chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received flu shot on 9/5/18, then came into the pharmacy on 9/8/18 to report that his blood sugar yesterday morning (9/7/18) had been in the 200s and said that it has never been that high. He admitted to eating poorly the night before, but associated the blood sugar spike to be a side effect from the flu shot he received because he insisted that he has eaten poorly before without such a high blood sugar level. He reported that his blood sugar level this morning (9/8/18) was normalized (106), but said he still had a bit of a headache which he also associated with the flu shot he received. He just wanted to let us know about these potential side effects,
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient was vaccinated with the first dose of GARDASIL (lot # reported as 0636AA; expiry date: 11-AUG-2013) on 14-JUN-2012, the second dose (lot # reported as 0636AA; expiry date: 11-AUG-2013) on 12-JUL-2012 and the third dose (lot # reported as 1745AA; expiry date: 13-SEP-2014) on 17-DEC-2012. The patient is not experiencing any known symptoms. Additional information has been requested.
This spontaneous report as received from a physician refers to a 5 year old patient (gender was unknown). On 04-AUG-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dosage, route and lot# not reported), right after being administered VARIVAX (dosage, route and lot# not reported) on the same day. No adverse effects reported. The outcome of event was unknown. No Product Quality Complaint (PQC) filed. Additional information has been requested.
Shingles again/Suspected vaccination failure; Shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received the 2nd dose of Shingrix in mid-January 2022 and on 19th March 2022 got Shingles again. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Spoke with this patient's grandmother, who was caring for the child at the time of the event who stated that, after taking approximately a 5 hour nap after immunizations, upon awakening the patient turned very pale, became limp, unresponsive to shaking, and her eyes were rolled back. No respiratory distress noted. The episode lasted 10 - 15 minutes. The EMS was called, upon arrival examined her and stated she was okay. Assessment was she was hypotonic, hyporesponsive reaction to DTaP.
Admission Date: 5/8/2023 Discharge Date: May 11, 2023  PRESENTING PROBLEM: Shortness of breath  Hypoxia COVID-19  HOSPITAL COURSE:   75-year-old female with past medical history significant for rheumatoid arthritis (on Rituxan), type 2 diabetes, CKD stage IIIB, hypertension, lymphedema.  She presented to emergency department on 05/08 with several days of fatigue, poor appetite, altered mental status and dyspnea.  Patient also had a fever.  On arrival to hospital patient was found to be hypoxic to 86% requiring administration of nasal cannula.  Labs were notable for leukopenia, mild BUN elevation and creatinine elevation 1.78.  Viral panel was positive for COVID-19.  Chest x-ray was reviewed, showed hyperinflation but otherwise negative for an acute cardiopulmonary process.  Blood cultures were obtained.  She was given dose of Rocephin, DuoNeb and fluids and admitted to Medicine Service for further assessment and management.   For patient's acute hypoxic respiratory failure in setting of COVID-19 pneumonia, she was started on remdesivir and Decadron.  Rocephin was not continued as there was no evidence of community-acquired pneumonia clinically.  Patient's oxygen requirements improved and was able to wean off to room air after several days.  Patient's fatigue was also improving and her mental status returned to baseline.  Physical therapy recommended subacute rehab however patient refused this.  Elected to return home with home healthcare services.   Of note patient was also seen by infectious disease and wound care in the hospital for diabetic ulcer of toe of left foot.  Patient's ulcer was treated with Betadine and dressing changes.  Patient and family have been educated on management of diabetic ulcer of the toe at home.  She was treated with cefazolin for mild cellulitis to left lower extremity completing a 7 day course with Keflex at the time of discharge.   Patient's blood glucose was slightly elevated in the hospital stay, this is secondary to Decadron.  Insulin was slightly increased but will return to prior home dose of long-acting insulin.  Victoza will be resumed at that time as well.  Once Decadron course is completed expect that her blood glucose levels should normalize.   Patient is being discharged home in stable improved condition with home healthcare services.  She should follow up with primary care physician within 1-2 weeks to monitor blood sugar, blood was (BMP, complete blood count).
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
I had sore throat and running nose.  Then, I my blood pressure was really high.  Then, I had no energy and very weak.  I had a lot of mucus and congestive.  I had body aches as well.  I was also coughing and sneezing.  These symptoms are still ongoing since Dec 28th, so about 3 weeks now.  On Dec 30th, I was tested positive for Covid-19.  I went on Jan 12th for another Covid-19 test, negative results for that one.  I do have an appointment on Jan 21th, to see my doctor about this.
First, I am an RN for over 30 years. I had my original 2 Moderna vaccines in 2020. I had my first booster in December 2021. I then had this Booster shot of Moderna November 2022. The night or into the early morning hours after injection, I was awakened with the worst pain in both hands. Throbbing arthritic type of pain. Crippling pain. Never had this pain in my life. I also had terrible pain in my right thigh muscle. I had not done any type of exercise or activity to have caused this. This pain woke me up and I had to just rub my hands. I had to get up at 5am and jump in shower and allow very hot water to run on my hands and thigh. It went from a pain level of 10 to a pain level of maybe 4. I also was drenched in sweat. No fever when I took my temperature but did have some chills. I never have woken up drenched in sweat, even with menopause. I returned to bed bit couldn't sleep. At 9am, I took another hot shower allowing the water to run on my painful hands and thigh. I can only correlate this episode as being related to the vaccine. As an RN, I have thought of other things these issues could be caused by but realize, it had to be from the vaccine. Believe this or not. I know it was from the vaccine. I took some Motrin. Next day around 3pm, the pain in my hands and thigh just vanished. Vaccine related? Of course it was. This should at least be listed as a possible side effect.
Information has been received on 11/28/01 from a registered nurse concerning a 22 month old female with no past medical historu and NKDA who "sometime after turning 1 year old" was vaccinated with a dose of varicella virus vaccine live (site unknown) "in Switzerland". There was no known illness at the time of vaccination. Subsequently, the pt developed a rash on 11/25/01. On 11/28/01, the pt was seen in the doctor's office with "a rash over body". The pt's parents also reported to the nurse that the pt had also been "very fussy". The pt sought unspecified medical attention.
Pt. felt dizzy, given water and saltine crackers and resolved after 5 minutes. 22 weeks pregnancy.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Fainted within 5 sec of receiving immunization, unconscious for less than 1 min.
Chills; Fatigue; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No concomitant medication was reported. No treatment history was reported.
second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included DIMETHYL FUMARATE (TECFIDERA) for Multiple sclerosis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Second dose in the series appointment was cancelled, rescheduled appointment is 60 days later after initial dose. No treatment information was reported.
Expired dose of Moderna administered on 02/08/2022. Expiration date of 02/02/2022. No treatment given. Pt reports sore arm at time  of notification of incident.
The day after the vaccine: fairly intense /severe aches & chills for ~24 hours  The 2nd day after the vaccine:  short-duration moderate headache in the morning
body aches, joint pain lasting ~6 hours; left armpit pain that has lasted 10 hours so far
Widespread >50 papules/macules, vesicles. Dx: varicella Tx: acyclovir, atarax
Pfizer on 1/4 and 1/26.  Positive on 8/7 8-6/8-16 admitted
Patient experiened pain described as needles in the right side and progressively got worse.  Patient saw doctor on 10-15-09 in the morning to diagnose the symptoms.  Physician diagnosed patient with shingles.
Patient is 33 y/o male. He was given a high dose flu shot versus quadrivalent flu shot.
started feeling achy around 1 am He is having fatigue and shortness of breath also.
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature.  They has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule
Day after immunizations pateint complained of leg pain, has a large red bump. Saw provider today, looks like a hive, pt has a fever since last night, 101?.
3-4" circle of swelling, redness and warmth beginning about 6 hours after vaccine.  Still present 30 hours after vaccination.
Acted anxious, whiny and aggressive after both doses of H1N1 shots 11/13/09 and 12/14/09. Ran fever after 1st vaccine for 48 hours.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.21 years. Concomitant products were not provided. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. On 06-Apr-2021, the vaccine with batch number 044B21A was moved to fridge. On 16-Apr-2021, 9 vials were moved to the clinic. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.Temperature recordings were taken using a traceable temperature monitor at every hour.It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Redness and itching on my right arm - appeared at the injection site 8 days after injection.  Referred to as COVID Arm on the internet.
Chronic UTI. UTI symptoms started on 1/24/21. I have been on five courses of antibiotics; Keflex, Cipro, Bactrim, MacroBid and a second round of Cipro. Symptoms of infection are persisting today 5/26/21. I have had full pelvic ultrasound, been to physical therapy for pelvic floor exercises. I will visit a Urologist today for further treatment of this persistent infection.
Vaccine dilution error.  The Pfizer vaccine was diluted with 1.5ml of the diluent NaCl 0.9% instead of the recommended 1.8ml.  The 0.3ml dose was given with this slightly higher concentration of vaccine.
Patient presented with 1 day of progressive bilateral painless visual loss. His vision was 20/20 which changed to 20/400. Over the next several days, his vision started to improve.
The syringe was larger and looked full. It took a long time for medication to go into the arm due to the amount of liquid injected into the muscle.  Right away the full left arm and breast were painful.  The arm pain continued to get worse and felt like she hit her funny bone but more extreme and this pain lasted all night into the next day.  She was unable to sleep due to the full arm pain.  The significant pain in the breast area lasted all day into the next day too. Also, felt chills and body aches starting that evening into the next day and night. We did not know the dose was only supposed to be 0.5 ml at the time of injection. We suspect she received at least 5 ml instead of the recommended 0.5ml.The name of the nurse that administered the vaccine is written on the vaccine card but not sure of spelling. RN?
This is a spontaneous report from the non-clinical study program "IBCC (Inbound Call Center for HCP's). A contactacble pharmacist reported that a male patient had a reaction with PREVNAR13 last year and want to know if he would get the same reaction with PREVNAR13. Pharmacist stated the patient had a four days of 104 Fahrenheit fever and swelling on injection site.
Hot also Redness and swelling on arm of injection and hot also all the way down to her elbow. Told by MD to ice it and take Tylenol Benadryl, and Aleve 2-3 days for it to go away.
About 12 hours after receiving second dose of COVID-19 Vaccine I began feeling nauseous and I vomited twice. Within 36 hours I was feeling better, but on day 3 post-vaccine I experienced more nausea and vomited daily for about 9 days. I saw multiple healthcare providers and no clear answer was determined. On day 5 post-vaccine I started taking a PPI treatment (Omeprazole).  On day 11 post-vaccine the vomiting stopped.  4/12/21 - vaccine administered 4/12/21 - first symptoms 4/14/21 - symptoms seem to be gone 4/15/21 - symptoms return 4/23/21 - last date of symptoms
Headache one hour after injection. Given acetaminophen and released. Later during day-evening-had medicinal taste in mouth and projectile vomiting. Then no other symptoms.
PATIENT REFERS FACE SWELLING, UPPER AND LOWER EXTREMETIES TINGLING. WAS TAKEN TO THE ER. WAS GIVEN BENADRYL AND SOLUMEDROL.
Lichens planus  Corticosteroid injection (extended release), corticosteroid topical (patient discontinued, due to lack of effectiveness), antihistamines oral and topical (tried before seeking medical help)  Itchy rash starting on back then progressing to top of thighs (welts), then arms, now neck going up back of scalp.  When rash progressed to involved all body parts as described, patient sought medical care with dermatologist
Mild diarrhea 24 hrs after injection; Left arm shoulder/rotor cuff extreme pain; Swollen lymph nodes in neck 3 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021 at 16:30 (at the age of 61-year-old), as dose 1, single in right arm for COVID-19 immunization at Public health department. The patient's medical history included allergies to hornet venom and molds. Patient's past drugs included prednisone, xarelto, levofloxacin and lanolin; and experienced allergies. Concomitant medication within 2 weeks of vaccination included Balloon, tramadol, acetaminophen, vitamin B-12 (CYANOCOBALAMIN); all taken for unspecified indications, start and stop dates were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 04:30, 12 hours after vaccine, the patient experienced left arm shoulder/rotor cuff extreme pain. This was opposite to the injection arm. On 25Feb2021 at 16:30, 24 hrs after vaccination, the patient experienced mild diarrhea. On 24Feb2021 at 19:30, 3 hours after vaccination, the patient experienced swollen lymph nodes in neck. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with Nabumetone 500mg for inflammation and Tramadol 50mg. It was reported as unknown if patient had COVID prior vaccination and patient was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Day 6 post second injection developed raised rash with itching, swelling, tenderness & warmth.
Extreme muscle pain joint pain skin pain freezing shivering my hot water was even freezing to me was very hard to walk or even move couldn't get myself to the ER. 10/08/2015 body still hurts but not so severe I can walk however still hurts.
Patient was administered Moderna Bivalent booster dose as a primary administration. He had not received any primary doses prior to this vaccination. Patient waited 15 minutes after administration without any adverse reaction. We contacted patient an hour later and still denied any adverse reaction. Instructed patient to call clinic with any question or concerns.