chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after receiving Dtap #4 mom reports tiny bumps & redness at injection site. No swelling. Pt had similar RXN after shots at 2 mos and 4 mos of age. Reported to VAERS.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The RECOMBIVAX doses were exposed to 50 Fahrenheit since 07-NOV-2013. On 10-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (dose, lot and expiry date were unknown). The patient had received improperly stored RECOMBIVAX. No adverse effect was reported. This is 3 of 3 reports from same reporter. Additional information has been requested.
Urine is a very strange color; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of CHROMATURIA (Urine is a very strange color) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (Urine is a very strange color). At the time of the report, CHROMATURIA (Urine is a very strange color) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Arm pain; Slight chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergy to Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and SACCHAROMYCES BOULARDII (FLORASTOR [SACCHAROMYCES BOULARDII]) for Irritable bowel syndrome, RALOXIFENE for Osteopenia and Osteoporosis.   On 16-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue). On 14-Feb-2021, PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) High.         Treatment information not reported.   This case was linked to MOD-2021-027332 (Patient Link).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to MOD21-088435, US-MODERNATX, INC.-MOD-2021-116485 (E2B Linked Report).; Sender's Comments:  MOD21-088435:wife's case US-MODERNATX, INC.-MOD-2021-116485:wife's case
Numbness on the left side of the face; This is a spontaneous report from a contactable physician (patient). A 47-year-old non-pregnant female patient received the first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1284), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose in left arm for covid-19 immunization.  Medical history included trigeminal neuralgia. Concomitant medication included colecalciferol (VITAMIN D) and multivitamin. The patient experienced numbness on the left side of the face on 22Dec2020 at 16:00, started within 2 hours of the shot and had continued for 2 weeks. The event was reported as non-serious by reporter. The patient didn't receive treatment for the event. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination, and was not tested for COVID 19 since vaccination. The outcome of the event was not resolved.
11/11/2003 arm started swelling and can't pick up anything that weighs anything causing arm extreme pain. Have no strength in arm.
Noticed petechial rash on both legs upper and lower. Does not hurt or itch. Took Claritin.
Patient walked to car past immunizations wi.  Minutes past shots she sat in car slumped down wtih legs and arms twitching.  Mom's sister has history of seizures.  Mom reported he just had a seizure. Patient pale but able to walk with assistance. Thready pulse @54 beats/minute. Patient speaking slowly. Pt reports thought she fell asleep and dosen't remember what happened in the car. Pulse improved to 68 and strong within 5 minutes. B/P 108/68; Color pink and is now speaking clearly. Ambulatory with assistance. Mom took patient to ER.
Feeling gassy; Having soft stool; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Feeling gassy) and FAECES SOFT (Having soft stool) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Osteo arthritis knees on 01-Oct-2014, Valvular heart disease NOS (sulfa drugs) on 23-Jun-2011, Hypertension since 11-Nov-2019 and Obstructive sleep apnea syndrome on 21-Feb-2019. Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs). Concomitant products included CENTRUM SILVER +50 from 11-Nov-2019 to an unknown date, BIOTIN from 11-Nov-2019 to an unknown date, CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) from 11-Nov-2019 to an unknown date, AMLODIPINE BESILATE, ATORVASTATIN CALCIUM (AMLODIPINE + ATORVASTATIN) from 11-Nov-2019 to an unknown date and ROSUVASTATIN from 11-Nov-2019 to an unknown date for an unknown indication.   On 03-Mar-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Feeling gassy) and FAECES SOFT (Having soft stool). On 18-Apr-2021, ABDOMINAL DISTENSION (Feeling gassy) had resolved. On 20-Apr-2021, FAECES SOFT (Having soft stool) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.         Treatment Medication for gas included.   Reporter did not allow further contact   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR FUP added, reporter's demographics was added, patient's medical history was added, concomitant medications was added, event outcome was updated
shingles behind the right ear; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included not immunocompromised.   On 13-OCT-2023, the patient received Shingrix. In OCT-2023, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles behind the right ear). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The physician administered Shingrix and about 5 to 6 days after that male patient developed shingles behind the right ear. The reporter did not consent to follow up.
Soreness at injection site; Deep fatigue; fibromyalgia; This is a spontaneous report from a contactable consumer (reported herself).A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 08Mar2021 14:15 (age at vaccination 67-year-old) as dose 1, single for covid-19 immunization.Medical history included fibromyalgia, cervical arthritis, hypertension and ventricular bigeminy. The patient had known allergies to codeine, erythromycin. The patient was not diagnosed with COVID prior vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included valsartan, acetylsalicylic acid (ASPIRIN 81), pravastatin, ubidecarenone (COQ10 [UBIDECARENONE]). There was no other vaccine in four weeks.On 08Mar2021 at 18:00, the patient experienced soreness at injection site, deep fatigue (bear in mind, she had fibromyalgia, pain and fatigue were a large part of the syndrome. but it was pronounced a few hours after the vaccination). The events were not treated. The patient did not had Covid prior vaccination and not tested for Covid post vaccination. The patient had not yet recovered from events.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Patient states that approx 45 minutes after receiving the injection he developed nasal passage & throat edema to the point he was unable to swallow. Went to the Hospital ER at approx 1350, received epinephrine and steroids. State HR, Pulse ox all remained WNL. Was in the ER for approx 1.5 hours.
Breakthrough COVID-19 Infection; Breakthrough COVID-19 Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 12Apr2021 as dose 2, single (Lot number: EP6955), on 12Dec2021 as dose 3 (booster), single (Lot number: 33130BA) and on 28May2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 59 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "High Cholesterol" (unspecified if ongoing); "Pre-Diabetes" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "tree nut allergy" (unspecified if ongoing), notes: tree nut allergy. Concomitant medication(s) included: LEVOTHYROXINE; ROSUVASTATIN; FARXIGA; ORACEA [DOXYCYCLINE]; OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "recovering" and all described as "Breakthrough COVID-19 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: No other vaccine in four weeks. No covid prior vaccination.  No follow up attempts possible. No further information is required.
Client (DOB: 2/19/1970) received the 2nd Pfizer COVID vaccine lot # EW0162 and expiration date 4/18/21 at approximately 2:53PM. Client reported to nurse that she wanted her temperature checked because for her first dose she had experienced tingling, neck pain and flushing.  Staff asked how client felt and client reports she feels way better than the first dose but still experiencing mild tingling in right arm.  Client reports feeling warm and that she had already waited 25 minutes and did not want to wait much longer because her husband was waiting in the car and he is a doctor.  Staff took clients vitals: oxygen: 99%, blood pressure: 118/82, and pulse: 85. Client reports that her neck also hurts just like last time but less: pain 4/10. Staff advise client tell her PCP and gave emergency precautions. Client did have redness in her right hand and Staff offered Benadryl but client reports she wanted to leave.  Staff had Lead Staff double check client before she left. Staff spoke with client. At this time client stated feeling fine. Mild redness noted on right hand. Client denied pain, full sensory and motor function. Per client ready to leave.  At 3:30 pm client left facility with a steady gait.
Family woke to infant in body shaking seizure which lasted 6 minutes from time they awoke to finish. Start of seizure not witnessed. Felt hot at home. Upon ambulance arrival, baby's temp about 101.8 (right). History of non-febrile febrile seizure on 12/26/05. EEG/Cat Scan/MRI to be done. MD diagnosis: febrile seizure for 12/31/05 visit.
Patient fully vaccinated with Pfizer vaccine. Last dose on 2/26/2021. Tested positive for COVID 19 on 9/27/2021. Admitted to  Medical Center on 11/13/2021 related to COVID and expired on 11/13/2021 while still hospitalized.
It was reported that a pt (9 of 10) received a Fluzone SV '00-'01 on 9 Oct 2000. Reportedly within 48-72 hours post vaccination the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided, further information requested.
patient received MENQUADFI during Pregnancy with no reported adverse event; Initial information received on 13-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 16 years old female patient who was exposed to vaccine meningococcal a-c-y-w135 (t conj) vaccine (Menquadfi) during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received MENQUADFI during Pregnancy with no reported adverse event occurred at 3 weeks of pregnancy and the patient was exposed to MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE at 3 weeks of pregnancy, during first pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  The date of last menstrual period was reported as 09-Feb-2022. The estimated due date is 10-Sep-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies: not reported  Concomitant medications included influenza vaccine inact split 3v (Flulaval) and Trumemba.  On 16-Feb-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine at a dose of 0.5 ml with lot U6936AA via intramuscular route in the right deltoid for Immunization.  On 16-Feb-2022 the patient developed a non-serious patient received menquadfi during pregnancy with no reported adverse event (exposure during pregnancy) following the administration of meningococcal a-c-y-w135 (t conj) vaccine. Relevant prenatal testing after exposure included   Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.
symptoms include pain at area of injection, loss of ability to move arm at injection. both injections, flu and pneumvox, were given on same arm as requested by the patient. one injection was given higher than the other. it is believed to be the flu shot but it is not certain that it is the flu shot that was given higher and may have caused pain and loss of mobility of arm at shoulder joint.
burning pizza sensation on tongue; tingling on the tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 64 years 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: TONGUE DISCOMFORT (non-serious) with onset 24Mar2021, outcome "not recovered", described as "burning pizza sensation on tongue"; PARAESTHESIA ORAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "tingling on the tongue". Therapeutic measures were not taken as a result of tongue discomfort, paraesthesia oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness, pain & swelling appeared on lt arm 1 1/2 days p/vax;
diagnosed with pneumonia in September 2022 and October 2022; diagnosed with pneumonia in September 2022 and October 2022; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, dosage regimen, formulation, lot #, expiry date, anatomical location and route of administration were not provided) as prophylaxis. On an unspecified date in 2020, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.  On an unknown date in September 2022, the patient was diagnosed with pneumonia. Later, in October 2022, the patient was diagnosed with pneumonia again. At the time of report, the outcome of the events was unknown. The action taken with the suspect therapies regarding the events was not applicable.   The causal relationship between pneumonia and the suspect therapies was unknown.  Upon internal review, the events pneumonia in were determined to be medically significant.
Pfizer-BioNTech COVID-19 Vaccine EUA. Woke up around 2 am day after vaccine was administered with a fever and nausea. Nausea went away, but developed headache and body aches. Fever continued throughout the day. Woke up next day feeling fine.
Massive migraine, palpitation,  HR in the 100s,, chills, body aches, all lasted for the entire night and the day after
I was in another state, and I woke up feeling bad, so I took an at home test for COVID-19. The test came back positive, so I went to the local urgent care and was prescribed PAXLOVID. I took it for a couple days and had a bad relapse case, so I went back to the urgent care and got another prescription for PAXLOVID and I felt better after a couple days.
Rash radiating from injection site. Pt was told to take antihistamine & see PCP. Pt stated would take medication & see PCP if rash progress or saw any other symptoms.
an adult patient received a pediatric dose; Pediatric dose in an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 24-OCT-2023, the patient received the 2nd dose of Engerix B. On 24-OCT-2023, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: an adult patient received a pediatric dose) and adult use of a child product (Verbatim: Pediatric dose in an adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date- 25-OCT-2023 A licensed vocational nurse called in to request information about the procedure after an adult patient received a pediatric dose, which led to underdose and adult use of a child product. The reporter provided information about patient, vaccine and event. The reporter consented to follow up.
Muscle twitching and involuntary limb twitching. Hives on face. (All still happening today) March 02, 2010.
PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT, BUT RATHER A VACCINE ADMINISTRATION ERROR OCCURRED. ACCORDING TO THE COVID-19 VACCINE EUA PROTOCOL, THE PATIENT IS A MINOR AT THE AGE OF 14 AND SHOULD NOT HAVE RECEIVED THE VACCINE.
Patient was diagnosed with ITP approximately 6 weeks after his MMR vaccine with a platelet count of around 11,000. He had experienced increased bruising in the weeks leading up to his diagnosis that we initially dismissed as him being a toddler
After the vaccine my lymph nodes swelled under my arms. I was having sever joint pain. I also was having pain in my ribs on the right side. It became more significant and I started running a fever. My primary care doctor recommended I go to the doctor, so, I went to the emergency room. I was diagnosed with pancreatitis. After a lot of testing they were unable to determine how it happened. I think this was triggered by my vaccination.
Fever 102.8 9:00pm 3/29/2021-9:00am 4/02/2021, body aches 9:00pm 3/29/2021-mid day 4/2/2021 , headache immediately until 4/04/2021, nausea 3/30/2021-4/02/2021
Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain and left  neck pain. 12/30 developed a small headache that progressed into a severe headache with nausea and vomiting.  Went to ED on 12/30 at 12:04pm and discharged at 15:55. Received 0.9 % sodium chloride 999 mL, ondansetron 4 mg, CBC And Differential (Abnormal), Comprehensive Metabolic Panel (Abnormal), Lipase, acetaminophen 650 mg, SARS-CoV-2 NAT, IP UA w/Microscopic, Reflex Culture (Abnormal).  Instructed to take ondansetron-ODT 4 mg disintegrating tablet by mouth every 8 (eight) hours as needed for nausea.
felt muscle spasms almost every ten minutes  for three days in row; This is a spontaneous report from a contactable healthcare professional (patient herself). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in the left arm on 19Dec2020 07:45 at single dose for COVID-19 immunisation. Medical history included Bell's palsy from Jun2020 to an unknown date, and low Vitamin D.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included zinc (ZINC), ergocalciferol (VIT D), vitamin c, vitamin b6, and cyanocobalamin (VITAMIN B12). One week and a half after she received her COVID vaccine, on 30Dec2020 at 10:00, the patient felt muscle spasms almost every ten minutes for three days in row. No treatment was received for the adverse events. Clinical outcome of the event was unknown.