; Headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in injection site/vaccination site pain, fever/ pyrexia, severe chills/ chills, shaking/tremor, very weak/asthenia, tired/fatigue, lethargy, headache, did not feel well/ malaise.  The patient's medical history included Covid-19 (1 Feb 2021). No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache and did not feel well. On the same day, the lab test performed included body temperature 102 degree F (high)  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache, did not feel well were recovering.
Muscle weakness in my legs; Unable to stand; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Dec-2022, the patient experienced MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness in my legs) and GAIT DISTURBANCE (Unable to stand) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that, after vaccination on Thursday afternoon, by Friday patient was on the floor because of muscle weakness in legs unable to stand. Had to have the fire dept come to get patient up. Patient was lucky that son was there, because patient live alone. Patient had to have someone with patient for the next four days before patient could stand by self and use walker.  Treatment information was not provided.
Mid-May, welts began to appear all over my body, filled with water and it looks like acne but it is not. They are painful and itchy. They burn me when it's hot day. They are on the head, face, neck, arms, thighs and legs.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose of Shingrix received on 5th August 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist was unable to locate lot number and expiration date of first dose. No further information was reported. The pharmacist provided permission for follow-up. The case had been linked with US2021151018, reported by the same reporter; Sender's Comments: US-GLAXOSMITHKLINE-US2021151018:same reporter
Hives covering entire body. Went to urgent care facility and was given an antihistmine and steroid.
I realized I was hearing white noise and it would never stop and still has not stopped. I have seen an ENT and had a hearing test. The test showed that I have lost some of my high pitch hearing.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 25 year old female patient with asthma and unspecified reaction to latex. On 09-APR-2013 the patient was vaccinated with the first dose of GARDASIL (INJ 0.5 ML) (lot # H019088, expiration date 26-JUN-2015), intramuscular for prevention of HPV. There was no concomitant medication reported. On 22-MAY-2013 the patient had a positive pregnancy test. It was reported that patient's last menstrual period of 21-MAR-2013 and Estimated delivery date of 26-DEC-2013. Initial exposure to GARDASIL was at 2 weeks. The pregnancy outcome was unknown. On an unspecified date the patient was contacted in the office. The nurse stated that the patient had not had any adverse reactions. Additional information has been requested.
25 y.o. male PT with local reaction to anthrax left arm approximately 11cm x 11 cm induration area at site of injection.
Caused me to start my period 3 weeks early.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unspecified date for an unknown indication.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and sulfamethoxazole; trimethoprim (BACTRIM) and amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication and experienced drug allergy.  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 COVID vaccine. On 02Apr2021 at 12:00 the patient experienced that the vaccine caused her to start her period 3 weeks early. Her cycles were always regular and 28 days. Just finished her period one week prior. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event irregular periods was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial report was received from a consumer, who was also the patient's parent, on 13 June 2013. A female patient had received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an hour later became very white and limp. She was taken to the doctor. The patient's outcome was not reported. Documents held by sender: None.
12 month old received 1 mL dose instead of 0.5 mL dose; 12 month old received 1 mL dose instead of 0.5 mL dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix 1440 adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 24-JUL-2023, the patient received Havrix 1440 adult. On 24-JUL-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: 12 month old received 1 mL dose instead of 0.5 mL dose) and inappropriate age at vaccine administration (Verbatim: 12 month old received 1 mL dose instead of 0.5 mL dose). The outcome of the overdose and inappropriate age at vaccine administration 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 Information: GSK receipt date: 27-JUL-2023 The nurse stated that new shipment of Havrix vaccines came in, and office did not realize the new shipment was 1 mL doses instead of 0.5 mL doses. A 1ml of dose was given on 24 July 2023 to a 12 month old patient which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up. This case had been linked with US2023103052 by same reporter for different patient. The vaccine administration facility is the same as primary reporter.; Sender's Comments:  US-GSK-US2023103052:Same reporter
Death. Found resident expired in bed, hands gripped on his gown over his sternum at 6:15am on 6/14/21. He had no complaints of discomfort before going to bed or overnight.
Following the administration of the vaccine, patient started vomiting, then she reported feeling hot all over her body. She was pacing and was not able to settle. Patient was given 50mg oral benadryl and was taken to the hospital by medics.
Tested positive for COVID-19 on 8/3/2021, asymptomatic.
1st time in hospital ER 2/1/2021. 1st -SVP Superventricular Tachycardia over 180 heart rate. Metoprolol Tartrate did not work and they put me on Metoprolol Succinate. Two weeks later went back to ER over 200 heartrate. Lots of different meds, Denizen-did not work. I was admitted in ICU 12pm to 4am 16 hours. Metoprolol Succinate dose was increased. Rythemol -160 mg every hours. Heart started slowing down. My chertinine kidneys were not normal. Not Anxiety as the doctor thought it was. I don't think it was anxiety. EKG machine showed Afib, multi spots in the heart.
Mom states child woke her up screaming at 12:00AM Thursday night. Symptoms started with swollen glands on back of neck. Friday a rash appeared on face. Saturday a red flat spotty rash covered his whole body. Pt ran fever of up to 104.7 for 4-5 days. Child was seen at hospital. They said child had a virus s/s was not related to vaccines. Also had white bumps inside cheeks.
Patient received vaccine and 48 hours later developed right sided dystonic reaction with significant muscle contractions which have now been going on and worsening.
Gave 2nd Moderna vaccine around 5:45pm.  He came back at 6:55pm stating he was not feeling well, he was dizzy, light headed, visibly sweating and general not feeling well.  His bp was 150/109 HR 69.  I asked if he wanted me to call an ambulance and he declined.  At 7:05 he retook bp on a different  machine.  It was 139/97 and he said he was feeling better.  He is going to repeat bp in 30 min and go to hospital if still very high.  Pt has history of high bp.
Chills, 99.9 fever, body aches, sore and stiff arm at injection site.
Flu vaccine administered 10/16/02 in the office. Approximately 40 minutes to 1 hour after injection, patient presents with severe chills, SOB, nausea, shaking. Patient admitted to hospital immediately.
Intense pressure in ears and eustachian tubes.  Dizziness, intense thirst, hot flashes and head tightness.  Faintness and extreme fatigue and weakness.  Muscle pain and spasms throughout right arm, shoulder, and right side of neck.  Tight throat - felt like I was being choked.  Could not swallow food without extreme difficulty for 6 - 8 months.  Rapid weight loss.  After 2 weeks, developed pain along side of face and jaw and TMJ that has not gone away after 1.5 yrs.  Also currently have eustachian tube dysfunction.
156/96 BP & 140/92BP During routine OBGYN visit. Diagnosed with Chronic Hypertension. 4 pregnancies' and no live birth. 9/23/2021 for current est. DOD.
Information has been received from a licensed practical nurse concerning a 5 year old white male who on 7/26/99 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 630678/0426J). On 6/15/04, the patient presented with a full blown case of chicken pox. Treatment was unknown as the family was on vacation at the time and only saw the physician upon returning. A product quality complaint was not involved. Follow up information was received from the licensed practical nurse who indicated that on 6/15/04, the patient's mother called the physician's office while on vacation to say that her son was polluted with chicken pox. Acetaminophen, diphenhydramine hydrochloride, and calamine (+) camphor (+) pramoxine hydrochloride baths were recommended. Subseuqently, the patient recovered.
04/16/21 2:30 pm increased injection site pain and low grade headache 04/16/21 9:30 pm fever, migraine, severe neck pain, extreme fatigue,  injection site pain 04/17/21 1:00 am fever broke 04/17/21 9:00 am injection site pain and rash small hives around injection site
approx 2hr p/vax pt seized for 15-20sec observed by mom who is also RN;also had extremities became cyanotic 1-2 hr p/vax;
pt recv vax & cried for 24 hr, sl fever;mom states pt started crying 1/2 hr p/vax w/occasional screaming;given APAP & called MD;parent switched to another brand of APAP;pt cried all noc;pt was OK by evening of 12APR96
client stated that she started feeling bad on her way to school today and  had to pull over due to vomiting. client stated that she has a severe  headache. states symptoms began after taking flu and pneumonia  immunizations. she also states innoculation location is very tender to  touch. + Temperature = 104 degrees (on 11.4.2010).  11.5.2010 = her temperature at about 1500 was 105.3.  She has  had a migraine for two days that will not go away, her neck is not stiff, when  she bends over she gets dizzy and her stomach turns, she hasn't been eating  much, she has been drinking powerade and water, and she has been sleeping a lot.   11.8.2010 VET CALLED THIS MORNING TO REPORT THAT SHE IS HAVING MUSCLE SPASMS IN HER RIGHT  ARM, AND CONSEQUENTLY CANNOT LIFT OR MOVE THIS ARM
I just got my third one Saturday I hope this is the last one; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case reported by the patient herself/himself The patient received the 3rd dose of Shingrix,which led to extra dose administered. The reporter stated that he/she just got his/her third one Saturday and patient hoped that ws the last one.
Early arrival/irregular menstruation (1week early) not normal; This is a spontaneous report received from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 18Mar2021 at 15:15 (at the age of 36-years-old) as a single dose, for COVID-19 immunisation. No relevant medical history and allergic history were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included KELNOR for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021, the patient had early arrival/irregular menstruation, one week early (polymenorrhoea) which was usually not normal. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of event early arrival/irregular menstruation was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received Pfizer Peds Bivalent dose instead of Pfizer Peds Mono Vaccine as first dose in primary series. No symptoms/issues reported to pharmacy of adverse reactions.
Patient stated that he didn't feel well then his pupils dilated, his eyes rolled back in his head and he seized for approximately 15 seconds. Afterwards his pupils remained dilated and fixed until he regained consciousness. Patient was assisted to the floor where we waited for paramedics to arrive. The patient stated he was okay and refused to go with paramedics.
c/o severe headache; crying in tears; (2:15 pm) denied pain at injection sites teen alert orientated denied difficulty breathing or other anaphatic symptoms; To take Tylenol; and watch for other signs and symptoms teen has not had headaches in the past. 4:15pm Follow up call: headache improved relieved with Tylenol
This spontaneous report was received from a medical assistant referring to a currently 5-year-old patient of an unknown gender. There was no information about the patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot number: M031568, expiration date: 24-DEC-2017 (strength, dose, frequency, route, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature that remained between -15 and - 10 Celsius degrees, for 60 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports from the same source. There was no product quality complaint involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA002316: US-009507513-1703USA002315:
Headache began 8 hours after shot. 16 hours after shot, woke to body aches and worse headache. Upon waking (8am next day) temp 100.1, headache worsened. Fever and headache persisted despite tylenol (1000 mg q 6 hrs x 3). Slept 10 hours (36-46 hours post shot) and woke without symptoms.
Client received a Moderna Covid Vaccine at a Drive through clinic. The client was under the age of 18, thus did not meet the miniumum age requirement for the product.
shortness of breath and irregular heartbeat (also picked up by my blood pressure monitor) occurred after both the first and second injections.  Was able to control them by deep breathing and resting.  Both abated about a week after the second shot on April 15, 2021.  No prior problems with either symptom, or afterward.
33 yo male with a history of severe needle phobia presents with a syncopal episode after receiving the COVID-19 Janssen injection. Injection was given at approximately 1:38. Patient sat in chair for 4 minutes complaining of "dizziness" after injection. Patient was brought back to our in-house ER bed when he started "feeling better" at 1:42 pm so he could lie down. Patient presented with syncopal episode at 1:43 while being assisted to the back. Episode lasted for 30 seconds. Vital signs taken at 1:43 pm were the following: BP 108/61, pulse 48, sp02 96%, temp 97.2. Patient was able to drink orange juice at 1:43. Vitals taken again at 1:54 pm were the following: BP 103/63, pulse 62, sp02 98%. Patient drank another orange juice at 2:08. Vitals taken at time patient left vaccine clinic 2:09 were the following: blood pressure 108/77, pulse 70, and sp02 100%. Patient left vaccine clinic at 2:19 stating he felt "good enough to walk out of building." No further care was needed.
suspected Vaccination failure; determined I have had a shingles outbreak; itching and blisters on my legs; right foot deformity (boot, brace); anxiety; fall; broke my arm; itching and blisters on my legs; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in childhood) and mouth ulcer (susceptible to outbreaks for many years).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 3rd January 2020, less than 2 years after receiving Shingrix and Shingrix and an unknown time after starting calamine, the patient experienced arm fracture and fall. In January 2020, the patient experienced itchy legs. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, foot deformity and anxiety. The patient was treated with calamine and alprazolam (Xanax). On an unknown date, the outcome of the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy legs, blister, arm fracture, foot deformity, fall and anxiety to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. In 2019, the patient received the 2 doses of Shingrix and believed it prevent from attack. The patient fell and broke his/her arm. The patient had a right foot deformity (boot, brace) and developed itching on both legs. The patient finally determined he/she had a shingles outbreak with itching and blisters on legs. The patient enquired what could be done to completely dry up the itching and blisters. This case was considered as suspected vaccination failure as details regarding time to onset for the events and lab test confirming zoster virus was unknown at the time of reporting.