chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arrythmia under control with medication; after second dose patient went into SVT; bruising from her deltoid to the bottom of her latissimus dorsi; anemic; periodic chest pain for a couple of months; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (arrythmia under control with medication) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrythmia under control with medication) (seriousness criterion medically significant), SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi), ANAEMIA (anemic) and CHEST PAIN (periodic chest pain for a couple of months). At the time of the report, ARRHYTHMIA (arrythmia under control with medication) was resolving, SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi) and ANAEMIA (anemic) outcome was unknown and CHEST PAIN (periodic chest pain for a couple of months) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Echocardiogram: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. There was no diagnosis of myocarditis or pericarditis and no medical history of arrhythmia. Patient had seen a cardiologist.  Company Comment: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Initial report received from a physician in the USA on 02 November 2006. An 11 year old male patient felt warm (febrile) on the eve of his vaccination with Adacel (lot number C2609AA, route of administration not reported) in the right deltoid on 26 October 2006. At his visit to the ER on 29 October 2006, he had 10x5cm local redness, induration, and slight bruising was present on his right deltoid. The diagnosis was cellulitis and antibiotics were prescribed. He visited his doctor on 30 October 2006-the redness/induration were resolving but not completely gone. He had his last vaccine at 4-6 years old and he did not have any illness at the time of vaccination. The doctor was unsure of the needle length used. At the time of the report, the patient was not recovered.
This spontaneous report was received from an administrator and refers multiple patients of unknown ages. On unknown dates, the patients were vaccinated with PROQUAD lot # M022402 or lot # M044720 for prophylaxis. Concomitant therapies included sterile diluent. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA005904.
FEBRILE - 101 (2200), TACHYCARDIA (100+ BPM), RAGING A-FIB (ARRHYTHMIA) & HYPOTENSION (75/50); SLEEP MEDICATION INEFFECTIVE.  ALL SYMPTOMS PERSIST (NO DETECTABLE DEHYDRATION) ,   INTO 4 FEB 2021. NO PAIN OR FEVER ABATEMENT MEDICATIONS APPLIED. AT 1600, 4 FEB 2021, 10 MG ZALEPLON AND 5 MG AMBIEN ADMINISTERED. 75 MINUTES OF SLEEP, FOLLOWING WHICH SUB-LINGUAL TEMPERATURE WAS NORMAL, BUT OTHER SYMPTOMS PERSISTED. SLEEP IMPAIRMENT AND OTHER SYMPTOMS PERSISTED 4, 5 AND 6 FEB, BUT SLIGHTLY IMPROVING EFFICACY OF SLEEP MEDICATIONS AND OTHER SYMPTOMS.  AT 2000, 6 FEB, 10 MG AMBIEN (SLEEP ONSET UNTIL 2130), 10 MG ZALEPLON AT 2200 (SLEEP UNTIL 0030, 7 FEB), 10 MG AMBIEN 0030 (SLEEP UNTIL 0430), 10 MG ZALEPLON 0430 (SLEEP UNTIL
Swelling of groin and both legs from umbilicus to feet 2 days after vaccines given. Increased fussiness and crying, treated with Tylenol. Diagnosis: local vs allergic reaction.
This spontaneous report as received from a registered pharmacist refers to a elderly female patient of unknown age. The patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # H013399; exp date 07-MAR-2012) on 13-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 13-OCT-2012, the patient developed arthralgia, fatigue and pain at the injection site after receiving PNEUMOVAX23. The patient sought unspecified medical attention and was given unspecified antibiotics and antihistamines as treatment. On an unspecified date in 2012,the events arthralgia, fatigue and pain at the injection site was resolved. This is one of the two reports received from the same reporter (MARRS# 1210USA008578). Additional information is not expected.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the staff member works for the doctor. The age at vaccination was not reported. But, it could be 58 or 59 years. The patient experienced pain, redness and swelling at the injection site, which measured 6-8 inches in diameter. The symptoms lasted for one month before resolving. No additional details were provided regarding this event. The account representative stated that a staff member reported this to him but he did not know her name. She worked for the doctor listed in this report.
Redness, swelling and pain at injection site. Dizzy, stomach cramps and nausea. Both upper legs are sore.
Injection site reaction considering of swelling, burning pain, redness, malaise,  subjective chills
pt recv vax 20AUG97 & broke out w/mild case of chickenpox on 12JAN99, 50-75 eruptions estimated-chickenpox;
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (2nd dose given from beyond use date vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (2nd dose given from beyond use date vial). On Jun 16, 2021, administered expired product (2nd dose given from beyond use date vial) resolved. The reporter did not provide any causality assessments.
Development of Shingles in right groin/low back the morning following her second dose of shingrx #2.
Started last night around 8:30 when I went to bed. Ringing in the left ear. I did notice a week ago same thing when I went to bed but it stopped after a short period of time. This time it has not stopped and continues today while I am at work. Both does of vaccine were administered in my left arm.
SkinRash Narrative:  Swelling of left arm/forearm/axillary. 01/26/2021 Rash on face and discoloration.  Other Relevant History:
Pt received her 1st dose of the J&J Covid19 vaccine. While sitting in observation the pt reported feeling dizzy and faint. BP 100/70 HR 70 O2Sat 98% . Pt was laid down. EMS called and evaluated the pt. Pt signed refusal for transport to the ED. Pt reported feeling better prior to leaving.
10 days after geting the vacination I had sharp pains when I took a deep breath on the left side of my chest & pain running up the left side of my neck.  It was not getting better 3 days later. I called my primary physician who advised me to go to the emergency room.  I feared a heart attack or blood clot. Tests came back negative / they diagnosed as Pleurisy. I felt better 2 days later.  I found it odd that I had this pain after getting the vaccination.  I had no immediated side effects, they occured 10 days after the injection.
After having the vaccination, two months later my son began having blood clots in his eyes, hemorrhaging in his eyes and multiple seizures. He now has to take anti seizure meds daily and suffered from bleeding and fluid on his brain.
Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time.
Twelve hours after first Covid vaccination, patient developed fever, diarrhea, dizziness, chills; progressed to severe heart palpitations, HR elevation >202, BP 200/117.  Cardiac symptoms may be tied to low potassium following diarrhea. Treated at hospital with fluids, potassium, and beta blockers. Released and following up with other MDs.
This spontaneous report was received from healthcare worker regarding few patients. The reporter stated that she had seen few patients aged between 12-16 years, faint after receiving meningococcal vaccine (manufacturer unknown) or TDaP. The outcome of the event was unknown. The causality of the event with meningococcal vaccine (manufacturer unknown) was not reported. The case is linked to #1407USA005329 via same reporter link. Additional information has been requested.
stutter step; heightened state of emotion; disconnected feeling from body; diarrhea; dizzy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea) and DIZZINESS (dizzy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, IBUPROFEN, GABAPENTIN, OMEPRAZOLE, LISINOPRIL, DULOXETINE, ONDANSETRON, ATORVASTATIN, TRAZODONE, DOCUSATE SODIUM and SALBUTAMOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and FATIGUE (fatigue). On 19-Feb-2021, DIARRHOEA (diarrhea) and FATIGUE (fatigue) outcome was unknown. At the time of the report, GAIT DISTURBANCE (stutter step), EMOTIONAL DISORDER (heightened state of emotion), DISCOMFORT (disconnected feeling from body) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on treatment medication were included.
Right side of neck is swollen; Feel lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded). At the time of the report, SWELLING (Right side of neck is swollen) and DIZZINESS (Feel lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication were not reported.  No treatment information was mentioned by the reporter.
Headache began around 4pm, lasted for approximately 3 hours, skin hot to touch, but no fever.  Pt. reported fatigue and soreness at injection site.  He took OTC ibuprofen with minimal relief.  Symptoms have resolved today.  He does report a headache today, but feels that is related to allergy symptoms.
Exacerbation of dysautonomia. Symptoms different from previous events, more severe, and have lasted for over 2 months. Symptoms include stuttering, difficulty word finding, concentration difficulties, exhaustion, dizziness, occasional confusion. Initial event was significant, lasted for 2 hours, during which I was able to hear as if at a distance, but unable to see, and did not have motor control to respond. Since then, vagal symptoms have occurred with regularity, are not always relieved by usual measures. Underwent full cardiac workup including Holter monitor, EKGs, echocardiogram, lab work, including CBC comprehensive metabolic. Also ACTH and cortisol. All were within normal limits. Was then evaluated by neurology. General exam was within normal limits, sleep-deprived EEG was normal. Head CT, head MRI both normal. Fludrocortisone 0.1 mg daily added to medication regimen. After one month midodrine 25 added to regimen. Symptoms have improved to the point that 30 to 40 hour work week now possible. However symptoms do persist, and an episode has never lasted this long in the 20 years I have had this diagnosis. Nor have symptoms ever been this severe.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On unknown date, the patient was vaccinated with PROQUAD, albumin status of rHA (recombinant human albumin), (lot # R015739, expiration date: 02-DEC-2019), dose, route of administration and injection site were not provided), for prophylaxis. It was unknown if the sterile diluent (lot# and expiration date were not provided) used to reconstitute the vaccine was stored properly. On unknown date, the vaccine was stored in temperature -9 Celsius degrees to +8 Celsius degrees, for 36 hours and 27 minutes. There was previous temperature excursion: from -14 Celsius degrees to 10 Celsius degrees, for 3 hours and 6 minutes. The digital data logger was involved. There were no adverse effects.
Vaccine exposure during pregnancy; Inappropriate Reconstitution Technique/not shaken prior administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of wrong technique in drug usage process in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 14-JUL-2023, the patient received Boostrix. On 14-JUL-2023, an unknown time after receiving Boostrix, the patient experienced wrong technique in drug usage process (Verbatim: Inappropriate Reconstitution Technique/not shaken prior administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the wrong technique in drug usage process and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-JUL-2023 The patient was in her third trimester of pregnancy and was feeling fine. The phone number provided for healthcare professional. The reporter did not consent to follow-up. The reporter was a pregnant woman who stated that she received Boostrix at the time of reporting and noticed the vaccine was not shaken prior administration, which led to wrong technique in drug usage process.
Redness at injection site, area of redness getting larger, not itchy, hot to the touch; reported to pharmacy, referred to Primary Care, lesion measured approx. 8cm X 4cm, no systemic symptoms.
Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm tenderness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not have acute illnesses at time of vaccination or up to 1 month before vaccination.  The patient's past medical history included Syncope (had two syncope events in 2020 after heart surgery related to low blood pressure medication) in 2020, Low blood pressure and Cardiac operation. Concurrent medical conditions included Allergy (poultry), Allergy to antibiotic, Pernicious anemia since 1970, Thyroid disorder NOS since 08-Oct-2020, Red blood cell count abnormal and Cholesterol since 10-Aug-2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, FOLIC ACID (FOLVITE [FOLIC ACID]) for Red blood cell count, DOCUSATE SODIUM for Stools hard, LEVOTHYROXINE SODIUM (SYNTHROID) from 08-Oct-2020 to an unknown date and LEVOTHYROXINE SODIUM (LEVOTHROID) from 08-Oct-2020 to an unknown date for Thyroid disorder, CYANOCOBALAMIN, LACTASE (LACTAID), CYANOCOBALAMIN (VITAMIN B-12), LORATADINE (CLARITIN [LORATADINE]), ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL (OMEGA-3 FISH OIL), VACCINIUM MACROCARPON FRUIT (CRANBERRY FRUIT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3 and CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm tenderness). At the time of the report, PAIN IN EXTREMITY (Arm tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) in the normal range (for the past two years).         Patients blood type reported as A positive. No treatment medication were provided.   This case was linked to MOD-2022-539711, MOD-2022-539722, MOD-2022-536098 (Patient Link).
My mom had the vaccine on 2/26/2021 and on  2/27/2021 she said she was feeling more tired. On 2/28 she had a fall on her home and I had to take her to the hospital and it was a suspected hip fracture but it turned out to be a severe contusion. She had a subsequent fall within 2 weeks and it was a non injury fall.
Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This patient reported different events with two vaccine doses: This is the second of two doses. This 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810), via an unspecified route of administration in the left deltoid arm on 19Feb2021 from 08:15 to 08:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 08:15 (at the age of 77-year-old) as a single dose for COVID-19 immunization, then on 31Jan2021 she became totally nauseous, light headed, very chilled, extremely tired, very cold and felt asleep under warm down quilt until 14:00 (total 13 hours) with recovery without any hospital admission and treatment received. On 25Feb2021, the patient experienced some fatigue for one day. The clinical outcome of some fatigue was resolved in Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093680 Same patient, different drug (first vaccine dose) and events.
Resident received vaccine per pharmacy at the facility at 5 pm.  Approximately 6:45 resident found unresponsive and EMS contacted.  Upon EMS arrival at facility, resident went into cardiac arrest, code initiated by EMS and transported to hospital.  Resident expired at hospital at approximately 8 pm
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 02Nov2023 to  06Nov2023. No follow-up attempts are possible. No further information is expected.
Patient came to ED lethargic with chest congestion, cough, fever, and SOB.  Patient admitted to hospital with Covid.
Received vaccine 3/5/13 evening & had nausea & weakness that night. Developed red ring about 2 inches across over injection site next am and had it itching over both arms and up to neck & scalp, progressed to tingling and achiness by evening of 3/6/13. Dr treated w/VALTREX on 3/7/13.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 08-SEP-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M015695 with expiration date 26-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.