chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An expired dose of VARIVAX (R011809 4/23/2020) was reconstituted with expired STERILE DILUENT (N029293 4/25/2020) and administered to the patient on 5/14/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 14-MAY-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R011809 and expiration date: 23-APR-2020; strength and route not reported) for prophylaxis, which was reconstituted with an expired sterile diluent (lot # N029293 and expiration date: 25-APR-2020) (expired product administered). There was no temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent. No product quality complaint (PQC) involved.
Pt. was given pneumovax shot (I.M. Right Deltoid) on 2/5/09 @ 1415 in his home.  Pt. called clinic this morning and left a voicemail reporting that he had "excruciating pain in the right shoulder joint."  I called the pt. back and the pt. reported that he fell asleep shortly after leaving his residence.  He awoke at approximately 1730 (2/5/09) with intense pain in his shoulder and arm.  He said, "I felt like it was broken."  Pt. denied any swelling, redness, or tenderness.  He went back to sleep but then awoke approximately an hour later and his condition was the same.  At 0300 on (2/6/09) he woke up and tried bandaging his arm to his chest to immobilze it so that he could sleep better but he reported that doing that did not help the pain.  When asked if he had taken anything for pain or used a cold compress, he reported having used an ice-pack on the area and he had a "cabinet full of pain-management drugs" and was taking oxycontin to manage the pain.
I tested positive for COVID-19 on 6/29/2022. When I woke up I had a headache, phlegm in my throat, and congestion. I was prescribed PAXLOVID and I am still feeling kind of bad because it has only been 24 hours.
Information has been received from a physician concerning a pt who was vaccinated with Hep B vaccine. Within 3 days of vaccine, the pt experienced joint pain and arm pain "not at the injection site." Additional information has been requested.
(+) H1N1 test even after receiving vaccine. Required hospitalization and ventilator. 1st symptoms = headache, pale, general "not feeling well".
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case : 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case : 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513- 1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
TC from son (MD): Pt had dried like zoster rash to forehead X 3 days with mild fever only. Now has vesicular (urticaria) rash with sciatica without fever. Now without resp issues. MD starting with VALTREX - Recom. MD eval and eval and tx and symptoms. Initial report received on 01 May 2009 from a health care professional. A 70-year-old male patient had received a right arm subcutaneous booster injection A1229-2), a second subcutaneous left arm injection of YF-VAX  (lot number UF4 left arm injection of TWINRIX (manufacturer GlaxoSmithKline, lot number AHAB. The patient had no concurrent illnesses at the time, but had medical history has not required treatment in the last four years. The patient has been well taking PREVACID and LIPITOR as concomitant medications (indications not reported on 26 April 2009 (time of onset unknown).The patient developed dried like zoster three days with mild fever only. Subsequently (date not reported), the patient reported as urticarial and sciatics. At that time, the patient did not have reported) the patient developed respiratory issues (not described). The patient was recommended to get further medical evaluation and treatment for symptoms the time of this report, this was in process. The recovery status of the patient. Follow up information received on 03 June 2009 from health care professional. The patient did not have a prior history of sciation. The patient has chronic left lower extremity pain as well as foot drop in the left lower extremity with difficulty walking. The patient is being monitored by a neurologist and dermatologist for pain management. The final diagnosis was shingles. No further information was provided. Documents held by sender: None.
no fever hx when returned for skin test reading 1JUL96;heat & swelling started 27JUN96 evening by pt statement;sl redness under Td site w/heat on side of arm;40cm down & 90cm across side of arm;sl redness, heat & soft swelling;
experienced arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced arm soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (experienced arm soreness). At the time of the report, VACCINATION SITE PAIN (experienced arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt had a previous hospitalization from 9/1/21 - 9/4/21, dx with COVID pneumonia, A Fib with RVR, acute cystitis; dc'd to home with O2; EMS called 9/7/21 to transport to hosp due to increasing SOB; O2 saturation 77% on RA; non-productive cough, body aches, fatigue and malaise with left sided chest pain; found to be in A Fib with RVR and treated; CT of chest showed COVID pneumonia; severe sepsis secondary to COVID pneumonia; transferred to ICU; ABX, baricitinib, Vitamins C, D and zinc, Decadron, heparin; O2 supplementation; worsening respiratory failure with episodes of A Fib with RVR; poor prognosis; transitioned to comfort measures; pt passed away in the hospital
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that the patient received the 1st dose of GARDASIL (dose, route and lot # not reported) on 09-JUL-2010 and the 2nd dose of GARDASIL (dose, route and lot # not reported) on 30-JUL-2013. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Case number PHEH2012US015704 is an initial spontaneous report received from a nurse on 06 Aug 2012. This case refers to a 54-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the last dose of post exposure series of RABAVERT vaccine (batch number: 502011A) intramuscularly on 03 Aug 2012. Later (dates not specified) she experienced high fever of 102 F, stiff neck, muscle twitches, fatigue and headache. The outcome of these events was reported as condition unchanged at the time of this report. The causality of the events was not reported. No other information was available.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a one months old (also reported as 2 months) female patient who was received a 0.5 mL dose of QUADRACEL (lot number: C5222AA, expiry date: 20-Jun-2019) via intramuscular route in the left thigh instead of PENTACEL (batch number and expiry date were not reported) on 30-Jul-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A few hours after his vaccines he noticed swelling inside his arm pit versus on the outside of his shoulder area. He was concerned enough to call us. Afterwards, he did call his PCP who stated this is a side effect noticed (not super common but can happen) I suggested a warm compress.
patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.   This case was linked to MOD-2021-418964 (Patient Link).
Patient got vaccine on 03/29/22.  Patient came to pharmacy on 03/31/20 stating his right arm, upper back and upper chest have a rash.  Patient went to physician and it was confirmed he has shingles.
Employee Received FLUBLOK QUAD at 8:45 am IM in R Deltoid, by 9:08 she began itching her upper R arm, then L arm, then L lower leg. Employee Health Nurse instructed to go to ER. Another Employee Health Nurse walked her downstairs to the ER, where she began to have continuous clearing of throat, some coughing. Before arriving downstairs at ER, patient began to have shortness of breath and nausea. Patient arrived at ER with itching, shortness of breath, headache and nausea.
Patient felt the following morning (10/6/16) and rest of day on the day after the vaccinations that she was extremely fatigued and could not move or talk (she was unsure when the onset may have been because she stayed up late at night then fell asleep; her husband returned home from work on 10/6/16 at 4.30pm to find her laying down not able to move or talk to him; the effects gradually wore off and by the second day post-vaccination was feeling better and back to normal(10/7/16).
Most Notable Symptom: Swollen lymph nodes for 3-4 days. Most severe in armpits. Dull aching pain. Other Symptoms: Injection painful when administered (burning -sensation). Injection site swollen for 3-4 days.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: called 911 and gave her epipen upon discovering a quick reaction it was hard to figure syncope and anaphylactic but after epipen pt recovered fine and escorded by 911 also advised to take her to pcp. pt family was informed and came to pick her up
Patient woke up with a fever of 101.5 which varied during the day from 101 to 103.5, slightly nauseous with headache and joint pain, lower back pain, chills and some dizziness with position changes. Also left arm with a noticeably red area and warm to the touch. Patient had pain between left elbow and shoulder. She was taking Tylenol at home for the pain and fever. Health Services transferred her to the Emergency room. The Emergency room treated her arm as a cellulitis and gave patient Vantin and Bactrim DS. Patient in observation for 24 hours and then discharged home.
Approx 1 day after receiving vaccine, patient died while working in the yard.  He had complained earlier at work of soreness in knees.  He was mowing after work in his yard.  He was found in the front of his house where it appears he fell and hit his head.  It is not clear what made him fall.  The mower was left in the yard and the mowing was only partially completed.
Had soreness in injection site / slight soreness in the injection site; Headache for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain and headache. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient for himself/herself. Age at vaccination was not reported. The age grp was selected as an adult as per vaccine indication. The patient had soreness in injection site for a couple of days and a headache that might or might not be as result of reaction. No rash occurred. The reporter reported that would not stop him/her from getting second shot. The patient was awaiting to get the second shot.
Information has been received from a health professional concerning a 22 year old female with no known allergies who, "21 years ago," in approximately 1986, was vaccinated with a dose of MMR II.  Post vaccination the patient developed a cyst at the injection site.  The patient recovered.  At the time of this report, no other information was available.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
Information has been received from a 57 year old black female with a pcn allergy who on 2/22/02 was vaccinated with the first dose of hep B vaccine recombinant. Concomitant therapy included Procardia, and amiloride hydrochloride-HCTZ. In February 2002, a few days after vaccination, the pt noticed two skin discoloration on her thigh (later reported as vitiligo). On 4/13/02, the pt was vaccinated with a second dose of hep B vaccine. In April 2002 after vaccination, the pt experienced some sort of skin reaction all over her chest and arms and hips which she called discoloration of the skin (later reported as vitiligo). The pt was treated with triamcinolone. The pt's outcome was unknown. Follow-up reports the vitiliog "seemed to be triggered by the vaccien according to the pt and history of time sequence." On 9/17/02 the physician reported that the pt had not returned for follow up and no further info was available at this time. Additional info has been requested.
Suffered from hemorrhoids for two weeks. Never before had suffered from the condition. Chills and dizziness for three days.
Fever of 102.4, mid back pain, chills sweating,  difficultly in finding the right words, weak. Tylenol and ibuprofen.
Rash at injection site. Warm to touch. Rash appeared 2 days after administration.
Headache, Myalgia, Fever, low grade temp 99.1F chills Narrative: Received Vaccine 1/21/21 has very bad headache today, with muscle aches ,chills, temp 99.1F. Self monitoring at home using acetaminophophen PRN.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Received injection and little or no pain at time of injection.  Later in the evening arm started hurting from left shoulder to elbow, hurt to life arm, next day was better.  Next few days it felt like getting better, but then last Wed Nov 9, it was so sore that it awakened her if she moved wrong.  On Thursday it hurt to cross over to right to put deodorant on , put bran off and on , put shirt off and on.  This was same Nov 9-13.  Now this week is better, just achy. Aleve helps.
1/28/21: Tingling at sides of tongue within 10 minutes (had this after vaccine #1, too).  A warm rush up the back of my neck.   1/29/21:  Pain at site of injection.  Chills, fever, aches, extreme fatigue and sleepiness.  During night had racing, repetitive dreams.  Experienced polyuria, with diuresis resulting in 10 pound weight loss over 3 days.   1/30/21:  Extreme fatigue and sleepiness, chills, aches, nausea, diarrhea 1/31/21:  Fatigue, headache but only with cough, pain at back of my neck and skull 2/1/21:  Fatigue, headach but only with cough, pain at top of my head and toward the front of my skull. 2/2/21:  Mild fatigue, head pressure at temples and top of my head and toward the front of my skull.  Mild roaring in my left ear, dizziness when I turn my head quickly.  Neck is still somewhat stiff.   2/3/21:  Anticipate being able to return to work
right foot "tendonitis" prior to receiving vaccine but "feels like maybe it has it gotten a little worse"; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (right foot "tendonitis" prior to receiving vaccine but "feels like maybe it has it gotten a little worse") in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-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 TENDONITIS (right foot "tendonitis" prior to receiving vaccine but "feels like maybe it has it gotten a little worse"). At the time of the report, TENDONITIS (right foot "tendonitis" prior to receiving vaccine but "feels like maybe it has it gotten a little worse") outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information not provided. Treatment included Voltaren cream
Developed irregular heart rate and presented to the ER. Was diagnosed with A-FIB with RVR and failed medication conversion. Was cardioverted into normal sinus rythym.  A-fib episode happened 4 days after 2nf Moderna vaccine. She has no history of A-fib
90 days since her first dose; Got Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Got Covid) and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Got Covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (90 days since her first dose). The patient was treated with BAMLANIVIMAB for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (Got Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: received on 26-JUN-2021 in which No new information
I feel a little Tachycardia; This is a spontaneous report from a contactable nurse reporting for him/herself.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt a little tachycardia on an unspecified date with outcome of unknown. The heart beat was 101 and body temperature was 97.7 F. The patient asked if she should go see her doctor or the emergency room or should she wait.  Information about lot/batch number has been requested.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          Treatment medications were not provided.
DOSE WAS GIVEN AFTER EXPIRATION DATE. EXPIRATION DATE WAS 07/13/2022. DOSE ADMINISTERED ON 08/04/2022.