chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the of an allergic reaction in a 6 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The reporter is the aunt of the pt. A physician or other health care professional has not verified this report. The pt had no pre existing medical conditions. On an unspecified date, in Oct 2004, the pt received the first dose of Pediarix at an unspecified injection site. At an unspecified time following the first dose of Pediarix, on an unspecified date in 2004, the pt experienced a systemic red rash with spots "the size of a pen needle. The pt was seen at a physician's office and was treated with an unspecified corticosteroid.  The rash resolved on an unspecified date on or before 17Jan05. Approx three month following the first dose of Pediarix, on 17Jan05, the pt received the second dose of Pediarix at an unspecified injection site. This is longer than the recommended interval of six to eight weeks between doses of Pediarix. On an unspecified date on or before 28Feb05, the reporter stated that the pt experienced, a systemic allergic reaction with redness like mosquito bites the size of a dime with swelling. The reporter stated that the pt had 25 red spots on his legs, 15 red spots on his back, and 10 red spots on his arms. The pt was seen at a physician's office and was treated with diphenhydramine hydrochloride (Benadryl). The allergic reaction was ongoing at the time of initial reporting, 28Feb05.
Patient got FLUVIRIN injection in left arm on 09/22/11, on 09/27/11 started ZITHROMAX (generic) for a cold. On 9/28/11 got a diffuse rash on arm where injection was given painful & red.
tiene calentura con 98.9°F/ has a fever, at 98.9 ° F; se siente mal/ feels unwel; escalofríos/ chills; dolor de cabeza/ headache; tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen; está en la cama/ is in bed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache) and PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY.  Concomitant products included MONTELUKAST, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CITALOPRAM, ALPRAZOLAM and TRAZODONE.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed). At the time of the report, PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included energy go stick,trazadone Treatment information was not provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt lost consciousness for aprrox. 10 seconds. initial bp 101/40 returned to normal after 5 minutes. pt picked up from pharmacy and driven home by friend. spoke with pt on phone. pt was recommended to follow up with doctor by pharmacy, but reported not having done so yet.
vaccine which underwent temperature excursion; administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, ER8734 and EP7534) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter  It was reported that there was a temperature excursion involving 14 Moderna Covid-19 vials. Reporter mentioned that they have 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022, plus 5.11F which occurred for 7 minutes; thermometer in the freezer and the other 2 data loggers did not record any.  It was reported that vials were stored in freezer and after temperature excursion the vials were quarantined in the freezer.  No treatment medication was provided by the reporter.
Myalgia, Arthralgia, Fever, lung pain, fatigue Narrative:
Admitted to hospital with difficulty speaking, full body tremors, weakness, sensitivity to light,  inability to walk, episodes of confusion, ataxia. Evolved into insomnia, digestive issues, tachycardia, high blood pressure, right side headache, difficulty with temperature moderation (shivers or fever), lack of sweating on right side of body, after the hospital visit.  Admitted to Hospital, observed and a full workup doneNo treatment. Blood work showed b12 on low end of normal (~320). Advised to take b-compex, b12, magnesium supplements. Scheduled PT for treatment. No other treatment. Symptoms are resolving over months.
the site of injection of my virus injection was hurting so bad; This is a spontaneous report from a non-contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis which she just take care of the pain when it gets too bad with over the counter. The patient's concomitant medications were not reported. The patient was about 5 feet 1 inches, and 150 pounds. The patient queried if it was okay, because she had already done it, for her to take an ALEVE PM tablet because the site of injection of her virus injection was hurting so bad on 23Jan2021 with outcome of unknown. She queried if ALEVE, would hurt in any way, the effects of the virus vaccine. Therapeutic measures was taken as a result of the event with ALEVE PM.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHES; MENSTRUAL CRAMPS; DIARRHEA; CHILLS; FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a parent concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced menstrual cramps. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, menstrual cramps, diarrhea, chills, fever, headache, and tiredness on APR-2021. This report was non-serious.
LEFT ARM WHERE DTAP#5 WAS GIVEN HAS REDNESS SWELLING AND THREE BLISTERS. RIGHT ARM WHERE MMRV WAS GIVEN HAD SLIGHT REDNESS AND SWELLING.
Intense lower back pain after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Intense lower back pain after the second shot) in a patient of an unknown age and gender 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 BACK PAIN (Intense lower back pain after the second shot). At the time of the report, BACK PAIN (Intense lower back pain after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Chills; Body ache; Mild fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 21Apr2021 at 18:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to hydrocodone bitartrate; paracetamol (VICODIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included beclometasone dipropionate (QVAR) and salbutamol (ALBUTEROL); both for an unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 08:00, the patient experienced chills, body ache, mild fever and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, body ache, mild fever and headache were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, between January, 2016 and March, 2017, these patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. Time frame of temperature excursion was from January, 2016 until March, 2017 (exact hours not provided). There were no previous temperature excursions. A data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1704USA000110: US-009507513-1704USA000068: US-009507513-1704USA000112.
Patient called stating that she received her flu vaccine and today experiencing chills, headache and runny nose. Advised patient to follow up with doctor. Per patient she is seeing her doctor tomorrow.
Client complaining of right neck pain after receiving the vaccine. Fire Rescue onsite to evaluate patient.  Client was released to go home at 3:10 pm.  Per Fire Rescue no additional evaluation needed.
Woke up from sleep with fever of 102.7 and shaking in chills. Took tylenol at about 4am because I could not sleep. Fever waned to 101 and came back at 11am at 102 degrees. Started feeling nausea around noon and had body aches in my joints, specifically my hips and left elbow. Took Tylenol again. Fever continued until around 7pm and then it lowered to 99.1. By 8am the next morning all symptoms were gone and temperature was back to normal. The injection site and arm never hurt besides joint pain.
Constant pain in my left upper arm.  Moving my arm into certain positions brings on the pain (specifically, when reaching "up and to my left" with my left arm).  It has been happening since I received the first of 2 vaccines.  For the first few days, I thought it was just 'injection site pain', but it persists to this day...  in contrast, I have not had any pain in my right arm, in which I received the 2nd shot, 3 weeks later...
Hives starting from my head down to face and chest; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 35-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 12Jan2021 04:45 PM at single dose for COVID-19 immunization. Medical history included known allergies: latex and avocado. Concomitant drugs were not reported. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 12Jan2021 07:30 PM, patient had hives starting from her head down to face and chest. Diphenhydramine (BENADRYL) was given as treatment. Outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
VERY FAINT METALLIC TASTE (5 MINUTES AFTER THE VACCINE WHEN STARTED SALIVATING); This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced very faint metallic taste (5 minutes after the vaccine when started salivating). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very faint metallic taste (5 minutes after the vaccine when started salivating). This report was non-serious.
R arm pit pain, 2 to lymph node inflammation, no local reaction at the site of injection, OTC pain meds.
High blood pressure. I normally have low blood pressure. My readings have been up to 190/127. I've never had a reading over 140 before. Last reading was 149/100.
Fever and chills that lasted for four hours, from 2AM the following night until 6AM.  Soreness in the shoulder and upper arm.
States feeling hot & flushed all over 1 hr after shot was given.  Temp was taken at his job =99.2.  Tylenol given by nursing staff.
Mother states broke out from head to toe with eczema. Mom states child has eczema, but never has broken out like this. Had MMR 7/7/05. Broke out on 7/8/05 used TMC as child has eczema. Clarinex, been giving Benadryl for this doesn't feel its any better taking Advil PRN.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
rt thigh w/6 1/2" inflammation erythema, warm to touch;onset 13NOV;immunizations given 12NOV96;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 17-JUN-2015 the patient was inadvertently administered expired GARDASIL injection (lot # H015555; expiry: 13-APR-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. No further information provided. There was no Product Quality Complaint (PQC) involved. Outcome of the medication error was unknown. Additional information has been requested.
I experienced a severe headache, fever, shivering, chills, body aches, fatigue, muscle pain, swelling and rash on my arm, and belly pain after receiving my second SHINGRIX vaccine. The only side affect I experienced with the first shot was a very sore upper arm that lasted 5 days. It is day three and I am still feeling fatigued.
PT presented on 02/11/2022 for worsening generalized weakness, fatigue and fall.   On arrival to ED patient was found to have BP 131/81 with tachycardia 108 with SpO2 98% on room air with temp 99 F with normal other vitals. Labs showed normal CBC/CMP/HS troponin with elevated lactic acid 2.6 with elevated CRP 6.09 within normal procalcitonin with unremarkable UA.  COVID-19 positive   Chest x-ray showed faint patchy subsegmental atelectasis/airspace disease in both lower lungs CT head negative for any acute intracranial process   Patient was admitted for further management of possible COVID-19 pneumonia and she was started with IV fluid/PT/OT.  Patient was not hypoxic on admission.  However during hospital stay patient developed hypoxia requiring NC O2 and she was started with dexamethasone/Remdesivir by ID.  Hypoxic respiratory failure got better and she is on 2 L NC O2 at this time. Patient finished Remdesivir / and about 5 days of Decadron.
The pt experienced a high fever of 104 for 2 hours following vax. Severe joint pain and headache. Joint pain has continued over the past eight years worsening 3 years ago. This has been reported to a doctor but no treatment has been recommended. 60 day follow-up states the pt continues to get worse every year.
Patient only received diluent that was supposed to be mixed with the Menveo vaccine. Patient came back later that afternoon and was given the Menveo vaccine. Patient experienced no adverse reactions after receiving vaccine.
soreness on left shoulder; stomach spasm; vertigo; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (lot number: ek4176), via an unspecified route of administration in left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization.  Medical history included glaucoma, gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia (Bhp), and cholesterol. Concomitant medications included tamsulosin, metoprolol, and travoprost. Patient experienced soreness on left shoulder, stomach spasm and vertigo started on day 4 of vaccine on 15Jan2021 21:30. Patient went to hospital ER on tenth day after vaccine and released from hospital ER after 2.5 hours. AE result in: Emergency room/department or urgent care. Treatment was not received for these events. Outcome of the events was resolving.
Chronic headache, no treatment, condition improving but ongoing Left arm soreness and tingling, no treatment, lasted two days, condition has resolved
Chills, shivering, headache, gassy stomach.  Later  - 2 AM awoke with  rapid heart beat, difficulty breathing and dizziness upon arising.  Following day temperature of 100.
This is a 94-year-old male with past medical history of hypertension, hyperlipidemia, paroxysmal atrial fibrillation on chronic anticoagulation with Pradaxa, status post permanent pacemaker-Boston Scientific, insulin-dependent type 2 diabetes mellitus, BPH, history of bladder cancer status post ablation currently under remission, chronic right lower extremity wound. He came to the hospital with a chief complaint of mechanical fall.  Patient reports that he has been having difficulty maintaining his balance and progressively having worsening generalized weakness so he has been falling multiple times at home.  Denies any specific head injuries or other injuries.  Patient denies any other symptoms like fevers, chills, cough, chest pain, shortness of breath, palpitations, abdominal pain, nausea, vomiting, burning or painful urination, diarrhea.  T: 98.6 °F  TMIN: 98.3 °F  TMAX: 98.6 °F  HR: 85  RR: 18  BP: 111/58  SpO2: 95%  WT: 82.7 kg  BMI: 27.95 XR Chest 1V [Auth (Verified)] (01/12 1149): FINAL IMPRESSION: Bilateral perihilar predominant airspace opacities are nonspecific but favor pulmonary edema/congestion. Re-tested positive for COVID-19 on 1/12/22.
Vomiting & diarrhea for 4 days. Local rxn /w local adenopathy.