chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician assistant and nurse concerning a 17 year old female who on 25-DEC-2008 was vaccinated with the first dose of GARDASIL (lot# 661764/0650X) 0.5 ml at 15:00 PM. About 10 second after receiving GARDASIL, the patient was dizzy and fell to the ground. Her muscles in her left arm, where she got the vaccine, locked up. When she stood up she was confused. She was observed for about an hour however did not have any injuries from falling to the ground. The only thing she ate during the day before hand was a "small slice of pizza". The patient recovered from the events on the same day. Follow-up information was received from the licensed practical nurse. The student was vaccinated with the first dose of GARDASIL IM into the left deltoid using aseptic technique in the afternoon on 26-NOV-2008 (previously reported as 26-DEC-2008). Within 1 minute post injection, the patient was getting up from exam table and stated "I am dizzy". She fell to the left side of bed and had the back of her head on floor, left arm contractured and bilateral myoclonus lasting about 20 seconds. The patient was confused upon awakened. The patient was given BENADRYL 25mg and monitored for 1 hour. The mother was advised to check neuro status every 2 hours. Additional information is not expected.
(L) deltoid with 50 mm x 50 mm redness and swelling 2 days after DTaP
Nine days post vax, developed 3x2 cm area of redness & induration at injection site, with 2-3 pustules, Keflex began by mouth. Redness cleared over 5 day period.
The first dose of the vaccine caused extreme cramping and bleeding but the second dose is the one which I am reporting.   Two days after receiving the second Moderna vaccine I started having the most painful menstrual cycle I have ever experienced in my life.  It is also the heaviest case of bleeding that I have ever experienced.   The pain was so severe, I was unable to get out of bed or do anything for a few days. I was on 800 milligrams of motrin twice per day and I had a heating pad on my stomach or lower back at all times of the day or night. I was unable to sleep due to the pain.   I went through an entire tampax regular size box in less than a day and a half. Meanwhile, I was bleeding through all of my clothes for several days and soaked my sheets in blood the first night.
Presented in office on 1/24/2014 states has had pain at injection site since injection given. No redness no swelling no lumps or skin changes.
Headache, Myalgia, NauseaVomiting, Chill, otalgia, fatigue Narrative:
New onset of headache with photophobia and neck muscle aches x 2 days. (Onset 9/11/18. No fever, no nausea or emesis. No neck rigidity on exam. Vitals: T: 97.1 HR: 78, RR 18, BP: 123/80; Normal functions and neurological exam.
Noticed night sweats next night which continued for 2-3 weeks, which then subsided. Hot flashes mostly at night with abdominal pain, like a phantom uterus. (I had a Hysterectomy). Felt like a severe hormonal imbalance. Next noticed my heart would pound and skip beats routinely from climbing steps or minor exercise off and on for about 9 months. I took anti-inflammatory med which eliminated symptom gradually. Now a mammogram has led to biopsies and cancer checks.
Severe rash/hives covering 40 to 50% of her body.  Patches of raised irritated skinS specifically under both breasts, around mid abdomen at waist band, at the underwear line on both legs, neck, face, around eye,scalp, random spots on legs and back.  At most severe stage 6 days after vaccination, swollen face, neck and around eyes.  Patient reported severe itching, burning and hot sensations at sites of rash.  She was started on a steroid but called the Dr after 4 days complaining that there was no improvement. Dr. then told her to discontinue that steroid pack and prescribed a stronger 20 day dose of Prednisone 20mg tab.   At the time of this reporting the rash has diminished by maybe 30%. Patient still has severe itching and burning and had been remediating symptoms with oatmeal baths, cool showers, aloe vera w/lidocaine cream.  She cannot wear clothing for more than a couple hours and had her sleep disrupted to the point of only sleeping about 4 hours per night. Dr. also prescribed cimetadine and triamcinolone cream.
APPROXIMATELY 12 MINUTES AFTER VACCINATION, DEVELOPED LIPS TINGLING, FLUSHING, SLIGHT WEAKNESS IN LEGS AND REPORTED FEELING 'OFF'. RECEIVED 50MG DIPEHNHYDRAMINE IM AT 1:43PM. STAFF MEMBER REPORTED SHE FELT GOOD ENOUGH TO DRIVER HERSELF HOME AT 3PM. WAS INSTRUCTED TO CALL PCP OR GO TO URGENT CARE/ER IF SYMPTOMS PERSISTED/WORSENED.
My Brother was found dead at home -  Not sure it's vaccine related - but  he did not have major or urgent health issues .
Case number PHEH2015US016740, is a combined initial and follow-up spontaneous report from a health care professional received on 26 Aug 2015. This report refers to a 23 years old female patient. Medical history was not reported. Concomitant medication included ORTHO-TRI-CYCLEN LO. Her vaccination history included administration of first dose of RABAVERT (batch number: not reported) on 20 Aug 2015 after a bat was found in their home. The patient was inadvertently vaccinated only with the diluent as the second dose of RABAVERT (batch number: not reported) into left deltoid muscle on 23 Aug 2015. The patient also received IG injection for the post exposure. The patient experienced immediate pain with the injection in the left deltoid muscle that lasted about an hour and resolved. The patient did receive the actual vaccine for the second dose but that was administered in right thigh. Seriousness and causality of the event were not reported.
When pt. awoke and stood up she passed out while standing up.  When she fell it is believed she hit her head on her dresser and  was knocked out for 2 minutes.  Her mother was unable to wake her during the 2 minutes.  EMS was called.  When she did awake she was very disoriented and said she could not hear.  By the time EMS arrived she was coherent and they checked her blood pressure (which was normal) and her temperature (which was 101.5).  She was not taken to the hospital as EMS advised against it stating the hospitals are full of covid patients.  Her pediatrician was contacted, she was not seen.
This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On 12th March 2019, the patient experienced tiredness, weakness and headache. On an unknown date, the outcome of the muscle soreness, tiredness, weakness and headache were unknown. It was unknown if the reporter considered the muscle soreness, tiredness, weakness and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX and experienced shoulder muscle soreness last night from the reporting date, but that was expected. On the reporting date, the patient really tired, just worn out and feeling a little weak and had headache. The patient asked, how long the symptoms might last. The patient refused to give her date of birth and physician's (MD) contact details.
Left arm redness, raised area approx. 9 cm in diameter, warm to touch, non-tender, itching. Instructed to take BENADRYL for localized reaction.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced muscle pain, fatigue, pain in arm, general body pain and eye red. On an unknown date, the outcome of the muscle pain, fatigue, pain in arm, general body pain and eye red were unknown. It was unknown if the reporter considered the muscle pain, fatigue, pain in arm, general body pain and eye red to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced muscle pain, fatigue, red eyes, pain in her arm and body and wiped out feeling after receiving a dose of SHINGRIX. The reporter consented to follow up.
Reaction: Pt received vaccine in L arm. Pt had immediate vagal response post vaccine administration. Friend supporting pt until staff assisted pt to floor. Pt placed supine, legs elevated, pulses present, airway patent/breathing and able to communicate with staff. Pt reported being confused. Vital signs at 1401: HR 69, Spo2 97% on RA. 1402 Pt placed on 6L 02 for comfort. 1405 HR 61 BP 135/75 RR 16 Spo2 94%. Overall vagal response lasting 20 seconds. 911 called at 1400. Prior to EMS arrival patient A&Ox4, able to move herself to chair position with stand by assist. Patient tolerated a couple bites of granola and a few sips of water and juice. Patient than lied upon chairs with staff supervision until EMS arrived around 1420. Patient ambulated out of clinic with EMS.  No record available if patient seen anywhere after episode
Puffy below injection; Redness; Rash; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on on 22Mar2021 at 00:00 as a single dose(at the age of 78 years)  for COVID-19 immunisation. Medical history included diabetes, high blood pressure and hyperthyroid. It was reported that the patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 00:00, the patient experienced redness, rash and puffy below injection. 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 events. The clinical outcome of redness, rash and puffy below injection were 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: amended Lot as unknown, anatomical site was deleted, closure statement updated and narrative data amended.
ADMINISTERED SECOND DOSE (BOOSTER) OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced administered second dose (booster) of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered second dose (booster) of the janssen covid-19 vaccine was not reported. This report was non-serious.
Information has been received from a physician concerning a 5 year old male pt with a history of ventricular septal defect repair who on 05Jun03 at 10:00AM was vaccinated with the second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , SC administration in the right thigh. On 05Jun at 12:00PM, the pt developed scattered hives after MMR. It was unknown if the pt recovered from scattered hives. Additional information has been requested.
Patient started to feel light headed , cold sweat, pale  and nauseated about a minute after the injection.  I had patient lay down on the floor with her feet up on the chair for about 15 to 20 minutes. After 20 minutes patient feels better.
she received the first dose 2 weeks ago and developed itching around her mouth and hives around her mouth. She did not have any systemic symptoms including shortness of breath, hives all over, swelling in her body, GI symptoms. She states that she took 2 Benadryl at the site where she was vaccinated and it went away later that night. She does remember being very drowsy after the Benadryl.
pt recv vax 16OCT96 & pt exp fever that according to pt mom was not high & a cough;pt recovered from sx 18OCT96;
CHILLS; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, nausea, and fatigue on 15-MAR-2021. This report was non-serious.
Information has been received form a health professional concerning a 35 year old female with no known drug allergies who in 1996 was vaccinated with varicella vaccine. A titer taken in early 2001 did not show seroconverion. Addiitional info has been requested.
Strong headache; Feeling like throat was closing; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an Intramuscular route of administration in the right arm on 30Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications were not reported. The patient's past drug history included DK (MANUFACTURER UNKNOWN), since unknown date for an unknown indication. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021, the patient initially experienced a strong headache but then progressed to feeling like the throat was closing. It was reported that the patient went to urgent care for tx. The events resulted in emergency room or department or urgent care. The clinical outcome of the events strong headache and feeling like the throat was closing was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills, dizziness, nausea, muscle and joint aches, I fell and could not get up at all. My bowels let go. I still cannot walk right I still have a sore throat. I would not go through this again. Bad headaches.
After the vaccination in the observation area the patient could not follow commands. She had a blank stare. She was breathing but not responding. Her grandmother, who was with her, said she has a history of seizures, and she always makes sure that her granddaughter takes her meds. Vitals were taken and EMS was called.
4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; 4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; 4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route in the left arm on 02Feb2021 at 15:00 (at the age of 57-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had known allergic to amoxicillin. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), via an unspecified route in the left arm on 12Jan2021 at 15:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not use other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 06Feb2021 at 08:00, the patient experienced vertigo/dizzy. She could not walk for about 30 minutes without holding on to something. The patient did not receive treatment for events. The patient underwent lab tests and procedures which included COVID test nasal swab was negative on unspecified date of 2021. The outcome of events was recovered on unspecified date of Feb2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Diagnosed with type 2 diabetes. Prior to vaccine, A1C was always under 7.
Worsening of tinnitus occurring periodically from April 7, 2021 til current date 4/17/21
I developed arrhythmia after I received the COVID-19 vaccine booster shot. The first two doses of COVID-19 vaccine I received were Pfizer which did not cause this side effect, though I developed fever after the second dose. After I received the booster shot, I had fever for two days and then I started to have premature heartbeats. Then it went away for a month. It started again in February is getting worse. Now I have a lot of premature beats (every other beat), very frequent and all day long for the past few days, sweating during sleep, and sleepy during the day. I saw emergency today. The doctor has prescribed me metoprolol. I strongly believe this is caused by Moderna vaccine. I would like to mention that when I took Shingles shot a few years ago, I also developed arrhythmia for about two weeks. I am general healthy and do no have any other health related issues. I strongly believe the symptom is caused by the COVID-19 vaccine.
Enlarged lymph node in left armpit, baseball size.  Painful/bruised, appeared less than 24 hours after second injection of Moderna #2.
Tightness in throat, tingling in tongue and lips within minutes of injection. BP, HR, O2 saturation, physical exam - Normal symptoms improved with po BENADRYL.
Heart Failure Ejection factor dropped to 24%. Down from 44% . Like I fell off of a cliff. Not a slow decline.
7/20/21 runny nose, ear congestion, loss of smell 7/22/21 fever, headache 7/28/21 symptoms resolving 7/30/21 fully recovered, sense of smell returned
took 2 shots /they are terribleand they do leave scars; This case was reported by a consumer via interactive digital media and described the occurrence of scar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced scar. On an unknown date, the outcome of the scar was unknown.   It was unknown if the reporter considered the scar to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not provided. The age group was not reported but it was captured as adult as per vaccine indication. The patient took the shot and would not wish them on his or her worse friend, they were terrible and did leave scars just like chicken pox do. The reporter stated that 2 of his or her sister's did not take them but 1 and he or she, did an slept in the same bed till mamma had to make a bed in a chair away from the other kids. The patient had them so bad then shingles 4 years ago. For tolerance of 2nd dose refer case US2021AMR077290.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077319:same patient
COVID-19; COVID-19; Crohn's aggravated; Streptococcal sore throat; This is a solicited report based on information received by Pfizer from a company (Manufacturer Control Number#: 21K-163-3939945-00). A 34-year-old female consumer (patient) reported that:  Solicited report by a consumer of an adult female with events of non-serious CROHN'S FLARES, STREP THROAT and COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced Crohn's Flares, Strep Throat and COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 07Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA(ADALIMUMAB). The reporter's causality for the event(s) of Crohn's Flares, Strep Throat and COVID-19 was not provided.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of Crohn's Flares, Strep Throat and COVID-19 was not provided.  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Causality for events 1)Crohn's aggravated, 2)Streptococcal sore throat, 3) COVID-19 Causality as per reporter was Possible  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.; Sender's Comments: As per the information in the case provided, the causal association between the events Drug Ineffective, COVID-19, Crohn's disease, Pharyngitis streptococcal and the suspect drug COVID-19 Vaccine 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.
Patient became pale and lost consciousness for approximately 2 seconds.  Felt clammy and heart beat was slow.
Chills, headache, diarrhea,  nausea, fatigue, started that night and lasted thru the next day.  I took no medication.
Patient has experienced extreme fatigue limiting daily routines such as shopping, talking care of her house, cooking and even walking since getting the last vaccine approximately 3 months ago.
Pt c/o tingling in bilateral hands and heart racing resolved within 5 minutes of the initial response; no complaints of any other symptoms; pt observed for 30 minutes Vitals Obtained: initial vitals B/P 140/72 HR=100-107, R=22, 02 sat 99-100 on Room air  Final Vitals: HR=67 02 sat 98% on Room Air
36 weeks pregnant; patient complained of pain in right arm (opposite from injection site) and right leg.
Effect 1: About a week(5 days or so) severe pain in left leg from the knee down and ankle. Severe as in can?t stand the pain and feels like the leg from the knee down to ankle was being cut off.  Effect 2: got my period 7 days after the vaccine was given and it hasn?t gone away. Heavy bleeding and fatigue. I typically don?t get a period and am irregular so this is not normal for me personally.
Had H1N1 vaccine, next morning had hives on hands and feet, took Benadryl and hives resolved.