chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 22 year old female with a history of a "cardiac surgery" who on 07/07/03 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent. On 07/07/03, immediately upon injection of the vaccine, the pt experienced flush, shortness of breath and malaise of very short duration. It was reported that the symptoms lasted less than 5 minutes and the pt completely recovered without treatment. The pt was not hospitalized. Unspecified medical attention was sought. Additional information has been requested.
Patient advertently received Moderna Vaccine that's not approved in their age group. Patient was counseled at different store to receive 2nd dose.
R-sided chest pain starting 4/27/23, diagnosed as pulmonary emboli on 5/2/23. Hospitalization at local hospital 5/2/23-5/4/23. Now home on O2 and Eliquis, doing better.
tiredness; achiness; doesn't feel good; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PAIN (achiness), MALAISE (doesn't feel good) and ANXIETY (uncomfortable) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PAIN (achiness), MALAISE (doesn't feel good) and ANXIETY (uncomfortable). At the time of the report, FATIGUE (tiredness), PAIN (achiness), MALAISE (doesn't feel good) and ANXIETY (uncomfortable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information provided patient said feeling better and all her events resolved 4 weeks back   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-May-2021. Events outcome was updated.
General feeling of malaise / axilla pain tender to touch / arm pain at injection site and radiating down to elbow.
Immediately post vaccination @ 1217, Pt c/o chest pain that radiates to left arm & up left side of neck. EMS called. Initially pt states pain 6/10, denies any other Sx. Pt VS @ 1219: 132/60, HR 75, O2 99% RA, RR 16, 98.7.   @ 1220 states 3/10, @ 1230, prior to EMS arrival, pt states 0/10.  EMS arrival @ 1235, EKG NSR, per EMS, pt refuses hospital transport & signs AMA form. Pt d/c w/family & spouse @ 1248.
Rash within an hour on neck, chest, wrists, knees, ankles.; Significantly swollen lymph node at base of neck and subclavicular lymph node on side of injection within 2 days.; Body aches; diarrhea; Swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection; Swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), via an unspecified route of administration started on 18Dec2020 18:15 at a single dose in left arm (as reported) for COVID-19 immunization. Medical history included chronic autoimmune inflammatory disorder, autoimmune hypothyroid, polycystic ovarian syndrome (PCOS), Raynauds, asthma, fibromyalgia. There were known allergies: some preservatives, several antibiotics, multiple foods. No Pregnant at the time of vaccination. Concomitant medication included loratadine (CLARITIN), famotidine, ergocalciferol (VIT D), nortriptyline, valaciclovir hydrochloride (VALTREX), received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020 19:00, the patient experienced rash within an hour on neck, chest, wrists, knees, ankles. significantly swollen lymph node at base of neck and subclavicular lymph node on side of injection within 2 days. body aches, diarrhea x 1 day. swelling over anterior and posterior deltoid above site of injection, swelling across clavicle on side of injection within 3-4 days after injection. Treatment, including ibuprofen (ADVIL), famotidine, clarithromycin (CLARITIN), heat, was received for adverse events. No COVID tested post vaccination. Since the vaccination, the patient was not tested for COVID-19. This is a non-serious report. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. The outcome of events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches; Felt really sick - felt like going to die; chills; arm pain was incredibly bad; received three doses of the Moderna COVID-19 vaccine because they are overweight; A spontaneous report was received from a consumer concerning a 42- year old-male patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced extra dose administered,felt like they were going to die, felt really sick,chills, body aches and arm pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08-jan-2021,the patient received their first of two planned doses of mRNA-1273 (lot/batch 007L20A) for prophylaxis of C OVID-19 infection. On 01-Feb-2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 007L20A) for prophylaxis of COVID-19 infection. On 02 Mar 2021, a month after the second, the patient received a third dos of mRNA-1273 ( lot: 027A21A).  On an unknown date, after the second dose, the patient reports feeling "like they were going to die" and feeling really sick including chills, body aches, and incredible arm pain. They did not feel anything after the first dose or after the third dose. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, extra dose administered, was considered as resolved on 02Mar2021,T  The outcome of the events,chills,malaise,feeling abnormal,pain and pain in extremity was considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report also refers to a case of Extra dose administered for mRNA-1273 (lot # 007L20A), with no associated AEs. Further information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years 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: "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "asthmatic bronchitis" (unspecified if ongoing); "lichen planus" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PANTOPRAZOLE. Past drug history included: Actifed, reaction(s): "Known allergies"; Diclofenac, reaction(s): "Known allergies"; Voltaren, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: 10 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 including oral Paxlovid from 10May2022 to 15May2022. The patient had symptoms of rhinorrhea, positive rapid antigen test 10 days after completing Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009323: US-009507513-2001USA009327: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009324:
Received IPV Fri 6-10-11 MOC reports he had fever to 100.8. TYLENOL given q 4 hours, Sat 6/11/11. Red area and pain (R) thigh injection site. Would not walk by self PM everything ok.
Rash, "hive-like" legs, arms, ear, ill and anorexic. Referred to PMD. Transferred to hospital and dx'd with HSP (Henoch-Schonlein Purpura). The follow-up states that after the pt got admitted to the hospital he experienced fever of 102 deg. F. and also refused to bear weight and hands, knees and feet became swollen with increased sleeping and decreased appetite. Rash progressed further to hands, feet, several on face, and non on trunk.
gout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced GOUT (gout). At the time of the report, GOUT (gout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dizziness   140/90   Pt. felt dizziness after receiving COVID-19 vaccine.  Stated felt better.
hives on throat the day of injection,  next day had on lip and left eye and forehead.  Reported several days after vaccination.
Significant URI Sm, paroxysmal cough, patient report of wheeze over next 2-3 days.  However of note, probably contact in waiting room with countless flu A positive individuals or fomites(presumed H1N1) in clinic day of administration of vaccine.
I had chills; Nausea; This case was reported by a consumer and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced chills and nausea. On an unknown date, the outcome of the chills and nausea were unknown.  It was unknown if the reporter considered the chills and nausea to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shot this past Saturday. The patient experienced chills and some nausea. Rather have the side effects than to have Shingles. Also stated that would get second shot.
Chills, headache 1/19/2021 Motrin Chills, temp 100.3 1/20/2021 Tylenol
This spontaneous report was received from a license vocational nurse refers to two unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of an improperly stored VARIVAX (Merck) (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
Sudden onset of tingling in arms with rash.  Seen in ER and treated successfully with IM Benadryl.  Next day reoccurance of tingling but circumorally while in clinic.  Successfully treated again with IM Benadryl.
Heavier longer period, period came early again with every shot, fever, chills, abdominal to hip pain, muscle aches, pain at injection site, soreness in arm pit, headaches, nausea, diarrhea, vomit (once), hoarse felt like vocal chords straining for 4 days.
PRESENTING PROBLEM: Bilateral pulmonary embolism (HCC) HOSPITAL COURSE:  35-year-old female came in with shortness of breath and pleuritic chest pain who was found to have bilateral pulmonary embolism with moderately extensive clot burden.  Her BNP and troponins were normal and no signs of right ventricular dysfunction on CT scan.  Patient was placed on heparin drip and her symptoms improved.  Ultrasound Doppler of bilateral lower extremities were negative.  This was an unprovoked PE.  Patient was switched to and discharged with Xarelto.  She will benefit from a hypercoagulable workup once she is off of anticoagulation.  After vaccine: patient reported difficulty breathing and fast heartrate
severe itching from head to toe; severe hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching from head to toe) and URTICARIA (severe hives) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A), 029K20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (severe itching from head to toe) and URTICARIA (severe hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (severe itching from head to toe) had not resolved and URTICARIA (severe hives) outcome was unknown.            No concomitant medications were reported.  Patient has no pre-existing condition and prior allergy.
Pain at injection site, body aches, chills, fever, nausea. Tested Covid + in November 2020.
This spontaneous report was received from a physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M008551 and expiry date: 02-JUN-2018 (dosing and route not provided). No adverse effects and no product quality complaint (PQC) was reported. No further information reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Swelling, tightness, pain and warmth noted in triceps area of injection site, almost immediately. Then 4 to 5 days, post vax, pt noted about 12 scaly, pruritic papules in the right elbow, over a 2
49 days since 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose) 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.   Reporter did not allow further contact
Patient got shot 9am and at 4pm had episode of shakes and not feeling well: low grade temp. Ambulance called, eval neg. lasted 1 hr.
arm swelled immed-red-down below elbow;pt ran fever-pt rx ATB;
Left arm 2x4cm reddened area with swelling. Placed on Keflex 250mg BID X 10 days.
Stomach cramps, cold sweats, dizziness, diarrhea, headache, fever, muscle aches, fatigue, dry heaving.  I have been resting and hydrating but the symptoms are not getting better. This is the sickest I have ever felt.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Checked off "seizure", but not sure if that's what happened. He was unresponsive and his whole body tensed up several times. His brother administered an EpiPen 0.3mg that they brought with them. We called 911 and I held the patient's head as he sat in the chair so his neck wouldn't bend too far. Police, EMT's and Paramedics arrived and took him away. His brother came back to thank us and another customer who assisted, and said his mom thinks it was caused by nerves b/c patient is afraid of shots
Swelling and redness at site that started on 12/30/2030. Approximately 7 days later, right upper arm continues to be swollen, red, warm and itchy.
Soreness persist in the muscle almost a month; soreness moved down to the left forearm; soreness moved down to the elbow; soreness in the left arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness moved down to the left forearm), VACCINATION SITE PAIN (soreness in the left arm at the injection site), ARTHRALGIA (soreness moved down to the elbow) and MYALGIA (Soreness persist in the muscle almost a month) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN (ALVASTATIN) for Cholesterol, ALLOPURINOL for Gout.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness in the left arm at the injection site). On 23-May-2021, the patient experienced ARTHRALGIA (soreness moved down to the elbow). On 26-May-2021, the patient experienced VACCINATION SITE PAIN (soreness moved down to the left forearm). On an unknown date, the patient experienced MYALGIA (Soreness persist in the muscle almost a month). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (soreness moved down to the left forearm), VACCINATION SITE PAIN (soreness in the left arm at the injection site), ARTHRALGIA (soreness moved down to the elbow) and MYALGIA (Soreness persist in the muscle almost a month) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR received on 9-Jun-2021 contains significant information. The outcome of events were reported as recovered.
A non-serious spontaneous report of flu-like symptoms has been received from a consumer concerning her friend's five-year-old daughter, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not provided. The patient received FLUMIST via nasal route on an unspecified date in Oct-2008. Two days after FLUMIST vaccination, the patient experienced flu-like symptoms. She was evaluated by her physician. No medications were provided. The event resolved five days after onset. Per the reporter, the patient's physician was not sure if the symptoms were caused by FLUMIST.
Patient walked over to post-observation area and had a near syncope episode. Patient's  vital signs taken and was observed for an additional 30 minutes. Water and snacks were offered. Patient left with companion who was driving the patient home.
8/7/21 Came to ED with shortness of breath and fall from standing.  Was exposed to COVID on 7/31/21 and started having symptoms on 8/2/21. Had been vaccinated but test was positive for COVID on admission. On and off ventilator. Started on dexamethasone and remdesivir on 8/9.  Oxygen requirements continued to increase. Patient/family elected for comfort measures only and patient died on 8/14/2021.
LEFT ARM SWOLLEN AND RED, SPREAD TO WHOLE ARM FROM FINGER TO SHOULDERS AND SWOLLEN LEFT ARMPIT AND BREAST, VERY PAINFUL.  BODY ACHES, FEVER, FATIGUE.
nosebleeds and went to the hospital for 7 to 8 hours; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours). At the time of the report, EPISTAXIS (nosebleeds and went to the hospital for 7 to 8 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  Concomitant drug details not provided.
Pt noticed rash develop to her left arm at site of injection 5 days after receiving vaccine.  Since then the rash has spread to allover her body and is slightly itchy.