chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 32 F for 48 hours (lowest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Arm was very sore; Muscle ache throughout my body; Headache; Sore throat; Swelling mouth; ulcer on tongue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 09:30 (at 39 years old, not pregnant) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient used nickel on an unspecified date. First dose received Saturday 24Apr2021 on left arm, next day (all events also reported started 28Apr2021) arm was very sore and muscle ache throughout my body and headache. Couple days later sore throat and swelling mouth and ulcer on tongue. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event wasUrgent care and Rx. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, nasal swab on 29Apr2021, negative results, nasal swab on 01May2021, unknown results. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2 year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in right thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA010889:
Flu shot given too high in arm. Patient complaining of tightness and soreness in arm.
This spontaneous medically confirmed report (initial receipt: 13-Oct-2015) concerns a 4.5 year old patient. On the 03-Oct-2015, the patient who was under five years of age received AFLURIA (batch number not reported) 0.5 mL annually via intramuscular route. The outcome was not reported. Follow-up (21-Oct-2015): It was reported that a 4.5 year old patient (weight: 34 lb, height: 3.35 inches), received AFLURIA (batch number: U56907). There was no adverse effect. Reporter's comments: The case was classified as off-label use.
First developed headache and fatigue in the morning, which evolved into eyelid swelling on 11/24 afternoon as well as eye pain and photophobia. Pt then developed swelling of face on 11/24 diagnosed as angioedema.  The angioedema lasted from 11/24 to 12/9. During this time he took intermittent Benadryl which was temporarily beneficial. On 12/8 he was tx with Singulair and Zyrtec with full resolution on 12/9 of symptoms.  He also experienced facial paresthesias from 11/27 to 12/10 and an episode of SOB on 11/28.
This spontaneous report as received from a licenseed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigeration malfunction, GARDASIL was exposed to -2F for one month; this includes more than two cycles into and back out of the temperature range of below 0F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of influenza in a 9-year-old female patient who received Influenza vaccine unspecified. On an unknown date, the patient received Influenza vaccine unspecified. In February 2015, an unknown time after receiving Influenza vaccine unspecified, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to Influenza vaccine unspecified. Additional information was provided: No other events were noted or reported.
had to get injections for pain in both of his knees; patient has no use of his hands; has numbness in his hands; This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced knee pain, mobility decreased and numbness in hand. The patient was treated with medication unknown (Knee Injection (Medication Unknown)). On an unknown date, the outcome of the knee pain, mobility decreased and numbness in hand were unknown.   It was unknown if the reporter considered the knee pain, mobility decreased and numbness in hand to be related to Shingrix.  Additional details provided as follow: The reporter was patient's sister in law. The age at vaccination was not reported. The patient was administered with both doses of Shingrix and sometime after the vaccination, the patient had to get injections for pain in both of his knees. The reporter stated that the patient had numbness in his hands, and he had no use of his hands. Healthcare professional's information was not provided. The reporter consented to follow-up.  This case had been linked with US2021060556, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060556:same reporter
I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have vaginal bleeding; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included birth control. Unspecified concomitant medication was reported. On 03Oct2021, the patient had vaginal bleeding, she was not due to start my cycle for another 2 weeks as she just got off 2 weeks ago. The patient had mild bleeding and blood clots and cramps. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left lower leg below the knee became extremely red and swollen with hives which lasted 30 minutes.  No other symptoms noted.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that when she was getting SHINGRIX, the pharmacist who was administering the vaccine commented that her husband (the pharmacist's husband) complained about his arm hurting after the vaccination. No other information was provided. Clarification has been raised for the confirmation of the patient involved with same reporter.
Redness and swelling in a 1 1/2 in diameter around the injection; Redness and swelling in a 1 1/2 in diameter around the injection; Soreness lasting til 48 hours afterinjection; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC), paracetamol (TYLENOL), naproxen sodium (ALEVE) all for unspecified indications from on unknown date. The patient had known allergies to tetracycline, amoxicillin and zithromax. 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 09Apr2021 at 12:00 the patient experienced redness and swelling in a 1 1/2 in diameter around the injection with soreness which lasted till 48 hours after injection. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome the events redness and swelling in a 1 1/2 in diameter around the injection and soreness were recovered on 11April2021.   No follow-up attempts are needed. No further information is expected.
Red flat rash, with calor, lateral aspect of the R deltoid, bicep, which was associated with low grade fever. The fever resolved in 1 day. Rash remained with generalized swelling and calor, 3 days.
minor experience I had. It was a very brief and short lived. My minor events could have been due to other environmental factors.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (minor experience I had. It was a very brief and short lived. My minor events could have been due to other environmental factors.) in a patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (minor experience I had. It was a very brief and short lived. My minor events could have been due to other environmental factors.). At the time of the report, VACCINATION COMPLICATION (minor experience I had. It was a very brief and short lived. My minor events could have been due to other environmental factors.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Throat felt like I swallowed a marble, felt a bit tight, but not so tight that I could not breath, and got sore.  Had a cough impulse.  Had a headache.  Injection site  on arm was quite sore.  Stomach felt upset.  Called pharmacy. They said the symptoms did not fit any known profile.  Said to talk with my doctor if I felt the need.  Doctor on duty told me to go to urgent care.  Did so.  Vital signs normal. PA gave me benedryl and a steroid shot.  I went home and immediately threw up.  Took one benedryl pill (25 mg) after waiting a couple of hours. Went to bed.  Today still have a headsche.  Throat is ok.  Feel tired.  Arm is back to normal. They told me before I left to go to the ER if I got worse.   ormal
Discharge Provider:  Primary Care Provider: MD Admission Date: 8/24/2022 Discharge Date: Aug 28, 2022  PRESENTING PROBLEM: DKA, type 1, not at goal (HCC) [E10.10] Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus (HCC) [E10.10] COVID [U07.1]   HOSPITAL COURSE: 43 y.o. female with h/o brittle type 1 IDDM with neuropathy, prior DKA, prior diabetic foot wounds resulting in bilateral BKA, HLD, depression, anxiety, chronic pain and remote seizure disorder, who admitted to the Butterworth ER on 8/24 with c/o 2-day h/o generalized abdominal discomfort with nausea and vomiting.nShe presented to an urgent care center earlier in the day and was found to be COVID positive.  Additionally, she was found to be hypotensive and markedly hyperglycemia, prompting referral to the ER. In ED, found to be in DKA, likely 2/2 COVID infection, as patient endorses compliance with her diabetic regimen. She started on Endotool. Regarding her COVID, patient was not in respiratory distress and saturating well on room air, symptomatic supportive treatment only with improvement in symptoms. Endocrinology consulted. Patient transitioned off Endotool 8/26 to subq insulin, tolerating diet, and medically stable for discharge 8/28
Around 8 pm I became super itchy all over my legs broke out in a hives like rash I felt like my legs were on fire I wanted to cut them off I went to urgent care several days later after trying Benadryl and was put on a steroid dose pack which helped until the last 2 days of the medication then the itching spread to my abdomen, back, arms and chest I have bumps that burn all over my body and I have to take steroids to help I've put on weight and I'm trying to stop the steroids but here I am 2 months later with this reaction still I'm severely upset!!!!!
I had Shingle vaccine yesterday afternoon(8/30/3022), had low fever last night, the temperature was 99.5 this morning. My blood pressure was 73/112  heart rate: 100 at noon, lower than my usual 80+/120+. Around 6:30pm after dinner, my blood pressure dropped to 43/77,  I felt dizzy,  I went to bathroom and dropped to floor and fainted for a couple of minutes.  I was awake after a few minutes, and my blood went back to 75/106.    I am healthy and never had low blood pressure or faint before. I monitor my blood pressure because I  sometimes had blood pressure higher than 80/130 and wanted to document it to show to my doctor on my next appointment.
Fever-100 Malaise/extreme fatigue  11:30pm  11/15/21-9:30pm 11/16/21.  Muscle and joint pain same dates as fatigue  Bedridden and asleep 9:00pm  11/15/21 to 8:00pm  11/16/21 yes 23 hours.  Extreme pain at injection site
Patient received 2 bivalent booster vaccines. Pt parents were informed, his physician was informed.
18 hours after dose, chills, low-grade fever, joint pain, arm soreness laying about 18 hours Treatment-Advil every 6 hours
This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 6, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On Feb 6, 2021, second dose was administered to his shoulder bursa instead of deltoid muscle. On an unspecified date in 2021, he had shoulder pain. At the time of report, his shoulder was still very painful. He already consulted to an orthopedic doctor and prescribed with steroid injection and oxycodone. The outcome of shoulder pain: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Within first 24 hours of second dose of vaccine, had the expected fatigue, muscle aches and headache. ~24 hours from second dose, developed rash on chest, neck and right side of face. Felt hot and burning/prickly, not itchy. Also had 4" diameter red swollen arm at injection site. ~36 hours from dose had rapid heart beat, shortness of breath and dizziness. Went to local urgent care, where they identified frequent premature ventricular contractions on EKG and referred me to the local ER. They confirmed diagnosis and rehydrated me, releasing me several hours later with a referral for follow up with a cardiologist. Since then, I have been fully worked up by my primary care physician and the cardiologist who identified the PVCs continuing to exist. This was not a pre-existing condition.
Pain in (R) upper arm, pain with any movement of shoulder or elbow. No signs of infection; no significant swelling, erythema or induration. No specific treatment prescribed. Pt. reassured and told to follow-up if symptoms don't resolve next wk.
about 8 hours after getting the injection she developed a headache, her vision gets blurry then feels dizzy. At times per her fitness watch her heart rate goes up to 120 and normal is the 60's for her. She has fatigue and reports feeling like jello inside. She reports a feeling like she had a fever the night she got the vaccine
This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 18 hrs after receiving SHINGRIX, the patient experienced pruritus, localized erythema and blister. On an unknown date, the outcome of the pruritus, localized erythema and blister were not recovered/not resolved. The reporter considered the pruritus to be related to SHINGRIX. It was unknown if the reporter considered the localized erythema and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband along with the patient herself. At 14:00, the patient received SHINGRIX. On the day of reporting i.e. 19th October 2018, the patient noticed itching behind her neck, blister behind her neck, blister popped and release a fluid. There was redness where the blister was located. This case has been linked with US2018190928 (husband's case), reported by the same reporter. The contact details of the physician were updated.
Double vision about 25 minutes after treatment. Driving home and had to pull off side if road. Lasted 2 to 3 minutes.  Continued then on to home.
This spontaneous report as received from a registered nurse and refers to a 72-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (intramuscularly, lot # L040178 with expiration date 18-AUG-2017; dose was not reported). The vaccine was exposed to the temperature between 8 and 25 degrees Celsius for 26 hours. Previous temperature excursions included the temperature between 8 and 25 degrees Celsius for 14 hours 10 minutes and the temperature between 0 and 2 degrees Celsius for 24 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. No additional information is available. Additional information is not expected as all scheduled correspondence has been received. Sender's Comments: US-009507513-1701USA014175: US-009507513-1703USA012481.
dizziness; stomach hurts not consistent but comes and goes and when it comes it hurts; feeling weak; muscle achness; joint pain; chills; Headache; started feeling sick; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts) and ASTHENIA (feeling weak) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts), ASTHENIA (feeling weak), MYALGIA (muscle achness), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (started feeling sick), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizziness), ABDOMINAL PAIN UPPER (stomach hurts not consistent but comes and goes and when it comes it hurts), ASTHENIA (feeling weak), MYALGIA (muscle achness), ARTHRALGIA (joint pain), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided
1 1/2 hours after shot - red, hot, swollen area that grew to 4 inches diameter, 1 inch in height. Fever and chills for 24 hours. Entire arm with swelling and tenderness next day, extending to shoulder/neck. Slowly subsided over 6 days with use of cool compresses, BENADRYL and ibuprofen.
2 days later -arm soreness occurred. 5 days after injection: nausea, vomiting, diarrhea, and dehydration. Body aches and joints hurting 5 days later.