chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed Covid infection after the 1st dose of Moderna Vaccine/Contracted Covid; Doctor advised to wait for 3 months to get second dose/Over 35 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed Covid infection after the 1st dose of Moderna Vaccine/Contracted Covid) and PRODUCT DOSE OMISSION ISSUE (Doctor advised to wait for 3 months to get second dose/Over 35 days from 1st dose) 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.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (developed Covid infection after the 1st dose of Moderna Vaccine/Contracted Covid) and PRODUCT DOSE OMISSION ISSUE (Doctor advised to wait for 3 months to get second dose/Over 35 days from 1st dose). At the time of the report, COVID-19 (developed Covid infection after the 1st dose of Moderna Vaccine/Contracted Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Doctor advised to wait for 3 months to get second dose/Over 35 days from 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided by reporter. No treatment information provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received included new event, first dose date updated, event onset date updated.
Information has been received from a legal firm regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from July 1992 through August 1996. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info was received in the form of an immunization record. It was reported that the pt was vaccinated with a first dose of hep B virus vaccine on 5/14/93, a second dose on approximately 8/18/93, and a third dose on 5/10/94. Other immunizations included: diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and Haemophilus B conjugate vaccine on 7/12/92, 9/26/92, 11/28//92 and 9/25/93; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 8/8/96; poliovirus vaccine on 7/12/92, 9/26/92, 9/25/93 and 8/8/96; MMR II on 9/25/93 and 6/23/98; and varicella virus vaccine on 1/26/96. The pt was also administered a TB skin test on 5/14/93; results were not reported. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). No further info is available. A copy of the pt's complete medical record is available upon request
6OCT93 430AM woke up w/t105 R; pt pt in shower gave APAP; pt taken to MD;
Patient reports arm being sore, red and puffy. Difficult to sleep on and reports a low grade fever.
Patient was admitted to this facility on 8/31/2022 and record verified which indicated last dose administered on 2/25/2022. Patient received what was thought to be second booster on 9/2/2022 but when information was added to tracker it noted file had been updated with vaccine information indicating had already received second booster on 8/1/2022. Verified with administering facility that information was entered into tracker on 9/1/2022. Patient suffered no adverse effect.
I had an appointment on Sunday, Sept 4 at 11:40 am for a flu shot at the pharmacy.  I received a flu shot at approximately that time. The pharmacist was polite and professional. When she administered my flu shot, she stuck it extremely high on my arm, into the shoulder. I have never had anyone give me a shot that high before. It hurt far more than usual and it felt as if something was vibrating. I told her that, and said it hurt quite a lot. She replied that she put the needle exactly where it was supposed to be. She gave my husband a shot in the same place. Although he had no additional problems, my arm hurt far more than expected. It was centered on my shoulder. It throbbed and I had trouble sleeping. Moving my shoulder or lifting anything resulted in extreme pain. It is beginning to feel better after a week, although it's still very tender. I had a Covid vaccine today, where the pharmacist strongly suggested I make a complaint. The pharmacist was very nice but I really do think she needs retraining in exactly where in the arm to administer a vaccine. The pharmacist stuck the Covid vaccine in the deltoid muscle, where every other vaccine I've ever had went. The pharmacist stuck that flu shot much, much higher, at the very top of my arm into the shoulder.
a patient received a dose of expired Flublok, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA301296, 2019SA301057 and 2019SA301297 (same reporter).  This case involves a 76 years old patient who received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV) (lot QFAA1827, 30-Jun-2019) via intramuscular route in the left deltoid on 26-Oct-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Pt was given Quadracel instead of Dtap. Pt had no reactions and is aware to contact us if she does.
Patient presents today via virtual visit for rash.  Virtual appointment has been arranged since we are in the middle of COVID-19 pandemic.  Mother and patient were the historians.  Patient had Gardasil, influenza, meningococcal MCV for PE, and Tdap vaccination on 1/5/2021.  Patient went to the emergency room in on 1/10/2021 for a rash that developed on 1/8/2021.  The rash developed on bilateral lower extremities.  It started on the feet and has been ascending up the legs and is now located on the lower abdomen according to the ED notes.  In the ED note the rash was painful and pruritic.  According to the ED note the rash itself was very characteristic for Henoch Schoenlein purpura.  Patient does not have any abdominal pain but she does have bilateral knee arthralgia.  Patient had labs completed which showed mild leukocytosis.  Her electrolytes and LFTs were within normal limits.  Inflammatory markers including sed rate and CRP were both minimal.  UA were worse without any evidence of UTI.  There was no proteinuria.  She has microscopic hematuria.  In the ED she was mildly tachycardic.  She received 1 L of IV fluids and her heart rate trend went back to normal.    Patient then had follow-up appointment with her doctor on 1/11/2021.  Patient had urine analysis completed in the doctor's office which showed trace ketones and trace leuks.  Patient's CMP was within normal limits.  Patient's CRP was minimal.  Patient's sed rate was within normal limits at 15.  Patient clinically looks well nontoxic.  Mother reports that patient also had leg edema along with a rash which started to go down since the ED visit, however 3 days ago that the leg swelling came back.  The rash has not worsened, but it has persisted.  It continues to be painful and pruritic.  They have not been doing any treatments.  Patient denies fever, shortness of breath, dry cough, chills, shaking repeatedly with chills, muscle pain, headache, nausea, vomiting, diarrhea, sore throat, or new loss of taste or smell.
Patient's entire right are was red, swollen and itchy. He self-treated with diphenhydramine upon his doctor's recommendation. The swelling and redness lasted for about a week, but still has some itching as of today (11/9/19). He also received the Fluzone HD the same day in the same arm, but has never reported such a reaction to the influenze vaccine.
Severe menstrual  cycle changed after first dose of Covid vaccine, including severe abdominal cramping, increased  menstrual flow
CHILDS DOB PROVIDED ON CONSENT. WHEN VACCINE WAS BEING RECORDED IN DATABASE, CHILD'S DOB IS RECORDED, WHICH WOULD MAKE CHILD UNDERAGE FOR VACCINE AT THE TIME IT WAS RECEIVED.
Redness is hot on bicep after second dose/Redness at the injection site after second dose; Redness at the injection site after second dose; Soreness at the injection site after second dose; Body Pain after second dose; Joint Pain after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose), MYALGIA (Body Pain after second dose), ARTHRALGIA (Joint Pain after second dose), VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body Pain after second dose) and ARTHRALGIA (Joint Pain after second dose). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose). On 06-Apr-2021, the patient experienced ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 05-Apr-2021, MYALGIA (Body Pain after second dose) and ARTHRALGIA (Joint Pain after second dose) had resolved. In April 2021, VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose) had resolved. At the time of the report, ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose) had not resolved.            The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included cold compress and paracetamol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Pt recvd vax 21Mar88.Approx 21Mar91 pt tried to donate blood & informed pos for hep B. Pt denied hep B exposure.Lab evaluation revealed carrier state. MD felt condition 2nd to recving vaxs.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2013, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient suffered (emotional distress) and continued suffering significant medical expenses, pain, suffering (emotional distress) and other damages on unspecified dates. The final outcome of the events was not specified and they were considered to be related to ZOSTAVAX.
Pt recvd vax 27MAR92 &  3 days later devel erythematous, papular rash which was described as discrete & confluent w/rare pustula & also pruritic; fever 101, dry cough;
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 2-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Ache all over; Unable to breath well; Felt faint; Felt like an electrical shock from heart; Exhausted; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 00:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, pre-diabetes and reflux. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole magnesium (NEXIUM), losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), nicotinic acid (niacin) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN) started on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, 7 days after first vaccine, the patient experienced ache all over, unable to breath well, felt faint, felt like an electrical shock from heart, exhausted which lasted 3 to 4 days. The patient had made an appointment with cardiologist and not getting second vaccine with cardiologist approval. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event ache all over, unable to breath well, felt faint, felt like an electrical shock from heart and exhausted was resolved in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Assoc states felt heart beating fast, light headed, burning in throat to neck/chest area - lasted approx 8-10 min - radial pulse checked was 88-62 and regular - no hive, SOB, N/V.
Patient felt very warm.  Blood pressure was checked.  BP @ 1055 was 240/130. Oxygen saturation 99%, heart rate 65.  BP rechecked at 11:00 and was 236/138 on Left.  At 11:02 blood pressure was 232/124 on right arm, oxygen saturation 100%, heart rate 64.  Stat team called.  At 11:06 blood pressure was 210/120, oxygen saturation 99% and heart rate 61.  Patient transferred to ED @ 11:15.
Treated in ED- Allergic reaction to flu shot-gave patient 40mg IM x 1 today. PREDNISONE taper, BENADRYL prn itching. Skin- rt hand and jaw erthemic and slightly edematous, multiple small erthemic patches on rt arm. Erythemic swollen area where flu vaccine was given on rt deltoid area. Symptoms 1. Skin Rash, 2. Rash 3. Erythema Multiforme, 4. small erythemic patches on trunk, red and swollen jaw and rt hand.
Chills for 3 hours and than abnormal gait which got so bad that became unable to walk for 10 hours without falling down.  At first had to hang on to things to walk and than unable to stand or sit up- felt like I was being pushed backwards.  Emesis all day
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 13-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Received the the 1st  Pfizer COVID vaccine on 08/12/2021 and the 2nd Pfizer COVID vaccine on 09/02/2021.  The Decedent's wife had told Police that the Decedent was complaining about not feeling well ever since he got the 2nd vaccine.   09/12/2021 -- Decedent had an Asthma attack at 0400 hours. Per the Decedent's wife, the Decedent did at least 10 Albuterol and Nebulizer treatments before calling for an ambulance at 1857 hours.  While in the ambulance, the Decedent went unresponsive and then into Cardiac Arrest. EMS started CPR & ACLS procedures, and worked the Decedent for 1 hour before calling Time of Death at 2015 hours.
Itching on Right Arm up; Tingling sensation on Right Arm; Rash on Right Arm; Red spots rash; raised spots rash; Red rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy upper limbs in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 5th March 2019, the patient received the 2nd dose of Shingrix. In April 2019, 30 days after receiving Shingrix, the patient experienced itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash. On an unknown date, the outcome of the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash were unknown.   It was unknown if the reporter considered the itchy upper limbs, tingling of extremity, rash, erythromacular rash, swelling arm and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. One month after receiving Shingrix, the patient experienced itching, tingling sensation on right arm up and down. The rash appeared as isolated spots, red and slightly raised with the size of 1 quarter of a dime size. The rash appeared and disappeared on and off.
tested positive for Covid 19; received primary series; tested positive for Covid 19; received primary series; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid 19; received primary series". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Description of Event: 12-13 year old male tested positive for Covid 19; received primary series. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
20 minutes after vaccine. Developed red rosy cheeks, progressed to hives, urticaria that is worsening today. Now is febrile and having some difficulty with breathing.
Information has been received from a nurse referring to a 12 years old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided. On 20-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 lot # 1581027, expiration date 03-JUN-2019 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of the GARDASIL 9 was reported as -11.9 degrees Celsius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004571: US-009507513-1904USA004572.
Rash at injection site that occurred on the evening of 01/26/21: , 2 red areas, each about 2"x4"  parallel to floor, areas were flat, not blistered, not itchy, not painful, normal body temperature. 15 hours after noticing the area is much improved, however still present. Took Benadryl 50 mg at HS and Zyrtec 10 mg during the day following the reaction
Burning on and around the injection site, 5/27/2022 around 4:00pm, then itching and burning around 9:00pm same day. I put ice on it for 30 minutes.
Aunt called in on 9/27/02 at 3:15PM stating patient's legs were stiff and sore. Child doesn't want to walk or move legs as they are very sore from shots today. Child stated complaining after she got up from nap at 2:00PM today. A dose of Tylenol was given at 10:00AM today and none since. Advised to give another dose of Tylenol and every 4 hours as needed, warm compresses might be helpful to sore areas. Aunt to call back if symptoms don't resolve in a day or two. Aunt reports patient recovered after 1 day of soreness and is fine now.