chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Headache; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. In May 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 25-MAR-2016), " TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 1008 hours and the lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
20 minutes after receiving vaccine, patient experienced dizziness and having room spinning. no shortness of breath. no chest pain. no rashes. Appointment given to be seen and evaluated and discharged home
Fever COLD CHILLS, WEAKNESS Narrative:  EMPLOYEE STATES: "my side effects were the same as the worst day I had COVID and it lasted for 24 hours. It started with cold chills and weakness. I could only get 2 hours of sleep that noght due to how cold I was. I also woke up with a mild fever."  Other Relevant History:
Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs; No adverse event; A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event) in a 29-year-old 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.) and PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs).    Concomitant product use was not provided by the reporter.  The size of the vail was 5.5ml. The vial was initially stored in the refrigerator on 22-Sep-2022 at 5:15p and vial was opened for use on 22-Sep-2022 at 5:30p. The vial was first punctured on 22-Sep-2022 at 5:30p. The vial was stored post puncture at Room temperature. The vial did not underwent any temperature excursions. The vial was exposed to room temperature range for 15 hrs.  On 23-Sep-2022, the patient received bivalent booster shots past the 12 hour mark.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-650477 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650477:same reporter
The patient's injection site on his left thigh began swelling and turning red around midnight. The redness and swelling covered an area approximately 1 1/2"-2" in diameter. A rash was also starting, worsening with a fever around midnight. The patient was seen in the ER.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On unknown dates the patients were each vaccinated with a dose of improperly stored (-14 Degrees Celsius for 16 hours) VARIVAX (lot # L048465, expiration date 02-DEC-2017, dose and route unknown). No adverse experience had been reported. There was no temperature excursion issue previously. Additional information has been requested.
Allergic Rxn -  started on same day to have rash all over body, itch, red some hives. Also, with redness directly at the site of vaccination in left leg.
Upon receiving the vaccine, patient reported a "fatigued arm" and "numbness" in the injected arm. The reported AE resolved in 15 minutes without any intervention
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 69 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), 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) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gluten allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patiet was treated with Paxlovid from 29Aug2023 to 03Sep2023.
pt recv vax 2OCT97 & fever started that evening 103, contacted MD said take pt to ER if still inc fever Saturday;fever 105.6, lethargic, cyanotic, diaphoretic in ER;HR 206, gave repeated APAP, motrin, closely monitored, pulse ox check;
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/26/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 8/19/21 (EW0170) COVID Positive 9/29/21  10/4/21: The patient had COVID-19 pneumonitis on September last year, he is vaccinated and he had his booster vaccine this year, complaining from fever and chills with sputum productive cough and shortness of breath progressively worsen, no chest pain or palpitation or dizziness or orthopnea or lower limb swelling.  Known to have COPD not oxygen dependent at home.   At emergency, he was hypoxic oxygen saturation 86% and require 3 L of oxygen to maintain SpO2 above 94%, his labs show positive COVID-19 test, elevated D-dimer and proBNP and troponin and CRP, EKG show sinus rhythm without signs of acute ischemia.  CT chest angiogram did not show pulmonary embolism and show bilateral ground-glass opacity and emphysema.  11/1/21: Patient is admitted hospital on 10/04/2021 for COVID pneumonia with hypoxic respiratory failure, started on IV remdesivir, IV dexamethasone along with antibiotics. Rest of the medications were continued.  His condition got worse and, oxygen requirements went up, was placed on OptiFlow and pulmonology consult was requested.  Patient is seen and followed by pulmonary team, continued management as per their recommendations.  His home medication Tofacitinib was held during acute illness while in hospital.  Patient had severe thrombocytopenia, Oncology consult was requested, TTP over suspected and the ADAMTS 13 was ordered and was reported negative.  His recent SPEP from July 2021 did not show M spike, is suspected to have MGUS, and Oncology recommended to repeat SPEP and immunofixation.  Patient condition has gradually improved, started working with physical therapy and occupational therapy.  Pulmonology has cleared the patient for discharge to home.  Physical therapy and occupation therapy evaluation is done and patient and the spouse preferred for discharge to home with visiting nurse and physical therapy service.  His thrombocytopenia has resolved.  Patient does have significant elevated D-dimer and for that reason at the time of discharge he is discharged on Xarelto 10 mg for prophylactic anticoagulation.  Patient is to follow up with primary care physician in 1 week, his pulmonologist Dr. in 3-4 weeks and Oncology in 2 weeks.  Discharge plan is discussed with the spouse.
her arm swelled up; redness; This is a spontaneous report from a contactable consumer. This consumer reported for patient (mother) that: An 69-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered in left arm on18Mar2021 as Dose 2 SINGLE for covid-19 immunization (Age at vaccination was 69-year-old). The patient medical was none reported. The patient did not have any concomitant drugs was reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6205) on 25Feb2021 for covid-19 immunisation. On an unspecified date the patient's arm swelled up and redness turned a little bit. The reporter reported that the patient had a reaction with the second shot on 18Mar2021. When probed for consumer's weight, reporter stated that was on and off 145 (Pounds). The patient received treatment for the event Swelling arm with Benadryl and capsule of Aleve. The outcome of the event swelling arm was recovering while outcome of redness was unknown.  No follow-up attempts are possible. No further information is expected.
pt devel an irregular area (8x4cm) of erythema, edema, warmth w/o fluctuance @ inject site w/in 4 days of Td vax; Elocon cream & cool compresses were applied to the area;
Patient developed 3-4 cm area of redness, swelling and induration to left upper thigh at area of DTaP vaccination, 3 days after vaccine. Pt was treated with Keflex to cover possible cellulitis however this may have been a simple shot reaction.
Blood in stool x2 weeks after administration of Rota vaccine at 2mons and at 4 mos. Blood started both times night after administration
C/O Heaviness in her chest and difficulty breathing with tingling to her lips.  B/P 108/68;  Pulse 82.  R  20.  Recovered.  States did not know what anaphylaxis meant but knew she was allergic to PNC & Benadryl.  Advised to receive next dose at MD Office.  Recovered.
PER PARENTS, PATIENT RAN A FEVER FOR TWO DAYS AFTER RECEIVING 1 YR OLD SHOTS.  TMAX UNKNOWN BY PARENT. ON 01/01/2014 THE PARENTS NOTICED BLISTERS ON CHILD AND CHILD WAS FEBRILE.  ON 1/2/14 PATIENT CAME IN TO THE OFFICE.  PHYSICIAN DIAGNOSED THE PATIENT WITH VARICELLA.  DUE TO A SECONDARY SKIN INFECTION TEH PATIENT HAD TO BE HOSPITALIZED.
Besides the expected soreness at the injection site, I began feeling fatigued with  body aches around 3 p.m. the day of the injection. At midnight I had a 99.5 temp with chills, increased body aches, and  skin of my upper torso and arms were  sensitive to the touch. No rash though.  I took 2 Ibuprofen at that time but my temp peaked at 100.1 by 1 a.m.  I took 2 more ibuprofen at 4 a.m. and my temp started to go back to normal. I rested most of the following day because I still had the body aches and fatigue, not just tired. The skin sensitivity was gone. My temp started to increase again at 9:30 pm so I took 2 more ibuprofen. My normal body temp is usually 96.7 - 97.3.
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
On an unspecified date, the child received an injection of Engerix-B at school; number of previous injections of Engerix-B was not reported. On 9/26/00, an unspecified amount of time, post vax, the child developed angioedema, throat itch, pruritus and urticaria. He was taken to the local ER and treated with unspecified steroids. He remained symptom-free for the next 2 weeks. The urticaria then returned. He was seen by an Allergist and was treated with Zyrtec 10mg daily, cimetidine 75mg daily and Benadryl. As of 4/01, the urticaria persisted. The reporting Allergist considered the angioedema, throat itch, pruritus and urticaria to be of moderate intensity and possibly related to Engerix-B administration.
pneumonia vaccine administered in 2000 and 2004; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to an approximately 71-year-old male patient. His concurrent conditions included obstructive sleep apnea, arthritis, hyperlipidemia, high blood pressure and diabetes. The pt never smoked or used tobacco products. His medical history included chickenpox. His concomitant therapies included hydrochlorothiazide (+) lisinopril, simvastatin (manufacturer unknown), ibuprofen and metformin.     On an unknown date in 2000, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. On an unknown date in 2004, the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of administration, anatomical location, lot # and expiry date were not reported) for prophylaxis.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-1811USA007535:
Systemic: Chills-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Seizure-Mild, Systemic: hand spasms-Mild; symptoms lasted 1 day
Pfizer 5-11 Years vaccine dose #2 given too soon, 13 days early. Pt family informed immediately by provider and patient kept in the clinic for follow up more than an hour.  In the mean time CDC communicated  and recommended the timing for second dose of vaccine, family informed while in the clinic.  Up on leaving  the clinic patient doesn't have signs and symptoms of adverse effects.
Right arm with both Pneumovax and Fluarix had no reaction.  Left arm with Shingrix caused swelling, redness and pain.  Also, patient experienced flu-like symptoms, including body aches, fever/chills, headache and fatigue.  Was not able to work for 4 days.
Patient presents to ED after Cardiology called him to come in due to low potassium.  Denies muscle aching or chest pains at this time.  Does state he is feeling bloated despite having a hard stool about an hour ago.    1. Hypokalemia    2. Electrolyte depletion    3. Weakness    4. Left arm numbness    5. Chronic systolic CHF (congestive heart failure) potassium chloride (KLOR-CON M20) 20 MEQ CR tablet
lesions appeared on face, trunks body x 8 days ago;mild case of varicella;DPH PRN;
Narrative: Patient received three doses of Pfizer COVID 19 vaccine Jan/Feb2021. The patient tested positive for COVID 19 on 30 December 2021 and was admitted to the hospital with chest pain at that time was discharged and then readmitted on 10 Jan 2022 with chest pain was monitored and discharged on 11 Jan 2022 in stable condition.
This spontaneous report as received from a nurse prescriber refers to a currently 21-year-old female patient. The patient had no known drug allergies and no information was provided regarding her concurrent conditions, medical history and concomitant medications. On unknown dates the patient was vaccinated with the first and the second doses of GARDASIL (doses, route, lot# and expiry dates not reported). On 28-JUN-2013 the patient was vaccinated with the third dose of GARDASIL lot # reported as "H02002", expiry date 08-AUG-2015, intramuscularly. On an unknown date the patient experienced neuropathy. On 28-JUN-2013 urine and hemoglobin tests were performed and both showed normal results. The outcome of neuropathy was unknown. The causality assessment was not provided. Upon internal review neuropathy was considered to be medically significant adverse event. Lot number H02002 is an invalid lot number for GARDASIL.
A report has been received from a Health Professional concerning male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient had been received nasal FLUMIST QUADRIVALENT on 04-Oct-2013. It was reported that the patient had influenza A. The outcome of the event of Influenza A was unknown. The reporter considered the event to be non-serious.
Injection site was swollen, red, tender, and felt like a hard lump, about the size of a half dollar and lasted about 10 days.
Very Tired; Dizziness; She can't walk right"; Headaches after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), GAIT DISTURBANCE (She can't walk right"), HEADACHE (Headaches after the vaccination) and FATIGUE (Very Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (compazine) and Penicillin allergy.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, the patient experienced HEADACHE (Headaches after the vaccination). On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness) and GAIT DISTURBANCE (She can't walk right"). On an unknown date, the patient experienced FATIGUE (Very Tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), GAIT DISTURBANCE (She can't walk right"), HEADACHE (Headaches after the vaccination) and FATIGUE (Very Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up document was received on 03-MAY-2021.Newevent very tired was reported. It contains significant information.
After Moderna vaccine experienced some genital discomfort and painful sex. Saw Dr may 12, 2121 who missed it, and Was diagnosed with lichen sclerosis by other Obgyn about one month later. Symptoms began to appear after Moderna vaccine
The client reported that the same day he received the Janssen COVID vaccine he developed itching on his arm where he received the vaccine. The client stated the itching lasted 3 days. The client denied any other signs or symptoms of anaphylaxis.
pt recvd vax 18AUG95 & 21NOV95 pt was tested for varicella antibodies & was reported to have a neg seroconversion; No further details were provided;
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non-significant Follow up appended.
This spontaneous report as received from a female patient of approximately 64 years regarding herself. The patient has no drug reactions or allergies. The patient's medical history included shingles in 2011. The patient reported that, ever since her previous cases of shingles in 2011, she has been experiencing nerve tingling and numbness in her left leg at the location where she had shingles, which is "from the buttocks to the thigh: on the left side of her body. Patient's current conditions also included shoulder pain. On 03-JUL-2012, the patient was vaccinated with one shot (1 DF) ZOSTAVAX (Lot number, expiry date, route and dose were not reported) injections. Concomitant therapies included tramadol hydrochloride for shoulder pain. Approximately on an unknown date in 2013, within the past 2 months the tingling and numbness worsened "within the past 2 months" and now also includes the toes on the left side. She described this sensation by stating that her "nerves have been getting crazy". The patient sought medical attention (spoke with the physician). Lab Diagnostic Studies Performed was none. No treatment was given. The outcome of all the reported events was not recovered/not resolved. Additional information has been requested.
Vaccines given on 3/27/2019 per child got 2 shots in right arm and 1 in left.  Went to school on Monday and Tuesday and was feeling fine. Missed on Wed and Thur. Today tried to go but sent home due to rash.  Tuesday evening had tactile fever.  Wednesday rash started on trunk, then spread to face and full body. Sparing feet and palms of hands. 1 lesion on tongue. 1 lesion near right eye. Very itchy. Eating and drinking well. No decreased UOP. Continues to be in good spirits but is a little itchy. Tactile fever has continued until now. Relieved by Tylenol. Last dose of Tylenol was at 730am. No motrin given.   No contacts with same rash Several new products on skin in past 1m Arrived from country 1 m ago Previously well child. No admissions.  No family history immunosuppression.