chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sensitivity to high-pitched sounds; vertigo; ringing in ears. It is mostly to right ear; temperature was 99F; shaking so much; not having control of my body; chest pain; icky; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking so much), BALANCE DISORDER (not having control of my body), CHEST PAIN (chest pain), FEELING ABNORMAL (icky) and VERTIGO (vertigo) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shaking so much), BALANCE DISORDER (not having control of my body), CHEST PAIN (chest pain), FEELING ABNORMAL (icky) and PYREXIA (temperature was 99F). On 18-Mar-2021, the patient experienced VERTIGO (vertigo) and TINNITUS (ringing in ears. It is mostly to right ear). On an unknown date, the patient experienced HYPERACUSIS (sensitivity to high-pitched sounds). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 17-Mar-2021, TREMOR (shaking so much), BALANCE DISORDER (not having control of my body), CHEST PAIN (chest pain) and FEELING ABNORMAL (icky) outcome was unknown. On 19-Mar-2021, VERTIGO (vertigo) outcome was unknown. At the time of the report, TINNITUS (ringing in ears. It is mostly to right ear), HYPERACUSIS (sensitivity to high-pitched sounds) and PYREXIA (temperature was 99F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99 (High) High. On an unknown date, Acoustic stimulation tests: normal (normal) normal. On an unknown date, Tinnitus: normal (normal) normal.         No concomitant medications were reported.    This case was linked to MOD21-063201, MOD21-063202 (Patient Link).
Information was received on 03-MAY-2017 from a nurse (from a physician's office) via a company representative regarding a female patient (age not specified). Medical history, concurrent conditions were not reported. Concomitant medications included unspecified blood pressure medication (not further specified). On an unspecified date (reported as about a year ago), the patient was administered ZOSTAVAX (lot number, expiration date and dose not reported). The patient contacted the nurse this week (exact date unspecified), because she had an itchy rash. The primary reporter was unaware if treatment was provided or if the patient recovered. No further information was available. The reporter did not rate the causal relationship. Additional information has been requested.
Within 24 hours of ADACEL administration developed wheezing, weakness, chills, increase of chronic tinnitus.
Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised); Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 09-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Dec-2021, ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Reported stated that the Moderna COVID-19 vaccine was supposed to be a booster dose but HCP assumed that they were administering the first dose of a primary series.
Started with persistent cough and chills; then all-over aching and began running very high fever all night. About 4:00 AM started sweating profusely and shaking for a couple of hours. Experience weakness and dizziness throughout the next day (10/06/15). Did not seek medical treatment since I could not even get out of bed to get some Tylenol. (I live alone.)
Information has been received from a physician concerning a 61 year old female who on 07/01/03 around 1500 was vaccinated IM with a first dose of pneumococcal vaccine 23 polyvalent. On 07/01/03 by 1900, the pt's arm was painful from her elbow to her shoulder, and it also felt numb around the injection site. There was no fever, and the arm was not red or swollen. It was reported that the pt was also "having difficulty using the arm". It was also noted that "the pain does seem to have lessened somewhat from two days ago". No other information was provided. Unspecified medical attention was sought.  There were no lab diagnostic studies performed. There was no product quality complaint.  Additional information has been requested.
No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023).    Concomitant medication details not reported by the reporter. Vial did not undergo any temperature excursions. Vial was initially stored in the refrigerator on 16-MAY-2023. Treatment details was not reported by the reporter. The case contains information for patient 4 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master case patient no. 01
This spontaneous case, initially received on 29-Oct-2018 from a pharmacist concerns 59-year-old, adult, male patient. The patient had no relevant medical history. The patient's concomitant medications were unknown. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event or adverse reaction was reported. The reporter assessed the event as non-serious. This case: 201805050 was linked to the source case: 201805049 due to the same reporter.
Patient experienced unconsolable crying for 2-2 1/2 hours. Mom reports that child was "flinching", turning head from side to side, elevated temperature 102-103 degrees F. Noted "eye twitching", other "neuorologic" signs & symptoms.
Started to shake, tingling in extremities, complained of a headache, coldness. Patient was given 50mg of diphenhydramine and her symptoms resolved in one hour.
swollen left arm pit which is also slightly tender to touch; swollen left arm pit which is also slightly tender to touch; sore arm; low grade temperature (37.8 C); fatigue; chills; Second dose administered on 10Jan2021; first dose was administered on 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9Z61), intramuscular (left arm) on 10Jan2021 15:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL1284) intramuscular (left arm) on 29Dec2020 (02:00 PM) for Covid-19 immunization. The patient's medical history included Covid-19; no known allergies. Concomitant medication included citalopram hydrobromide (CELEXA) taken PO (oral) daily before, during and after vaccination period. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no issues on day zero; on day 1 (11Jan2021) she had sore arm, low grade temperature (37.8 C), fatigue, and chills. All have resolved by 6am on day 2 (12Jan2021). On day 3 (13Jan2021), she noticed swollen left arm pit which is also slightly tender to touch but not bothersome. No other lymph areas are noticeably swollen or tender at this time. There was no treatment received for the adverse event. The outcome of events sore arm, low grade temperature, fatigue, and chills was recovered on 12Jan2021; the outcome of events swollen left arm pit which is also slightly tender to touch was recovering. The patient has not been tested for COVID-19 since the vaccination.
Immediate upon injection = severe burning in upper arm, lasting 15 minutes 18 hours after injection = migraine, fever (100.8), backache, general fatigue - all lasted 24 hours 48 hours after injection = "COVID arm" (delayed cutaneous hypersensitivity) - got progressively worse for 2 days, still present 5 days post-vaccination
Patient received PREVNAR 13 in the left upper arm (deltoid) first, then, an inch below that shot she received the FLUZONE HD. The patient bled from the injection site, and in about 20 seconds, the injection site swelled up. The patient stated that she did not feel any pain at the injection site, or had any other symptoms. An ice pack was placed at the site and the patient was asked to stay for 20 mins. The injection site did not get any worse, but the patient left with a knot at the injection site after about 25 mins. She was told to contact the pharmacy if the swelling gets any worse or she gets any other symptoms.
On the day of the vaccine I had a very sore arm. Was away after some days. After 7 days started another reaction on the same arm of the vaccine, was sore, bigger and hot , after 3 days start some allergy, local bubbles and itching.
Case number PHEH2011US05576 is a combined initial and a follow up spontaneous report received from a health care professional on 29 Sep 2011 and 30 Sep 2011 respectively. The pharmacist stated that after attempting to withdraw reconstituted MENVEO with needles ranging in gauge from 18 to 27, and using different types of needles, they ended up taking the entire foil and the plastic thing off prior to withdrawing two doses of MENVEO that were subsequently administered to two patients. This case pertains to a 31-year-old male patient who was vaccinated with one of this dose of MENVEO (batch number: M100047) on 22 Sep 2011. It was also reported that they actually reconstituted the Men A lyophilized conjugate vaccine component of MENVEO with a sterile diluent, which was the reason there was difficulty withdrawing the dose after reconstitution. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. Potential medication error was reported due to potential that sterility of doses could have been compromised due to removal of the stopper prior to withdrawing up two separate doses of MENVEO. No adverse event was reported at the time of this report. The other patient was vaccinated 3 weeks before the time of this report (see linked case: PHEH2011US05580). Following an internal review on 10 Nov 2011 of the information received on 29 Sep 2011, following correction was done. The verbatim 'patient received dose after removal of stopper' changed to 'sterility of the vaccine doses could have been compromised due to removal of the stopper prior to withdrawing two separate doses', and coded to product sterility lacking. An event drug administration error is added.
Information has been received form a physician concerning a patient who was vaccinated with a dose of GARDASIL vaccine. Subsequently the patient experienced increase in anxiety after vaccine administration. Additional information has been requested.
mild facial swelling, peripheral edema, hypotension - started about 12 hours after vaccination. pt does have history of dermo-filler where facial swelling is present
One hour after vaccine baby was crying and irritable. Seemed uncomfortable. Mother gave Tylenol throughout the day but did not seem to relieve symptoms. Temp 102 rectal reduced with Tylenol but came back in two hours. Baby continues crying into the night, did not nurse well, seemed lethargic. Child seen in ER at 1AM.
from small swelling at vaccine site, to incredible swollen arm and lots of redness pain and heat. returned to Doctors office nest morning to show, and doctor said it was an infection, put me on antibiotics "cephalexin 500 mg "4 times a day. started antibiotics evening of 20 September  for most of September 21 it every symptom increased
Redness and warmness on site of vaccination shape of fluoride 6-8 inches, tired, was lifting, and wheezing a lot after vaccination. Pt feeling better 11/7/13.
t102 ax 1PM 6FEB95 until 5AM 7FEB95 body would get goose bumps & shake; vomited 8 or 9 PM; body weak; tub baths to cool body fevr & APAP q 4 hrs; mom didn't call MD or to to ER; seen by MD 7FEB95 215PM dx react to combination of vax;
Fever; Chills; Full body aches; Joint inflammation; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left arm, on 20Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 30Dec2020 at 09:30 AM for COVID-19 immunization (left arm). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a military base facility. On 20Jan2021 at 06:00 PM, the patient experienced fever, chills, full body aches, and joint inflammation. In Jan2021 (after the vaccine), the patient experienced headache and ibuprofen was received as treatment. No treatment was received for the other events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of "Headache" was unknown. The patient was recovering from the other events.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-JUN-2008, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 13-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Pt devel a rash while on therapy w/erythromycin & Symmetrel; pt recvd 1st dose of MMR vax 12JUL77 & 2nd dose on 7AUG91; On 8AUG91 pt devel h/a & a t101.6; 12AUG91 devel sore throat w/rhinorrhea;
FEVER 101 DEGREES, CHILLS, MUSCLE ACHES, FATIGUE, HEADACHE
Diarrhea; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up was received. Non-Significant follow Up-(Contact info updated).
My symptoms started on February 20, 2023. I was Diagnosed with Spontaneous dissection Artery I experienced pain in upper left abdomen, I had difficulty standing and walking, I was prescribed Tramadol for my pain and I was also taking Aspirin.
Per TC 9:35 AM 10/23/09 from grandmother caring for child. Relates began vomiting at 1:00 AM. Vomited 3 times during the night and now 3 times this morning. Unable to keep liquids down. Had called physician and was told to call vaccine administrator. Instructed to recall physician and ask if needs to go to the ER. TC to caretaker 10:10-to see doctor at 11:10 today.
After 2nd shot of Moderna COVID-19 vaccine, I had chills all night long. Then started experiencing chills and feeling cold at night thereafter; seems like most nights I would feel cold. This has never happened before and is still ongoing.
Drowsy, sore arm for 2 days, strong headache (same as when I had Covid)
7/17/2020 at 3:30pm. Lips tingling/numb, lips swelling, throat closing, odd feeling in chest, light headed, fartigue, started ~ 10 minutes after vaccine administered. Was not instructed to wait around for 20 minutes by vaccine administer.  Several hours later went to ER was prescribed an Epipen. Taking 50mg of Benadryl to manage symptoms every 4 to 6 hours. Symtpoms got slightly better and slightly worse.  Sunday 7/19/2020  went to urgent care.  As symptoms persisted and from taking this amount of benadryl began to have vision changes and dry mouth. Told to take 25mg of Benadryl every 4 to 6 hours and one zertec.   Sunday  evening symptoms started to worsen after taking reduced amount of benadryl. Returned to ER. Given 2 tablets of Decadron steriod.  Returning from ER new symptoms started to develop. Face started to swell, burning rash on back of neck, butt, groin and back of knees..  Monday 7/20/2020 returned to ER treated for benadryl poisoning despite taking doseage and frequency told to by medical professionals. (50mg every 4 to 6 hours and then cutting back to 25mg every 4 to 6 hours) and 10mg of Zyrtec / 24 hours, taken at 2:00pm. Was advised to continue taking Zyrtec and stop taking benadryl. Recieved IV, EKG, blood work done.  Tuesday 7/21/2020 ( took 10mg of Zyrtec at 2:00pm) ~ 2:10pm chest pain started, also felt cold feeling in chest, returned to ER. advised to stop taking all antihistamines.  Wednesday 7/22/2020 went to allergy doctor, advised to check back next week as antihistamines would affect results of any tests done  Thursday 7/23/2020 went to urgent care, recieved EKG and bloodwork which both checked back normal.  Friday 7/24/2020 through current date 7/26/2020 still feel intermittent chest pain, fatigue and lips/face slightly swelling.
Hard induration 2 inject site w/redness; occurred 7 days post inject;
A little fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little fatigued/tired) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (A little fatigued/tired). At the time of the report, FATIGUE (A little fatigued/tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
25th, severely sore arm, neck and head.  chills in the evening. 26th, severe sore arm and neck, faint/dizzy most of the day  27th, very sore arm, faint/dizzy all day 28th, sore arm, faint dizzy most of the day 29th, slight sore arm and faint/dizzy all day