chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest congestion; Nose congestion; A spontaneous report was received from a consumer concerning a female (age not provided) who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced nose congestion (nasal congestion) and chest congestion (lower respiratory tract infection).  The patient's medical history was not provided. Concomitant medication was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) via intramuscular route for COVID-19 infection prophylaxis.  After receiving the first dose, the patient reported experiencing nose and chest congestion.  No treatment information was provided.  No additional details were reported.  Action taken with mRNA-1273 in response to the events was unknown.    The outcome of the events, nose and chest congestion, was unknown..; Reporter's Comments: This case concerns a female of unknown age with a serious unexpected event of Lower respiratory tract infection and nonserious unexpected Nasal congestion.  Event onset with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.
Pt felt hot and experienced vomiting & dizziness s/p vaccination. BP 97/63; HR 73; RR 14; O2 Sat 98%.  Given 8oz of water & graham crackers.  Pt stable & released from vaccination site with family.
Co-administered the high dose flu and the booster dose of Covid had almost immediate full body flushing, bilateral red conjunctiva, low back pain, headache, and slight tightness in throat. Pulse rate - 112-119, R- 18, O2 sat - 95-96%. All symptoms resolved over 20-25 minutes. Called client to follow-up 4.5 hours later. She stated she was at home feeling completely fine.
4/9/21 night, about 12hr post vaccination, developed low fever, slight pain in elbow and knees. Took Ibuprofen, recovered next day. 4/13/21 morning around 10am, 4 days post vaccination, mid-level abdominal pain lasted ~1hr, then turned into low level pain, persisted until 4/13 night. 4/14/21, feel normal. 4/15/21 about 7am, abdominal pain again, and persists. Visited family doctor at 11:00am, doctor checked, no lab work was done. Send home with prescription: Ciprofloxacin HCl 500mg Tablet, was instructed to take 1 tablet twice a day for 7 days. Took first tablet at 3pm. Abdominal pain still persists at night.
Somewhat itchy localized 35 cm reddened and slightly raised rash limited to injection site.
Triggered a grand maul seizure, with hot and cold chills and a slight fever. Patient is doing much better this morning.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PT has a PMH significant for solitary nodule of lung, CVA due to cerebral artery occlusion, tobacco use, mitral valve disorder, hyperlipidemia, chronic obstructive lung disease. Patient presented to outside entity emergency facility on 3/22 with a chief complaint of "ACUTE LIMB ISCHEMIA". Pt passed away 4/6/21.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single, in right arm at age of 59 years old for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing); "first exposed at work" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: flu vaccine (at 5PM), administration date: 06Oct2022, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022 at 09:30, outcome "recovered" (16Oct2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: tested positive at 9:30 PM; (16Oct2022) Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. There was no other medication in 2 weeks. The patient was first exposed at work on 06Oct and 07Oct by someone who claimed they were recovering from the flu and had taken off work before. Patient received flu vaccine at 5PM on 06Oct. Patient first felt symptoms on 08Oct and tested positive at 9:30 PM on 08Oct. (Symptoms: fatigue, cough, headache). Patient began first dose of Paxlovid treatment at 6:00 PM on 09Oct2022 and finished in AM of 14Oct2022. Patient felt symptoms subside and tested negative on 16Oct. Patient returned to work 18Oct-21Oct.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
On Thursday of last wk, felt terrible stomach ache, back ache, and also the back ache went into the back of the head. The pain in stomach subsided and then the achiness in the rest of the body felt very fatigued, very weak this past weekend it was hot. At lunch on Saturday felt stomach ache very badly slept a little the stomach ache was severe TYLENOL was tried and it didn't help. Did have some nausea but never threw up. Talked to doctor on call and he recommended taking ALEVE. The ALEVE was taken for the aches and did relieve the aches eating a small amount satisfies the hunger pains but doesn't cause any touch in epigastrium. The stomach was better if had normal meal. It is getting slightly better.
Extreme weakness; Headaches; Lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. On an unknown date, the patient experienced 10 days of extreme weakness, headaches and light headedness. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the events extreme weakness, headaches and light headedness were recovered on an unknown date.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 13 month old female, a birth twin, with an unspecified allergy and a history of premature birth who on 21-MAR-2007 was vaccinated into the left thigh with MMRV (Lot # 653205/1131R). The patient developed a varicella like rash on 31 MAR 2007. The patient was examined on 02 APR 2007 at which time the patient presented with a scattered erythematous macular papular rash all over her body. The rash initially started as an erythematous rash on the chest and abdomen with vesicles. The patient was considered recovered as of 09 APR 2007. There was no concomitant therapy reported. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. The patient's twin sister (WAES # 0704USA00419) who was also vaccinated on the same day developed an erythematous rash, with more lesions and a fever. Additional information is not expected.
Within 1 minute of the injection my left arm became numb in some portions of my arm. My hand and fingers tingled.   For the 15 minutes I sat at the pharmacy the reaction continued. This was the same reaction that I had with the first shot but symptoms were worse. After the 15 minutes I left the pharmacy. Within 15-20 minutes of leaving the pharmacy the right side of my face became somewhat numb and the muscles were slow to respond. This is an ongoing issue the numbness is better but not gone but the muscle slowness continues.
Pain at injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site (left)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (left)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dose. On 17-Mar-2021, VACCINATION SITE PAIN (Pain at injection site (left)) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant medication were reported.   This case was linked to MOD-2021-047694 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: contact updated
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender who on an unknown dates was vaccinated with a three series doses of RECOMBIVAX HB (dose, route and lot # not provided). The physician stated that an unspecified amount of time after the RECOMBIVAX HB series completion, titers were drawn in unspecified lab tests and the patient was negative for hepatitis B immunity. There was no treatment given for the events. The outcome of patient's titers was drawn in unspecified lab tests and the patient was negative for hepatitis B immunity was reported as not recovered. Additional information has been requested.
Tingling in foot and thigh shortly (a few days)  after and pt thought nothing of it.   Went to ER on 19th and was transferred to hospital where she was inpatient 21st to the 28th. She was numb from the waist down and lost control of bowels and bladder,  Right side was the worst.  She is now back home recovering follow up with primary gained us the knowledge on 12/9   I called patient today
Miscommunication occurred between the patient and the technician. Clarified after given the Covid Pfizer Bivalent shot to the patient that had received the same vaccine back in September. Patient did not know they were the same vaccine and assumed it was two different vaccines. Assured the patient that she will feel the typical vaccine adverse effects like she did with the previous doses.
she really just felt terrible, felt like she had the flue; she really just felt terrible, felt like she had the flue; hives; chills; high temperature/sometimes having a fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EM9810) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (at the age of 80-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included covid-19 from 07Oct2020 to an unknown date (Tested positive for coronavirus on 07Oct2020). The patient's concomitant medications were not reported. On 12Feb2021, 12 hours later in the middle of the night the patient experienced chills, high temperature, it was up to102.5 and naturally that day it was about 101 and slowly started going down, states that she is still sometimes having a fever of about 99 or so, no tall the time. On 13Feb2021 hives on next night, on an unspecified date, she really just felt terrible, felt like she had the flue. On 12Feb2021, the patient underwent lab tests and procedures which included body temperature: 99, body temperature: 102.5, body temperature: 101. The outcome of events chills, high temperature was recovering, while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Intense headaches that won?t go away. Took advil and Tylenol which would help headache. Went to doctor after about 3 weeks of intense headaches and gave a shot of toradol and prescribed SUMATRIPTAN SUCC 50 MG TABLET to help relieve headache. Headache started the night of my Pfizer booster shot on 12/23/21 and today is 01/14/2022. Headaches are better when laying down but still intense throbbing at base of skull.
AT 1ST sore arm, lump, tired which continued then @8 days later became itchy with marks that look like bites near vaccinated arm elbow and then several days later dime size welts developed and site still has lump and is itchy and sore. advise a md visit , patient was advised by md to use Benadryl and triamcinolone cream on affected area. Md thought it was a result of bug bites because it has been so long since she got her shot but not sure md understood she had this is going on since she had the shot.  patient informed me today (7/16/20) and  just saw md today (7/16/20)
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right deltoid. For the tolerance of 2nd dose of SHINGRIX, refer linked case US2018GSK134394 for same patient. This case has been linked with case US2018GSK129131, US2018GSK129134 and US2018GSK129168 reported by same reporter.
Vaccines were given - mother noticed two dots where injections were given that never went away. Then noticed a bigger reddened area about a week later. Mother gave Tylenol.
Symptoms are: Head Ache, Full Body Aches, Nausea,  Diarrhea, Somnolence, low grade Fever, right arm Edema, Fatigue, and Irritability. Patient has been experiencing symptoms for greater than 72 hours. Unable to work and requiring loss of work to recover.  Recommended treatments were Diphenhydramine, Ibuprofen, Acetaminophen, hydration
1 wk following hep B shot pt became bery lethargic; no fever but very, very tired; pt is brain damaged slightly during birth;
The patient woke up in the middle of the night and could not move her head or upper body, reporting that it was very frightening. She reported extreme achiness and soreness in her upper body and arm throughout the remainder of the next morning and afternoon.
pt recieved vaccination. after recieving vaccination pt approached counter stating having palpiations and felt warm. we offered to call emergency medical services but patient declined offer. pt stated she will sit down for a little. after 10 minutes pt stated palpiations went away but feeling a little disoriented. she was instructed to wait in store for 30 minutes and recommended that she call for someone to drive her home. she called friend who came to get her and daughter to get her car. she walked out of store by herself to friend/family stating feeling better. before leaving she was instructed that if adverse reactions reoccurs or others arrise to call 911 to seek immediate medical attention.
Information has been received from a physician concerning a female who on 28Sep04, in the morning, was vaccinated with a dose of varicella virus vaccine live. Subsequently on 28Sep04 the pt developed chickenpox. Unspecified medical treatment was sought and the pt was given diphenhydramine hydrochloride (Benadryl) and oatmeal bath for treatment. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Calf soreness; stiffness; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer reported for himself that: A 62-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 01:30 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity; drug hypersensitivity the patient's concomitant medications were not reported. The patient experienced calf soreness and stiffness on 28Mar2021 and the events were assessed as Non serious by health authority. and outcome of the events was Not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
PREsented on 12/28 with shortness of breath, nausea and vomiting. COVID + with bilateral pneumonia and renal failure. On 12/29 had cardiac arrest, ROSC was obtained and was intubated due to respiratory failure. Given CRRT but kidneys continued to fail. Unable to wean from ventialtior. On bicarb drip but reamined aignificantly acidotic. Continued to decline and family made DNR  and subsequently passed.
20 yo female with recent hospitalization for myocarditis. Pt initially Dx with Covid 19 on 31 Dec 2020 and received Pfizer COVID Vaccines on 19 and 09 Feb. Pt reports on 21 Feb developing fevers of 107 and stomach upset, by 25 Feb she developed chest pain, SOB, weakness, continued fevers and diarrhea. She was seen at ER on 25 Feb where she was tachycardic, hypotensive, and hyponatremic with an elevate lactate. She was transferred to another hospital and found to have a Troponin of 0.629. she was admitted from 25 Feb to 04 March. During that time she had an ECHO with an EF of 35-45% with global hypokinesis and peak BNP of 1389. Pt is currently felling well with no chest pain or shortness of breath.
Approximately 10 minutes post vax, the pt's mom noticed swelling of right eye, no respiratory distress noted. The child was crying, rubbing eyes. No obvious rash, over the next 5 minutes the left eyelid began swelling. Mom chosed to take the child to the local ER. Child was treated with Benadryl.
No adverse reaction to patient noted  Vaccine administered over 12 hrs after vial was punctured
Stomach cramps, severe diarrhea, head ache, dizzy, chills, shakes, shot arm shoulder swollen to the size of a soft ball, all over muscle pain.  All still ongoing. Taking Tylenol and hot vegetable broth, hot shower, stay in bed.
Information has been received from a 62 year old female office manger via a company representative referring to the manager herself. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2015 (reported as about a year ago) the patient was vaccinated with ZOSTSAVAX (lot # and expiration date unknown, 1 dose, subcutaneous). On an unknown date in 2015 after receiving ZOSTAVAX (reported as about a year ago) the patient experienced a localized injection site reaction that there was a red area which went down and around her arm. The patient did not seek medical attention and no treatment was given for the event. On an unknown date the patient recovered from the event. Causality was not reported. Additional information is not expected as there is no consent to contact the physician.
Runny nose, fevers, body aches, red spots in mouth, covered head to toe in rash, rash around the eye, diarrhea. Saw Dr. at 3pm Monday November 25th. Said it was reaction to shot and that she had a cold and a throat virus. Treatment: alternating ibuprofen and Tylenol for pain and fever. Rash has gotten worse since Monday. Doctor prescribed us antibiotics for her runny nose.
Severe dizziness and vertigo symptoms commenced in early morning of March 20, 2021.   Accompanied by nausea.   As of this writing, 8pm 3/20,  very slight improvement from initial adverse event.
pt recv vax 1MAY97 & on 21MAY97 pt devel lesions especially on head;felt as if scalp was breaking out;there were five lesions on forehead, one on back & one on leg;reporter felt lesions were r/t to vax w/varicella;
Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.
Pt got HD FLUZONE at 1255pm on 9/23/2010 - reported chest tightness, chills, pain at site of injection & jaw pain at 4pm on 9/23. Recommended that pt call MD - I called left message with exchange will follow up in AM.
He was down the first day and had sore arm; He also has COPD and wears Oxygen 24/7; This is a spontaneous report from a contactable consumer (patient's wife). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 1 single and second dose (lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose 2 single, both doses for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her husband had both doses of the Pfizer covid vaccine, he was down the first day and had sore arm. He also had COPD and wears Oxygen 24/7. Reporter wanted to know about the 3rd dose for her husband and herself. She also stated that she saw in the news that Pfizer covid vaccine is only 39 percent effective against the delta variant and that really concerns her. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
Patient received vaccine at 10:46 AM. At 11:10 patient reported dizziess and was assessed by EMT monitoring postcare area. All vital signs WDL. Patient assumed recumbant position. By 11:26, patient denied any symptoms and was discharged at 11:27 by EMT.