chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FOUR HOURS AFTER VACCINATION, PATIENT DEVELOPED A LUMP BELOW INJECTION SITE ON RIGHT ARM (PNEUMOVAX SITE). THE AREA BETWEEN THE INJECTION SITE AND ELBOW BECAME ITCHY AND HOT TO THE TOUCH WITH RASH. THE FOLLOWING MORNING, PATIENT'S BLOOD PRESSURE WAS TOO LOW TO READ ON A MONITOR...EXPERIENCED BLACK OUT. PARAMEDICS TRANSPORTED PATIENT TO HOSPITAL FOR LABS AND EKG TO ELIMINATE POSSIBILITY OF CLOT. PATIENT CHECKED OUT OK AND WAS RELEASED. TWO DAYS LATER PATIENT STILL EXPERIENCING SWELLING DOWN TO WRIST IN RIGHT ARM BUT SYMPTOMS ARE IMPROVING. PATIENT IS FOLLOWING UP WITH PCP TOMORROW.
Stiff knee; knee swelling; Severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knee), JOINT SWELLING (knee swelling) and ARTHRALGIA (Severe joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (she had surgery several years ago.). Concomitant products included TRAMADOL for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ARTHRALGIA (Severe joint pain). On 17-Apr-2021, the patient experienced JOINT STIFFNESS (Stiff knee) and JOINT SWELLING (knee swelling). At the time of the report, JOINT STIFFNESS (Stiff knee), JOINT SWELLING (knee swelling) and ARTHRALGIA (Severe joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not  provided by the reporter. The patient had consultation with the physician in orthopedic clinic regarding the knee problems.   This case was linked to MOD-2021-218965.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: follow-up document received on 24-06-2021 and contain non significant information. On 09-Aug-2021: Significant Follow-up received and added new events of knee swelling and stiff knee
Staff reported numbness, tingling and heat all the way down her left arm.  She was sent to ER for further evaluation and monitoring.
(L) arterial thigh-mildly raised, erythematous area around injection site, no warmth (R) anterior thigh- area of redness. Small bruise-lateral. Normal gait. No treatment.
Information has been received from a registered nurse referring to a 15 years old patient of unknown age. The patient's medical history and concurrent condition were not reported. On 06-JUL-2016 the patient was inadvertently given a dose of PROQUAD (lot# M004892, expiration date 25-JUL-2017, therapy type rHA) subcutaneously. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
no additional adverse event reported; inadvertent administration of expired VARIVAX to patient; inadvertent administration of PROQUAD and VARIVAX to patient; This spontaneous report was received from the officer manager concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 01-APR-2020, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, (dose, route and frequency were not provided), lot# R030801, expiration date 22-APR-2020 and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route and frequency were not provided) Lot No. R035221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 04-DEC-2020, but upon internal validation established as 04-DEC-2019. Both therapies were administered for prophylaxis and were reconstituted with a sterile water diluent (Lot # and expiry date unknown) (Accidental exposure to product). No additional adverse event was reported.
11Oct90 pt vax w/ 2nd hepta B; exp soreness in lower arm and knot on arm described as reactive lymph node attrib to vax. Tx w/ ASA + unspecified anti-inflammatory. 3 weeks later sx resolved.
pt recv vax;HA & fever but mild soreness of lt arm; APAP given; warm to touch, edema, redness & pain;
Acute upper respiratory infection; asthma attack; flu like sympthoms; malaise; This case was reported by a physician via other manufacturer and described the occurrence of acute upper respiratory tract infection in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. On an unknown date, the outcome of the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise were unknown.   It was unknown if the reporter considered the acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received dose of  shingrix and experienced acute upper respiratory tract infection, asthmatic attack, influenza-like symptoms and malaise. The information regarding consent to follow up was not reported.
The pt had seizure about 10 hrs after vaccine and than 2 days after had another. Symptoms included spitting up, shaking, and disorientation, history of seizures with moderate control on carbachol. Had Hep A 4/24/01.
PT WAS FULLY VACCINATED WITH PFIZER - DOSE 1 :3/6/21 (EL3302); DOSE 2 : 4/06/21 (ER8730). S/O 8/24/21; TESTED + 8/27/21
Rash spread to chest, back and legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spread to chest, back and legs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 immunisation.     No Medical History information was reported.   On 20-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash spread to chest, back and legs). At the time of the report, RASH (Rash spread to chest, back and legs) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-110113 (Patient Link).
cardiac arrest with ventricular fibrillation due to acute myocarditis Went into cardiac arrest at home.  Compressions performed until first responders arrived, took over compressions, administered 3 doses of epinephrine with shocks in between doses (VFIB).  Sinus rhythm restored and transported to BSW ER.  Spent 6 days in ICU, 3 days on Med Ward.  Fitted with Zoll Life Vest and discharged.  Prescribed MAGOX 400 mg daily, metoprolol 50 mg daily.  Scheduled for follow-up with Cardiology and Cardiac Rehab.
Swelling and pain at injection site, pain extended through shoulder and neck, fever (not recorded temp., feels hot according to wife).
Fever, Cough, Chest Congestion, Sore Throat, Nasal/Sinus Congestion, Chills, Cold Sweats
metal taste; soreness at injection; on the outside of my left arm a pain shot down my arm all the way down my pinky finger; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Milk allergy" (unspecified if ongoing); "Mitral valve replacement", start date: Dec2018 (unspecified if ongoing), notes: mitral valve replacement on 12/2018.; "Atrial fibrillation" (unspecified if ongoing), notes: had AFIB; "lactose allergy" (unspecified if ongoing), notes: lactose allergy. Concomitant medication(s) included: BABY ASPIRIN; METOPROLOL TARTRATE; XARELTO; CLARITIN [LORATADINE] taken for hypersensitivity. The following information was reported: DYSGEUSIA (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "metal taste"; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "soreness at injection"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "on the outside of my left arm a pain shot down my arm all the way down my pinky finger"; FATIGUE (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "tired".  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. It was unknown if patient received any treatment for the reported events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE reported.; HCP reported ROTATEQ was administered after a temperature excursion to a patient on Nov 7, 2022.; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 07-NOV-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot number: U038854, expiration date: 20-APR-2023 (dose and dose number were not reported) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  The administered dose of the suspect vaccine experienced a temperature excursion of 33.9 degrees Fahrenheit for 2 hours. There was no previous reported temperature excursion. It was unknown, whether a digital data logger was involved.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2212USA000635:2212USA000635
R jaw swelling, tender - able to work. Doesn't think this is related to the shot. Seeing his personal MD 12/12.
No adverse reaction. Patient received 2nd booster and didn't meet the CDC requirements of being age 50+
Fatigue, body aches, sore throat, loss of voice, which has lasted about 3 days but still have dry cough, drainage, redness and warmth around injection site.
1st dose 01Nov2021 2nd, 31Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MS5HC, expiry date 8th July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st November 2021 with batch number:2NT5L and expiry date:12th May 2023).   On 31st August 2022, the patient received the 2nd dose of Shingrix. On 31st August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 31-Aug-2022 Reporters comment: The pharmacist reported that patient did not receive second dose until 31Aug2021. The reporter consent to follow-up. Additional Supportive information: The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Patient inadvertently received a monovalent Pfizer Covid-19 dose as a booster instead of the recommended bivalent booster dose. Patient was notified and will receive bivalent 2 months from 1/26/23.
FEVER, CHILLS, HEADACHE, SHIVERING, BODY ACHES, GENERAL WEAKNESS, PAIN AT INJECTION SITE
Patient had dizziness when she got down to the emergency department.; transient ischemia attack (TIA); Hypertensive emergency; This is a spontaneous report from a contactable pharmacist reporting for two patients. This is the second of two reports.   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EH9899), intramuscular at 0.3 mL, single in the arm on 23Dec2020 for Covid-19 immunisation. Medical history included hypertension, allergies to sulfa, morphine and cipro.   There were no concomitant medications. The patient experienced hypertensive emergency on 23Dec2020 with outcome of unknown, patient was getting her blood pressure checked and the patient was in the 170s systolic on an unspecified date with outcome of unknown, patient had dizziness when she got down to the emergency department on an unspecified date with outcome of unknown.   The events were described as follows: Patient was getting her blood pressure checked and the patient was in the 170s systolic. She was taken down to the emergency department. She had a blood pressure of 191/105 in the emergency department. Patient had dizziness when she got down to the emergency department. She does not have further details to provide since the patient is being worked up right now to see if she experienced a transient ischemia attack (TIA). Patient has a history of hypertension.  The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: While the patient is a known hypertensive and events may be intercurrent events, the causal relationship between BNT162B2 and the events hypertensive emergency, dizziness and transient ischaemic attack cannot be completely excluded due to temporal association. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020510735 Same reporter/different patient/similar events
fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: unknown), via an unspecified route of administration on 09Jan2021 15:50 at a single dose for COVID-19 immunization. Medical history included menopausal, GERD, sinus disorder, and allergies. Concomitant medications included colecalciferol (VITAMIN D 3) taking for a year or two for menopausal, cyanocobalamin (VITAMIN B12) taking for a year to help with hair, nail, and immune system, calcium taking for a year for supplementation and menopausal, famotidine taking for a year for GERD, fexofenadine hydrochloride (ALLEGRA) taking for a year for sinus and alllergies, and unspecified multivitamin taking for 5 years at least for iron supplementation. The patient received the first dose of bnt162b2 (lot number: EJ1685) on 19Dec2020 at 16:15PM in the left arm. She had a very sore left arm for a day and it swelled up a little. She felt some fatigue a little the next day on 20Dec2020 Sunday but it didn't prevent her from going to work. 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low grade fever for maybe 12 hours but she couldn't find a thermometer and did not know her temperature. She developed a reddening on her face, but it was not very pronounced, on the nasal labial area or smile line area. It was more pronounced on the first dose, she noticed it for about 8 to 12 hours Sunday 20Dec2020. All of her symptoms resolved by 21Dec2020.  She received the second dose 9Jan2021 at 15:50PM in the left arm. She noticed nothing right away but maybe 6 hours later, her left arm was very sore. She had more of a fever which she measured at 99.4 Fahrenheit on 10Jan2021. Her normal is 97.1 to 97.5 Fahrenheit which she knew because she had to get screened at work. This time, after the second dose, she also noticed she had bone and muscle aches but was all short lived on 10Jan2021. She went to church and wasn't feeling good from about 10:00AM to about 19:00PM. She did treat the fever and muscle/bone aches with Tylenol extra strength rapid relief 500mg each. She took two by mouth once 3 hours before the vaccine and again once during the night and once yesterday 10Jan2021 afternoon for a total of three times and it did help. She also rested on Sunday 10Jan2021 afternoon, took extra fluids so by the time she had to go to work she felt normal. The vaccine was not administered at military facility. No additional vaccines were administered on same date of bnt162b2. The adverse events did not require a visit to the physician's office or ER. There were no prior vaccinations (within 4 weeks). The patient had no family medical history relevant to the adverse events. Outcome of the event wasn't feeling good was unknown and of the other events was recovered on 10Jan2021.
Persistent, inconsolable screaming and behavior occurred within 24 hours of vaccination. This was followed by loss of communication skills, social skills, ease with food and general regression in all areas. Treatment: speech, occupational  and behavioral therapy.  Nurse follow up on 07/21/04 states: "strabismus, developmental delays  As per annual follow up report: Residual symptoms of autism, asperger continue, not withstanding extensive treatment and progress.
chest pains while doing cardio exercise and lightheadedness immediately afterward. pounding heartbeat often waking me at night.
Abdominal pain lasting now  5 days.  Much worse first day, but still persists.
Consumer reports that pt recvd flu-vax 7NOV91 & exp fever of 99 lasting 24 hrs & vomiting approx 4 hrs p/vax; 10NOV pt taken to Er dx dehydration (no tx); @ the time of the report, pt had not vomited w/in the past 24 hrs;
At approximately 11:30 AM the patient complained of dizziness. Patient assisted to cot. Tight clothing loosened and cool cloth applied to forehead. While assessment continues patient complains of nausea and tingling in her legs. Patients appears lethargic, diaphoretic and complains of SOB. 11:40AM EPI Pen administered to left thigh emergency services called. Patient head elevated. Denies CP. Reports legs are numb.  Vital Signs throughout clinic are as follows:  BP - 170/120, P ? 100, RR - 15, 02 Sat 99% T ? 96 202/120, 90, 97% 220/100, 100, 99% 200/100, 91, 99% Patient continued to report dizziness, nausea, SOB and numbness to legs until Emergency services arrive promptly and patient transported to nearby hospital.
breast bone pain; Swollen lymph nodes on left side of breast; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, first week after the second dose, the patient experienced swollen lymph nodes on the left side of breast which gradually shifted to the right side with breast bone pain at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes on the breasts with breast bone pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient's mother) communicated to a Pfizer sales representative. A 2-year-old male patient of an unspecified ethnicity received 4 doses of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient's mother reported that the patient has been sick so pneumococcal titers was measured and was found low so the doctor recommended revaccinating with pneumococcal 13-val conj vac (dipht crm197 protein). It was not reported if the patient actually received the additional dose. The outcome of the events were unknown.
Ruptured Ovarian Cyst, abdominal pain, fever on 6/29/2021
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information received on 04-Apr-2011 and incorporated into case: no late occurring adverse events.
patients that were over 15 weeks of age received their first dose of ROTATEQ; No known adverse effects; This spontaneous report was received from a physician and refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions, pertinent medical histories, drug reactions/allergies and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis.   At the time of vaccination, the patients were over 15 weeks of age. There were no known adverse effects.
pt recv vax & states would like to ly down then pt started uncontrolable jerking to inc & dec bilat extremity lasting 5sec;no loss of conscious noted;pt alert & oriented x 3;
14-15 cm round wheel raised and hot after swimming in clorinated pool-day after vaccines.
When aspirating the needle prior to inject of HIBTITER, there was a return of blood, so the needle & syringe were removed w/o injecting HIB; the leg became red & swollen; MMR was given in the opposite leg;
About 1 week after shot, Joint pain increased, and my hands became very sensitive to cold(like an amped version of Raynaud?s Syndrome).  Feeling of tiredness in the chest.