chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site Red, Hard, Warm Area, appeared approx two days after injecction. Pt also reports chills, temp of 99 po, pain at site.  Pt advised to place warm compress on site, gentle ROM, Tylenol for pain and to return to clinic if not improving.
This case was reported by a nurse via sales rep and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without experiencing any adverse event). On 11th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, general body pain and fever. In June 2018, the outcome of the chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional information was received as follows: The nurse reported that the patient experienced chills, body aches and slight fever for 24 hours or less. The reporter did not agree for follow up contact. This case was linked with case US2018GSK106729, reported by the same reporter.
EXPIRED VACCINE USE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 45 year old male.  The patient's pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 042A21A,expiry: 06-JUN-2021) dose was not reported, administered on 02-JUN-2021 15:41 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine use. On 02-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the expired vaccine use and out of specification product use was not reported. This report was non-serious.
I had a fever of 104 for 3 days, but my intestines were so painful for weeks afterwards. It is now 4 months after and I am still having gastro issues and have been to my Gastroenterologist, my PCP, had a colonoscopy and endoscopy, and have had to be on hardcore pain killers and have missed a lot of work due to the side effects from the vaccine.
Moderna COVID-19 Vaccine    A large red, swollen and inflammed area developed around the site of the injection and also a larger  area of redness appeared on the inner part of my left arm. The area was itchy and swollen.
Thyroid glands, that is been swollen; I am sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOITRE (non-serious), outcome "not recovered", described as "Thyroid glands, that is been swollen"; ILLNESS (non-serious), outcome "unknown", described as "I am sick".  Additional information: Patient was  calling regarding the swollen glands, side effects. Patient had her/his thyroid glands, that was been swollen for 2 days and this does not seem to go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Beginning at about 24 hours: Injection site slightly swollen and very sore. Hurt, but did not interfere with regular activities.  Low fever up to 99.8  Took one Tylenol tablet at bed time. Low fever (99.3) the next day until afternoon.  Fever gone by 48 hours.  Arm pain and swelling also mostly gone by 48 hours.
Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI-Contact information updated On 07-Jun-2021: patient details were added (age, height, weight, gender),facility was added, medical history was added,
2 days p/vax pt devel an inj site rxn characterized by erythema & itching;pt was seen by MD treated w/DPH & application of ice & recovered;this is 1 of 3 pt of this facility to have an adverse exp p/flu vax lot#4978156
I receive my second vaccination for Covid on January 4, 2021.  Less than 36 hours later I experience a rapid heart rate (110 - 128) and shortness of breath not related to activity.   I had anticipated body aches, chills etc and did have those as well.  Over the course of 4 - 5 days those resolved but my tachycardia and shortness of breath have not.  I waited another week to see if it would improve and when that did not occur I made an appointment to see Cardiologist because quite frankly, I was fearful of my symptoms.  My lungs remain clear, I have no difficulty taking a deep breath and my SAO2 is high 90's.  I had my annual physical 1/18/2021 and my lab work was normal as was my EKG.  I have never had shortness of breath and my heart rate was normally in the 70 - 80's range at rest.  Doctor ordered testing and the results are in My Chart.  I had a Echo/Stress/Echo which was normal.  My EF was 60% and in spite of my extreme shortness of breath on the treadmill, there was no ischemia induced.  Bp was elevated initially and during the test but returned to 130's/70's in recovery phase.  SAO2 was 97% to 100%.  I did a home sleep study on 1/31/2021 with results pending.  Doctor stated there was nothing on my testing that would account for my symptoms.  At my initial visit (1/26/2021)he started me on low dose Cardezem 120mg to address my heart rate.  My heart rate has improved with Cardezem (increased to 240 mg 2/2/2021) but my shortness of breath with minimal exertion has not.  I believe Doctor plans to order a PFT next.  Because of the timeframe for new onset symptoms and my Covid 19 vaccination, I wanted to reach out to you for guidance.  ? Second Covid Vaccination 1/4/2021 ? Shortness of breath and tachycardia 1/5/2021 ? Scheduled appointment with Cardiologist for 1/21/2021 and it was cancelled and rescheduled for 1/26/2021 ? Dr. appointment 1/26/2021, started on Cardezem 120 mg qd ? 1/31/2021 Sleep Study completed, results pending ? 2/2/2021 Echo/Stress/Echo completed, Cardezem increased to 240 mg qd ? PFT order pending ? Follow up with Doctor scheduled for 2/18/2021
Patient is fully vaccinate.  Boosted on 11/23/2021.  Admitting dx: fatigue, fall, hypoxia, pneumonia due to COVID.  Patient placed on decadron, lovenox and Remdesivir.  Oxygen requirements improved and was discharged with home oxygen.
Lower Back Pain, Middle Back Pain,  Knee Pain, Shin Pain, Elbow Pain,  Sluggish, Pain will range from 2-10.  If a full days work is performed the pain can escalate to a 10 by night time.  Stiff and barely can move in morning
migraine; fever; swollen arm 3 out of 4 times; feeling off balance for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing); "congenital heart defect" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling off balance for 3 days", "Migraine", "swollen arm", "fever"; Bnt162b2 (dose 2, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling off balance for 3 days", "Migraine", "swollen arm", "fever". The following information was reported: MIGRAINE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm 3 out of 4 times"; BALANCE DISORDER (non-serious), outcome "recovered", described as "feeling off balance for 3 days".  Additional information: The reporter (consumer, patient) stated she has had many side effects from her previous four doses of the Pfizer BioNTech COVID-19 Vaccine: "migraine, fever, swollen arm 3 out of 4 times, and feeling off balance for 3 days." She asked if there were any other side effects that are different with the new bivalent booster compared to the original. She also asked what ingredients are different in the new bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021432814 same reporter/patient, different dose number/events;
Body rash and hives. Extreme itching. Onset day 5 after vaccine.
her patient received three doses of Moderna Covid19 Vaccine; three doses of Moderna Covid19 Vaccine on 05Feb2021,12Apr2021and 11May2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (her patient received three doses of Moderna Covid19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three doses of Moderna Covid19 Vaccine on 05Feb2021,12Apr2021and 11May2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043l20a) for COVID-19 vaccination.     No medical history was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (her patient received three doses of Moderna Covid19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three doses of Moderna Covid19 Vaccine on 05Feb2021,12Apr2021and 11May2021). At the time of the report, EXTRA DOSE ADMINISTERED (her patient received three doses of Moderna Covid19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three doses of Moderna Covid19 Vaccine on 05Feb2021,12Apr2021and 11May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Pt. did not have any adverse events that occured during the time of vaccination. PCP has been in contact and on call MD recommend that pt. return in 8 weeks to complete vaccine series with either moderna or pfizer
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:
Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of body, sweating on neck, and light headed, clamminess to hands. Vitals monitored. no medications given.
had vax 5JAN95; in Am 6JAN95 had convuls (lasted 3 mins generalized); ? if associated w/fever dx w/strep pharyngitis 8JAN95;
Itchy raised bumps at site of injection, appeared ~ 5 days post injection. Rash resolved with Benadryl.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered after more than 1 temperature excursion; 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 12-Jan-2021, excursion time was 8 AM, temperature was 34 and 9 AM, temperature was 34. Total doses given for the day was 30, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. 3 vials were sent to clinic on 12-Jan-2021.  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 vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.
Anxiety levels high; A little depression; Weakness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety levels high), DEPRESSION (A little depression), ASTHENIA (Weakness) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARBAMAZEPINE (TEGRETOL), RISPERIDONE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced ASTHENIA (Weakness) and HEADACHE (Headache). On 30-Mar-2021, the patient experienced ANXIETY (Anxiety levels high) and DEPRESSION (A little depression). At the time of the report, ANXIETY (Anxiety levels high), DEPRESSION (A little depression), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Started with a feeling of neck stiffness and tingling of the tongue around 10 - 15 min after vaccine, but did not report symptoms.  Around 4:20PM it had progressed to cough, difficulty breathing, severe abdominal pain.  Co-worker reported that he was grabbing the chest and could not understand what he was saying.  He looked pale and diaphoretic.  Center's medical staff quickly administered one dose of epinephrine and symptoms improved quickly, but then patient tried to drink water and noticed that could not swallow, for which the center team administered a second epinephrine dose and called 911.  He was transfered to ER and released home later that night.
Vertigo; Dizziness; Headache; Tinnitus; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 28Mar2021 at 10:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included eczema, obesity, sleep apnea, birth control, seasonal allergies, pollen allergy, dust allergy and mildew allergy. Concomitant medications included ethinylestradiol; norethisterone acetate (JUNEL) for birth control from an unknown date and unknown if ongoing. 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 04Apr2021, the patient experienced vertigo, dizziness, headache, tinnitus and brain fog. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events vertigo, dizziness, headache, tinnitus and brain fog were resolving, at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient reports feeling of swelling in the left hand ~25-30min after 2nd dose Pfizer covid vaccine administration. She stated this occurred with first dose and resolved when given Benadryl. I gave the patient 25mg PO Benadryl at 1550 which she states improved the swelling feeling within 10 min. She remained under my observation until 1620. Vitals remained stable and PE findings WNL. She assured me she does get drowsy side effect from Benadryl and was able to drive herself home.
I developed symptoms 12/13/2022 coughing. 12/14 horrible cough with fever. I took a home COVID-19 test, and it was negative. I was nauseous, I took a chest pusher &Tylenol. On Dec 15 I tested Positive for Covid, I contacted my Oncologist Team and recommended cough medicine, I did not do well with that, I did a telehealth on Dec20, main complaint was cough and congestion. I had Xray of the chest and it was no pneumonia. I used Nyquil - that helped the cough. On Jan 9th I went to a walking clinic, and I developed a secondary infection, and they recommended Amoxicillin for 7 days. A month later I was fine.
Urticaria 48 hours post vaccination on 9/12/11. Was given BENADRYL.
Patient was to received their first bivalent booster dose (3rd dose total).  Patient instead received the Pfizer monovalent vaccine by error.
First, both arms turned ice cold from shoulder to hand. Then, after a few minutes, my hands became weak and shaky. Another few minutes and I got a wave of absolute exhaustion and could just manage to get myself to bed, and fell asleep in a second. I awoke two hours later, feeling generally better.