chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approximately 5 minutes after vaccine, patient began shaking, blood pressure dropped to 78/60, nausea and chills began
Left shoulder injection site - urticaria left sub scapular chest skin - urticaria immediately following injection of IM vaccine (L). BP 100/70 - seated, P = 67, T = 97.8 orally. BENADRYL/Diphenhydramine 50mg po orally.
rash at the injection site; injection site hard; injection site swelling; a bump at the injection site; itching at the injection site; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (a bump at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, SIMVASTATIN, ROPINIROLE and TRAMADOL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On 15-Jan-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment reported- Aleve for the symptoms Other concomitant medications included- medicine for constipation as needed and medicine for reflux.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR: 2 reactions from shot, call back.
Sore arm starting about 4.5 hours after injection and continuing but better into the next day, headache for 2 days (manageable with Advil), and diarrhea beginning the day after injection (may be unrelated to vaccination).
Itchy red rash 2/18-2/27/21.  Flu like symptoms 2/21-2/24/2021, but no fever - just no energy, stuffed head, headache, achy, slept 15 hours one night, 13 the next.  By 2/24/21, better but still listless.  Essential tremors possibly were worse until 3/1/21.
Itchy skin; covid virus; covid virus; Lost weight; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4403544-00.  An 86-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2020, outcome "not recovered", described as "Lost weight"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "recovered" and all described as "covid virus"; PRURITUS (non-serious), outcome "recovered", described as "Itchy skin". The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) gained 5 pounds back; (2020) Lost 20 pounds; (2021) Lost 8 pounds. It was unknown if the patient was enrolled in a Covid vaccine trial.  The reporter's assessment of the causal relationship of "covid virus" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "lost weight" related to BNT162b2. The reporter considered "itchy skin" not related to BNT162b2. Causality for coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE): The reporter's causality for the event of lost 20 pounds and lost 8 pounds was related (also reported as possible), for the event of itchy skin was Not related and for the event covid virus was not provided. Causality for adalimumab (HUMIRA): The reporter's causality for the event of lost 20 pounds and lost 8 pounds was no reasonable possibility (also reported as not related), for the event of itchy skin and for the event covid virus was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
had weird suicidal thoughts; panic attack; brain fog; depression; anxiety; stress; This is a spontaneous report from a contactable consumer (patient). This 27-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FF2589) via an unspecified route of administration in the left arm on 20Sep2021 at 07:00 PM at age of 27 years old as single dose for COVID-19 immunization. Medical history was none. The patient had no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Concomitant medications were unknown. No other vaccine in four weeks. The patient received the first Pfizer Vaccine dose on Monday, Three days later he experienced a panic attack. The patient had  never had any anxiety or panic attacks before. He experienced 4 more attacks the next day. He had had brain fog ever since 23Sep2021 (7 days). He had had weird suicidal thoughts. Again, he had never experienced depression or anxiety before. He had read blogs of others having the same side effects from this vaccine. Adverse event start date and time were reported as 23Sep2021 07:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received. The patient was treated for stress with Hydroxyzine. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Urinary tract infection due to medication error, had consult with doctor by telephone, received prescription for Cephalexin 500mg twice a day for five days. I do not believe this event was related to the COVID vaccine.
the thumb was hurt for scratching so much; a mild itchiness all over the body; This is a spontaneous report was received from a contactable consumer or Other Non-Hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 29Jan2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medication was not reported. The reporter mentioned that he received the first dose of covid vaccine on Friday 29Jan2021. He was asked to wait 30 minutes along with his wife for some adverse effects, but nothing happened. However, during night he started with a mild itchiness all over the body, not severe. On 30Jan2021, Saturday night it was severe but Sunday night it was selective: began in the right hand (arm where he received the vaccine) and 30-40 minutes after it disappears and appears in the right ankle. This repeated from knee to thigh and then through the other half of the body ending in the right hand, in 4 of 5 fingers, the thumb was hurt for scratching so much. He stated that this only happens through the nights and he is fine during the day and he is taking Zyrtec. He just wants to know if can continue taking this medicine or other. The patient was recovering from the events.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fever for three days from 99 to 101 degrees, Nausea and vomiting, Diarrhea, Loss of appetite, Headache, Lethargic.
Symptom onset was within 20 mins of vaccination starting with nausea and followed by vomiting and fever.  Fever, nausea, diarrhea, sore throat, difficulty breathing, severe fatigue, headaches
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On unknown dates the patient was vaccinated with three doses of GARDASIL (lot# not reported), 0.5 ml, intramuscularly, with a one month interval between each dose. No adverse effect reported. Additional information has been requested.
1 day after DTAP #4, developed fever and had syncopal episode with post-ictal phase, probably a febrile seizure. Over next few days, developed URI.
Fever and generalized weakness on 12/26/22 with a positive home COVID test.
Pt recvd measles vax 21SEP92 & 27SEP92 devel a rash on trunk, face & arms; pt did not exp a fever; MD dx pt w/pityriasis rosea; no further details were provided;
Started with aches, fever and nausea a little over 24 hours after the injection.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with GARDASIL (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot # not reported) that were improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Drug ineffective; and on Monday she tested positive for Covid; and is experiencing fever; and is experiencing fever and fatigue; This is a spontaneous report from a contactable consumer(Patient herself). A female patient of unspecified age had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 02-APR-2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, Caller reports that she got her first dose 2 weeks ago today and she tested positive for Covid and was experiencing fever and fatigue. She is supposed to go back for her second dose on April 26th but reported that her Quarantine ends by April 25th and she wasn't sure if she was supposed to go or delay her second dose. Caller also reports that her husband also had the same situation. She reports that he received his first dose, tested positive but had more severe symptoms with congestion, fever and fatigue and he is also supposed to go for his second dose on April 26th. Caller reports that she already spoke with safety, no reference number for that encounter. E-transmitting. Survey offered. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-400030, MOD-2021-400062 (Patient Link).
FACIAL NUMBNESS, NAUSEA, DIZZINESS. SENT TO ER. UNSURE OF OUTCOME AT THIS TIME.
Screaming, fussy, thigh, red, warm swollen, temp 100.9R.
Clients wife reported on 1/18/2021, that her husband died unexpectedly the day after receiving the COVID 19 vaccine. I called and spoke with her. She stated that the client had started experienced some tightness in his chest the evening of 1/11/2021. She stated that it was normal for him to have the tightness in his chest if he got stressed. She stated that she found him on the garage floor on 1/12/2021 at 2120. He was taken by ambulance to the hospital. She stated that the hospital told her that his COPD had caused him to go into arrythmia.
States that she fainted after feeling "that I couldn't function, I yelled for my husband and then I passed out."  Husband witnessed this.  No injury, woke up within seconds "I was all sweaty & clammy".  She stated that she was very fatigued starting a few hours after the shot was given and slept from 3:30 pm to 9:30 pm then went back to bed, arising at 1:30 to get a snack when the incident happened.
today she is noticing that she is retaining alot of fluid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (today she is noticing that she is retaining alot of fluid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Hypertension and Thyroid disorder NOS (Thyroid). Concomitant products included FLUOROURACIL, FOLINIC ACID, OXALIPLATIN (FOLFOX), LEVOTHYROXINE, ROSUVASTATIN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced FLUID RETENTION (today she is noticing that she is retaining alot of fluid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FLUID RETENTION (today she is noticing that she is retaining alot of fluid) outcome was unknown. No treatment medications were reported. Patient reported cholesterol as medical history. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up appended.
Extreme upset stomach, looked very pale. Paramedic came to take care of her brother who was having reaction to ADACEL. She was checked out by paramedic too. Pt felt "fine" afterwards and went home with mom.
Headache, Myalgia, Fever, CoughWheeze & NauseaVomiting Narrative:
Felt weak; Diarrhea, loose stools; Sore left arm; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Hypothyroidism. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), HCTZ and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jan-2021, the patient experienced ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-Jan-2021, ASTHENIA (Felt weak), DIARRHOEA (Diarrhea, loose stools), VACCINATION SITE PAIN (Sore left arm), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03 MAY 2021 contains non-significant information.
Adacel Vaccine that had been frozen and thawed/no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional with follow-up on 08-Aug-2019.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224076, 2019SA224136, 2019SA224141, 2019SA224142 and 2019SA224145.  This case involves 12 patients who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that Adacel vaccine that had been frozen and thawed/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C55608AA, C5585AA and expiry date: 25-JAN-2021 and 10-Mar-2021 via intramuscular route in unknown administration site respectively.  It was a case of actual medication error due to incorrect product storage.  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 holder's 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.
given a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix) (batch number unknown, expiry date 26th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had been given a dose of Havrix that had expired on 26th October 2021. lot number not available to reporter.  The reporter consented to follow up by email.
Symptoms: Rash, Hives,Swelling of lips occurred 9 days following first vaccination. Contacted doctor 3 days after symptoms began.  Treatment: Doctor recommended starting Antihistamine and continuing through second vaccination.
DIFFICULTY SWALLOWING; WAKE UP ALMOST EVERY HOUR; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; LETHARGY; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 170 pounds, and height was 175 centimeters. The patient's concurrent conditions included Tourette's syndrome, seasonal allergy, penicillin allergy, non alcoholic, and cigarette smoker, and other pre-existing medical conditions included no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: 01-FEB-2023) dose was not reported, frequency 1 total, administered on right deltoid 07-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for Tourette's syndrome.  On 07-APR-2021, the patient experienced soreness on the injection site which lasted for 2 weeks. He also experienced lethargy. Then on the last week of APR-2021, he developed throat pain, cough and high grade fever. His chest was hurt really bad and he felt as if his lungs was on fire. He was also coughing really hard that woke him up every hour. The fever lasted of a day and the rest of symptoms lasted for 3 days. He did not performed COVID test because he just thought the symptoms were just allergic reaction. Then, on the 24-MAY-2021, he started to develop the same symptoms that he had before. It was started as a pain on the throat, he thought it was just an allergy because he had a seasonal allergy. He had a difficulty swallowing which developed into cough. His chest hurt so bad that he felt as if his chest and lungs were on fire. He described his coughing associated with burning sensation that caused him to wake up almost every hour. He also noted that after vaccinated he still followed social distancing and wearing mask protocol. His HCP did not prescribe any medication for COVID-19 infection, but he was taking Tylenol, increased his fluid intake and started using a nasal spray.  On 28-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive., Fever (NR: not provided) 102 F and the patient had confirmed covid-19 infection, confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and soreness on the injection site on 21-APR-2021, had not recovered from difficulty swallowing, confirmed covid-19 infection, and wake up almost every hour, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210557859-Covid-19 vaccine ad26.cov2.s - CONFIRMED COVID-19 INFECTION and CONFIRMED CLINICAL VACCINATION FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient had welts appear on her abdomen 5 hours after the vaccination. She took diphenhydramine 75 mg. for 2 days to relieve symptoms. After the 3rd day symptoms persisted. I recommended she call dr.
Patient arrived to the ED with complaints of renal failure. She was subsequently admitted for management and is still currently admitted with plans to discharge today to hospice.
2 days after administration the patient experienced SOB, vesicular rash, the site was warm, red and 2-3 inches in diameter. The pt was dizzy and nauseated.
(R) arm swollen, red 4-5". Pt treated with PRELONE 15mg/5ml - 5ml daily x 4 days. BENADRYL 12.5mg PO. Per ED MD: swelling 10 x 15cm.