chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. In May 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, 30 days after receiving SHINGRIX, the patient experienced herpes zoster. The patient was treated with Antivirals for systemic use. On an unknown date, the outcome of the herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced lesions on his upper left shoulder those were consistent with herpes zoster, about 1 month after vaccination. At the time of reporting, the lesions were 1 day old and the physician intended on treating with an antiviral. The healthcare professional who was a dermatologist called and said that, he was seeing the patient for an unrelated issue. The patient thought he got bit by something on his shoulder, but the healthcare professional felt it was a shingles rash.
Rash small red spots on face 4 days after second shot.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH mRNA COVID-19 mRNA VACCINE; Lot no. EN6206), 2nd dose single on the right arm via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included Arthritis and Hypothyroidism. Concomitant medication included bupropion (MANUFACTURER UNKNOWN), Metoporaltrx (MANUFACTURE UNKNOWN) Levothyroxine (MANUFACTURER UNKNOWN), Estradiol (MANUFACTURER UNKNOWN). The patient was allergic to Penicillin, Demerol. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not enrolled in clinical trial. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 10:00, the patient experienced rash small red spots on face 4 days after second shot. It is unknown whether the patient received any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Atrial fibrillation; Heart racing; Sore arm; mild body aches; Premature ventricular contractions; This is a spontaneous report from a contactable consumer reporting for her husband. A 36-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history included drug allergy to amoxicillin. Patient did not have COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced atrial fibrillation (caused hospitalization on 17Jan2021) on 17Jan2021 at 09:00 with outcome of recovered on 17Jan2021 at 10:30, sore arm (non-serious) on 15Jan2021 with outcome of recovering, mild body aches (non-serious) on 15Jan2021 with outcome of recovering, heart racing (non-serious) on 17Jan2021 at 06:00 AM with outcome of recovering, premature ventricular contractions (non-serious) in Jan2021 a couple of times a day with outcome of recovering over the next couple of weeks. The patient underwent lab tests and procedures which included echocardiogram: normal on unspecified date, electrocardiogram: atrial fibrillation on 17Jan2021, heart rate: 170 on 17Jan2021. The events needed a physician office visit. Therapeutic measures were taken as a result of the events and included treatment with metoprolol, flecainide and heart monitor for 2 weeks. He took metoprolol for the next week as a precaution but did not go back into atrial fibrillation. Patient did not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
History of mast cell activation and patient stated she "usually has reactions to everything."  Patient experienced tachypnea and anxiety immediately following administration of dose of vaccine.  SxS persisted for approximately 45 minutes.  EMS was called to the scene to evaluate patient.  symptoms decreased after 45 minutes and patient stated she did not want to go to the hospital.  Reference EMS Incident for full PCR.  Advised patient to contact her primary care physician for follow up.
Received varicella vaccine on 1/8/01 and developed varicella disease on 3/19/03, over entire body.
COULD HARDLY MOVE HER ARM; SWOLLEN; RED,ARM WAS RED; FELT REALLY TIRED; WOLE FACE GOT RED; HEART BEATING FAST; INCREASE IN BLOOD PRESSURE AND HEART RATE; POUNDING; the arm where the injection went up and down like the map; RASH; ITCHING; mouth was exceptionally dry; fast and slow heartbeat; DIZZY; weakness; felt like she was running 100 miles; muscle and body ache; whole face got red; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (COULD HARDLY MOVE HER ARM), PERIPHERAL SWELLING (SWOLLEN), ERYTHEMA (RED,ARM WAS RED), FATIGUE (FELT REALLY TIRED) and ERYTHEMA (WOLE FACE GOT RED) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Arthritis. Concomitant products included METOPROLOL, HYDROCORTISONE and NYSTATIN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (COULD HARDLY MOVE HER ARM), PERIPHERAL SWELLING (SWOLLEN), ERYTHEMA (RED,ARM WAS RED), FATIGUE (FELT REALLY TIRED), ERYTHEMA (WOLE FACE GOT RED), HEART RATE INCREASED (HEART BEATING FAST), HYPERTENSION (INCREASE IN BLOOD PRESSURE AND HEART RATE), HEADACHE (POUNDING), INJECTION SITE SCAR (the arm where the injection went up and down like the map), RASH (RASH), PRURITUS (ITCHING), DRY MOUTH (mouth was exceptionally dry), HEART RATE IRREGULAR (fast and slow heartbeat), DIZZINESS (DIZZY), ASTHENIA (weakness), HEART RATE INCREASED (felt like she was running 100 miles), PAIN (muscle and body ache) and ERYTHEMA (whole face got red). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (COULD HARDLY MOVE HER ARM), PERIPHERAL SWELLING (SWOLLEN), ERYTHEMA (RED,ARM WAS RED), FATIGUE (FELT REALLY TIRED), ERYTHEMA (WOLE FACE GOT RED), HEART RATE INCREASED (HEART BEATING FAST), HYPERTENSION (INCREASE IN BLOOD PRESSURE AND HEART RATE), HEADACHE (POUNDING), INJECTION SITE SCAR, RASH (RASH), PRURITUS (ITCHING), DRY MOUTH (mouth was exceptionally dry), HEART RATE IRREGULAR (fast and slow heartbeat), DIZZINESS (DIZZY), ASTHENIA (weakness), HEART RATE INCREASED (felt like she was running 100 miles), PAIN (muscle and body ache) and ERYTHEMA (whole face got red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient was given the Moderna vaccination at our clinic today. No adverse reactions are known at this time.  Patient was not at the appropriate age to receive this vaccination.  Patient was 16 years of age (03/17/2004), where Moderna only covers people 18 years of age and above.  The administrator was notified and contacted the patient and spoke with their mother explaining what had happened at the clinic today.  Patients mother was very upset and agitated and stated that she would be calling the physician in the morning.
Chills; A spontaneous report was received from a 69-years-old  female patient concerning herself  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the event chills.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, chills was not recovered.
Extreme swelling in lymp nodes under the arm, speading to breast tissue.  Slight swelling in neck area.  Fever 100-101 for 2 days. Extreme loss of strength, tiredness, chills.  Could barely get out of bed. Could barely keep eyes open.  No appetite.  Slept for 20 hours on day one.  Day 2, extreme sleepy & tired, could keep eyes open for 6 hours during the day.  Day 3, could stay awake for 8 hours only.  It has taken 4 weeks to get back to normal awake habits and ability to resume fitness routine.  Dose 1 History: Extreme lymph node swelling under the arm.  Fatigue, weakness, tired.  Heart palipations.  Awoke in middle of the night with coughing / choking.  Massive ear wax drain. (no history) Increased appetite. My brother died of covid19 - Delta Variant on July 21, 2021.
Pt was in for her second COVID vaccine at our COVID clinic.  Her first dose was Moderna. Pt was given Pfizer for her second dose. Administration error.
client given Pfizer COVID 1`9 vaccination on 4/1/22. Discovered at 3:00pm that vial used had been thawed on 2/24/22. Making it 5 days outside of the recommendation. Manufacturer contacted and determined that vaccine was still stable at time of administration
2.5 weeks after first dose.  Pale face  Dizzy  Vomiting  Double vision  Pins and needles  Right throat  Shortness of breath Loss of coordination  -went to hospital ER and thought it was an allergic reaction but it wasn?t
vaccinated and got sick; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old male patient received BNT162b2 (BNT162B2), 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) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer of Colon", start date: 1997 (unspecified if ongoing), notes: Cancer of Colon Had his first surgery 20 years ago in 1997.; "high blood pressure" (unspecified if ongoing), notes: high blood pressure Controlled by bisoprolol. He was diagnosed when he was 25 years old.; "Anxiety" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "surgery on rotator cuff" (unspecified if ongoing), notes: He has had surgery on rotator cuff for a sports injury,. Concomitant medication(s) included: AMBIEN taken for insomnia; CLONAZEPAM taken for anxiety; BISOPROLOL FUMARATE taken for hypertension; ATORVASTATIN CALCIUM taken for blood cholesterol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "Covid-19"; ILLNESS (non-serious), outcome "unknown", described as "vaccinated and got sick". The patient underwent the following laboratory tests and procedures: Colonoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; Endoscopy: (unspecified date) Unknown results, notes: regular testing every 6 months; SARS-CoV-2 test: (Apr2022) Negative, notes: After taking Paxlovid for 5 days, he had two days of home test that were negative; (Apr2022) Positive, notes: Between 25Apr2022 and 27Apr2022 they were positive again; (22Apr2022) Positive, notes: He was positive for a 22 day span since the 22Apr2022; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19, illness included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was vaccinated fully as of March 2021. Presented to ED and diagnosed with COVID-19 infection leading to hospitalization
sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. The consumer reported same events for 2 patients. This is the 2nd of 2 reports. A 67-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single  for covid-19 immunization. The patient's medical history and concomitant medications were not reported. According to the reporter the patient was sick with covid-19 after getting fully vaccinated with the Pfizer covid-19 vaccine on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127923 Same reporter/ drug/ event for different patients
The patient developed a rash on her thighs two days after her vaccination.  On 07/21/2021, her physical exam revealed :  "Rash, maculopapular in both thighs which has become confluent, no open areas."
This spontaneous report was received from a registered nurse refers to a currently 4 year old female patient. On an unknown date, the VARIVAX was improperly stored. On an unknown date, the patient was vaccinated with VARIVAX (dose, route and lot# were not reported). No adverse effects reported. At the time of the report the action taken was not reported. This is one report of several reports from the same source. Additional information has been requested.
loss of taste; loss of smell; symptoms similar to a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection). At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment has provided no concomitant medication has given   This case was linked to MOD-2021-016500 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA015114: US-009507513-1704USA010748: US-009507513-1704USA015113:
Computer glitch  didn't transmit vaccine given earlier , so patient was given a second dose one week later.
Patient reported that she had rash at injection site and around that area, she also reported itching even after 7 days.
Got covid; Got covid; Immunisation (Dose 3); FLU and BNT162B2 were taken on same date (04Nov2021); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 (Lot number: ew0217) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 04Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=el3247,, prev_dose_lot_unknown=False,, prev_dose_administration_date=16Fe, b2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Left, arm},), administration date: 16Feb2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=el3247,, prev_dose_lot_unknown=False,, prev_dose_administration_date=27Ja, n2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left, arm}]), administration date: 27Jan2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Immunisation (Dose 3)"; PRODUCT USE ISSUE (medically significant) with onset 04Nov2021, outcome "unknown", described as "FLU and BNT162B2 were taken on same date (04Nov2021)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Severe left arm pain at 2am. Muscle spasms under injection site, hand/arm numbness. Had to take rest of week off work couldn't lift my left arm above my shoulder and in so much pain.
A couple days after receiving Dose 1 of the Pfizer vaccine, I have noticed a significantly drier mouth/tongue that has lasted a week and continues. While it is not debilitating/posing a major issue, and I cannot be 100% sure the vaccine was the cause, it is a significant difference from anything I have experienced in the past.
VAERS reporting as required by law, death occurred on 01/31/2022. Moderna COVID 19 vaccines completed on 5/21/2021 and 6/17/2021.
Daily fever (100-101) and chills since receiving vaccine.  Persistent moderate cervical lymphadenopathy
His arm was sore; he has had no reaction at all after this dose which concerns him that he did not receive much of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm was sore"; UNDERDOSE (non-serious), outcome "unknown", described as "he has had no reaction at all after this dose which concerns him that he did not receive much of the vaccine". Additional information:  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is an 89-year-old gentleman with a history of CVA X as well as factor V Leiden mutation who presents to hospital after feeling very weak specifically he describes an episode where he felt that his legs were paralyzed.  He sustained a fall he was on the ground for several hours.  The patient has had some cough denies fevers chills headache sore throat dysphagia odynophagia chest pain shortness of breath abdominal pain nausea vomiting diarrhea.  No melena hematemesis hematochezia no dysuria hematuria.  The patient tested positive for COVID-19.
Moderna vaccine given on  or about 1:40 PM. Patient complained of being dizzy during the mandatory observation time. Nurse was walking her to the recliner then suddenly she stated "I'm dizzier.....I'm dizzy" then she slowly descended to the floor. Nurse STAT was immediately called.  She woke up after calling her name, removed her masked and asked to take a deep breath.  She responded to all commands. ED nurse stat responded and patient taken to the ED for evaluation via wheelchair.
Narrative: 74yo M was admitted from the emergency room due to progressive shortness x 5 days after having a COVID exposure. Patient is fully vaccinated but reports approximately 10 days ago he was around a boy who was coughing a lot. Over the past 2-3 days his wife has been ill and plans to go now to get tested for covid. Patient reported taking otc cough medication and benadryl to assist with sleep, without any relief. Symptoms reported; +nonproductive cough, +wheezing, +DOE, sob, +subjective fever, +hot/cold flashes, right sided generalize pain to include right side of abdomen, decreased appetite, no food intake in 2-3d, 1 loose stool, +insomnia- 2-3hrs of consecutive sleep, +sore throat, +headache, -n/v/d, no swelling of upper/lower extremities, no rash or neurological issues, +dizzy, - denies any chest pain and urinary hesitation (new). Patient reports being in good health prior to exposure. HOSPITAL COURSE: 74 yo patient who was treated for acute COVID 19 pneumonia and acute hypoxic respiratory failure from 9/21-9/24/2021. He is fully vaccinated with Moderna vaccine. The patient was treated with IV remdesivir and steroids. D-dimer negative for PE. He was weaned from supplemental oxygen. 02sat 96% on Room air. He was able to walk daily without any assistance. The patient was medically stable for discharge on 9/24/21. The patient will be monitored through home telehealth COVID 19 monitoring program post discharge. Patient in agreement to follow up plan and PCP appt on 7-10 days.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included antiviral COVID-19 treatment of Paxlovid from 01Jul2022 to 03Jul2022, orally.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.