chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
cramps, nausea & h/a x 5 days p/vax;sx onset 4hr p/vax;
approx 20 minutes post vaccine administration - pt felt lightheaded and c/o palpitations. initial BP 220/100, pulse 65, pulse ox normal. given water and allowed to rest. 15 minutes later BP 195/96, HR 56. his lungs were clear, no SOB or wheezing. on tongue/facial swelling or tingling/itching. pt's heart was sinus regular to brady with frequent PVCs. denies chest pain.  pt then noted blurry vision in addition to lightheadedness and feeling shaky. continued palpitations. he was escorted to ER. in ER, his BP is 145/84. EKG shows SB w/ PACs. he felt better and was  dc'd home.  no medications administered. to f/u with PCP.
sore and a bump on my arm; a bump on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jul-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received 2 shingles shots. The second shot was sore and a bump on his/her arm. It went away and he/she was good now. Additional Supportive information: Follow-up would not possible as no contact details were available.
Client was given expired dose of hep B in error vaccine exp 11-13-11 after 30 min. No adverse s/s observed or voiced.
This spontaneous report as received from a nurse practitioner refers to a 73 year old female patient. In January 2013 the patient was vaccinated with ZOSTAVAX (strength, dose, and indication were not reported). Concomitant medications were not reported. The nurse practitioner reproted that in January 2013, the patient was administered XZOSTAVAX "right over her elbow" instead of in her deltoid. The nurse practitioner reported that she thought the ZOSTASVAX as administered into the patient's bursal sac. She stated that the patient developed discomfort within 24 hours of receiving the ZOSTAVAX. She also states that the patient was seen by her physician on an unspecified date in 2013, who diagnosed her with bursitis and she was prescribed an unspecified antibiotic. The nurse practitioner reported that the patient "still had sponginess of that elbow" (not recovered). The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
25APR96 maculopapular rash,bilat cervical lymphadenopathy,loss of milestones,can't see;29APR96 adm to hosp w/sx irritability&loss of milestones&rt sided extremities weakness;dx acute encephalopathy,congenital cataracts,rt hemiparesis;
Flu like symptoms; Chills; a lot of pain in arm; Feverish; Dizziness; feeling achy; Nausea; Lethargic; This is a spontaneous report from contactable consumer (patient's mother). A 24-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 12:30 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at hospital. Medical history and concomitant medications were reported as none. The patient experienced a lot of pain in arm in Apr2021: Caller stated that the patient was more scrawny and weighs under 100 lbs. Flu like symptoms on 07Apr2021: Stated that they got home around 2:30pm and was feeling normal, this occurred in the evening, about 5 hours after the shot. Feverish in Apr2021: Stated that she did not know the exact temperature because it was not taken. The patient also had dizziness, been feeling achy, a little nausea and lethargic in Apr2021. Patient felt this way now but felt less feverish but still lethargic, nausea, and achy. This was ongoing now. She also had chills yesterday (07Apr2021) and in the morning today. The patient had a dentist appointment today that was canceled. Treatment was received for the events included Tylenol. The outcome of events "a lot of pain in arm, flu like symptoms and feverish" were unknown while outcome of other events were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain in left shoulder blade, back, shoulders and chest, felt like weight on chest.  Adjusted meditation to capsule from tablet, blander diet, stress test. Symptoms decreased.
Patient felt dizzy about 5 min after administration. Her vital signs were stable. The dizziness lasted about 5-10 minutes and then it resolved.
I?ve been struggling with chronic nausea, moderate nausea all the time, severe nausea a couple of times per day.
Headache   chills fever   for three nights with severe night sweats.  loss of appetite and overall exhaustive feeling when trying to do activity  I am a very fit and active adult and this was hard
DIZZINESS< VERTIGO  for 3 weeks. Pain at injection site delayed 2 weeks. Cannot function properly. Light sensitive.. Neck pain.
I began vomiting at 3 AM, and continued vomiting often until 9:30 AM on 1/18/21 I am hoping it was not a reaction to the vaccine but I thought I should report it just in case.
Patient received undiluted Pfizer Pediatric vaccine 0.2ml  (Father was informed and told to watch /monitor injection site and expect arm will be extra sore.  He should ice the area, give tylenol and keep the child hydrated)
Tinnitus  Sounds like I?m in a teeny tiny room with 1 million crickets
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-393453, MOD-2021-393454 (Patient Link).
Patient was administered 0.3 mL monovalent Pfizer vaccine instead of intended 0.3 mL bivalent Pfizer booster. Medication administration error due to Pfizer monovalent/bivalent vials looking similar with same-colored caps.
Information has been received from a physician concerning a 13 year old female with asthma who was vaccinated with GARDASIL. The patient experienced an asthma attack 24 hours after receiving the vaccine. Subsequently, the patient recovered. The asthma attack was considered to be immediately life-threatening. There were not lab diagnostic studies performed No further information is available.
Left arm (where shot was given) continues to ache and be somewhat weak through left hand more than a week after the vaccine. Feel a lump and tenderness in left underarm. Tenderness has spread to chest near collar bone.
This spontaneous report as received from a pharmacist refers to a 3 week old female patient. On 20-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot number was J004387 with expiry date of 04-JAN-2015. On 21-SEP-2014, 2 days after onset of therapy the patient experienced cellulitis. The patient sought medical attention. Doxycycline was given for the event. The outcome of cellulitis was reported as recovering/resolving. Additional information has been requested.
Information has been received from a medical assistant concerning a female patient who was vaccinated with the first dose of GARDASIL and had fainted. Unspecified medical attention had been sought. The patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Bump at vaccination site about 1 week after receiving vaccine, which has become blotchy, red, and hot 10 days after vaccine.
Patient inadvertently received an extra dose of IPV (polio vaccine). Denies any adverse symptoms.
Nose bleed; This is a spontaneous report from a contactable Consumer. This 53-year-old female Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown; 53-year age at the time of vaccination), via an unspecified route of administration on 25Jan2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. patient had the first dose of the Pfizer vaccine on 25Jan2021 and has reported having a nose bleed starting from 28Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sleeping on and off because she feels tired; head feels very heavy; I get dizzy standing; My body feels achy; I feel sick; I feel Slightly nausea; head is pounding; Sleeping on and off because she feels tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping on and off because she feels tired), HEAD DISCOMFORT (head feels very heavy), DIZZINESS POSTURAL ( I get dizzy standing), PAIN (My body feels achy) and MALAISE (I feel sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleeping on and off because she feels tired), HEAD DISCOMFORT (head feels very heavy), DIZZINESS POSTURAL ( I get dizzy standing), PAIN (My body feels achy), MALAISE (I feel sick), NAUSEA (I feel Slightly nausea), HEADACHE (head is pounding) and FATIGUE (Sleeping on and off because she feels tired).        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Sleeping on and off), HEAD DISCOMFORT (head feels very heavy), DIZZINESS POSTURAL (dizzy when standing), MALAISE (Feels sick) and NAUSEA (slight nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2. On an unknown date, the patient experienced SOMNOLENCE (Sleeping on and off), HEAD DISCOMFORT (head feels very heavy), DIZZINESS POSTURAL (dizzy when standing), MALAISE (Feels sick), NAUSEA (slight nausea), HEADACHE (head is pounding), MYALGIA (Body feels achy) and FATIGUE (Feels tired).        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Exaggerated chills, sleepiness, no fever, slept under 3 blankets for interrupted 15 hrs.
Patient states she had red, swollen arm with itching approximately 7 days after first vaccination.
I ended up with Covid Toes.  The fourth toe on the left foot pulsated with pain for several hours that night.  Two nights later the same thing happened on my right foot.  Several of my toes ended up with scabs on the tips of the toes.  My dermatologist told me that my toes had hemmouraged on the inside and the scabs were a result of that.  She had not seen anything like that.  I have  looked at all the images of Covid Toes on the internet and have not seen any with scabs on the tips of the toes.
Started with a horrible headache, immediately followed by body aches with increased stiffness in joints. 24 hours later, I have chills, low-grade fever (99.2), headache, entire body aches, injection site pain and redness and some chest tightness. I basically feel like I did, when I had COVID in April.
Shortly after receiving the H1N1 vaccination I just could not get enough sleep.  I began sleeping through my alarm at 5:00am and not being able to get out of bed until 12:00 or 1:00pm.  I would nod off while driving to work, even though it is only a 30 minute drive and I had only been awake less than 2.5 hours.  I actually drove my car off the side of the road once, I woke up and I was just sitting in my car....  I would fall asleep at the light at the exit ramp of the freeway to work.  I would be so overcome with the need to sleep, I would shut my office door and sleep on the floor at 9am.  I would sleep in my car instead of eating lunch.  I came home from work and took 3-4 hour naps.  On the weekends, I would sleep 15-19 hours a day.  I tried to drink caffeine (I usually don't) and it did not help me stay awake.  In mid-December I went to see my gynecologist, thinking maybe I was anemic.  She woke me up (I fell asleep in the exam chair!) and told me that there was no way the extreme sleepiness was caused by my cycle. She ordered a multiple sleep latency test - I averaged 5 minutes to fall asleep for each nap.  Since then I have been in an out of doctor's offices, trying a variety of pills, lifestyle changes, anything to get my life back.  I used to be able to function daily, not since November 2009.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient described having a very sore arm and the area of the vaccination a circular area turned red and swollen and hard.  Patient reported symptoms remained 5 days after recieving vaccine.  Advised patient to contact her physician for further evaluation
I first developed a deep chest cough. That then lead to a feeling of fatigue. The Morning of 10/28/09 I developed significant headaches, muscle aches, chills and a fever. The the muscle aches have largely gone away, I still am experiencing bad headaches along with chills and fever.
pt recv vax 12DE95 & 20FEB97 pt devel approx 35-40 lesions that were described as chickenpox;
After second Covid vaccination patient developed catamenial anaphylaxis to Prostaglandins during menses, starting the month after vaccine.  Had a reaction (moderate) in Oct with body flushing, abdominal cramping, diarrhea. Period started 4 hours later.  November worse reaction with facial swelling/body flushing, abdominal cramping, rigors, vomiting and diarrhea.  Period started within a few hours.  December was associated with abdominal cramping and diarrhea only. Period started a few hours later.  Patient had Covid 12/25/21, mild case. January 2022 reaction was anaphylactic with facial/lip swelling, hives, rigors, abdominal cramping, nausea, vomiting and diarrhea, full body flushing.  Periods started a few hours later.  Required Benadryl 50 mg, Pepcid 40 mg, Prednisone 40 mg, Phenergan 12.5 mg and Zyrtec 10 mg (in addition to her regular dose).  4 hours later symptoms subsided.  This event is likely to continuing to occur monthly at her menses
Exposure during breast feeding; Sleeping continously; lethargic/sleeping continously and is not her usual self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 month-old female patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 06May2021 18:15 (Lot number: EW0168) as dose 1, single for covid-19 immunisation. The mother of the patient was 34 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother is expected to deliver a baby(s) on 18Nov2021. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "Exposure during breast feeding"; LETHARGY (non-serious) with onset 08May2021 15:00, outcome "not recovered", described as "lethargic/sleeping continously and is not her usual self"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping continously". Therapeutic measures were not taken as a result of lethargy.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other medical history asthma not active currently. Device date was reported as 09May2021. Known allergies Ibuprofen, paracetamol. Parent last menstrual period date was reported as 10Feb2021. Delivery date was 18Nov2021. Reported event included that the mother was a breastfeeding mother of 23 months old daughter. She was also 11 weeks pregnant when she took first dose of vaccine on 06May2021. She checked with Gyn and Paediatrician before taking vaccine. Had usual muscle pain after vaccine and continued breastfeeding. Her daughter was sleeping continuously and was not her usual self since Saturday 08May. She was very lethargic. She has not taken any medication. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021516967 same reporter/drug with different AE/patient
Tingling in throat, after first vaccine.; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient experienced tingling in throat, after first vaccine on an unspecified date. The outcome of the event was not reported.  Information on the Lot/Batch number has been requested
I had nausea and dizziness and then passed out.  I hit my forehead on a blunt object so I had a gash over my eyebrow.  It was stitched up.  CAT scan was normal.
A legal complaint was received from an attorney alleging that a 78 year old male pt received Orimune vaccine (poliovirus vaccine live oral trivalent) in 1960, when he was approximately 35 years old, that was contaminated with SV40. According to the legal complaint the pt was diagnosed with "mesothelioma in which SV40 was a substantial factor and therefore one of the causes of his mesothelioma." The pt died as a reuslt of the adverse event. Reported on 04/03/2003: "Additional information received 03/19/2003 contained laboratory tests performed and indicated that patient was not deceased.  A legal complaint was received from an attorney alleging that a 78-year-old male patient received Orimune vaccine (poliovirus vaccine live oral trivalent) in 1960, that was contaminated with SV40.  Medical history included a hernia repair, prostate surgery, cigarette smoking, pipe smoking and occupational exposure to asbestos.  According to the legal complaint the patient was diagnosed with "mesothelioma in which SV40 was a substantial factor and therefore one of the causes of his mesothelioma".  Laboratory tests performed in August 2001 included a chest x-ray that showed fluid in the lungs and pulmonary function tests for shortness of breath.  In August 2001, a bronchoscopy, mediastinoscopy and biopsy were also performed that revealed mesothelioma.  This case was considered medically important.
Red/irritated skin, rash, hives, and itchy skin along both legs (front and back) - I took one Benadryl pill and put anti-itch cream on both of my legs. The rash/hives were gone by morning.
Received Menactra 48 hours ago in left arm.  Now red, tender area with blistering lesions.  Addendum 9/8 - arm improved.
AUG 25, 2021 Atrial Fibrillation/Flutter  Medical Center  EVENT MONITOR SUMMARY:  Indication for placement: assess afib burden/rate control  Requestor- (Privacy)  The monitor was placed 6/25/21 with 269 hours usable  Finding- sinus rhythm/1st degree av block rate 44-119 avg 66 bpm  also 27% afib- V rate 52-188 avg 98 bpm longest run 20 hours  also 2 episodes VT- fastest/longest run 4 beats up to rate 154 bpm  all ectopic beat types rated as rare  Final Interpretation: 27% afib with reasonable ventricular rate VT as above.?rare overall ectopy?device activations without abnormality beyond sinus brady  /es/ (Privacy) Staff Cardiologist?Signed: 07/28/2021 12:32
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Patient has received excess doses. 6 doses total moderna 1/7/21 and 2/4/21, pifzer 8/8/21 and 8/29/21 and boosters of moderna 1/24/22 and 5/24/22. Unaware until after booster was given due to patient telling different information when questioned before getting vaccine.