chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had flu shot at Health Department Monday, November 5, 2018. Presented to physician's office November 6,2018 10:03am with complaint of swollen tongue. Admitted for observation to Hospital. November 6, 2018 12:08 pm. Treatment: Solumedrol 80mg IV Q6 hours; Benadryl 25 mg po Q6 hours; Zantac 300mg po bid; Continuous  pulse ox; Oxygen if sat < 90; notify for respiratory distress; Continue home meds. Discharged improved on November 08,2018 9:30am on po prednisone.
Fever; Chills; body aches/muscle soreness; body aches/muscle soreness; This is a spontaneous report received from non-contactable consumer (patient) via Pfizer Sales Representative. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in the left arm on 14Jan2021 15:00 at single dose for COVID-19 immunization in a hospital. Patient medical history and concomitant medications were reported as none. The patient had no other vaccines in four weeks and no other medications in two weeks. Patient previously received the first dose of BNT162B2 at the age of 47-years on 24Dec2020 at 03:00PM in the left arm, for Covid-19 immunization in a hospital. On 14Jan2021 23:00 patient experienced fever, chills, body aches/muscle soreness. No treatment was received. Patient was not tested for Covid post vaccination. Outcome of events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
The injection was put in on top on my shoulder. I?ve had moderate to severe joint pain when moving my arm, especially lifting my arm or lifting in a backwards motion. There is no swelling, redness on the skin and it?s not sore to the touch. It?s painful inside my joint. Even after taking ibuprofen I?m waking up in pain many times  in the night and need assisting putting in coats and getting dressed.  I?m not able to pick up anything heavy.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
raynauds; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "raynauds".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Onset of redness, swelling, pain, increased warmth on left thigh at site of vaccine. Increasing in size, presently 12 cm x 12 cm, indurated, warm, red. Low grade fever. Given Tylenol and Benadryl.
abdominal abscess after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL ABSCESS (abdominal abscess after first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL ABSCESS (abdominal abscess after first shot) (seriousness criterion medically significant). The patient was treated with CLINDAMYCIN for Abdominal abscess, at a dose of 150 mg and METHYLPREDNISOLONE for Abdominal abscess, at a dose of UNK (steroids). At the time of the report, ABDOMINAL ABSCESS (abdominal abscess after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. It was reported that patient today should receive the second dose of Moderna covid-19 vaccine, but mentioned he was under two prescription clindamycin 150 mg, methylprednisolone (steroids) to an abdominal abscess. Company comment: This case concerns a male patient, with no medical history reported in this case, who experienced the serious unexpected event of Abdominal abscess. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine.  The event was assessed as serious due to Medically Significant. At the time of the report, the outcome of the event was reported as Unknown.  Further information disclosed states that the patient received Clindamycin and Methylprednisolone as treatment drugs.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.; Sender's Comments: This case concerns a male patient, with no medical history reported in this case, who experienced the serious unexpected event of Abdominal abscess. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine.  The event was assessed as serious due to Medically Significant. At the time of the report, the outcome of the event was reported as Unknown.  Further information disclosed states that the patient received Clindamycin and Methylprednisolone as treatment drugs.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.
Breakthrough case admission after 3 vaccines  Moderna 4/15/21 lot# 030A21A;  Moderna 5/13/21 Lot# 030A21A;  Pfizer 12/6/21 lot# FJ1620
Redness, swelling and itchiness/stiffness of left arm around vaccine site ? lasting three days now
PATIENT HAD A GOLF BALL SIZED KNOT DEVELOP IN HIS ARM AT SITE OF INJECTION AFTER SHOT GIVEN AND UPON ARRIVAL FOR SECOND SHOT STILL SLIGHTLY SWOLLEN
Menveo and Menquadfi; received MenQuadfi instead of BEXSERO; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30th April 2023) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Menveo .5 ml. On 11th July 2022, unknown after receiving Menveo, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The health care professional reported that a patient was to receive Bexsero and Menveo. The patient received MenQuadfi in left deltoid instead of Bexsero.   The patient was administered Menveo in left deltoid as prescribed. The reporter gave consent to follow up. Additional supportive information: The patient received and a dose of 0.5 ml of Menquadfi instead of Bexsero along with Menveo, which led to overdose and wrong vaccine administered.
8 x 8 cm indurated area to left upper arm after FLUARIX and HAVRIX given 2 days ago.
got tested positive for covid; got tested positive for covid; earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "sugar type 2" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got tested positive for covid"; EAR PAIN (non-serious), outcome "unknown", described as "earache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: got tested positive for covid. Clinical course: Reporter and his wife had 5 doses of Pfizer covid 19 vaccine and a booster. Reporter mentioned that they got tested positive for covid and they experienced sore throat and an earache. Caller mentioned that he had a bunch of underlying condition like blood pressure sugar type 2 and Obesity. Reporter wanted to know if when will he be sick with covid 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366293 same reporter product AE different patient;
Given PNEUMOVAX 23 9/30/11 - edema, redness at site noted, with pain/hardness on 10/2/11. Increased temp 100.2 to 103.0 noted on 10/2/11. Suspect UTI/catch on 9/29/11, A/B started while awaiting C & S. Redness and warmth, ache continue on 10/3/11. Ice to site PRN. No induration - edema. Redness only - fading on 10/3/11.
Headache, Myalgia, Fever, c/o injection pain and swelling,sweats,chills,fatigue. Told to follow up with primary care physician if no improvement  Narrative:
pt recv vax in AM 3SEP96 & mom brought pt back saying pt slept 20min & has cried since then-won't eat;states is having muscle spasms;mom gave APAP;pt observed in office 1-1 1/2hr given more APAP by MD
Right arm and right side of neck went numb between 08:40am and 09:10am.
5 days later, still have a fever; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191), via an unspecified route of administration, administered in left arm on 19Jun2021 at 15:00, as dose 2, single (age at vaccination: 22 years), for covid-19 immunization. Medical history included lyme disease in the past from an unknown date and unknown if ongoing, biotoxic illness from an unknown date and unknown if ongoing. Concomitant medication included liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa [sulfanilamide] and experienced allergies (known allergies: Sulfa meds). Previously, the patient also received first dose of bnt162b2 (lot number: EW0191, age at vaccination: 22 years), as dose 1 single on 29May2021 at 14:00, administered in left arm. The patient stated that, on 20Jun2021, at 08:00 AM, he started experiencing fever and 5 days later, he still had a fever. Reportedly no other vaccine was administered on the same day of COVID vaccine and also no other vaccine within 4 weeks. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19, prior to vaccination. On 23Jun2021, the Nasal Swab sample was taken from the patient to test for COVID-19 and the test result was pending. No treatment was received for fever. The outcome of the event was recovered.
No adverse events. Patients received bivalent vaccine as first dose instead of the monovalent vaccine.
rare blood cancer; This is a spontaneous report from a non-contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included autoimmune disease. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) on an unspecified date for COVID-19 immunization. The patient experienced rare blood cancer on an unspecified date after vaccination and will be starting chemotherapy soon. It was also reported that the patient's doctor wanted to give her a COVID booster shot so she wanted to be in a COVID booster trial. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient was administered Menveo powder component with a non-GSK diluent; patient was administered Menveo powder component with a non-GSK diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered Menveo powder component with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: patient was administered Menveo powder component with a non-GSK diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was a clinic supervisor. The reporter called to inquire that any information available and how to proceed.  The reporter stated that they had the liquid component left on hand but the powder was missing.  The reporter was unable to provide any patient or vaccine details due to healthcare professional still investigating. The reporter did not consent to follow-up. The reporter reported that they were sure a patient was administered Menveo powder component with a non-GSK diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-SEP-2010, a pharmacist at a pharmacy administered the ZOSTAVAX) to the patient (lot number, dosage and route of administration not provided). On or about 04-OCT-2016, the patient was treated by a healthcare provider at a hospital (Emergency room) 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. 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Elevated heart rate for approximately 8 hours (normal resting heart rate 52, elevated to 76) Extreme fatigue 24 hours
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received MENVEO (batch number M16109, expiry date March 2018). On 15th August 2017, the patient received MENVEO. On 16th August 2017, 1 days after receiving MENVEO, the patient experienced injection site pain. On 17th August 2017, the patient experienced cyanosis peripheral. On 16th August 2017, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the cyanosis peripheral was unknown.  The reporter considered the injection site pain and cyanosis peripheral to be probably related to MENVEO. Additional details were provided as follows: The patient received MENVEO left arm. Then the patient left for school. The pain went away by the end of the day. On 17th August 2017, the patient woke up to Blue Fingers on left hand. The reporter felt, may the nerve was hit. The patient's mother was taking the patient to the emergency room. No additional information was provided.
Muscle and joint pain lasting for greater than 8 days.  Treated with Advil and aspirin and improving after 8 days.
Spoke with mother; states Imm's given at 4:00p on 9/11/07. Gave motrin prior to visit and continued to give motrin after injection q 4-6hr. Infant began running increased temp. 9/11/07 at 1030pm. Mother states today (9/13/07) Infant no longer has temp and is doing fine.
Faint 11-25-2009 1 PM. Headache, hair drenching sweats, chills, sore throat, last 2-3 days had an earache and diarrhea and nausea, extreme fatigue, joint and muscle aches.
At the time of vaccination, the vaccinator inserted a needle into the arm of the patient.  At this time the vaccinator noticed that the dose of vaccine had been injected into the cap of the needle, and none was remaining in the syringe.  The vaccinator did NOT push the plunger.  Some vaccine from the cap did drip down the arm of the patient.  Nothing was injected.  The vaccinator then removed the needle, picked up an additional dose, re-inserted the new needle, and gave the dose.  Only one dose was given to the patient (no additional or partial dose was administered), but the patient was stuck twice.
I was unable to form a complete sentence. Experienced extreme mental fog. I couldn?t think of very common words to use and would forgot what I was saying within seconds of starting talking. This symptom was worst the first 2 days after the vaccine and started feeling better after day 4. I also had chills and a headache.
Initial report received on 12 November 2009 from a healthcare professional. A 36 year old male patient, with no known allergies and no medical history, received a first right deltoid intramuscular injection of H1N1 (lot number UP010AA) on 11 November 2009. The patient had previously received FLUVIRIN (Novartis, lot number not reported) on 20 October 2009. On the night of 11 November 2009, the patient had a "knotty area" on the left side of his neck which was tender to touch. The next day, on 12 November 2009, the patient still had a palpable lump of the left side of his neck as well as swelling to the left side of his neck. Corrective treatment was not reported. At the time of the report, the patient had not recovered.
fever for 24 hours, severe chills or 4 hours, headache, muscle aches, nausea and vomiting
BREAKTHROUGH ROTAVIRUS DISPITE 3 DOSES OF ROTATEQ AT 2, 4, & 6 MTHS OF AGE
Parkinson's symptoms, which had been stable and predictable for several years, suddenly became much worse. Difficulty walking, remembering words, hallucinations, sleeping, completing sentences all became much worse over the span of a coyple of months. The shot in December was her 3rd shot.
whole body erythema beginning 6hr p/vax;pruritis;no urticaria;no resp sx;t96.9;tx DPH;
Swelling and tenderness at the site of injection, diffuse joint aches, headache.
No adverse event; Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date).    The concomitant medication was not reported by reporter. Pharmacist reported that they just found out last 18-Mar-2023 that they accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date. They were from 2 different vials but the same lot number.  HCP worried of providing patient's details because of HIPAA.  This case contains information for the 2nd of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-716518 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716518:Patient 1
Starting at 9:30pm I started having violent shaking and chills, Temperature 100, followed by severe body aches  and profuse sweating throughout the night. By the following morning shakes and chills dissipated but body aches and fatigue persist with some light headedness and mild cold sweat.
Concentration of the vaccine was higher than anticipated; ~1mL of diluent was used instead of intended 1.8mL. Only one vaccine from this batch was administered to this patient and the rest of the vaccines were disposed upon recognition of the error, which was discovered after reviewing the remaining quantity of diluent. The patient showed no adverse reaction upon administration or the following observation time. The patient was informed of this larger concentration after recognition of the error, patient was okay with resolution, and facility plans follow up the with patient on the week of 8/1/21.  Future quantities will be evaluated by a pharmacist.