chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Everything was going faster and speech was accelerated; The patient felt like she was on Speed. Everything was going faster and her speech was accelerated. No heart collocation and no temp (just felt like her whole world was racing); BNT162B2 was administered 59 days after the primary dose.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 10May2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included left anterior descending coronary artery stenosis (RA. Stint placed at the LAD) from an unknown date in 2005 and unknown if ongoing and COVID-19. The patient had known allergies to sulfa drugs, injection iodine and penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and experienced drug allergy. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 (at the age of 66-years-old)as a single dose for COVID-19 immunisation. On 10May2021 at 16:45, it was reported that the patient felt like she was on speed, everything was going faster and her speech was accelerated, no heart collocation and no temperature (just felt like her whole world was racing).  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like the patient was on speed, everything was going faster and speech was accelerated was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Spoke with patient's wife, reports patient woke up this morning feeling dizzy and "drunk" unable to stand or walk without holding onto things in the home for balance. Checked blood pressure this morning 141/81, Pulse 53. Patient believes he is dehydrated from working outside yesterday painting the porch however wife is unable to keep patient awake long enough to push fluids, patient complains of nausea, dizziness, unable to eat, patient began vomiting while on the phone with wife. After patient was settled wife retook blood pressure now reporting 181/102. Advised patient should be seen urgently for evaluation, she and patient are agreeable she states she is going to try to get patient into the car to go to ER if she is unable she will call EMS for transport.
Received vaccination at 2:30pm on 4/7. From 10pm that same evening until 10am the next morning, I experienced a severe headache - took ibuprofen with no relief, fever of 101, sweating (my air conditioning was on 66 degrees and I was still sweating) and nausea without vomiting. The symptoms persisted overnight until subsiding the next morning. Soreness at the injection site continued for an additional three days until approximately Saturday morning. No other symptoms since then to date.
Pt developed a low-grade fever, post vax, and began losing skills after 18 month DTAP and then lost all skills of language, cognitive and pragmatic. He formed major sensory issues by the age of 27 months. He now has severe autistic disorder. The annual follow-up states "severe autistic disorder, intestinal dysbiosis, severe malabsorption, leaking gut syndrome, heavy metal toxicity, chronic yeast infection, severe food allergies."
Patient woke up on tuesday 09-21-2021 walking and patient felt "queasy" and "blacked out." Patient able to call family to come get patient. Wednesday 09-22-2021 patient "couldn't walk and left arm was numb and could not use it." Patient states she called ambulance and they told her she had "afib." Ambulance took patient to hospital  where they diagnosed her with "TIA and afib." Patient states she spent "1 day at hospital."
product storage error/vaccines were administered to an unknown number of patients at unknown dates; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) (batch number 9R2D7) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 7745R) for prophylaxis, HAV (Havrix 720) (batch number Y3ME2) for prophylaxis, HBV (Engerix B Junior) (batch number 99A45) for prophylaxis, Hib (Hiberix) (batch number 4R9T4) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVA950A) for prophylaxis, Men B NVS (Bexsero) (batch number XX33P) for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Infanrix, Kinrix, Havrix 720, Engerix B Junior, Hiberix, Menveo, Bexsero and Boostrix. On an unknown date, an unknown time after receiving Infanrix, Kinrix, Havrix 720, Engerix B Junior, Hiberix, Menveo, Bexsero and Boostrix, the patient experienced incorrect storage of drug (Verbatim: product storage error/vaccines were administered to an unknown number of patients at unknown dates). The outcome of the incorrect storage of drug was 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: 11-OCT-2023 The office manager states Infanrix, Havrix, Engerix-B, Kinrix, Hiberix, Menveo (2 vial), Bexsero, and Boostrix had excursions from 01-SEP-2023 to 22-SEP-2023 and were exposed to 33.76 F (Fahrenheit) and 51.35 F and 31.3 F and 41.0 F. The reporter did not know how long the vaccines were above the recommended range.  Prior 01-AUG-2023, 34.70 F and 51.35 F, from 04-AUG-2023 to 31-AUG-2023, 34.70 F and 51.35 F, from 25-JUL-2023 to 31-JUL-2023, 35.51 F and 41.93 F. Time above recommended range unknown. These vaccines were administered to an unknown number of patients at unknown dates. The vaccine administration facility was the same as primary reporter. The healthcare professional (HCP) did not had any patient identifiers or expiration dates for the vaccines at the time of the call. The reporter consented to follow up via postal.
Mass - Information has been received from a health care professional concerning a 6 year old male who on 11 Feb 1999 was vaccinated with one dose of varicella virus vaccine live  (site unknown) On 06 May 2000 the patient developed lesions.  By 10 may 2000 the patient had approximately 63 lesions and was afebrile.  The patient sought unspecified medical treatment
Day 1 after shots, localized redness and swelling at injection sites (sub q, worse than IM).  Day 2 after shots, left leg was swollen from thigh crease to knee. Red blotchy rash covering entire thigh.  Day 3, swelling was subsiding and area was bruised in appearance.  No treatment was needed other than Tylenol and cool compresses.
Received adult dose Pfizer -Biontech although patient is 7 days short of becoming 12 years old.   No adverse effect present per Mom 8/11/22 1pm
FREEZING; BODY ACHES; MUSCLE ACHES; FEVER (FELT FACE WARM); HEADACHE; FELT FATIGUED; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 155 pounds, and height was 66 inches. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and did not have alcohol (on the day of vaccination).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced felt fatigued. On 28-MAY-2021, the subject experienced freezing. On 28-MAY-2021, the subject experienced body aches. On 28-MAY-2021, the subject experienced muscle aches. On 28-MAY-2021, the subject experienced fever (felt face warm). On 28-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigued, headache, fever (felt face warm), freezing, and muscle aches, and the outcome of body aches was not reported. This report was non-serious.
(L) arm, back of arm site reaction, redness 66mm, induration 32 mm. Client noticed 11/18/11 at 06:00pm. States reaction reduced the last two days. Referred to MD, client states she will go today.
cough, tired, headache, stomach problems, within two days of seeing my family doctor with the cough I developed pneumonia, sickness, severe stomach pain - urinary track infection ,having trouble  drinking water and I usually drink a gallon of water a day, can not go to the restroom bowels are painful  fever,
Narrative: Second Moderna COVID vaccine admin 2/18/2021. Pt. passed away at Hospice 3/23/21 at 11:45PM. He had severe dementia, was in inpt hospice.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported, 1 single shot, subcutaneous). Concomitant therapy was not reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Random sharp pains through out my body; Random sharp pains through out body, foot, leg, hand, arm.; Random finger pain at joint; Nausea; Fatigue; Bad headache/Bad sharp pains in the back of head; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03May2021 at 14:45 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient reported as shellfish, peanuts in past drugs. Concomitant medications included salbutamol (VENTOLIN), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC), all started on unknown date within 2 weeks of vaccination for an unknown indication. 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. On 03May2021 at 15:30, the patient experienced random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache. The clinical outcome of the events random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache was not recovered.   The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received  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  1. known_allergies: Shellfish, peanuts captured as RMH 2. Treatment Received updated to NO for all AEs 3.  "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (batch no. 082B22A) for COVID-19 vaccination.No Medical History information was reported. On 19-Sep-2022, the patient received dose of mRNA-1273  (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273(Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered 2 days after use by date to 2 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18Aug2022 and date of administration of vaccine on 19Sep2022). No concomitant medications were provided. Vial size was 5.5mL. The vial did not undergo any temperature excursions and the vial was initially stored in refrigerator on 18-Aug-2022. No treatment medications were reported
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08May2021 at 15:15 as dose 2, single (Batch/Lot number: unknown), in right arm, on 11Nov2021 at 16:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 26Apr2022 at 18:15 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxazosin, reaction(s): "Known allergies: Doxazosin"; Hydantoins, reaction(s): "Known allergies: Hydantoins"; Tadalafil, reaction(s): "Known allergies: Tadalafil"; Phenytoin sodium extended, reaction(s): "Known allergies: Phenytoin Sodium Extended". The following information was reported: VACCINATION FAILURE (congenital anomaly, medically significant), COVID-19 (congenital anomaly, medically significant) all with onset 28May2022 at 08:00, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical information: Treatment drug included Paxlovid from 28May2022 to 01Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Irregular heartbeat noticed approximately 36 hours after first Covid19 Moderna vaccination.  Symptoms continued periodically to, and through, the date of the 2nd Covid 19 vaccination.  Subsequently confirmed via EKG and 2-week heart event monitor to be AFIB. Echocardiogram shows Tricuspid Valve Regurgitation and dilated right atrium.  AFIB episodes are paroxysismal and typically last 8-10 hours each.  No previous symptoms or problems prior to the two Covid 19 vaccination doses.
I have shingles on my right side almost 3 months to the day since i had the second shot. They were both Pfizer brand vaccinations. Took the shot in my right arm both times.
dizziness; This spontaneous case was reported by a patient and describes the occurrence of   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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Headache, Myalgia, Arthralgia, Localized pain, redness; chills, fatigue
Severe Fever, body ache, headache 12 hours after shot. Muscle pain and lung tightness , congestion for week after shot was received
Over a period of two weeks has experienced alternate swelling of different body parts. Usually occurring after accidentally rolling over and sleeping on the arm which received the shot (recipient is a side sleeper). First lower lip swelled on one side (the left side), then left ankle, then vulva area/clitoris, then left arm around the inside of elbow, then back of right leg around the inside of knee, then back of left leg around the inside of knee, then back of left arm again around the inside of elbow, then under left breast, then around the basal joints of both hands/base of thumb and space between thumb and forefinger (left hand more generalized hand swelling, right hand more between the thumb and index finger), then on left side at point of bending over at the waist (top of thigh), then under lower left buttock cheek, then under lower right buttock cheek. slight swelling on both wrists also.
The pt developed an exaggerated localized reaction with hyperemia and induration incompassing over area of 8.5 x 8cm to Lt brachium (shoulder).
I received my Moderna shot on Saturday 1/23/21 around 4PM. On Tuesday -- 1-26/21 -- AM I woke up with a slight pain on the side of my left foot.  In the middle of the pain there was a small black dot .  I am an unusually healthy 83 y.o. physical active, ex Marine, with a high tolerance to pain.  So at first I paid no attention to this and went and played pickleball that very day.  But the next day I awoke to find that the foot was not only bright red and swollen, but painful.  I immediately called my doctor and the next morning I had a telephone conference with him.  We discussed the possibility of what could have caused this problem.  Although I am pre-diabetic (111) he ruled out diabetes.  He also ruled out gout. This only left the possibility of an infection.  But since I had not stepped on any nails, etc. the only possibility was a bug bite.  So he prescribed an antibiotic, which I started taking that very day.  After several days the foot got progressively worse and turned into a ulgy, oozing sore and redness grew to the whole left side of my foot.  So I made an appointment with my doctor for a physical visit, however this was delayed until 2/5/21.  By then the swelling and redness had subsided considerably and the wound was healing.  He ordered lab tests to rule out the possibility of diabetes and gout.  He also gave me a prescription for stronger antibiotic and antibiotic ointment.  Unfortunately the lab was by appointment only and I did not get the tests done until 2/12/21.I would not even be writing this except for the fact that on 1/27/21 I also developed a rash all over on my back that was very itchy.  This is when my attention turned back to my vaccine shot, and the reports that Maderna had a track record of rashes from their shots.  So I thought I had better write to see if it would be safe for me to get my 2nd Maderna shot which is scheduled in just 6 days (2/20/21).I do have a history of occasional painful rashes since childhood and I am wondering if the Moderna shot could have possibly triggered one, or both, of these problems?  If it will help I did have photos taken of my foot during this episode and will be happy to send them to you if you feel it necessary?Thank you for your immediate consideration and response.
Patient in waiting room post injection and 10 mins later she expressed her lip was slightly numb.  I took her to procedure room and she stated it felt numb.  She was able to walk normally into room.  She stated she had not eaten or drank anything this morning,  Pt was speaking in full sentences and no signs or symptoms of swelling or dysphagia noted.  Pt was able to drink water and crackers and tolerated well.  O2 sat 96 percent.  pt remained in observation for 1/2 hour and left stating she felt better.  I followed up with her today and she stated her hand and arm felt numb an hour later or she said the site was painful too.  8/10 on pain scale which has subsided she said,  She was able to work on Sunday and Monday and feels better today she said.
Patient received the Jansen vaccine in April then came to our facility informing us that he had not been vaccinated and we went ahead and administered the Pfizer vaccine serues
8 days after vaccination, developed itching, redness, and swelling to area of injection site
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 04-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065237 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065237:Linked with second dose
Felt faint, was diaphoretic, pale. Pt refused transport to hospital. Sat in chair after having flu shot, EMTS on scene. Generalized pallor and diaphoresis. Pt was conscious and alert and oriented.
This spontaneous report as received from a currently 85 year old female patient refers to herself. Patient's medical history, drug reactions or allergies were not reported. In approximately 2011, also reported as: "2-3 years ago" the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, route of administration not reported). Concomitant medications were not reported. On an unknown date, also reported as: "about 6 months after getting vaccine" the patient developed shingles multiple times after receiving ZOSTAVAX. There were unspecified prescription and over the counter (OTC) medications given as a treatment for the event. The outcome of the event was reported as recovering/resolving (also reported that symptoms improved). The patient sought medical attention by office visit. The relatedness between the therapy with ZOSTAVAX and the reported event was not reported. Additional information has been requested.
Local Arthus reaction, induration 9cm x 9cm area tender. Tx with Benadryl 1% Cortizone ointment