chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Got a second dose from a vial not properly stored), EXTRA DOSE ADMINISTERED (Received another second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Another second dose on 21Apr2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Got a second dose from a vial not properly stored). On 21-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received another second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Another second dose on 21Apr2021). On 12-Apr-2021, PRODUCT STORAGE ERROR (Got a second dose from a vial not properly stored) had resolved. On 21-Apr-2021, EXTRA DOSE ADMINISTERED (Received another second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Another second dose on 21Apr2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication were reported. No treatment medication were reported. Patient received another Second dose on 21-Apr-2021 of Lot number was 042B21A. HCP stated the patient is not taking any medications regularly. HCP inquired if it would be ok for this patient to receive the booster dose now, since they already had 3 doses of the Moderna vaccine. HCP states that apparently 800 people received a dose of the Moderna vaccine that was not properly stored. Reporter did not allow further contact
Patient received 6 total doses of Anthrax vaccine. Dose#1: 15 Feb 2003 Dose#2: 10 Nov 2003 Dose#3: 10 Mar 2004 Dose#4: 24 Sep 2008 Dose#5:  6 Jul 2009 Dose#6:  8 Jan 2010 Approx. 3 months after receiving dose #4 (the only vaccine received during this time) the patient started experiencing depression, withdrawn behavior and mood swings. Approx. 5 months after that administration patient had symptoms of worsening depression and was suffering what was called adjustment disorder. In July paient received dose #5, the following month patient was taken to ER by wife for worsening mental health changes and hallucinations. Patient was also diagnosed with Bell's Palsy 11 days after receiving dose #5. Dose #6 was given in January 2010 with admission to psychiatric facility following that administration. Patient shows no improvement at this time.
Fever of 103.8 that would not come down with medication.  Fever was gone within 24 hours of onset.
Herpesviral infection, zoster keratitis, herpesviral keratitis, and herpes dendritic keratitis; Herpesviral infection, zoster keratitis, herpesviral keratitis, and herpes dendritic keratitis; Information has been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt  of unknown age. Medical history, concurrent conditions and concomitant medications were not reported.  In or around 13-NOV-2015, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving Zoster Vaccine Live (ZOSTAVAX) the pt suffered skin lesions and was diagnosed with herpes viral infection, zoster keratitis, herpesviral keratitis and herpes dendritic keratitis. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX). She suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   Upon internal review ophthalmic herpes zoster was considered as medically significant. The reporters considered herpes zoster and ophthalmic herpes zoster to be disabling.
Patient called saying she was having double vision, blurry vision and a little confusion.  I told her that these were not normal side effects from the vaccine and that she should follow up with a health care provider right away or go into an urgent care facility to be examined.
This spontaneous report as received from an other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with M-M-R II (albumin status RHA) lot # M029919, M048368 and M040558 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown.; Sender's Comments: US-009507513-1708USA002090: US-009507513-1708USA002734: US-009507513-1708USA002735: US-009507513-1708USA002736:
Patient felt tongue heavy , no swollen and itching ears, no swollen on the tongue or perioral and no drooling, speech fluent - took Benadryl and left declined epi and wants to go home - feeling better and left
Bad head ache, muscle aches-esp around my middle. fever, chills. Effects returned briefly next day.  I took Advil to get relief
Became SOB, Expected Chest pain, Chest Soreness, Abnormal EKG-Abnormal holter monitor with arrhythmia, Sent to cardiologist, Put on Toprol to control fast heart rate.Had Echocardiogram which was normal,Still having SOB with heart racing and feeling tired. Feels not like her self.Very fatigued.
Mixed Shingrix with NS instead of Shingrix adjuvant; Mixed Shingrix with NS instead of Shingrix adjuvant; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9PR2P, expiry date 17th April 2023) for prophylaxis.   On 12th January 2022, the patient received Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received shingrix mixed with normal saline instead of shingrix adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No additional details available at time of reporting. The reporter consented to follow up.
The vaccine was expired/ expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medication reported by reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Received a new document, address of the reporter, patient initials, date of birth, the expiry date and patient route of administration of second dose was updated.
Case of an 18 yo female who present with an apparent varicella vaccine reaction - vesicle at area around vaccine around mouth at cheek - with itching. Tx with ZOVIRAX and was ordered titers.
70mm x 90mm induration.  No warmth noted.  Left deltoid.  Raised swollen area noted under left clavicle.  Not red.  No fever or chills.
2 wks following vax started having breathing difficulties has had acute breathing spasm which have continued & pt has hyperventilated; pt felt warm @ time of episodes; Pt seen by MD late OCT91 no treatment given;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not applicable for this report. It was reported that, everyone she knew that had received the SHINGRIX vaccine had an extremely sore arm that lasted for 3 days at the minimum. The caller refused to provide any additional details.
Pt developed redness and warmth in right deltoid region - with redness and firmness. No fever and some pain which is improving. No blisters or discharge. Exam 10-12 diameter erythema, deep into muscle, with tenderness. P: ice, heat and antipyretics.
I got diagnosed with COVID at the end of April. I blamed it on allergies at first. I live with 4 other people, and they went to city, state. They were told that the people they stayed with were positive. I went to an urgent care center due to shortness of breath, and sinus symptoms. The sinus symptoms included sinus pressure, stuffy nose, and sinus headache. I had the symptoms for about 3 weeks. I was not able to think straight either. I also had confusion. They prescribed the inhaler.
10 days after vaccination, patient developed a flat erythematous patch on her L arm below vaccination site. It continued to get larger for 2 days, as well as lighter red. Not itchy or painful.
This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 13May2021 13:00 at age of 24 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart pain, pushing down on the chest, and being very heavy, feels really weak, short of breath, he can't get deep breaths in, uncomfortable, all on 16May2021.  The outcome of all events was not recovered.   Clinical course: Caller stated he got the vaccine 13May2021, the first dose. Caller states he had bad heart pain, that he was 24 years old and it was like it was not sharp but it was like it felt heavy all the time, like his chest was heavy like somebody was pressing on it (on Sunday he began to have heart pain that he describes as being worse in the morning, pushing down on the chest, and being very heavy). Stated he felt really weak. Caller stated these started on Sunday, 16May2021 last week and it was pretty uncomfortable. Caller stated he wanted to know what to do next, should he reported to his doctor or got it checked and was it normal. Caller stated he was also short of breath, he can't get deep breaths in and that started the same day 16May2021. Caller provided all his symptoms were persisting. States they all started in the afternoon. Caller stated it was the Pfizer Covid 19 vaccine. Stated the 1st dose was 13May2021 in his left arm at 1pm. Caller does not have dose, NDC, lot or expiry date to provide as he does not have his card. Events were not required to visit emergency room or physician's office. There had no evets occurred I following prior vaccinations.  There had no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's Medical History and relevant test were none. Vaccine was not administered at Military Facility.
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient presents to emergency department (ED) tachycardic (heart rate 180s) found to be in SVT and hypokalemic. Blood pressure normal and denies chest pain. Vagal manuvers did not resolve SVT. Administered adenosine with resolution of SVT. Administered oral potassium replacment and discharged to home stable.
icy cold sensation in the chest; icy cold sensation in the chest; This is a spontaneous report from a contactable consumer or other non hcp.     A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: unknown), via an unspecified route of administration, administered on unspecified date for COVID-19 immunisation. The patient stated an icy cold sensation in the chest could be a side effect for the administration of the second dose of the Pfizer's COVID-19 vaccine on an unspecified date. The Consumer reports that she was administered with the second dose of the Pfizer's COVID-19 vaccine and that night she woke up in panic with an icy cold sensation in the chest and she had to call the #. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Waking up the day after my vaccination, my right arm was so sore I could barely lift it over my head. I also had minor chills and fever but that cleared up after I took acetaminophen. By Friday (two days after my vaccination) the soreness had reduced but I had developed a 4" x 3" rash around the injection site. It was both itchy and slightly painful, but not enough that I felt the need to take a painkiller. Today (five days after my vaccination) it has finally receded away.
High fever developed 2-3 days after shot (104.7).  Now 12 days with a fever in range 102-104.7 degrees.    Rapid COVID test day 1 of fever - negative  Doctor visit day 3 - (5/27) Rapid COVID test - negative Antibiotics prescribed 5/27   Back to doctor 6/1 (day 8 of fever - antibiotics not helping) PCR COVID test sent out (result - negative) High protein in urine - sent to ER at CHOP  ER at CHOP: Performed EKG, chest x-ray, full blood workup, tested for Mono, Epstein Barr, etc.  Results normal, other than elevated glucose, asparatame aminotransferase, and carbon dioxide in blood.  Sent home to return for repeat testing and full body scan/imaging if fever still present after 14 days.
Severe headache, severe body aches and pains, fever, rash behind neck, left arm very red swollen very hot, red left eye, diarrhea, runny nose, voice seems very harsh now, burning sensation in the back of neck, severe throbbing stabbing pains in my legs, nauseous, dizzy,
Pt woke up with increased shortness of shortness of  Breath.  On cpap at home at 90% pulse ox, legs 3+ pitting edema, short 2 word sentences.  EMS placed pt on bipap and was admitted 3/3. COVID positive 3/3. On 3/4 Ax4, not in acute CR distress, o 6 L NC, denies pain, on foley due to retention, pt otherwise stable. Sepsis alert triggered at 8 due to WBC at 24.3. Pt otherwise stable on 3/4. On 3/6 doctor at bedside suggested foley be removed and foley was removed per order. 3/7 patient was MRSA+ on 5L NC, Vanco and Rocephin. Patient stated he is feeling better, discharged to home 3/7.
Trouble breathing then eyes swollen, extremely red, eyeballs filled with gunk, difficulty seeing, then vomiting, diarrhea, tachycardia, difficulty swallowing,..in that order.
low-grade fever, upper body aches specifically in back, shoulder, and neck.  nausea, light sensitivity. fatigue. symptom onset of ~30 hours.
woke up with a red arm (where I got vaccinated), very hot (almost like a rash); rash; red arm; fatigue; fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (woke up with a red arm (where I got vaccinated), very hot (almost like a rash)), RASH (rash), PYREXIA (fever), VACCINATION SITE ERYTHEMA (red arm) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypothyroidism. Concomitant products included THIAMAZOLE (TAPAZOLE) for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever). On 10-May-2021, the patient experienced VACCINATION SITE WARMTH (woke up with a red arm (where I got vaccinated), very hot (almost like a rash)), RASH (rash), VACCINATION SITE ERYTHEMA (red arm) and FATIGUE (fatigue). The patient was treated with LORATADINE at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 08-May-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (woke up with a red arm (where I got vaccinated), very hot (almost like a rash)), RASH (rash), VACCINATION SITE ERYTHEMA (red arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was about to start radioactive iodine treatment. The patient took Loratadine and 1 Advil.
armpit real sore; injection site really raised and swollen; rash across entire back, chest, belly, and butt crack; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (armpit real sore), RASH (rash across entire back, chest, belly, and butt crack) and VACCINATION SITE SWELLING (injection site really raised and swollen) in a 47-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.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash across entire back, chest, belly, and butt crack). On an unknown date, the patient experienced AXILLARY PAIN (armpit real sore) and VACCINATION SITE SWELLING (injection site really raised and swollen). At the time of the report, AXILLARY PAIN (armpit real sore), RASH (rash across entire back, chest, belly, and butt crack) and VACCINATION SITE SWELLING (injection site really raised and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.
The patient presents following 75 year old female with history of htn, dyslipidemia, hypothyroidism, dementia, and restless leg syndrome presents via EMS after falling. Patient's daughter present at bedside and informs she was at her aunts house and was found on the floor but nobody witnessed the fall. Daughter sts they heard her fall and family members presented to bedside to try and assist her but had to call EMS for lift assist. Patient c/o left leg pain, doesn't complain of any other symptoms.  Hip fx. left.  (Covid 19 incidental finding)
Patient arrived at vaccine site at approximately 1535 reporting that he had received the Janssen COVID vaccine in another country approximately 3 months ago but was not given proof of vaccination. He requested to receive the Pfizer COVID vaccine as he is required to have proof of COVID vaccination. PHN called PHN supervisor and the medical team. Doctor from the medical team approved Pfizer vaccine series for the patient. Patient returned to vaccine site and received dose 1 of the Pfizer COVID vaccine (lot FF8839) at approximately 1800. Patient wait in observation area for 15min, no report of adverse symptoms. Patient left walking at approximately 1815 with steady gait.
Child told mother to look at her arm around 6:30 PM on Wednesday, November 30, 2011 because it was itching her. Left arm was red in color and not hot. Child had no fever or pain. Mom took child to the ER. Child is currently taking antibiotics and Benadryl. The redness has reduced and child still continues to state that it does not hurt her. Fever has not occurred.
ADMINISTRATION OF AN EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 47 year old male. 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administration of an expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955892.
Low grade fever (100.7), chills, body aches, headache, fatigue, mild nausea, hypersensitivity to sound, and a deep sense of doom/sadness/despair, which could have been severe fatigue.  I took Tylenol which didn't help. I called CVS and spoke to the pharmacist who said to also take an NSAID, which I did several times over a few days.  These clinical signs mostly resolved w/in 24 hours, except the fatigue and headache.  I was exhausted and slept a lot during the following week.   I also began to have chest flutters, flashes of dizziness and flashes of doom/despair in the middle of concentrating on something completely different, like at work.  I listened to my heart with a stethoscope after the flutter event was over and there was no arrhythmia at that time of auscultation and my HR was 74-80.   Each of these happened a few times the next week. Now those are mostly gone.   I continue to be tired and fatigue easily and need to take 1-2 hr naps in the middle of the day or after work, when I can.    Yesterday at work (4/13/21) I had extra sensitivity reaction to a repeated high pitched noise which, though didn't seem like would cause a lasting issue, then did cause me to be very fatigued and agitated afterward.  I also did then have an earache which hasn't resolved.  I am not sure if related to my original sound sensitivity.    A person I work with, who previously had COVID and got her 1st Pfizer shot last Saturday, also described she was having chest flutters, tachycardia, and feelings of doom several times over the last few days, which validated my own experience of signs after my vaccination.