chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient presented to pharmacy 4 days after receiving vaccine with a bruise on her arm at injection site along with a red rash going down her arm that was patchy in appearance. Pt showed me a photo from the day after the injection and the rash appeared much worse on the photo. The patient inidcated she was in a lot of pain, but did not have an itch or any warmth to touch. Advised to consult with physician if it doesn't get any better or gets any worse. She stated the pain was much improved.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age was not reported) who was vaccinated with a dose of FLUZONE HD (lot UJ006Ab, Expiry date: 14-Apr-2019) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was reported that when the needle was in the skin giving FLUZONE HD, had some dripping out of the syringe. Pharmacist thought from the hub of the needle. He felt he assembled the needle normally and tight enough. It was also a case of syringe issue. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Patient received PNEUMOVAX and developed an adverse reaction to the vaccine 1 hour later. Pt complained of dizziness, shaking, chest tightness and elevated blood pressure. EMT was called and pt was hospitalized.
It was on 02/28/2023. I started with a little sore throat and on that day, it progressed into flu like symptoms. I was very cold, had a fever and felt achy. Muscular aches and pains. I had nasal congestion. I think that's about it symptom wise. I took an at home COVID-19 test that day. It was positive. I called that day for a telehealth visit and had that the next day 03/01/2023. He did prescribe Paxlovid and so I filled that prescription and started taking that medication. I started that on 03/01/2023. On the 2nd day of taking the medication, I started feeling itchy all over. I took the medication for one more day and the itching began to get worse and there was a rash on my torso. I called the doctor from the telehealth visit and he said to stop taking it. It sounded like I was having an allergic reaction to it so he mentioned to start taking Benadryl. After the first day, I felt better and better each successive day during the infection. Eventually after 6 days, I felt like my symptoms had all subsided.
shortness of breath; felt crappy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and FEELING ABNORMAL (felt crappy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) (on her left side). Concurrent medical conditions included Penicillin allergy. Concomitant products included ATENOLOL and APIXABAN (ELIQUIS) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 DYSPNOEA (shortness of breath) and FEELING ABNORMAL (felt crappy). At the time of the report, DYSPNOEA (shortness of breath) and FEELING ABNORMAL (felt crappy) outcome was unknown.            No treatment medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
COVID BREAKTHROUGH: 75-year-old female who was admitted to hospital, secondary to generalized weakness, and altered mental status, likely secondary to Metabolic encephalopathy likely secondary to infectious etiology, compounded by history of advanced dementia; in addition, she was found to be COVID positive.  Her Oxygen sats remain greater than 94% on RA, CXR shows no acute abnormality.  Spouse reported no recent fall, injury to head or neck. She denies headache, dizziness, syncope, chest pain, shortness of breath, or palpitations.
Patient was given half dose of Moderna Bivalent Booster 0.25mcg, patient was to be given 0.5mcg. Wrong dosage given.
expired vaccine used; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 002F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) 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 did not provide any causality assessments.   No concomitant medications were reported. It was reported that expired vaccine was given to the patients past the expiration date. After being vaccinated, there were no complaints regarding any of the patient's health. No treatment medications were reported.  On 14-Apr-2023, case was made as invalid due to other patients involved without particular patient identifier.
2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever  99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up
five-days post vax pt RU arms raised reddened area appeared-hot touch- approx size softball w/localized itching; reddened area extended w/2 separate areas; appearing between acronion  process & elbow-approx size of 1/2 dollar w/in 24 hrs;
Started as quarter-sized, red, swollen, painful lump just below vaccine injection site 8 days after first vaccine.  Redness spread out to cover approximately 50% of my upper arm over the next couple of days.  Pain subsided after the first day or 2 as it spread, but became hot and intermittently itchy.  Red area was flat and was visible for several weeks, although it started to fade and become less inflamed after the first 4-5 days.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 06-NOV-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2015) that was improperly stored. No adverse effects was reported. The primary reporter reported that these doses were administered following an excursion of 14F from 28-AUG-2015 through 17-NOV-2015. This is one of 3 reports from the same reporter. Additional information has been requested.
Redness at injection site, painful to the touch, hot to the touch. Slight fever 99.4
He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A2HA and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Artificial cardiac pacemaker user. Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) had not resolved.            Treatment information was not provided.  Patient went on a semi check up on 13 Aug 2021, after receiving both doses and found out that, he had Atrial Fibrillation on a continuous bases since Mid March 2021.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient´s history of pacemaker use could suggest an underlying cardiac disorder which could be a confounding factor for the event. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient´s history of pacemaker use could suggest an underlying cardiac disorder which could be a confounding factor for the event. Further information has been requested.
diagnosed with myasthenia gravis/trouble with her vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 at 01:15 as dose 2, single (Lot number: EP6955) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREVACID. Vaccination history included: BNT162b2 (DOSE 1, lot number EP7533, at 09Apr2021 12:00 PM, vaccine location Left arm), administration date: 09Apr2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: MYASTHENIA GRAVIS (caused and prolonged hospitalization, disability, life threatening) with onset 07May2021 at 13:15, outcome "recovering", described as "diagnosed with myasthenia gravis/trouble with her vision". The patient was hospitalized and prolonged hospitalization for myasthenia gravis (hospitalization duration: 25 day(s)). The event "diagnosed with myasthenia gravis/trouble with her vision" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2021) myasthenia gravis; Lab tests: (2021) Nothing wrong. Therapeutic measures were taken as a result of myasthenia gravis. Clinical course: No other vaccine in four weeks. No covid tested prior and post vaccination. No Known allergies. Within a week of receiving the second dose, patient had trouble with her vision. She saw her eye doctor, nothing wrong, she saw her general practitioner, bunch of test, nothing wrong, saw a neurologist many many tests including a blood test where she was diagnosed with myasthenia gravis. AE treatment included Thyectomy, 17 plasmapheresis treatments.
Pt devel irregular area (12-14cm x 10 cm) of erythema & warmth @ inject site w/in 1 wk of recveving TD; area was sl firm centrally & w/o fluctuance; Lidex & cool compresses were applied to the area;
This spontaneous report as received from a registered nurse refers to five unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that, on an unspecified dates, the five unspecified patients received improperly stored GARDASIL with lot # K003520 and expiration date 20-NOV-2016, (strength, dose number, dose and route unspecified). GARDASIL was exposed to temperature of - 0.1 degrees C for time frame of 14 hours, in which 5 doses were administered; there was no previous temperature excursion. No adverse effects were reported. Product quality issue (PQC) was not involved. No further information was provided. Additional information has been requested.
Severe pain in lower left back, started earlier in the day and increased quickly throughout the evening.  I couldn't stand, walk or move.  Ambulance took me to the hospital.
pt recv vax 12NOV98 & had local reaction to rt arm swelling, redness, warm to touch;
3 hrs after receiving FLUZONE developed cough, wheezing, "film" in eyes, swelling in throat. No other sxs. Recovered by following morning. Similar episode 5 yrs ago after flu shot.
increased fatigue; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208) at the age of 48 years, in left arm, on 07Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 06Dec2021 at 10:30 as dose 3 (booster), single (Lot number: 3303080), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "Migraine" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Antibiotics" (unspecified if ongoing), notes: Known allergies: Antibiotics; "Known allergies: Narcotics/ Opioids" (unspecified if ongoing), notes: Known allergies: Narcotics/ Opioids; "Known allergies: Narcotics" (unspecified if ongoing), notes: Known allergies: Narcotics/ Opioids. Concomitant medication(s) included: SYNTHROID; CELEXA [CELECOXIB]; METFORMIN. The following information was reported: PAIN (non-serious) with onset 17Mar2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "increased fatigue". The events "increased fatigue" and "body aches" required physician office visit. Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. The patient experienced increased fatigue and body aches for 3-4 weeks after first dose; for 6-7 weeks after second dose and after third dose, 5-6 months of increased fatigue and body aches, still happening. The patient did not experienced covid-19 prior to the COVID-19 vaccine. The patient was not tested positive post COVID-19 vaccine.
Information has been received form a health professional concerning a 4 month old patient who on 04-NOV-2008 was vaccinated late with ROTATEQ. On 14-JAN-2009 and 17-SEP-2009 the patient received the second and third dose ROTATEQ respectively. The patient did not experience any known symptoms. At the time of this report, the patient outcome was unknown. Follow up information has been received form the nurse practitioner who indicated that a male patient with no known allergies or drug reactions and no pertinent medical history who on 17-SEP-2009 receive his third dose of ROTATEQ (Lot # 661430/1033X) PO at 14:00. There was no illness at the time of vaccination. No adverse event was reported. No labs or diagnostic tests were performed. No further information is available.
Pt vax w/DTP/HIB/OPV w/in 24 hrs devel generalized urticaria requiring office visit; recovered; event occurred in 1991;
1. Oxygen desaturation. Respiratory problem. Hypoxia. 2 episodes on 2/12/20 She required blow by O2 for desaturations. Given oxygen need, CXR was done with low lung volumes and left upper patchy atelectasis. She was placed briefly on oxyhood on 2/12/20 for a few hours.  The information was taken from discharge summary. 2. Low blood sugar. Hypoglycemia. Required dextrose containing IV fluids. IV fluids were weaned on 02/15/20.  I am the mother. My  blood sugar was a fine during my pregnancy. Glucose test was good.I kept tracking my sugar during my pregnancy, and it was all good. It should not happen with my baby.
12 hours after injection: Chills  lasting several hours with  dizziness ~ 20 hours after injection: Blacked out momentarily, nausea, loss of appetite, fatigue, soreness at injection site and throughout arm and shoulder lasting  ~ 24 hours This was the 2nd dose of vaccine after having Covid diagnosis on 12-23-2020, with fairly mild symptoms
Vaccinees rec'd a series of 3 Engerix-B vax in APR, MAY & NOV90, & experienced pain on inject. Reporting nurse indicated that "too many" vaccinees (employees & pt) c/o inject site & muscle pain when administered Engerix-B.
Extreme arm pain, inability to move - developed after typical soreness began to resolve three days following the injection.
sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 041B21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LACTOBACILLUS NOS (CULTURELLE) and AMBEREN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (sore arm after 1st dose). On 28-Mar-2021, MYALGIA (sore arm after 1st dose) had resolved.            no treatment product was reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090536, US-MODERNATX, INC.-MOD-2021-090151 (Linked Report). This case was linked to MOD-2021-090143 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090536:Case for dose 2 US-MODERNATX, INC.-MOD-2021-090151:cross linked case
Fever Cough  Fatigue  Muscle or body aches  Headache  Nausea or vomiting  Diarrhea Decreased Appetite
Some behavior changes after Kawasakis 7/08.  Then after DTAP on 5/09 he regressed 3/4 of vocabulary and started running back/forth flapping arms - within the first 24 hours after shots. Dx: Autism.
a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263392, 2019SA263393 and 2019SA263394 (same reporter).  This case involves a 20 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the left deltoid on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Initial and follow-up information has been received from the Merck Pregnancy Registry via a health professional concerning a 23 year old female with migraines, seasonal allergies, sulfonamide allergy and penicillin allergy who on 18-APR-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 657617/0384U). Concomitant therapy included ALLEGRA and birth control (therapy unspecified). The reporter indicated that the patient was pregnant, but she did not know if the patient was pregnant at the time of the vaccination. The date of the patient's last menstrual period was 26-APR-2007. The estimated conception date was 11-MAY-2007. The estimated date of delivery is 31-JAN-2008. The patient sought unspecified medical attention. There was no laboratory or diagnostic tests performed. Other medications used during this pregnancy included prenatal vitamins and ZOFRAN for vomiting. Follow up information was received on 24-MAR-2008. Labor was non-progressing and a C-section was performed at 41 weeks from LMP. On 04-FEB-2008, the mother delivered a live born male infant, 8 pounds seven ounces, 20.5 inches long, head circumference was 14 inches. The infant's apgar score was 9/9. The infant was normal with no congenital anomalies. There were no infections or illnesses during pregnancy and no concurrent medical conditions. Upon internal review, the non-progressing labor was considered to be an Other Important Medical Event. No further information is expected.
3 days after--intense headache, throbbing head/neck heaviness--heavy to lift, pain behind ear, dizziness/lighthead/nausea 7 days after--treated for minor sinus infection--ear pain and dizziness etc were not related ENT said 10-14 days after- multiple cold-sores on face--potentially more coming
nerve pain; tingling; numbness; headache; muscle and joint discomfort; muscle and joint discomfort; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 42-years), administered in arm left on 15Feb2021 at 13:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no known allergies. The vaccine facility type was reported as other. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination. On 15Feb2021 at 13:15, the patient experienced nerve pain, tingling, numbness, headache, muscle and joint discomfort. It was further stated that after the vaccine the patient I had nerve pain in my left side of my face. A tingling and numbness lasted 3 days. I had a headache and muscle and joint discomfort as well. The treatment received for the events was reported as unknown. The patient has been tested covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test: pending on 17Feb2021 Pcr covid test type post vaccination. The clinical outcome for all the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.