chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & exp abdo cramps; next day had nasal congestion, cough & a rash on face & chest described as whelps by pt's mom; 27AUG93 pt taken to ER & was found to have diffuse sandpaper erythematous rash, pharyngitis shotty cervical nodes
Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022; Vaccine was administered to the patient after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 225.6. No concomitant medications were reported. It was reported that, the pharmacy has sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date. The vials did not undergo any temperature excursions. No adverse event reported by the patient. No treatment medications were reported.
lost her voice; feeling bad; bad headaches; weakness; pain in the ribs and stomach; pain in the ribs and stomach; chills; diarrhea for 3 days; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "unknown", described as "feeling bad"; HEADACHE (non-serious) with onset 25Mar2021, outcome "unknown", described as "bad headaches"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "weakness"; MUSCULOSKELETAL CHEST PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "pain in the ribs and stomach"; CHILLS (non-serious) with onset 25Mar2021, outcome "unknown", described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (28Mar2021), described as "diarrhea for 3 days"; OROPHARYNGEAL PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "sore throat"; APHONIA (non-serious) with onset 27Mar2021, outcome "unknown", described as "lost her voice". Additional information: The patient was wondering if it was normal to have these adverse events a week later after getting vaccinated. The patient was also concerned about her second dose because she will have her Stelara injection on the date of her 2nd dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One hour after vaccination, she experienced itchy throat, facial flushing, tongue swelling, respiratory distress, and abdominal pain and cramping.   Patient self-administered epinephrine injection 0.3 mg in the car on the way home.  Administered a second dose at home 45 minutes later.  Then went to Hospital ER. she was given injections of benadryl and phenergan.  observed and released.
Headache; General fatigue; I was sick for a day or two; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, VACCINATION COMPLICATION, HEADACHE, and FATIGUE in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACYCLOVIR, BABY ASPIRIN, and HYDRALAZINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ILLNESS and VACCINATION COMPLICATION. On an unknown date, the patient experienced HEADACHE and FATIGUE. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and TYLENOL for Adverse event, at an unspecified dose and frequency. In January 2021, VACCINATION COMPLICATION had resolved. At the time of the report, ILLNESS had resolved, HEADACHE, and FATIGUE outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-345824 (Patient Link).
Patient developed a bump/mass at site of injection on left arm. Arm had stayed sore from day of injection and lasted for several weeks. May need to be surgically removed.
coughing, choking, extreme fatigue, rash, blood in urine, symptoms still note resolved, in process of diagnosing autoimmune disorder, have seen Internal Medicine, Endocrinology, Dermatology,  ENT, Rheumatologist and family physician
Sharp stabbing facial pain, unilateral, felt trigeminal neuralgia. Developed approximately 3 weeks after ZOSTAVAX administration. 1 week after patient developed shingles-like rash in same area of face.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. "About a week ago" on approximately 26-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported). No other co-suspects were reported. No concomitant mediations were reported. The patient experienced injection site reaction "later the same day" the patient was administered ZOSTAVAX, which was "about a week ago" on approximately 26-JUL-2012. The injection site reaction was described as a red area at the injection site without pain or swelling (no reported rash). The patient sought for unspecified medical attention. At the time of this report the patient was recovering. Additional information is not expected.
The night of the second vaccine pt. began experiencing severe gastrointestinal distress that has continued to this day.
Next day, pt (volunteer), states she developed redness, swelling, itching, extending to elbow. Took 1 week to resolve. Did not come in to let us observe, but told us after the fact. no medical care sought.
patient states to me that he presented to ER on 7/6/2022 with paralysis issues.  They performed CT scan and other tests to rule out stroke and determined is was Bell's Palsy.
break of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On 19th July 2020, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a break of Shingles. The reporter consented to follow up.  The pharmacist did not had vaccine details on hand but agreed to follow up.
Husband had a cough at back of throat after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Husband had a cough at back of throat after Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    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 COUGH (Husband had a cough at back of throat after Moderna vaccine). At the time of the report, COUGH (Husband had a cough at back of throat after Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
joint swelling & pain in wrists, knees & shoulders approx 2-3 wks following vax administration; lasted 2 1/2 wks; reoccurred in 2-3 wks in same areas of body; for 11 months has come & gone;
experienced arm pain for about a week; 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 DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain for about a week after receiving Tdap vaccine of unknown manufacturer. The reporter did not consent to follow up. This case is 1 of the 4 cases, reported by same reporter.
Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Weakness-Mild
With in 10 mins: sharp pain & muscle cramping/spasms in right arm, then shooting pain head head on left side head... these two thing rotated off & on for hours.  Around 2 am(26th): extreme nausea, dizziness, full body aches, headache,  fever  Continued until 6am (March 27th), dizziness still there, fever, dizziness, and slight nausea. When eating: hard to digest solid food. Pain in stomach about 15 mins after eating.
20 minutes after receiving the vaccine, I had a severe headache with pain in ears, itching and swelling in my throat and increased heart rate.  I took 10 mg of  liquid cetirizine hcl oral solution which I carry with me.  I waited an additional 25 minutes at the facility and the itching and swelling and heart rate diminished.  I took 800 mg ibuprofen and 1000 mg Tylenol to treat the severe headache.  About 30 minutes after that, my headache was much better.  I went home and slept for 3 hours and felt almost normal thereafter.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:
FLUZONE vacc. given at 1500. Pt. felt reaction approx. 5 min after injection. Tingling and heat down Lt. arm with redness. Redness and tingling to Rt. side of face including lips. Pt. also complained it felt like her throat was swelling. Pt. had difficulty speaking.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration and the vials did not undergo any temperature excursions.  No concomitant drug information was provided.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple dates, the patients were vaccinated with improperly stored GARDASIL lot # K011562, expiry date 08-APR-2017 and K011325, expiry date 08-APR-2017, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a 74 year old female patient concerning on herself. Information regarding pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, approximately in 1980, reported as "about 30 years ago", "sometime between 1979 and 1981", the patient was concomitant vaccinated with a dose of PNEUMOVAX (dose, lot number, expiration date, route of administration and anatomical location were not reported) (she would had given a vaccine reported as "PNEUMOVAX 5" because PNEUMOVAX 23 did not come out until 1983) and an unspecified flu vaccine (dose, lot number, expiration date, route of administration and anatomical location were not reported). There were no concomitant therapies reported. On an unknown date, the patient had an unspecified reaction to one of the vaccines, she also stated that her lungs "collapsed" (pneumothorax) after she received both vaccines, but she could not determine which one caused the adverse events. On an unspecified date, the patient visited her physician for medical attention and received an unspecified treatment. The patient was inquiring as to whether PNEUMOVAX 30 year ago was a live virus vaccine. She also stated that her provided was recommending PNEUMOVAX 23 at the reporting time, and she was concerned as to whether she should receive it. At the reporting time, the patient had recovered from the events of pneumothorax and adverse reaction. The reporter did not assess the relatedness of the adverse event with the PNEUMOVAX. Additional information has been requested.
Right thigh experienced hot, tingling numbness, down leg to foot and up to thigh progression.  Seen by primary care physician 10/22/2009, treated with oral steroids and antiviral medication.  Follow up appointment with neurologist on 10/26/2009 with symptoms resolving.  Patient experienced total resolution of symptoms without residual effects.
Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 19:00 as dose 5 (booster), single (Lot number: GH49697) at the age of 84 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 02Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Essential tremor" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "IV Iodine allergy" (unspecified if ongoing); "Percocet allergy" (unspecified if ongoing). Concomitant medication(s) included: VIT B12, start date: 04Feb1995; PROPRANOLOL, start date: 21Jun2021; IRON, start date: 06Oct2021; ACCORD ANASTROZOLE, start date: 21Dec2021; AMLODIPINE, start date: 21Oct2022, stop date: 24Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 97.7; SARS-CoV-2 test: (30Mar2023) Positive, notes: day 6; (01Apr2023) Negative, notes: day 8; (03Apr2023) Positive, notes: day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti-viral details: Product COVID 19 Treatment, Brand: Pfizer, Treatment start date 24Mar2023, Treatment stop date 29Mar2023, Indication: Treatment of COVID-19. Other medication: Folic Acid (brand: Finest Nutrition) with start date 06Jan2023. Paxlovid last dose am 29Mar. No symptoms so far, temp 97.7 this am.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143143 same patient, different drug, different event;
42-year-old female presents with fatigue, scratchy throat but no fever.  She had her second COVID-19 vaccine on Wednesday and felt like she had some vaccine reaction initially.  She had an increased level of fatigue yesterday.
Approx Early April I developed "Dry Mouth" with the expected symptoms of intermittent difficulties of generating enough Saliva.   I had never had this before but now suffer from this every day at different degrees of discomfort. I therefore initially contacted 3 Doctors 1. My Dentist who empathised but all he did was suggest EPIC tablets which minimise Tooth Decay for people with Dry Mouth. 2. My GP whose office is where I had my shots.  At the time I was due for my 6 month elderly care checkup which consisted of a full set of blood tests as well as a Diabetes Test and a Urine Culture. All of these showed nothing unusual . She then recommended that I checkout and try all the over the counter aids for Dry Mouth. 3. A week or so before I noticed the Dry Mouth, a Dr had given me a Cortisone shot for a Frozen Shoulder.  However when i asked him whether he thought it possible that it caused it, he strongly said NO.  At GP advice I bought Biotene Rinse and FlourideToothpaste. I bought a spray (Pro-Sys) and recently XyliMelt tablets which seem to be the only one that generates Saliva.  With the problems still happening I recently contacted an ENT doctor who checked me out and sent me to a lab for Blood Test looking for Anti-Bodies for sjogren's syndrome. Luckily these were also negative although I have read that its possible to take quite a while to show up.  NO I have not had the lip biopsy that I have read about.
Day after 2nd Moderna shot,  I experienced low fever, massive headache, fatigue, and feverish buzzing in my ears. Felt better the next day, but continued to have severe migraine for the rest of the week. Buzzing in the ears was annoying, but I thought it would pass. This is known as tinnitus, and sounds like cicadas. I am able to work during the day, but the high frequency buzzing in my ears has not stopped or decreased in intensity in the 5 weeks since the vaccine. It is especially bothersome at night, when it's quiet and I'm trying to fall asleep. I have notified my doctor's office about this. Currently, there is no medical treatment for tinnitus.
Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient c/o itching and redness on bilateral wrists. RN notes mild rash and administers benadryl 25 mg PO at 2:14pm. Patient also given water to drink. Patient states at 2:20pm that itchiness has decreased. No respiratory distress. No anaphylaxis symptoms or other complaints by patient. At 2:25pm, patient states that there is no itching. RN observes that rash is gone. Patient d/c home with daughter at 2:30pm. Stable and ambulating to exit.
(R) arm swollen at site of vaccine injection. Instructed to use ibuprofen PRN for pain, encourage movement of arm, and monitor for signs of infection.
Body aches, Tired, Headache, Chills,  Took Tylenol
I got the vaccine on May 25, in the afternoon around 5:15 PM I had no symptoms until November when I had COVID-19. I had pain in my body, head and fever at night. Leaving work I went urgently to a center and they tested me and I came out Positive. They gave me Muxinex for phlegm and they gave me a pill and a syrup to loosen up my stomach because I was very constipated. They gave me milk of Magnesium. A 7-day treatment with the pills, from then on I began to improve and after 5 days I went to work.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Positive). At the time of the report, COVID-19 (COVID-19 Positive) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.