chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower torso started itching; broke out with red bumps that are filled with fluid kind of like a blister; broke out with red bumps that are filled with fluid kind of like a blister; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0181 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 30Jun2021 at 02:00 PM (at the age of 67-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included HBP (Blood pressure high), depression, osteoarthritis and penicillin allergy. Concomitant medications included benazepril, meloxicam and citalopram. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 04Jul2021 at 8:00 AM, the 4th day after the inj the patient lower torso started itching and broke out with red bumps that are filled with fluid kind of like a blister and she itch constantly, it is very uncomfortable. This is the sixth day and they have went away. The AE did not result in emergency room or physician office visit. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Initial report received on 04 June 2007 from a health care professional.  A 50-year-old male patient, with a cardiac history which included cardiac stint placement 18 months prior to vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in his mouth.  There was no illness at the time of vaccination, and no further care was required.  At the time of the report, recovery status was not reported.  Follow-up information received on 16 July 2007 from a health care professional.  The patient was vaccinated on 02 November 2006, and the event was experienced on that day and the following day.  No diagnostic testing was performed.  Fluzone SV 2006-2007 lot number was U2193AA.  The duration of the event was 18 hours.  The patient recovered from the event.  The reporter in this case is the same as in cases 2006-02707 and 2007-02050.
Pt recv vax & following day devel redness,swelling lt thigh. Tx w/warm compress. Next day pt devel small red bumps rt thigh, then on chest & behind ear.
she started with brain fog in end of May; She had difficulty breathing that started around 13Jun2021.; nausea after the 2nd dose/She had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had difficulty breathing that started around 13Jun2021.), FEELING ABNORMAL (she started with brain fog in end of May) and NAUSEA (nausea after the 2nd dose/She had nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 048B21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced NAUSEA (nausea after the 2nd dose/She had nausea). On 13-Jun-2021, the patient experienced DYSPNOEA (She had difficulty breathing that started around 13Jun2021.). On an unknown date, the patient experienced FEELING ABNORMAL (she started with brain fog in end of May). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (She had difficulty breathing that started around 13Jun2021.), FEELING ABNORMAL (she started with brain fog in end of May) and NAUSEA (nausea after the 2nd dose/She had nausea) outcome was unknown. Inhaler for breathing      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included pepto bismol and Inhaler for breathing.     This case was linked to MOD-2021-118645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up added: new adverse event Nausea was added.
To bed for 3 hours.  Headache, general malaise. Some nausea
Mother brought patient in for second dose of pfizer but received the dose too early. 1st dose was 06/03/21 so their second dose should have been 06/24/21
fever; body aches; runny nose; cough; abdominal pain; COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown"; ABDOMINAL PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results.  Clinical Course: Contracted COVID 2 months after receiving the updated bivalent booster. COVID was moderate fever, body aches, runny nose, cough, abdominal pain. Bad symptoms lasted 4 days. Lingering abdominal pain and runny nose for 1 more week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Encephalitis.  A 60-day follow up report received 6/10/2003 adds no new info.  Annual follow up on 03/17/04: "It is unknown if pt recovered from adverse events."
Excruciating pain down my left arm. From the shoulder to my wrist. Feels like fire. Worst pain I've ever felt. It is constant. I cannot function or concentrate.
extreme shivers (teeth chattering), headache lasting more than 24 hours, muscle aches, low fever, tiredness, backache.  Had to leave work and sleep 14 hours.  After sleeping headache remained, but muscle aches were improved.
Patient came into office to recieve booster dose of Moderna. at the time we did not have the new booster series so she was given the primary series at the booster dosage of 0.25mL. it was not noticed that the refridgerator exp date was past and the vaccine was past use date.
Moderna was received from deep freezer on 8/6/21. Was placed in refrigerator on 8/6/21. 30 day expiration date was 9/5/21. Moderna was left in  refrigerator and used until 9/13/21. On 9/14/21 we realized we were beyond the 30 days and immediately notified the Pharmacy for direction. The Pharmacists are in communication with Moderna to see if the doses are considered valid or invalid. Risk Management is involved to decide on the best course of action and if we notify the patient before we hear back from Moderna.
I have experienced a fluttering in my chest; some slight dizziness over the past year or so; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 09Nov2021 at 09:15 as dose 3, single (Lot number: FF2590) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: " Relevant past drug history: allergy " (unspecified if ongoing). Patient had past drug history as allergy without name of drug provided. Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EN6196, administration time: 12:00 AM, prev dose vaccine location: Left arm), administration date: 02Mar2021, for COVID-19 immunization; BNT162b2 (Dose 2, single, lot number: EN6203, administration time: 08:30 AM, prev dose vaccine location: Left arm), administration date: 24Mar2021, for COVID-19 immunization.  The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown", described as "I have experienced a fluttering in my chest"; DIZZINESS (non-serious), outcome "unknown", described as "some slight dizziness over the past year or so". Patient had experienced a fluttering in my chest and some slight dizziness over the past year or so, which she had attributed to hunger, dehydration etc. The events "i have experienced a fluttering in my chest" and "some slight dizziness over the past year or so" required physician office visit. She had mentioned this to my Doctor at yearly physical in Oct2022.   Clinical course: Patient had 4th dose of BNT162B2 (Lot number: FN2908) on 06Jun2022 15:30 PM at the age of 66 years, in left arm for covid-19 immunisation.
Vomited x 1; eyes and lips became swollen and puffy after leaving office. Returned 30 minutes later; pulse 98%, BP 112/68. BENADRYL 1tsp po given in office.
POST VACCINE PATIENT BECAME DIAPHORETIC, DIZZY, HAVING VISUAL DISTURBANCES AND NASUEA. BROUGHT TO OBS VIA WC, PLACED IN TRENDELENBERG ON STRETCHER, VSS THROUGHOUT OBSERVATION. S/S RESOLVED AND PATIENT ESCORTED TO  EXIT WITH NO ISSUES AT 1450. 1445 INITIAL BP 131/72 HR 70 SATS 96% RA 1448 SITTING BP 125/71 HR 66 SATS 97% RA 1450 STANDING BP 121/55 HR 82 SATS 97% RA
pt recv vax 5DEC95 & 4FEB97 pt devel a rash consisting of 20 lesions;
Pt started feeling ill the night of the day she received vaccine. Chills, sweats, arm red and warm. Came to clinic on 12/11/15. VS-129/79 P-99 T-100.5. PPD placed same day. Assessed by physician in clinic.
Deep Vein Thrombosis. Pain began in right groin on Apr 17 2021. Pain increased throughout the day. Apr 17 2021 pain began in lower right leg; cramp feeling in shin and calf. By that afternoon, Lower right leg showed swelling. Pain and swelling worsened by Monday Apr 19 2021 and I sought medical care that afternoon. Ultrasound showed DVT extending from groin to foot. Placed on Elaquis and Norco for plan. D/c HRT immediately.
Ringing in the ears. Within a week I noticed very substantial ringing in my ears. It has not subsided.
Swollen right leg, red after immunizations yesterday (06/28). Started turning red today (06/29). Walking normally, no complain of pain but did not sleep well. Parents gave her TYLENOL.
This case was reported by a pharmacist and described the occurrence of coughing up blood in a 31-year-old male patient who received TWINRIX (batch number 3EX72, expiry date 22nd March 2016). On 23rd September 2014 15:00, the patient received TWINRIX (intramuscular) 1 ml. On 24th September 2014, less than a day after receiving TWINRIX, the patient experienced coughing up blood. On an unknown date, the outcome of the coughing up blood was unknown. It was unknown if the reporter considered the coughing up blood to be related to TWINRIX. Additional information received: On 24 September 2014, the patient coughed up blood in the morning, when he woke up.
ABOUT 6 INCHES RED CIRCLE AROUND INJECT SITE, AREA IS SWOLLEN AND TENDER.
received a 3rd dose when he did not need one....series started at age where only 2 doses are needed
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) instead of a first dose of VARIVAX (Merck). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
pt recv vax 14MAY97 & 30MAY97 pt devel clinical varicella;pt clinical varicella persisted @ the time of report;
Fever x 3 days last week. Rash started yesterday fine/pink generalized rash on trunk possible roseola infantum.
I had a headache and sore throat on night of July 24th.  I had runny nose and was really tired.  I slept most of the next day.  I called the doctor to get medication.  I was warned about Paxlovid causing rebound case.  I still have a runny nose.  I am just taking it easy and laying low.
Discharge Provider: Private MD Primary Care Provider: Private MD Admission Date: 7/23/2022 Discharge Date: Jul 31, 2022  PRESENTING PROBLEM: COPD exacerbation (HCC) [J44.1] Respiratory tract infection due to COVID-19 virus [U07.1, J98.8]   HOSPITAL COURSE: Patient is a 57 year-old female with PMHx significant for chronic obstructive pulmonary disease on 2-3 L at baseline, pulmonary hypertension, heart failure with preserved ejection fraction, obstructive sleep apnea, chronic pain, depression, history of DVT off anticoagulation and active tobacco abuse presenting with chief complaint of shortness of breath.  The patient was found to have COVID-19 and acute chronic obstructive pulmonary disease exacerbation.  She was requiring 5 L by nasal cannula.  She was treated with Decadron 6 mg daily, IV Remdesivir, doxycycline, nebs, Symbicort, Singulair with improvement.  PT/OT initially recommended SAR however patient progressed to home with outpatient therapy.  The patient discharged home with improved and stable respiratory status back on her baseline O2.
Pt came to pharmacy day after injection with redness and swelling below the injection site, pt was concerned and RPh counseled them to follow up with MD. Office was closed when pt presented at pharmacy, pt and RPh to follow up with PCP tomorrow. Pt was counseled if got worse or any other concerns to go to urgent care or ER. Pt may need to see MD. Was not sure yet.
30 min post injection, patient was light-headed and nauseous. She, vomited once and went home from work. Patient stated she was fine after that "dizzy spell".
A non-serious report of "doctor cut his hand on defective sprayer during administration" has been received from a health care professional concerning an adult male who was a physician administering FLUMIST to a patient. The doctor's medical history and concomitant medications were not reported. The adverse event of "doctor cut his hand on defective sprayer during administration" occurred during FLUMIST administration to a patient. One FLUMIST sprayer broke during FLUMIST administration to a patient and cut the doctor's hand. There was no signs of damage on the outside of the product packaging or plastic molded tray. The FLUMIST sprayer which broke was the first one used from the box. The product was refrigerated at 40 Fahrenheit, and temperature was monitored twice a day. The sprayer broke after the physician had administered FLUMIST into the first nostril. The physician removed another sprayer from the package to administer the second dose. There was no injury to the patient as the sprayer had been removed from the nostril before it broke. The outcome of the event of "doctor cut his hand on defective sprayer during administration" is unknown.
REACTION AT INJECTION SITE ABOUT 4-5 INCHES IN DIAMETER. PATIENT REPORTED REDDISH BUMPS SWELLING AND TENDER TO THE TOUCH. PT TOOK ADVIL PT WAS RELIEVED.
Pt suddently became unresponsive to call only responding to pinch or pain stimuli by opening her eyes; Also noticed twitching of legs, pupils constricted, sluggishly reacting to light;
poss SIDS death; immun given 17DEC93; mom reports pt had no react to immun;
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl  reports rash at IV site from (Benadryl?)   No rash anywhere else.    Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time.   To follow up with PMD.   Headache.
She started running a fever and nose started running constantly with clear mucus that evening.  She had a fever that would not go away with Tylenol for 3 days.  Dr. said she maybe caught a virus and prescribed Amoxicillin.  6 days later still no sign of getting better she now has very congested cough and fever.  Doctor changed meds to Erythromycin and said she had bronchitis but didn't believe it was pneumonia.
A tick/twitch in the right eyelid that started shortly after shot. Is somewhat on and off and off but does consistently come back.
Patient had received a Tetanus injection this past week. On Saturday afternoon he began to lose control and strength of his left arm and hand. Has difficulty lifting his hand and turning pages. He states now he can wiggle his fingers a little bit. He still has numbness in his 2 little fingers. Dr. thinks that this is an allergic reaction from the Tetanus. He states it should continue to get better, patient can continue to move it around and massage it. If it does not get any better to give us a call back. States that patient is to have no more tetanus injections in the future. This will written on his chart.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 01-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour, the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 304, 59 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sore arm; Fever; Chills; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Felt tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS, Abdominal cramp and Diarrhea. On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Felt tired) had resolved.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-547078, MOD-2022-547108, MOD-2022-547110 (Patient Link).
Adverse reactions or side effects experienced: N/A; Vaccine administered on 22-NOV-2009 and then on 17-MAR-2011; This spontaneous report has been received from a lawyer, from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 1806USA003285), concerning a 60-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 22-NOV-2009, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and on 17-MAR-2011, she received another dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (Inappropriate schedule of product administration), both administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for both doses). No adverse effects were reported.; Sender's Comments:  US-009507513-1806USA003285:
Information has been received from a nurse in a physician's office concerning a 40-month-old white male with no known medical history or allergies who on 15-MAY-2003 was vaccinated in the left leg with a dose of varicella virus vaccine live (lot # 644250/1153M). There was no illness at the time of vaccination. On 20-SEP-2005 the patient developed an unusual case of breakthrough, which was described as 20-25 initial lesions which crusted over. On 29-SEP-2005 new lesions developed and "now" (30-SEP-2005) the patient has more than 50 lesions. No fever was present. The patient sought unspecified medical attention. The adverse event did not improve and the patient had not recovered. No further information was available regarding the adverse event. There was no product quality complaint reported. Follow-up information from the physician indicated that on 14-SEP-2005 the patient developed greater than 50 fluid filled vesicles with new lesions occurring over a two week period. The lesions were mostly located on the right torso with a few scattered on his arms, legs and back. All were scabbed over. Additional information is not expected.
I was sick for 4 days. I experienced a fever, chills, body aches, headache, cough, sore arm, and I was very tired. The doctor prescribed cough medicine.
Difficulty breathing, asthma like response.  Shortness of Breath, called 911.  Increased HR, felt like I was running.  Went to clinic, was given anti-allergy medication.  Went home. In bed for 5 days with fever of 103-104.  HR 170 when lying in bed.  Profuse sweating, headache, and difficulty breathing.  Monitored by family and many calls made to Dr. to make sure fever and breathing was within manageable range, not needing ER treatment.
Info has been received from a registered nurse concerning a 63 year old (previously reported as approx 50 year old) female who on 10/23/2002 at 14:00 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent given in the right arm (lot #640578/0996L). On 10/24/2002, 24 hours after receiving the vaccine, the pt experienced a painful injection site, and her arm was tender, red and swollen for a couple of days. After 6 days, on 10/29/2002, the pt recovered and had no more symptoms. No further info is available.
Nausea beginning at approximately 2:30 PM and vomiting occurred approximately 4:00 PM.  Nausea began to subside after vomiting.  No treatment given.  Patient called vaccine administrator at 5:30 PM.
diluent was administered alone; diluent was administered alone; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked for days/time that the patient should wait to receive Shingrix in case the diluent was administered alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional reported that the patient already had got 1st dose but they were not sure if it actually had happened, so they want to had data just in case. The reporter consented to follow up by email. No further information was available.