chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient did not report adverse event to the pharmacy at the time of the occurrence. She advised when called to return for second SHINGRIX dose. Stated reaction occurred the next day with a red rash from the injection site to the elbow with heat. Rash lasted several days. Patient applied ice at the direction of her niece an RN.
Tested positive for Covid 19 on 9/17/2021 - mild respiratory symptoms, but 3 days of lowered oxygen saturation requiring oxygen
Dizziness, warmth, "just not normal", scratchy throat.  Resolved in about 1 hour.
Information has been received from a physician concerning a 58 year old female patient with no pertinent medical history and allergy to sulfa, who on 22-APR-2011 was vaccinated subcutaneously, with a dose of ZOSTAVAX (Merck) (Lot #: 669538/1390Z, Exp: 19-OCT-2012). Secondary suspect administered on 22-APR-2011 included: hepatitis A virus vaccine inactivated (MSD) (Lot #, dose and route not reported). Concomitant therapy included, SYNTHROID, ACTIVELLA, ADACEL, yellow fever virus vaccine, poliovirus vaccine inactivated (unspecified) and typhoid vaccine (unspecified). Physician reported that on 01-MAY-2011 a rash appeared on patient's extremities, which spread to her chest and looked like chickenpox. No treatment was given for the event. No lab/diagnostic studies were performed. Patient sought medical attention through office visit. At the time of the report the patient's outcome was not recovered. Follow-up information has been received from the physician, who reported that the patient completely recovered from the rash on approximately 14-MAY-2011, around 3-4 days ago. No further information is available.
I received the flu shot, though not sure of the exact strain.  I selected a strain above, but am not sure if it is the correct one or not.  3 hours after receiving the shot, I felt a slight swelling and itching in my throat, making it a little more difficult to breathe.  My eyes became red and irritated, and heart rate was slightly increased.  These symptoms came on suddenly, and remained until I woke up in the morning.  HR remained increased during the night, about 6-7 BPM higher than normal. (I wear a pedometer and track my HR during sleep)
A month after being fully vaccinated, I developed inflammation in the body that triggered an alopecia spot and thyroid issues that were otherwise dormant for over 5 years. The inflammation caused a bald spot and then my thyroid gland became inflamed and I was diagnosed with Hashimotos Disease.
CHIEF COMPLAINT:   Sent from Nsg home for lethargy  since yesterday Covid + about 7-9 days ago. History of UTI. Alert responsive upon arrival  Is confused- baseline dementia   HISTORY OF PRESENT ILLNESS:     Presents with: _covid, and not well  Duration: _cosntnat  Onset: _acute  Course: _same  Location Pain Onset: _genrela aches  Location Pain at Present: _same  Pain Radiation: _denies  Pain Quality: _achey, dementia, limits hx
Information was received on 30-JUN-2017 from a field representative who overheard a physician explaining to an office staff member that a parent called in and reported that their four year old male child had developed a rash all over their body, which is suspected to be measles (event start date reported as "about 3 years ago"). The patient was en route to another country. It was confirmed that the child had received his first dose of M-M-R II prior to this symptom (date, lot#, expiration and dose not reported). Outcome of event was not reported. No further adverse event information was provided. No consent for follow-up. Upon internal review, measles was determined to be a medically significant event. Additional information is not expected.
Patient was not eligible to receive 2nd booster shot (4th dose), because he was 49 years old at the time and did not have any immunocompromising conditions.  The patient gave a false birthdate when making the appointment for the shot. Attempts to reach the patient have been unsuccessful so far, but a voicemail was left at the number on file. Outcomes and adverse reactions are therefore unknown.
Approximately three days after receiving my second Moderna vaccination, I realized that there were multiple spots(white in color) on my left arm in the same exact area that my vaccination was given.
Patient received vaccine 9/6, no immediate effects were noticed. Patient continued daily routine 9/6 and morning of 9/7. He and his caregiver started his routine home dialysis procedure 9/7, about 20 minutes after starting he started convulsing/trembling out of control, lost consciousness and was experiencing a fever of 104 degrees. EMS was called, and he patient was taken to the hospital where he remained unconscious in critical condition for 3 days. It was noted that he had elevated antibodies but hospital was unable to grow any bacteria from cultures. After consultation and workup it was determined that the situation was a result of the shingles vaccination.
Nausea, Vomit/Diarrhea, Chills (very cold head to toes), body/joints ache, stiff throat
On the evening after shot (given around 17:00) pt developed fever and was happier than usual. The next day she was lethargic, confused, decreased strength, incoherent, breathing heavier, had body aches, sore throat and slept all day. Then she was ok.
coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contactable consumer (patient's mother). A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) in right deltoid, on 11Jan2021 around 10:30, for COVID-19 immunisation. The patient was in high risk group, was living in senior facility and was disabled. Medical history included also ongoing hydrocephalus diagnosed when he was less than a year old, ongoing shunt (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017), vagal nerve stimulator implantation ongoing from 2003 (for epilepsy; has had multiple since then, last one in 2015), ongoing hemiparesis since he was a baby and epilepsy (he was taking epilepsy drugs but it was well controlled). Concomitant medications included oxcarbazepine (TRILEPTAL) ongoing from 2000, at 1800 mg daily (600 mg in the morning and 1200 mg at night), for epilepsy and levetiracetam (KEPPRA XR) ongoing from 2000, at 1500 mg twice daily (in the morning and at night), for epilepsy. He was on prior medications to these, since he was young. Over the years he has changed to newer and better medications. On 11Jan2021 around 8-9 PM the patient experienced seizure. The patient has not had a grand mal seizure in over 5 years. On an unspecified date in Jan2021, after the vaccine, his whole body felt sore. He was unsure if it was from the seizure or the vaccine. The reporter also noticed that the patient had been coughing quite a bit on 12Jan2021 morning. Events outcomes were unknown.
Rheumatoid Arthritis flare up; Smell alteration; Hives; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up), PAROSMIA (Smell alteration) and URTICARIA (Hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In April 2021, the patient ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up), PAROSMIA (Smell alteration) and URTICARIA (Hives). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) had not resolved and PAROSMIA (Smell alteration) and URTICARIA (Hives) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable  Humira was stopped on an unknown date in 2021 and resumed on an unknown date in April 2021.  Very limited information regarding these events has been provided at this time. The rheumatoid arthritis flare may not be unrelated to the patient's medical history. A causal relationship cannot be excluded for the events of parosmia and urticaria.  Upon internal review on 21 May 2021, Humira was updated to a co-suspect drug and narrative was updated.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-Jun-2021 as event outcome of hives and Parosmia (from recovering to recovered) was updated.; Sender's Comments: Very limited information regarding these events has been provided at this time. The rheumatoid arthritis flare may not be unrelated to the patient's medical history. A causal relationship cannot be excluded for the events of parosmia and urticaria.
Bivalent vaccines have undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Sep-2022 at 5:12 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 5:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions ) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.Refrigeration excursions were identified, state vaccine was housed in the units. . Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment medication reported by the reporter.
Within 3 minutes felt severe heat in chest, neck face, got clammy, sweaty the chest and neck felt like I was being gripped/squeezed. Was given water.  BP went up 163/101.  Nurse gave me benedryl.  Was offered steroid but due to previous allergic reaction it was decided it would make matters worse.  EMS called approx. 10:30.  Sent to Wake Med ER.   I was breathy when talking; had metallic taste immediately after jab that lasted into day 3; chest and throat felt like it was being squeezed.  I was monitored for several hours and all blood tests were normal.  BP came down to 143/93.  Released around 5:15 pm.  Took baby aspirin.  Day 2:  lungs felt like they were being squeezed, had eye pain, slept most of day, no appetite, no energy, any walking or moving was painful; body aches; back of lungs sore and chest very tender to touch or movement, headache.  Day 3:  same as day 2.  Took Ibuprofen for pain,  Day 4:  slight headache with sore throat; back pain still tired although sleeping well.  Tire easily when walking.
When the skin discoloration first began it was also accompanied by red target-like rings on the discoloration marks which led my husband and I to believe that he had gotten ring worm some how. They didn't seem to itch our son though, and we put Miconazole from the local store on it every day. It didn't seem to help though. He didn't run a fever or fall ill from it. We didn't take him to his doc appointment sooner due to those things and his next appointment was 03/18/2019. When we got to his appointment, I asked about what the ash and discoloration was. Dr. said it was eczema, not ring worm and that's why Miconazole didn't work. I asked how he could pick up eczema because that doesn't run on either side of our families. He was not sure. I looked within the vaccine insert under post market-experience on page 17 and found that his last visit and vaccine DTap/IPV/hib fit the time frame perfect.   Eczema is a particular type of inflammatory reaction of the skin in which there is erythema (reddening), edema (swelling), papulles (bumps), and crusting of the skin followed  finally, by lichenification (thickening) and scaling of the skin. Erythema occurs with any skin injury, infection, or inflammation.   Erythema multiforme is most often caused by Herpes Simplex Virus. He received the Varicella vaccine 09/24/2018.
She received MMR, dTAP, Hep B, and HIb vaccine at the same time. Immediately following, she had a seizure that lasted 1.5 minutes. Since then, she has developed facial ticks, teeth grinding, and restlessness. She also had a fever of 102 degrees F 3 days after that lasted 3 days.
9APR91 mom states pt had mattered eyes, sore throat, warm; 12APR91 lump lt neck; 15APR91 hospitalized, t102, ?rash, c/o ear; Dx acute tonsillitis, cervical adenopathy due to enterobacter sukazakii; Also acute gastroenteritis w/dehydrate;
Death.   Presented to the emergency department with diffuse ST elevations concerning for myocarditis.  His troponin was elevated at 113.  His lactate was 14.  He was in renal failure with a creatinine of 2.97, GFR 26.  D-dimer was elevated at 1.25 without any obvious pulmonary embolism according to the CT.  Upon presentation he was hyperventilating, not complaining of chest pain.  Labs demonstrate a significant metabolic acidosis with a pH of 7.124, PCO2 of 15.4.  O2 sat 96.8% on room air. Patient unfortunately went into cardiac arrest and was unable to be revived.  Cause of death suspected to be myocarditis and cardiogenic shock   In the setting of active COVID-19 infection.
On Friday 1/20, patient started complaining of severe bilateral gluteal pain. The pain is most severe when going from sitting to standing and vice versa, especially when initially sitting and applying pressure to her glutes. The pain does not waken her from sleep and does not radiate down her legs. Occasionally, the pain is so severe that she feels it in her lower back. She's been able to attend school because once she's seated, the pain typically subsides. She has had no fevers, rash, erythema, pruritis, discharge, other signs of infection, decreased urine output, or darker urine than normal. . Mom has trialed Tylenol 20 mL but is still in tears due to pain. She has not yet trialed ibuprofen because every store mom went to was out of stock of children's ibuprofen. . She did not have any significant strenuous exercise or viral illness preceding the onset of pain. The only trigger mom can think of is sitting on a cold metal bench as she started to complain of pain of that. She received her first COVID vaccine on 1/11, which was the only vaccine she received that day. No contacts with similar symptoms.  . Exam: Bilateral glutes - extremely tender to mild palpation. Right glute is tender to light touch at the 6 o' clock portion. No overlying erythema, induration, rash, or discharge on bilateral glutes - tissue appears healthy and normal. No changes in skin color, sweating, or hair raising with palpation or light touch. Extreme pain leading to tears when asked to go from standing to sitting on exam table and switching positions. Straight leg raise test negative bilaterally. . Advised to take Tylenol 650 mg q6h and Motrin 480 mg q6h for one week with re-evaluation in clinic at that time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. On 26-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of chills through her hands and legs, pain (felt achy), fatigue, pyrexia (fever) and arthralgia (flu-like joint pain) in a 77-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023MD20A) for COVID-19 immunization. No medical history reported. On Mar 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 2, 2021, patient experienced chills through her hands and legs, pain (felt achy), fatigue and pyrexia (fever). On Mar 3, 2021, patient experienced arthralgia (flu-like joint pain). The patient treated with ibuprofen; unspecified dose and frequency. On Mar 4, 2021, chills through her hands and legs, pain (felt achy), fatigue, pyrexia (fever) and arthralgia (flu-like joint pain) resolved. No concomitant medications reported. Action taken with mRNA-1273 in response to the events: not applicable.
This spontaneous report as received from a pharmacist refers to a 58 year old male patient. The patient's medical history was unknown. On 01-SEP-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K010466, exp 23-MAR-2016, dose, route and frequency were not reported). Concomitant therapies included CELEBREX, methotrexate, gabapentin, folic acid, ATIVAN, prednisone, INVOKANA, thyroid medication and nitroglycerin. On approximately 06-SEP-2015 (reported as 5-7 days after vaccination), the patient experienced pain and swelling in the same unspecified arm he received with PNEUMOVAX 23. On an unspecified date the patient was evaluated at an unspecified emergency department. He was not admitted to a hospital. On an unspecified date he was given a diagnosis of "necrosis" and "cellulitis" and was treated with unspecified steroids and unspecified antibiotics for an unspecified length of time. The primary reporter reported the patient's symptoms were life threatening and stated "if the patient did not get treatment, the cellulitis could have gotten worse". The outcome of necrosis and cellulitis was reported as recovered on an unspecified day. The reporter did not provide the causality between the vaccine and the events. Upon internal review, necrosis and cellulitis was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.
Heaviness in left jaw, then heaviness in upper right jaw; rush from head to toe; Racing heart; Slight throat swelling; voice sounded funny; Clogged ears; 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: ER8727) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included syndrome lupus, antiphospholipid antibodies and raynauds. The patient did not have allergies to medications, food, or other products. Concomitant medications included duloxetine hydrochloride (CYMBALTA), hydroxychloroquine phosphate (PLAQUENIL) and thiamazole (METHIMAZOLE); all taken for an unknown indication on an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:45 (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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 13:00, the patient experienced heaviness in left jaw, then heaviness in upper right jaw, then rush from head to toe and racing heart, then slight throat swelling (voice sounded funny) and clogged ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heaviness in left jaw then heaviness in upper right jaw, rush from head to toe, racing heart, slight throat swelling, voice sounded funny and clogged ears were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 17-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
The patient was in his usual state of health until 48 hours after receiving his 3rd "booster" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020.   The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest.  Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster.  The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED.
Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.