chrisvoncsefalvay/vaers-outcomes huggingface dataset:
REALLY SICK; FEVER; HEADACHE; VACCINE ADMINISTERED TO PERSON WHOSE AGE IS 17; This spontaneous report received from a parent concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced vaccine administered to person whose age is 17. On 29-JUL-2021, the subject experienced really sick. On 29-JUL-2021, the subject experienced fever. On 29-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and really sick, and the outcome of vaccine administered to person whose age is 17 was not reported. This report was non-serious.
Received vaccine at 3PM; at 11PM started to have fever and mild arm soreness, by midnight had migraine.  In the morning at 6AM, had full arm pain at injection site (muscle tight and sore) and fever and migraine continued.  At 8 AM, fever was gone, migraine mild, but became puffy (inflamed) in my face and gut.  At 1PM my tooth #23 was very sore (just had a filling replaced on that tooth four weeks ago) and entire jaw on right side as very sore.
Throat tingling 10 minutes after shot administered.   Sent to ER for treatment (solumedrol, famotidine, diphenhydramine administered)
Fatigue, body aches, fever, chest pain, chest tightness (lasted 5 days), dizziness.
Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (left arm).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment information was provided.   This case was linked to MOD-2021-237353 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contains no new information.
First dose - sore arm at injection site. Second dose - sore arm at injection site, body aches and chills on day one, and waves of severe stomach cramping and diarrhea on day two (considered trip to ER).
This spontaneous report was received from a healthcare worker regarding an one year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 10-MAR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported, lot # L046507 with expiration date 17-MAY-2017) and a dose of VARIVAX (Merck) (dose and route were not reported, lot # L041207 with expiration date 20-OCT-2017) during the same visit due to product confusion. It was reported that PROQUAD (Merck) was mistaken for which was the intended product. The reporter was not aware of any adverse effects. This is one of several report received from the same source. Additional information has been requested.
pt devel papular, erythema lesions w/vesicular lesions, two lesions crusted;
Became itchy the following morning and 24 hours after administration injection site became inflamed, a "large lump" that was hot and itchy and eventually peeled. Hive was approx. 3in. in diameter.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# K012457, expiration date 04-JUN-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016").  On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of VAQTA were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007121: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007249:
Extreme shortness of breath for approx 5 hrs (heavy panting) with a fever.  Used an prescription inhaler. 2 doses. Went to bed then woke in morning okay. Scared my wife.
Started feeling feverish at 8:30pm - roughly 10 hours after vaccination.  Recorded fever as high as 102.4 at 3:00am.  Fever ultimately broke and temp was normal when I woke up this morning.  Just tired and head-achy now likely from poor nights sleep.  Temps were taken with an oral, digital read thermometer.  I will follow up if fever continues.
Two weeks of on and off again  stomach ache/ rumbling etc   like I will get diarrhea, but don't.
Based on information provided by staff, here is a brief summary of the events that occurred today regarding 13 year old minor received 2nd dose of Moderna vaccine.  At around 11:15 AM, a vehicle with 2 minors (14 and 13 years old) and at least one adult (father of minors) arrived on location requested a change of vaccine type for both minors from Pfizer to Moderna since they claimed they could only register for Pfizer.  IT staff should have stopped the vehicle for age and vaccine verification and to obtain further clarification, but proceeded to allow the car to move forward.  The educator noticed that the vaccination card she received from one of the patients already had a Moderna sticker for the first dose and proceeded to get verification from IT. She also realized that this patient was a minor and said she asked team members to wait. The IT person stated that the patient was registered as having received Pfizer as the first dose on 9/8/2021 at this location. Educator gave back the vaccination cards to patients, which should have been retained for further clarification.   The driver proceeded to move forward where vaccinators were waiting.  Since everyone in the vehicle had their vaccination cards on hand, the vaccinator proceeded to administer the Moderna vaccine to the adult and to one of the minor patients without verifying the dates for eligibility for the second dose (28 days or more) or the fact that this was a minor getting a Moderna vaccine. Vaccinators did not verify with scanner or educator whether the patients were ready for vaccination. No one who received the vaccine got their QR codes scanned.  Site leads were in the vicinity and came over to check and therefore, vaccinators stopped and the other minor patient did not receive any vaccine. Our observation support staff asked the driver to wait in the observation area, but upon proceeding to the area, driver told the staff there (IT working on gift card processing) that they had already waited more than 30 minutes and drove off.  Our clinical lead was notified and she and another staff member arrived on site within the hour and we proceeded to conduct a tactical pause and re-training.
Information has been received from a health professional concerning a 26 year old female with sulfonamide allergy who on 22-FEB-2007 was vaccinated, in the left arm, with a first dose of Gardasil (lot # 655849/0263U). There was no concomitant medication. There were no adverse symptoms reported after the first dose. On 24-APR-2007 the patient was vaccinated with Gardasil a second dose. Immediately after the vaccination, the patient experienced left arm pain, nausea, dizziness and loss of appetite. On 25-APR-2007 the patient experienced a lot of pain in her left arm that radiated down to her hand. Her fingers were weak and she was unable to use her hand. Also on that same day the pain radiated to the patient's left leg for a half an hour. Patient was treated with ice and ibuprofen. On 26-APR-2007 the patient recovered. The reporting registered nurse considered unable to use her hand, nausea, loss of appetite, dizziness, fingers were weak, pain in left arm that radiated down her hand, and left leg pain to be disabling.
Patient administered incorrect Moderna vaccine. Patient was administered the correct dosage of 0.25ml. No adverse signs/symptoms after administration
Day 1- extremely sore. Day 2 extremely sore entire body but painful on left side of breast extending from my armpit to neck. Hurts if not touched but hurts a lot worse when touched.; extremely sore - felt like a badflu; Terrible headache; Very sore to move my arm; There also is a stinging type feeling in that arm.; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), high cholesterol, bipolar disorder, gastroesophageal reflux disorder (GERD). 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 vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), metoprolol (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 01Apr2021 at 16:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 18:00, the patient experienced day 1 extremely sore - felt like a bad flu, no vomiting, no nausea, no diarrhea and terrible headache. On day 2, she had extremely sore entire body but painful on left side of breast extending from her armpit to neck; hurts if it was not touched but hurts a lot worse when touched. She had a very sore to move my arm. She was having stinging type feeling in that arm. She did not have breathing issues at all. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flue like symptoms, headache, radiating pain, pain in arm and pricking skin sensation was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Pt's mother states pt started c/o backache from her waist up beginning night of vaccine given 3/13/06. Nausea developed next day (3/14/06). Febrile, never sought medical attention. No swelling in arms. Took till Sunday 3/19/06 to feel better. Arms tender to touch, compresses applied same day.
received the first dose of the vaccine two years prior/planning to receive the second dose/The vaccine was not yet administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two years prior).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable to this report. Pharmacist reported that the patient received the first dose of the vaccine two years prior and was planning to receive the second dose, which led to incomplete course of vaccination. The vaccine was not yet administrated.  No further information were reported. The reporter did not consent nor decline follow up.
Non-stop screaming, approximately 36 hours. Hospitalization 02/27/2000 to 3/01/2000. Nasal Discharge, mild cough, low grade fever. Started on empiric antibiotics of cefotaxime. On IV antibiotics and fluids while in hosp. Discharge summary states: sepsis ruled out.
Local injection site adverse events : symptoms of redness, swelling, warm to the touch, hardening  or area around injection site occurred about 4-5 hours after receiving the vaccine.  The size of irritation is approximately 2 inches wide. Patient is fine and  had no other adverse events from this particular influenza vaccine.  We put ice on the irritated area and gave one age appropriate dose of motrin.  Two other children siblings received the same vaccine at the same time and they did NOT have any adverse event.
Stopped eating and drinking x 3 days. Fatiigue, no talking. Brought to ER on Day 4; Admitted on  Day 4 with severe dehydration, in atrial fib, hypernatremia. IV fluids given. Went to CCU with heart monitor.  Hospitalist refused to feed her, she was aspirating.  I had to discharge her and bring her to another hospital to insert feeding tube temporaility to help her to start to eat again.
Received vaccine between 9 and 10 in the morning. Within less than one hour had a hive on face. Within another hour had hives all over face and on two fingertips. No itching or pain. No other symtoms. Child played without interruption. Resolved by 5pm without any medication.
asymptomatic but positive; asymptomatic but positive; This is a spontaneous report from a contactable Other HCP (patient's parent).  A male patient (son) of unknown age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller states his son went back to school and initially tested negative for SARS-Cov-2 following first dose, now is asymptomatic but positive. Asking if second dose would exacerbate. Outcome is unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event "asymptomatic but positive" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available.
1000-employee received vaccine 1005:employee relates a very dry mouth and possible difficulty swallowing(kind of like reaction to shellfish); 1030employee checks in to ED for further evaluation; 1100 employee discharged from ED
My 16 daughter still has a headache after receiving her second vaccine; still has a headache after receiving her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 daughter still has a headache after receiving her second vaccine) and HEADACHE (still has a headache after receiving her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 daughter still has a headache after receiving her second vaccine) and HEADACHE (still has a headache after receiving her second vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 daughter still has a headache after receiving her second vaccine) outcome was unknown and HEADACHE (still has a headache after receiving her second vaccine) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
The pt had his first Moderna covid vaccine on 3/19, and after the vaccination, he developed left upper lateral calf pain that lasted several weeks.  He then had his second Moderna covid vaccine on 4/22, with left knee pain, and again left upper lateral proximal calf pain.  He denies any chest pain, heaviness, tightness, pressure, palpitations, or dizziness.  He contacted his PCP, and he was advised to come to the ER for evaluation of a possible DVT.   This is very suspicious for a direct thrombotic side effect of the pt's Moderna vaccine.  The pt has a very high d-dimer, and we can not rule out a mid-distal thigh and left popliteal DVT, so the pt will be covered with Lovenox, and he will present to hospital tomorrow to obtain a venous duplex.  They can then, based on clot burden and his subsequent complaints on continuing lovenox bridge to warfarin or a direct acting anticoagulant.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown gender and age. On 22-OCT-2014, the patient was vaccinated with an expired dose of VARIVAX (Merck) lot # H013181, expiration date: 05-JUL-2014 (dose, dose number and route were not reported). No symptoms were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Hives, Pt was given prednisone 20 mg tablets on 09/22/2022
On 02/04/2021, by the end of the day my arm was hurting, and I felt like a truck had run over me. I had chills, fever, headache, and body aches. A few days after all of those symptoms, everything went away with the exception of the headaches which got worse. I also experienced a strange tingly sensation in my arms and legs after receiving the vaccine and that continued on until I received my next dose of Pfizer. The headaches also began to dissipate little by little after that second dose. I did call my doctor's office and spoke with a representative, but was never seen.
Fever, chills, cough, shortness of breath, fatigue, headache, loss of taste and smell, congestion
Patient developed cellulitis and abscess of left thigh, requiring surgical I&D and penrose drain placement. Wound culture grew MRSA. Was treated with course of Bactrim.
The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, 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 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) 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 (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023).    Concomitant medication was not reported.  It was reported that, all patients qualified d/+ age greater than 65 or immunocompromised.  Patient received Moderna vaccine as a booster.  Date the vial was initially stored in the refrigerator was 31-May-2023. Vial did not under gone temperature excursion. Moderna vaccines was still effective. There have been no adverse reaction for patient.  Treatment medication was not reported.  This case is for 7th patient out of 20 patients described by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:master case
Information has been received from a group of physicians at an inservice meeting concerning a male patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not reported). The group of physician's indicated that they had heard of a patient who developed necrotizing lesions after getting ZOSTAVAX (Merck) and died. The physicians didn't know if it was from the ZOSTAVAX (Merck) but they believed that it was. Necrotizing lesions was considered to be disabling and immediately life-threatening by the reporters. Attempts are being made to clarify the existence of an identifiable patient. Additional information has been requested.
1AUG96 pt awakened usual time c/o not feeling good, & slept most of day, eating little all day, but drinking;t100-mom gave APAP;also had shakes, chills,severe stomach pains, t102.6;to ER dx rxn to vax;