chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 10/96 shortly after became ill.  Dx giant cell arteritis.  Tx with pred.  Outcome fairly good.
My 70-year-old wife Received the 1st  Moderna Covid 19 Vaccine on 1/17/21 from Lot 037K20A at the center. She has developed a rectangular red rash approximately 7cm by 2.5cm at her vaccination site on her right arm. The rash is slightly raised above the surrounding skin area and is warm to the touch.  Should we be alarmed over this event? Do you want to review pictures of the rash? Our contact information can be found below.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions. This case contains information for the 28th of 43 adult patients described by the reporter. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
On 8/11/00, had mild right otitis, afebrile, acting well. On 8/18/00, recheck for fever, ear resolved, felt to be viral. Next day had a few pimples. They spread and lasted 9 days. Parents say child seen on 8/25/00, but our records show she called on 8/17/00 and was seen on 8/18/00. I still wonder if this was amox rash.
Hospitalized (9.20.21-9.21.21);  COVID-19 positive (9.20.21);  fully vaccinated  Discharge Provider: DO Primary Care Provider: None Physician, MD Admission Date: 9/20/2021 Discharge Date: Sep 21, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cholecystitis [K81.9] Epigastric pain [R10.13] Essential hypertension [I10] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) [A41.9] Acute cholecystitis [K81.0]   HOSPITAL COURSE: 56-year-old female presented with sepsis secondary to acute cholecystitis and possible choledocholithiasis.  Incidentally found was asymptomatic COVID-19 infection.  The patient was brought to the operating room where a laparoscopic cholecystectomy with intraoperative cholangiogram was obtained with failure to demonstrate choledocholithiasis.  She was admitted to the hospital postoperatively for additional resuscitation and monitoring.  She was tolerating a regular diet without difficulty having bowel function.  Positive urination.  Denies any shortness of breath or other respiratory symptoms.  No fevers or chills were noted.  She did have of worsening leukocytosis which is likely reactive due to surgery as she is asymptomatic with regards to other sources.  She was deemed stable for discharge with close follow-up with laboratory values and strict return to the emergency department instructions. CONSULTS / RECOMMENDATION: Case was discussed with Dr. of Internal Medicine given the asymptomatic COVID 19 infection.  He recommended close follow-up as well as incentive spirometer use.  Patient was sent home with an incentive spirometer. INPATIENT PROCEDURES: Laparoscopic cholecystectomy with IOC.
I began to have migraines approximately two weeks following my second Moderna dose.  The headaches reoccured every other day for about two months and gradually subsided.  My last migraine occured the following September and I have not had one since.  I reported this to our center and was told that there is no possibility that the injection could have caused this reaction.  I have since spoken with many people who have had the same experience.  The doctor that I mentioned is someone that I work with who I spoke with regarding this issue.
This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unkonwn). The healthcare worker reported that doses of GARDASIL (Lot # not provided) which were exposed to an unsupported temperature excursion on 08-DEC-2014, had been administered to the unspecified patients on unspecified dates since 08-DEC-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 93 year old female patient with no drug reaction and allergies and with no medical history. On 26-OCT-2013, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot number: J006828, expiration date 14-SEP-2014) for shingles prevention. Concomitant therapies included losartan potassium (manufacturer unknown), NASONEX, SINGULAIR, PLAVIX and LONOX. The patient who received a dose of ZOSTAVAX on 26-OCT-2013 in the morning, developed rash on her back later that evening. No lab diagnostic studies were performed. There was no treatment given for the rash on her back. The patient spoke to pharmacist (reported as patient seek medical attention). No intervention to prevent serious criteria was taken, no PQC was involved. The outcome of rash on her back was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and rash on her back was not reported. Additional information has been requested.
reported left facial pain and numbness from the ear to her mouth; reported left facial pain and numbness from the ear to her mouth; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient might have a possible reaction to the Pfizer COVID-19 vaccine. After receiving the first dose of the vaccine, patient reported left facial pain and numbness from the ear to her mouth on an unspecified date. Caller wanted to know if she should receive the second dose of the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
I was diagnosed with Lyme disease 10 years ago. About 3-4 days after receiving the vaccine I had sharp joint pain in my shoulders, wrists, and a stiff neck. I was unable to turn my head. I had swollen cervical lymph nodes. Both of my knees, hips, ankles and feet also had severe joint pain. I had a headache, and ocular migraines, and balance problems. My sense of smell was also heightened. I felt the sensation of bugs crawling on my skin, fatigued, and I felt depressed and anxious. I also had visual disturbances, and brain fog. I had experienced these symptoms before so I knew that it was my Lyme disease flaring up. I saw my primary care doctor a total of three times after having these symptoms. I was put on eleven different medications. I am still experiencing foggy brain, and sensation of bugs crawling on my skin.
Patient reports mouth sores,  bleeding gums, and nose bleeds the day following the vaccine (also started Accutane the day prior to the vaccine).
Beginning at 1311 Client received Pfizer Covid-19 vaccine.  Client noticed a small hive located on left cheek when she got to her car.1343 client brought into building by RN. RN notified coordinator. 1344 Instructed to administer 50mg of Benadryl IM. RN also noted a small red hive on abdomen and 2 red hives on lower back. No respiratory distress noted. Client denied difficulty in breathing. 1352, BP 128/63, HR 88, Sp02 97% RA. 1400 Benadryl 1mL/50mg administered. Lot # 080012 exp 08/2022. 1405 Small nickel sized redness located on left cheek- no raised only 1 small patch of redness located on back- no longer raised. 1420 on face very small light red patch- dime sized. Nothing noted on back or abdomen. 1430 small circular red area approx. 1/2 dime size located on L cheek, nothing on back or abdomen. 1432 client denies shortness of breath or difficulty in breathing. states she has no additional questions or concerns. client instructed to contact PCP. 1433 RN walked client to car. Clients husband met client at car. Stated he would follow her home. 1600- this RN called client- states is feeling "fine." Denies shortness of breath or any breathing difficulties. Denies increase in rash or hives. Denies being "itchy." Client will follow up with PCP.
Pt states inflammation in left arm after administration of flu shot. MD advised pt immunization administered high in bursa sac of left arm. Being treated with cortisone cream for 3 months.
Initial shot pain followed with arm pain and shoulder pain. Stiffness in movement. Started with jab in May.
PATIENT WAS GIVEN AN EXPIRED DOSE PER SPARROW POLICY. AFTER SPEAKING WITH PFIZER, THE DOSE HAD A 15 DAY GRACE PERIOD SO WAS STILL WITHIN THE TIME FRAME OF BEING GIVEN AND DOESN'T HAVE TO GET ANOTHER BOOSTER DOSE.   PATIENT WAS CALLED AND INFORMED BY DR. ABOUT THE SITUATION THAT OCCURRED AND MADE SURE NO OTHER QUESTIONS WERE HAD BY THE PATIENT.
1/10/18 vaccinated and next day with swelling seen in ED 1/11/18 Dx cellulitis Tx KEFLEX and Hydrocodone on 1/12/18 with swollen tender erythema.
ulnar neuropathy; Nerve and muscle problem in my right hand; My lively hood depend on my hand. I am a pianist; This is a spontaneous report received from a contactable consumer, the patient. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. On an unspecified date, the patient experienced nerve and muscle problem in right hand, ulnar neuropathy and he reported that lively hood depend on my hand. i am a pianist. Consumer stated, I have absolute muscle problem and I am a pianist. I went to the regular doctor so; I don't have the exact diagnosis yet but its looks like the ulnar neuropathy. When paraphrased the above concern, consumer sated, It's not muscle, its nerve and muscle problem in my right hand after the first shot. My doctor said it's most likely ulnar neuropathy (Consumer was unsure hence not captured as event) after the vaccine. Consumer stated, I do require a medical assistance because my lively hood depend on my hand. I am a pianist. The outcome of events was unknown.
Red blotchy rash near the injection site approximately 2" x 2". Some itching. Faded and resolved itself in approximately two days. (See image next page)
1830 hours after injection of Tdap, joints hurt and increased temp.  Took Excedrin.  Next Am called back to say temp still elevated 104 degree.  1830 next day spoke with family physician, advised to go to ER.  Blood work, cultures nasal swab done.  All negative advised to report incidence to Health Dept as reaction to vaccination. Temp broke 3/6/08 in evening.  NKDA reported.
Fever of 101.5 degrees fahrenheit; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever of 101.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature as 101.5 Fahrenheit on an unknown date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient up to date on COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Pt is a 78 YO female with a PMHx of COPD, CAD, and HTN who presented with shortness of breath and lightheadedness. Pt was found to have sepsis and acute on chronic hypoxic respiratory failure likely multifactorial in the setting of possible COVID PNA vs bacterial PNA vs COPD exacerbation. Pt was started on Decadron, Remdesivir, Ceftriaxone, and Doxycycline on top of her home inhalers (replaced with what is available at the hospital). Pt initially required HFNC, but was able to be weaned off to 3L NC. Pt was asked about the possibility of skilled nursing rehab, but declined and stated that she has good social support at home. Pt discharged to home in stable condition with 1 day of Cefdinir, doxycycline, and Decadron to finish 5-day course of antibiotics and steroid"
Felt dizzy, disoriented, was dropping things on floor, behavioral changes, felt really weird. 4 hours later fever started, chills, muscle aches, flu-like symptoms, severely nauseated, felt like if had taken mind altering drugs. Shingles by 29th spread to back, increased Zanvir dose, severely nauseated after vax, like auto immune system crashed. Severe headaches, very intense, still having them, would wake up at night, took medication. Went to see endocrinologist on 01/11/05 since had been feeling so poorly and BP was still high, TSH levels at 111 (back on 11/23/04 normal levels), they were back to normal on 1/24 when saw doctor again. Nausea started to subside by 1/20/2005 and today felt only fatigued. Visited massage therapist because LA felt numb and tingling and nurse mentioned it was a pinched nerve. Since Vax on 12/27 rapid heart rate and would wake up at night with nightmares, subside by 1/27/05. No fever on 12/27; thus received other vax. Outbreak of shingles around waist, doctor visit on 12/20/04 prescribed Zanvir (1000mg). Nausea after vax, fever, fever also caused auto immune system to weaken.
This is a spontaneous case, initially received on 16-Oct-2018, reported by other health professional (pharmacist), concerning an 80-year-old, elderly, male patient. The patient's medical history was not available at the time of the report. The patient had a prior history of medicine squirting back out of his arm after vaccination. The patient didn't receive any concomitant medications. On 15-Oct-2018, the patient was administered FLUAD TIV (dose: reported as 5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019). The vaccine squirted out of his arm after vaccination (explicitly coded as injection site extravasation) and hence partial dose was administered (explicitly coded as underdose). It was reported that, the patient would be revaccinated. At the time of the report, the outcome of the event injection site extravasation was not reported. The reporter assessed the case as non-serious.
Headache; body aches; "fevers"; fatigue and very tired; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203) via an unspecified route of administration in the right arm on 07Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:00 the patient experienced headache, body aches, fevers, fatigue and felt very tired. The events resulted in emergency room/department visit or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, body aches, fevers, fatigue and very tired were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 66 year old female patient with asthma and sulfur allergy (reaction unknown). On 13-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number was reported as J001009; expired date 24-APR-2014) in the left arm. Concomitant therapies included alendronate sodium/ cholecalciferol tablets 70 mg/once daily, QVAR nasal spray twice daily and NASONEZ 50 mcg/twice daily. On 13-JUN-2013 the patient experienced had a fever of 103 degrees Fahrenheit and experienced weakness, dizziness and headache after receiving ZOSTAVAX. The next day she still felt weak and had a headache but the other symptoms had subsided. The patient was also using NASONEX at the time of the adverse event. There was no laboratory diagnostics studies performed. The outcome of dizziness and had a fever of 103 degrees fahrenheit was reported as recovering/resolving. The outcome of weakness and headache was reported as not recovered/not resolved. The action taken was not provided. The patient had spoken with doctor for medical attention. Additional information has been requested.
mmrv given 2 days ago to rlt. moc noted redness and swollen. pt seen in appointment today. Dr. assessment noted rt lateral thigh with errythematous edematous area 1.5 x 20 cm nontender to palpation.
I tested positive.; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "absence seizures" (unspecified if ongoing); "essential tremor" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LAMOTRIGINE; PROPRANOLOL. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", described as "I tested positive"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "not recovered", described as "I tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: indication: Treatment of COVID-19; Negative, notes: Tested negative on Tuesday; positive, notes: The next Sunday my throat hurt again, I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid for the reported condition.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt reported redness, itching, swelling, and area hot to the touch that lasted about 2 weeks before slowly subsiding
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 28-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 28-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Mon- GARDASIL #3 & HepA #2 shots. Tues- Itching, soreness, ibuprofen 2/200mg, didn't help. Wed- Burning-whole body ached, ibuprofen didn't help. Thurs- Burning, muscle aches, exhausted, will increase to 600mg ibuprofen.
My left eye started drooping to the point where I could not see out of my left eye anymore. It was hard to eat and drink or do anything without assistance. My autoimmune disease targets my motor skills and muscles system. The pain associated with the disease is throughout my body and to the point where I can't even eat or drink without taking my medicine. I went to urgent care on July 3rd and I had to get a blood panel to check for anything out of the ordinary. I didn't get the results back until August 24th confirming that I do have an auto immune disease. No one in my family has any form of an auto immune disease and this occurred after receiving my 2nd dose of the vaccine. Missing work every 3 months to get infusions for the disaese.
Patient described swelling and itching at injection site. Also stated "tightness" up the left arm up into the neck. Patient went to a doctor where she worked and received BENADRYL.
Patient endorses hx of vasovagal reactions with vaccines, patient reports slight lightheadedness 1-2 mins after injection, patient denies syncopal episode and reports feeling better during the ?observation? window.  12/19: upon awakening, noticed redness and swelling to injection site.  12/20:  Patient reports improvement of redness and swelling at injection site.  12/21:  Patient endorses at time of wakening red rash (blancheable per patient), mildy pruritic to L side of chest wall.  When patient called (at approx. 10:35 am), reports rash has now become ?generalized.?  Patient denies changes in hygiene products.