chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Disease with Positive PCR Test Post First Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination). In March 2021, COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Reports redness and swelling with itching at injection site day after immunization given.  Nothing applied to injection site-reports scratching the site.
Patient had vaccine Friday, started having calf pain Saturday and diagnosed with DVT Sunday. This is in the setting of recently starting OCPs (high dose for 1 week then on regular dose at time of DVT) and some increased sedentary status due to menorrhagia. Unsure if this is related to vaccine but felt necessary to report.
Post vax, the pt was unresponsive, limp, and began to fall off table. He then had a tonic clonic seizure lasting 5 seconds associated with loss of consciousness.
flu; feels really sick; fever 102.3 ºF; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF). At the time of the report, INFLUENZA (flu), MALAISE (feels really sick) and PYREXIA (fever 102.3 ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever 102.3 ºF..         No concomitant medication details were provided. No treatment medication details were provided.
This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow up information has been received from a consumer (included medical records), concerning her approximately 18 week old ("4 month old") infant daughter with no pertinent medical history, who in September 2007, was vaccinated in the right thigh (previously reported as left leg) with the first dose of COMVAX (lot #655548/1243F) (previously reported as Hib conj vaccine (OMPC), with no events noted.  On 26-NOV-2007 at 2:30 pm, the infant was vaccinated IM in the right thigh with the second dose of COMVAX (lot # 657179/0223U) (previously reported as Hib conj vaccine (OMPC), in the left thigh with the second dose of DTaP (unspecified) (AVENTIS) (lot #C2797AA), and in the left thigh with the second dose of PREVNAR (WYETH) (lot #805100K). Concomitant therapy on 26-NOV-2007 included the second dose, oral, of ROTATEQ (lot #656393/0240U). Following the vaccinations on 26-NOV-2007, her daughter developed bumps at the injection sites of both legs. The mother called the physician and was informed "there wasn't anything to be concerned" about. On 02-DEC-2007 the infant recovered from the events. Additional information is not expected.
Fever; Pain in the arm; Lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN and HCTZ for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain). At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Pain in the arm) and PAIN (Lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.
PATIENT LOST CONSCIOUSNESS, FELL FORWARD OUT OF CHAIR (WAS CAUGHT AND ASSISTED TO THE FLOOR), PATIENT REGAINED CONSCIOUSNESS, EMERGENCY SERVICES WERE CALLED, PULSE, BLOOD SUGAR, OXYGEN, AND VISION WERE FINE, PATIENT VERY LIGHT HEADED, BLOOD PRESSURE EXTREMELY LOW, WASN'T RETURNING TO NORMAL
they came out with the two shots/ suspected vaccination failure; shingles on the top of my head and forehead almost got in my eyes; worst headache; someone setting on my chest; sleep setting up because it made my head hurt worse to lay down; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and morphine for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and morphine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache, chest discomfort and sleep disorder. The action taken with morphine was unknown. On an unknown date, the outcome of the vaccination failure, shingles, headache, chest discomfort and sleep disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache, chest discomfort and sleep disorder to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the 1st shot of Shingles only needed one, 4 years later had the shingles. The patient came out with two shots of Shingles. The patient stated he/she had the shingles on the top of head and forehead almost got in eyes. It was the worst headache ever and went to the emergency room and gave morphine, it helped with pain but felt like someone setting on chest, hated it. The patient stated he/she had to sleep setting up because it made head hurt worse to lay down. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Bad headache over left temple; Arm pain all the way down to fingertips; Nausea; muscle aches in both shoulders; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the upper left arm on 12Feb2021 02:00 PM (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation at a workplace clinic. Medical history included hypertension and high cholesterol; both from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone, atorvastatin (LIPITOR), potassium chloride and magnesium; all taken for an unspecified indication, start and stop dates were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. The patient experienced bad headache over left temple and arm pain all the way down to fingertips, nausea, muscle aches in both shoulders and fatigue on 13Feb2021 04:00 AM. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9 Days after flu shot: confusion, lethargic, tremors, severe weakness, anorexia, irritable,dizzy, sudden dementia Hospitalized a total of 13 out of 21 days with no diagnosis CT scans ruled out stroke. Weakness,confusion, poor memory,poor balance still continue over 3 weeks after onset. Seems to have ADEM!!!   11/09/2007 Received hospital medical records which reveal patient experienced altered mental status & memory difficulty.  2 admits in 10/07: 10/18-10/20 & 10/25-10/30/2007.  11/9/07 Received additional hospital records: 10/18 admission noted to have followed progressive episode of weakness, difficulty getting up out of  chair, unsteady gait & fever.  Dx at that time w/viral illness.   CT of brain on that admission was WNL. Neuro eval done.  Had further deterioration after d/c to home. Readmitted 10/25-10/30/2007 for persistent severe weakness, right abdominal/flank pain, nausea, poor appetite, difficulty swallowing & altered mental status.  ID, Neuro & GI consult done.  No D/C summary available for any of the admits. 11/13/07 Received med records & vax records from pcp.  VAERS database updated w/same.  Office visit of 10/16/07 revealed generalized body ache x 3 days, knee pain, RUQ & right posterior chest pain & chills.  Dx w/probable viral syndrome.  Tx w/antibiotics.  Returned on 10/18 w/o improvement, weakness, LBP & HA.  Admitted to hospital for further evaluation.  Returned to office on 10/22/2007 continuing to feel weak w/shaking, epigastric pain & decreased appetite.  Referred to neuro.
Pt inadvertently received 0.5 ML dose instead of 0.3 ML dose
extreme eczema; I am on fire; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 3 (booster),single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, ), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, ), for Covid-19 Immunization. The following information was reported: ECZEMA (non-serious) with onset Nov2021, outcome "unknown", described as "extreme eczema"; BURNING SENSATION (non-serious) with onset Nov2021, outcome "unknown", described as "I am on fire". Therapeutic measures were taken as a result of eczema, burning sensation.  Additional Information: The patient stated that, I received my Pfizer covid booster vaccine on 25Oct2021. The first week of Nov an extreme eczema outbreak occurred around my mouth and nose. Although there is no history of eczema in my family, and I have never experienced it in my seventy one years, I am on fire with is 24x7. I am being treated at (Clinic name withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very sore arm, required Tylenol Moderate fatigue  Sore are resolved next day Fatigue continues
Urticaria (hive) reaction six hours post vax. Lasted 36 hours. No respiratory symptoms.
The day of and after there was a headache and muscle aches.  Then around 0200 on 9/23 I woke up covered in hives, I took a benadryl and they did not go away. I tried cold showers and ice and they did not go away.   I went to urgent care on 9/25 and was given IM shots of steroids and benadryl to treat the hives.
This spontaneous report was received from a Licensed Practical Nurse concerning an 8 months old patient. The nurse stated that she administered ROTATEQ (dose, route and lot # not provided) to patient who was 8 months of age, vaccination date was not provided. No adverse symptoms were reported. Additional information has been requested.
I started getting a rash on my stomach and it moved up my body to the chest, mouth tenderness and inflammation in my gums. I had herpes virus 35 years prior to my vaccine and I think that vaccine triggered the virus and giving me a boost of that virus.
Soreness in whole upper left arm. Inability to lift arm above shoulder or from side to side without pain. Red rash appeared 05/06/2021 around injection site. Rash has a diameter of about 2 inches. 1st dose caused a sore arm but it took a day to feel and only lasted 2 days.
Vaccine administration error, related to temperature excursion, associated with an adverse event. The clinic explained prior to thawing and administration of the vaccine, it was stored in frozen temperatures for longer than recommended by the manufacturer. Outcome: Vaccine recipient contacted by staff.
patient sent home from work  on the morning of 1/21/2021 due to muscle pain, weakness, nausea.  Symptoms worsened including  decrease in o2 sats 72% (compared to normal mid-90%), patient was unable to ambulate due to muscle weakness/pain, pulse elevated to greater than 100 bpm.  Ambulance was called  and arrived to the  home where patient resides at 8:55 am on 1/22/2021.  Home director emailed symptoms to the pharmacy after the patient left for the ER.  Pharmacist called home director to get additional info.  As of 1:03 pm on 1/22/2021 patient has returned home after ER staff determined his symptoms were an adverse reaction to Moderna.  He was advised by the ER staff to rest and drink plenty of liquids.  Pharmacy advised home director to contact patient primary provider to report ADR and determine if the 2nd dose of Moderna is advised by the primary provider.  The pharmacist will follow-up with the house director status on 1/23/2020 before 3 pm and will have any additional ADR's reported to the pharmacy and the patients primary provider
Vaccine administered on 20-may-2022 and freezed on 25-may-2022; patient received an expired Moderna booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose) and PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022 at 10:17 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2022 at 10:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Moderna booster dose) and PRODUCT STORAGE ERROR (Vaccine administered on 20-may-2022 and freezed on 25-may-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was stored in refrigerator on 25-May-2022 and was pulled straight out of freezer and thawed out. The vial did not undergo any temperature excursion.
pt  had pain  in arm iced and took tylenol --- orginally  --   late rin day pt experienced chills/ hot flash    diarrhea / vomitting  and headache  lasted 2 days/  symptoms had resolved today 3/22 -- same day as reported to us.
Starting day 4 post vaccine developed heart flutters that would last several seconds before spontaneously resolving. This heart fluttering happened off and on over the next 6 to 7 days. On day 12 developed diagnosed atrial fibrillation with a rapid response rate which resulted in a hospitalization for 24 hours and treatment of a Cardizem bolus and Cadizem drip. Discharged home with outpatient cardioversion scheduled, however; spontaneously converted back to normal sinus rhythm but remain on a daily dose of Cardizem and a twice per day dose of Eliquis. I require follow-up with a cardiologist and will require the two new medications for at least three to four weeks post atrial fibrillation event.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection site area was slightly sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B228) for COVID-19 prophylaxis. The patient's past medical history included Chemotherapy, Radiation therapy, Lumpectomy in 2007 and Lymphadenectomy (all of the lymph nodes on her left side were removed). Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Type 1 diabetes mellitus since 1987, Breast cancer female (Left, cancer was 2 Centimeters in diameter - left breast has been larger/perkier than right breast) since 2007, Hypertension and Graves' disease. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), ATORVASTATIN, LISINOPRIL, METOPROLOL SUCCINATE, ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site area was slightly sore). At the time of the report, VACCINATION SITE PAIN (Injection site area was slightly sore) outcome was unknown. The patient received a Moderna monovalent vaccine as a booster dose, expiration date was not known. Patient received vaccine in her left arm. Injection site area was slightly sore. No treatment information was provided by the reporter. This case was linked to MOD-2022-674650, MOD-2022-674648 (Patient Link).
COVID-19 Vaccine EUA; Woke up next morning after vaccine shot feeling nausous, but did not vomit . Had tingling in both arms and hands for a short time and sweats. I applied a cold washcloth to my face and had a bite of a saltine cracker and some water which helped.  Later in day got very warm applied cold washcloth again and was sleepy on and off during the day. Mid day symptons went away just sleepy. Soreness near injections site for two days.
she had an accident; she broke a tooth; inflammation; I had pain in the arm; I had a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth), INFLAMMATION (inflammation), VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016CK1A and 042B21-2A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PRAVASTATIN, LISINOPRIL and METFORMIN HYDROCHLORIDE (CETAPIN) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth), INFLAMMATION (inflammation), VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever). At the time of the report, ACCIDENT (she had an accident), TOOTH FRACTURE (she broke a tooth) and INFLAMMATION (inflammation) outcome was unknown and VACCINATION SITE PAIN (I had pain in the arm) and PYREXIA (I had a slight fever) had resolved.            It was reported that patient had called to change her booster shot appointment which was on 04-FEB-2022, because she had an accident, she broke a tooth and because of the inflammation she was advised not to get the Moderna COVID-19 vaccine until it resolves.  No treatment medication details was provided.
Really sharp pain in left arm/pain 6-8 inches below the injection site; Had an injury to his left arm; This is a spontaneous report from a contactable consumer (the patient's son). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on an unspecified date (reported as 11 days ago) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an injury to his left arm, he went to his orthopedic doctor who proposed a cortisone shot. Reporter wants to know if he can take the cortisone shot given that he receives his first dose 11 days ago. On an unspecified date, the patient experienced really sharp pain in left arm/pain 6-8 inches below the injection site. It was reported that Reporter mentioned that his father had some pain 6-8 inches below the injection site. He wants to know if this was normal and state father had an injury to his left arm, he went to his orthopedic doctor and the doctor proposed a cortisone shot. He was due to receive the second dose on the 23rd or so, stated he had a really sharp pain in his left arm, states he can't say it came from shot, stated it might be from the patient's workout with 3lb arm weights. Reporter stated the patient was going to the orthopedic doctor today, they might want to do a cortisone shot in that left shoulder, Reporter wants to know if this was a good idea given that he was between the two doses of the vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.