chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a very sore left arm; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     The patient had no history of myocarditis or pericarditis. They had no history of Covid-19 infection.  Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (Patient had a very sore left arm) and CHILLS (chills) outcome was unknown.            Patient had previous doses of Moderna covid-19 vaccine -1st dose on 10-Mar-2021 (lot number and expiration date was unknown), 2nd dose on 02-Apr-2021 (lot number and expiration date was unknown) and 1st booster dose on 29-Oct-2021 (lot number and expiration date was unknown).  No treatment medication was reported.   This case was linked to MOD-2022-664796, MOD-2022-664801, MOD-2022-664802 (Patient Link).
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071156, 2019SA071154, 2019SA071155, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071147 (same reporter). This case involves Child patient (age and gender not reported) who was accidentally vaccinated with FLUZONE HIGH DOSE (formulation: Suspension for injection in pre-filled syringe) instead of FLUZONE QUADRIVALENT (batch number: UJ043AB and expiry date: 22-May-2019, dose, dose in series, route and site of administration were not reported) on an unknown date (during the 2018 - 2019 Flu Season). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
My arm was a little sore during the day. When I went to bed at 9:00 pm, I started having non-stop uncontrollable rapid shaking in both arms, enough so that I could not stop the shaking for 3 hours unless I anchored my arms under my legs, and even that just decreased the amount of shaking.
Pt noticed development of about 4 splotches approx. a nickel size to 2 inches across in size. She first noticed them approximately 48 hours prior to vaccination. Pt says they're slightly tender but do not itch and are not warm to the touch.
Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 28-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 2 milliliter (mL), administered by oral route, as prophylaxis (formulation, strength and  vaccination scheme were not provided, lot number 1658255, which has been verified to be valid, expiration date reported and validated as 07-FEB-2021). The vaccine administered experienced a temperature excursion below 2 degrees Celsius (C) (1.3C) for 0 hours 24 minutes (product storage error). There was previous temperature excursion below 2C (1.6C) for 24 minutes, as recorded by a data logger. Other lot numbers involved included: 1684157 and 1660998, which has been verified to be valid, expiration date reported and validated as 26-JUN-2021 and 03-MAY-2021, correspondingly.
Redness upto armpit; Rash at injection site.; Vaccination site pain.; Swelling at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness upto armpit), VACCINATION SITE RASH (Rash at injection site.), VACCINATION SITE PAIN (Vaccination site pain.) and VACCINATION SITE SWELLING (Swelling at vaccination site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ERYTHEMA (Redness upto armpit), VACCINATION SITE RASH (Rash at injection site.), VACCINATION SITE PAIN (Vaccination site pain.) and VACCINATION SITE SWELLING (Swelling at vaccination site). At the time of the report, ERYTHEMA (Redness upto armpit), VACCINATION SITE RASH (Rash at injection site.), VACCINATION SITE PAIN (Vaccination site pain.) and VACCINATION SITE SWELLING (Swelling at vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.; 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.
Migraine Headache; Vaccine location: Left Leg; This is a spontaneous report from a contactable nurse (patient herself). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left leg on 20Feb2021 as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included migraine from an unspecified date and unknown if ongoing. Patient had no known allergies. Concomitant medication included Excedrin, taken for unspecified indication, start and stop date not reported, taken in two weeks. Other vaccine same date as dose number 2 of Pfizer vaccine, was administered in left arm. On 21Feb2021 12: 00 AM, patient experienced migraine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment was received for the adverse event with Excedrin. The outcome of event was recovering.
Day of shot, arm was sore, I got sweats and fever, racing heart, did not sleep much, body fatigue, next day sore throat, fever persisted, maintained the fever for a couple of weeks. On 02/17/2021 I got my first hand mouth and foot disease bumps, they first came in my right and, within a few hours fever was 99.9, bumps spread to both hands, then on 2/23/2021 it spread to my feet then 02/28/2021 it finally hit my mouth, it spread to my cervix as well, some time in April. I have had foot hand and mouth disease before so I knew what it was. It took four to six weeks for it to go away.
after injection, had syncopal episode with very low BP 60/30's - regained consciousness immediately and given 1 liter IV fluids: transferred to ED for further E&M.  Labs, EKG.  no further intervention. Observed for 3 hrs and d/c to home
Rash about 2 inches in diameter near injection site. Some itching. Fatigue at times. Used hydrocortisone for itching.Rash was gone on March 10th. No more fatigue.
Fever up to 105.2 (a) approximately 12 hours after immunization and lasting around 8-10 hours.
pt states 24hr p/vax devel fine red rash that got hive-like later DPH given as needed & sx subsided p/48-72hr later;
This spontaneous report was received from a male patient of unknown age referring on himself. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown date, the patient experienced erythema and skin irritation. The outcome of erythema and skin irritation was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the reporter.
THIS WAS AN INCORRECT VACCINE.  HEPATITIS B SHOULD HAVE BEEN GIVEN, HOWEVER PATIENT WAS GIVEN HEPATITIS A.  AT THIS TIME WE ARE NOT AWARE OF ANY EFFECTS, BUT THERE MAY BE SOME IN THE FUTURE.
only effected was sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix and had sore arm. The patient stated that its was better than getting shingles. The patient was planned to receive 2nd dose in September 2021. This case was linked with US2021AMR151908 and US2021AMR151907, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151908:Same reporter US-GLAXOSMITHKLINE-US2021AMR151907:Same reporter
sore arm; vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge) and PAIN IN EXTREMITY (sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) 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.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up information received.  Reporter details.  Medical history.  Vaccination batch number, time and site of administration.  Event verbatim updated and added event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
ABOUT 4 HOURS AFTER VACCINE GIVEN I HAD A TEMP 103.5 FOLLOWED BY SEVERE NAUSEA AND VOMITING FOR ALMOST 24 HOURS, TO THE POINT THAT I NEEDED TO GO TO THE HOSPITAL FOR IVF AND ANTIEMETICS. SEVERE HEADACHE. FATIGUE THAT LASTED 5 DAYS
Patient left the pharmacy ambulating well and with full cognition. She went to her car and states that she became very nauseous and clammy. She called back into the store and told us what was going on. The pharmacist went to check on her and found her to be very confused and going in and out of consciousness. The pharmacist alerted a technician and 911 was called to evaluate. Upon their arrival they found the patient to be hypotensive (about 80/about60) and they took her to the ER for further evaluation. The patient was contacted the next day by the pharmacy staff and is well and has scheduled follow up appointments with her PCP to rule out any other underlying issue that might have cuased this.
For my first vaccine I experienced pain in my left arm which radiated to my fingers. I also had difficulty lifting my left arm up. These symptoms lasted 3 weeks. I also experienced nausea and headaches that lasted few weeks.
Rash, hard lump at sight.  By 10/20/2011, rash around mid section, tummy area continuing through 10/22/2011 and still in existence.  No pain, slight itching.
Injection site red, hot, swollen, and circular rash about 4 inch diameter developed 24  hours after injection. Still there. . Fever and chills and fatigue lasted 24 hours.
Information has been received from a physician concerning a female between the ages of 11 and 14 years old, who, on an unspecified date, was vaccinated with a dose of Gardasil.  Concomitant vaccinations on the same day were reported as "several other vaccines."  Subsequently the patient experienced "lots of anxiety and passed out within 2 minutes of being vaccinated."  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information is not expected.
Patient reported blurry vision 10 minutes after being vaccinated. He also vomited twice during observation time with me. He became better after giving some water and rest. Patient regain his vision 5 minutes later and refused extra help ( i was offer if he wants to call 911). He doesn't  have any primary  care doctor and always come to urgent care clinic as needed. Patient was consulted to report the adverse affect and seeking medical attention if his symptom become worse.
Patient presented as an adult Project Search student needing student health screening requirements for program within healthcare facility. Student and instructor present at time of appointment. Both reported students needed the 2021/2022 influenza vaccine. Instructor reported parent confirmed seasonal influenza shot needed and requested during this appointment. Registry of Immunization records provided by student and family. Last dose on records for seasonal influenza vaccine was 10/05/2021.  Student signed consent for vaccine. Denied allergy to eggs, reported no allergies. 2021/2022 Influenza vaccine given at this time. Later, upon entering vaccine, 2021/2022 influenza vaccine already given this year on 9/24/2021. Instructor came back and reported after appointment that parents did report after the fact that student had already received seasonal influenza vaccine.
pt recv vax 3DEC96 & 16JAN97 pt devel a rash;the rash was initially like a pimply rash w/no heads on the pimples;they were all over arms & legs, hands & feet;also reported that the rash changed to a blotchy rash;high lymphocyte count;
Elbow sore; Shoulder sore; A lot of pain; sore and tender; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Elbow sore), ARTHRALGIA (Shoulder sore), PAIN (A lot of pain) and TENDERNESS (sore and tender) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (Elbow sore), ARTHRALGIA (Shoulder sore), PAIN (A lot of pain) and TENDERNESS (sore and tender). At the time of the report, ARTHRALGIA (Elbow sore), ARTHRALGIA (Shoulder sore), PAIN (A lot of pain) and TENDERNESS (sore and tender) 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.   Relevant concomitant medications: Parkinson's meds.  Treatment details: None.
Patient reports 3 month history of bilateral eye inflammation and decreased vision of unknown etiology since 9/07. Patient had Gardasil on 7/25/07 and 9/26/07. Currently, she is off work and unable to drive. She is being followed by a neurologist and opthalmologist. 12/26/07-records received for 11/8/07-Eye inflammation, off work for 2 months secondary to decreased vision, 1/14/08-records received-DX: papilledema and panuveitis. Began in right eye and then left eye. C/O progressive vision changes and eye burning.
recurrent positive Ag test; recurrent positive Ag test; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EK5730), on 07Jan2021 as dose 2, single (Lot number: EL1284) and on 05Oct2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 4, (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). There were no concomitant medications. There was no other medication in 2weeks.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 19May2022, outcome "unknown", COVID-19 (medically significant) with onset 19May2022, outcome "recovering" and all described as "recurrent positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive Ag test was negative day 9; Positive, notes: positive Ag test positive day 15). Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details was started on 10May2022 and stopped 15May2022.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Moderna COVID-19 Vaccine EUA  most serious complain is lower back pain (around both kidney area), most serious during the first day, getting a little better on the second day, remain the same for 3 days (until today).  low fever(100.3)  /  fatigue /  muscle pain /  headache/ joint pain
Patient requested to have vaccine given to her in the EMS room due to a past anaphylaxis reaction to antibiotics and codeine. Patient was given 50mg benadryl PO at 0910 and vaccine was given at 0925.
vomiting; sicker than a dog; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. She previously received the first dose on unspecified date for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient took the second dose and she was in a hospital vomiting. She's sicker than a dog. Outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
fever of 99.6 degrees Fahrenheit; felt like the flu; Temperature of 101.9 degrees Fahrenheit; sore; A spontaneous report  was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore, temperature of 101.9 degrees fahrenheit, felt like the flu, fever of 99.6 degrees fahrenheit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 036A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced the event(s) sore, temperature of 101.9 degrees fahrenheit, felt like the flu. On 25 Mar 2021, the patient experienced the event(s) fever of 99.6 degrees fahrenheit.Caller did not consent for safety team to contact her HCP.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore, temperature of 101, 9 degrees fahrenheit, felt like the flu, fever of 99, 6 degrees fahrenheit was unknown.
Minor was 18 weeks gestational age at the time of vaccination. OB provider had no concerns during visits 8/30/22 and 9/27/22.
hives on back and torso; itching all over; This case was reported by a consumer via call center representative and described the occurrence of hives in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 1 day after receiving Shingrix, the patient experienced hives and generalized pruritus. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 75 or 76 years. The patient reported that he received Shingrix sometime in mid-May 2019. The patient reports the next day he experienced itching. The day after that, the patient noticed hives on his torso and back.  The patient went to the emergency room and was give steroids. The patient then followed up with his dermatologist who continued steroid therapy. The itching has subsided. The reporter had consented to follow up. Emergency room visit required. Lot number and specific date of injection and events was not remembered by the patient. The patient said that his pharmacist may have called the event into GlaxoSmithKline or VAERS. Outcome of the events were reported as Fatal in source document, which seems to be discrepant from narrative hence it was kept as recovering or resolving as reported.