chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he could barely walk because it had caused so much pain and swelling after he received the shot.; he could barely walk because it had caused so much pain and swelling after he received the shot.; he could barely walk because it had caused so much pain and swelling after he received the shot.; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients. This is one of the two reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included back surgery 20 years ago (2001). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunization. The reporter stated that the patient in the same physical therapy as she (reporter) was had the same thing happened. The patient had gotten his second Pfizer shot and he had had back surgery 20 years ago; he could barely walk because it had caused so much pain and swelling after he received the shot. The patient had to get epidurals. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101363269 same reporter/drug/events, different patient
two days out from when her menstrual cycle should have began; This is a spontaneous report from a contactable consumer (patient's Mother). A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration, in left arm, on 21May2021, at 08:45 (at the age of 14-years-old) as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother reported that her daughter received the first dose of Pfizer Covid Vaccine this morning, 21May2021, at 08:45 and daughter was at least two days out from when her menstrual cycle should have begun, no serious heavy bleeding (in May2021). Outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
During administration of vaccine patient grabbed left arm and stated "my whole arm hurts!". Immediately after administration of HPV vaccine, patient turned pale, eyes rolled backwards, and he began to sway his body. Immediately laid patient down with feet elevated.Patient ate PEDIALYTE popsicle. After 15 minutes observation in office, patient's color returned to face, reported no longer felt dizzy. Ambulated out of office with steady gait.
Expired vaccine was stored and then administered/Vial refrigirated after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 30-Oct-2021. Vaccine did not undergone any temperature excursion. No adverse events occurred for patient. No Treatment information was reported.   This case was linked to MOD-2022-504694 (Patient Link).
This case was reported by a other health professional via sales rep and described the occurrence of unable to walk in a adult male patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date unknown). On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 4th October 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced unable to walk (serious criteria disability and GSK medically significant) and generalized joint pain (serious criteria disability). On an unknown date, the outcome of the unable to walk and generalized joint pain were unknown. It was unknown if the reporter considered the unable to walk and generalized joint pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: Two days after vaccination the patient was unable to walk and had overall joint pain and was unable to go to work on 5th October 2015 and worked only a half day on 6th October. It was unknown if he required a doctor's care or if he received any treatment. He was not hospitalized. This case was linked to 6 cases reported by the same reporter.
Felt like little thrush; White stringy sort of in mouth; Black hairy spot on back center of tongue; Very bad taste in mouth; Joint sensitivity; Headaches; Fever; Pain; Chills; Aches; Elevated heart rate of about 120; A spontaneous report  was received from a consumer concerning a 59-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly on left non-dominant arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity. On 22 Feb 2021, the patient experienced the events very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills.Consent to follow up with safety.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, elevated heart rate of about 120, fever, headaches, pain, joint sensitivity, very bad taste in mouth, white stringy sort of in mouth, black hairy spot on back center of tongue, felt like little thrush, chills were unknown.
COAGULOPATHY, UNSPECIFIED TYPE HYPOTENSION CHRONIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 2/27/2022,  3/14/2022,  3/29/2022,  3/31/2022,  4/7/2022,  4/15/2022,  4/26/2022,  5/16/2022,  5/17/2022,  5/25/2022,  5/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Had 4 y/o vaccines yesterday. Left deltoid red and swollen at site of DTaP.  Mother stated swelling was worse this morning.
Minor Aches and Chills, Headache developed  approx. 16 hours after booster shot.  At approx. the 22 hour mark, I experienced severe lightheadedness followed by numbness and  tingling in both arms and legs, along with cramping in both hands, both calves and jaw. Symptoms lasted approx. 30 minutes.  I was completely symptom free in a few hours.
Second dose was administered to employee 2 weeks too soon. She will received another dose in 2 weeks to complete 2 dose series since 2nd dose is considered invalid per guidelines.
fever; chills; muscle ache; sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.; Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to; it is swollen and when pushed it is hard and stiff.; it is hard and stiff.; has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.) and SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included GLYCOPYRROLATE and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treated events with Tylenol and an ice pack per HCP.    This case was linked to MOD-2021-099429 (Patient Link).
Red, splotchy rash appeared on legs and progressed to forearms. Itchy at first then it subsided. Led to full body coverage of red rash. Spots and rash was not inflammed only erythematous. Patient saw primary care provider 6-7 days after rash appeared and was given a Medrol dose pack. Blood work was obtained and all came back within normal limits. Another round of prednisone was given as well as Kenalog. Improvement has been slow. Recovery is still in process.
Tingly hands and fingers all day and night.  right leg swells, aches and formed a big Knot. Blurry vision, saw double for a few days. I had less symptoms when I had covid.  This is crazy. Not a one size fits all shot!
Admission Error:  Patient stated she had never received a COVID vaccination and was given a dose of Janssen. When her data was entered, it was discovered she received a dose of Janssen on 3.22.21 at another location.
got covid; got covid; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Lot number: EL3247) at the age of 33 years as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=EL3247, dose number=2), administration date: 18Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (lot number=EL3247, dose number=1), administration date: 28Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 18Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "got covid"; COUGH (non-serious) with onset 02Jan2022, outcome "recovering", described as "cough"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 02Jan2022, outcome "recovering", described as "mild URI symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, cough, upper respiratory tract infection.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and Immunization
While in observation, pt experienced local site reaction (hives and itching), taken to med eval for further evaluation at 1200, VS at 1205 - BP 120/90, HR 106, RR 26, O2 sat 100 % on room air. Started to experience chest tightness and coughing, hives on legs, given benadryl 25 mg PO at 1213. Pt has season allergies, usually uses an inhaler but did not have it. Lungs were clear, no stridor, no wheezing. Started to feel better, declined further interventions, reviewed with mom any further concerns to call 911 or PCP follow up. VS at 1230 - BP 134/95, HR 94, RR 18, O2 sat 100% on room air.  EB, FNP
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On 23-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a pharmacy.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 24-NOV-2015, the patient was treated in a hospital, for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir, naproxen and oxycodone (+) acetaminophen (PERCOCET) for management of her painful symptoms and chronic pain.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Large, red , itchy patch appeared on arm at injection site seven days after shot. It is painful to touch.
Headache, Myalgia, NauseaVomiting, chills, diaphoresis, abdominal cramps. Narrative:
4d post injection c/o nausea with vomiting (L) post leg discomfort esp walking.
High fever of 101+ for 2 days, low fever for an additional 2 days, severe nasal congestion, persistent cough for one week, moderate to severe aches
fainted/Fainted after first dose; Lightheaded, after first vaccine.; Headache, after first vaccine.; Fatigue, and tiredness, after first vaccine; Brainfog, after first vaccine; This is a spontaneous report from Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported that a 34-year-old male patient received first dose of BNT162B2 on Apr2021 (at age of 34-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Agent states Caller reports some adverse events experienced with his first dose of the Pfizer Covid 19 vaccine. Agent states, that the Caller, is inquiring about the second dose. Agent states the Caller had his first dose 2 months ago. Agent states the Caller reports one hour after the vaccine, he became lightheaded, and 3 hours later, he fainted. Agent states the Caller mentioned he had a few other effects, but those two were his most prevalent ones. Caller states that he had other symptoms, that are normal after the vaccine, but reclarified that he had a headache, fatigue and tiredness, and brain fog. Caller asks, is it safe for him to get the second vaccine, Caller asks why did he faint, Caller wants to know, how can he be safe, if he takes the second vaccine, Caller reports that he does not have a doctor, and he hasn't seen a doctor in about 20 years. Caller states he always feels fine, and has never fainted, before this event. The outcome of event faint and lightheaded was unknown. The outcome of other events was recovered.   Information about batch/Lot number had been requested.
Eight days after 1st dose, rash appeared on arm below injection in upper arm. Grew to 4 inches. Took over a week to recover.
itching; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant list.  Treatment included as Tylenol and itch cream.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left arm almost immovable due to massive swelling; left side, all the way down to hip is numb and almost immovable due to unbearable pain; rash and redness developed from top of shoulder to elbow with large lump, near injection site, the size of a tennis ball under muscle mass; several light-headedness and complete blackouts with rapid increase in heart rate; rapid heart rate/palpitations and profuse sweating onsets, while sitting stationary.
Menstrual cycle disruption (delayed, shortened, heavy) Miscarriage Celiac?s disease
Tested positive for Covid 19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for Covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid 19). At the time of the report, COVID-19 (Tested positive for Covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Fever 101 degree F; Chills; Headache; Muscle aches; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Apr2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: RW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 25Apr2021 at 23:00, the patient experienced fever 101 degrees fahrenheit (F), chills, headache, muscle aches, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Apr2021 at 23:00, the patient underwent body temperature test and the result was 101 degrees fahrenheit. Therapeutic measures were not 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 fever 101 degree F, chills, headache, muscle aches, fatigue and nausea was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash on lower abdomen- 2 in below waist on the right and left sides of the body
Info has been received from a health professional concerning a pt, "in grades 3-5", who was vaccinated with a dose of varicella virus vaccine live. "Recently", since November 2005, the pt experienced a chickenpox outbreak. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Local reaction redness, warmth, erythematous plaque, tenderness. Empiric treatment with Augmentin in case of _________process but not likely-resolved in 3 days.
Patient came in to get her booster dose & requested Pfizer. Once she got home she reviewed her previous vaccination card & realized she had already had a booster done in Dec 21. This dose was a 4th dose.