chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Immunization given on 08/12/2002. returned to clinic on 08/13/2002 for physical. health care provider noticed an area of induration on right anterior thigh. Pt was active and not acting well.
I had pain on the left side of my neck and went up to my head. This went on for weeks. On Feb 16, 2022, I was diagnose with two carotid dissections.
Swollen/enlarged lymph nodes in both arm pits. Noticed shortly after receiving first dose but got considerably larger after second. Have not reduced in size at all at seven (7) months.
On 9/29 she reported that she developed soreness starting from site of injection through the elbow 4 to 5 days. The symptoms disappeared for 3-4 days then started again. I asked her to see a dr. She said I will be fine & I am leaving to another country for 2 weeks & I will call you back after I return.
pain at the injections site; Fatigue; Chills; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th May 2022, the patient received the 2nd dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, chills and muscle pain. On an unknown date, the outcome of the injection site pain, fatigue, chills and muscle pain were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, chills and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment:  The patient reported case for himself. The patient reported that he received his second dose of Shingrix and experienced pain at the injections site, fatigue, chills, and muscle aches. The reporter did not consent to follow-up.
burning feeling on both inner thighs; burning feeling on left side of breast; cramping sometimes in the toes, legs, ribs, and neck; cramping in stomach; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) for Blood pressure high, EZETIMIBE for Cholesterol high, LEVOTHYROXINE, PANTOPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Breast pain, Abdominal pain and Muscle spasms, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach) outcome was unknown.            This case was linked to MOD-2021-250501 (Patient Link).
have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest
Breakthrough COVID-19 diagnosed on 12/24/21 based on rapid home test and confirmed on 12/25/21 by PCR test. Symptoms included runny nose, cough, sore throat and headache for 5 days with minor continuation of symptoms for additional week. ( I was contacted by phone after submitting V-Safe report and requested to complete this report of an adverse event.)
Swelling + bleeding at time of injection consistent with hematoma x 4cm (L) deltoid. Txt with antbx prophylactically
Body Aches; Fatigue; Fever / Temperature; Chills; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 03-Feb-2021, the patient experienced MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills). On 05-Feb-2021, MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
There was temperature excursion from their freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Patient received the Meningococcal B vaccine to early.   Patient not 16 years of age.
Inadvertently 2 doses of Moderna COVID-19 vaccines administered to patient at age 17.  Dates of vaccines are: second dose administered 08/06/2021  see above details.   Patient did not report any adverse reaction after administration of vaccines.
Severe itchiness, swollen, hot to touch on and around the area, red in color, dizziness.
Fever 12 hours after shot that lasted 6 hours, headache for 48 hours following shot, chills, sweats, and fatigue continuing several days after shot. Treated with over the counter meds.
REACTED BADLY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: many allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reacted badly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reacted badly was not reported. This report was non-serious.
Within hours of the vaccine administration, the patient's arm (the one vaccine was given in) became moderately swelled, red and itched. It was still red and itchy the day after.
Sore arm for first few days.  Woke up on day 5 feeling off.  Had an aura start in the left side of vision and thought it was just a migraine.  Took migraine medication and 45 minutes later had a seizure.  This is the first in my life.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 13Sep2023 to 18Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300307996 same patient, different drug and different event.;
Received vaccine July 10, 2009 with no adverse reactions in left upper arm.  Pt called our facility July 20 to report that in the AM July 19 started to feel itching in both ankles and wrists, and on a line on front of left shoulder and bands around back of neck.  Also has a band on hairline on front of head.  Patient describes tingling and prickling feeling on affected areas, rash looks red, with and raised spots.  Describes as hivish in appearance.  SOne areas not as rashy, but still quite itchy.
a little bit of painful; really uncomfortable thought the night; quite a bit of swelling area gland underneath her arm,like a knife swollen,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,). At the time of the report, PAIN (a little bit of painful), DISCOMFORT (really uncomfortable thought the night) and LYMPHADENOPATHY (quite a bit of swelling area gland underneath her arm,like a knife swollen,) outcome was unknown.            Concomitant and treatment medications was not provided by the reporter. Booster of the Moderna covid19 vaccine, quite a bit of swelling area gland underneath arm, like a knife swollen, a little bit of painful really uncomfortable thought the night, and her husband up to his neck, but had gone away on him, and didn't took anything, because she read that should take Advil or Tylenol.
Pt received vaccination around 9am returned to vaccination room at 10:30 with complaints of itching, difficulty breathing, diaphoresis, and dizziness. Fire and medic called to triage pt on site. Pt walked away after treatment.
A 38 year old female pt, born in 12/18/64, was vaccinated three times with 1ml Rabipur for pre-exposure prophylaxis in February/March 2003. One or two days after the third vaccination on 3/5/03, she developed subfebrile temperature around 38C, lasting for four to six weeks. She also complained about headache, pain in limbs, eye pain (like neuritis opticus pain) and flu like symptoms, improving at reporting date on 4/16/03. The pt was hospitalized on 4/9/03.  A 15-day follow up report received 6/26/2003 adds: Seriousness criterion: Hospitalization. Causality: insufficient data. Addendum 06/10/2003: We also received this case. A 28-year-old (error) female pt-a physician-was vaccinated with 3 doses of Rabipur (batch #3084799). (Local?) redness was reported after the first 2 vaccinations. Four weeks after the 3rd vaccination she experienced malaise, fatigue and "toxic" and "infectious" symptoms, which lasted for weeks. Lab tests were normal, a delayed vaccination reaction was suspected. Company assessment: Seriousness criterion: hospitalization Causality: not related.
C/o pain, redness, swelling - redness measures 6" in length 3 1/2" in diameter - induration.
Itching all over/more itching/her palms of her hands are itching, both hands; Redness; Heat/warm patch area when it is flared up; It looked like hives with welts; It swells; her joints are stiff on both left and right hand; got kind of a little worse; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA6780) via an unspecified route of administration, administered in arm right on 22Jul2021 (at the age of 48 years old) as dose 2, single for COVID-19 immunization. Medical history included brain operation from 2017 to an unknown date she had brain surgery in the past for cysts on her brain, the last was in 2017. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ZW0187) via an unspecified route of administration, administered in arm right 01Jul2021 (at the age of 48 years old) as dose 1, single for COVID-19 immunization and within 1-2 days the patient experienced Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage and random patches of itching and redness in different locations. On an unspecified date in Jul2021, patient experienced itching all over/more itching/her palms of her hands are itching, both hands. On an unspecified date in 2021 patient experienced redness, heat/warm patch area when it is flared up, it looked like hives with welts, it swells, her joints are stiff on both left and right hand, after her second dose got kind of a little worse. The patient had calamine lotion as a therapeutic measure which helped with the itching. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
fever, fatigue, chills, myalgias; later also feeling heaviness in chest, sore throat, heaviness in the chest
When the patient woke up the morning after injection, small red petechial spots were noted on both lower legs. The number of spots increased slightly over the next 1 week. Also, the color changed from red to brownish and the spots went from flat to bumpy. Over the subsequent weeks, the spots appear to be gradually resolving to the point now at which they appear similar to freckles. No treatment was given. No other vaccines given within 1 month before this one.
Reporting nurse stated that pt had recvd Engerix-B in MAY 1991 & several wks later could not eat bread;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-APR-2012, the patient was inoculated at a medical center/hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or (as reported) 28-JUL-2016, the patient was treated by a physician/MD at a medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster dermatitis of the eyelid. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, and as a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Severe herpes zoster dermatitis of the eyelid was determined to be a medically significant event. Additional information has been requested.
Vaginal Spotting at 18 days into my cycle; Menstrual cramps; Sweating; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0183), dose 1 via an unspecified route of administration, administered in arm right on 11Jul2021 18:15 as (at the age of 48-years) dose 1, single for covid-19 immunisation. Facility type of vaccine was other. Medical history included known allergies: penicillin, shellfish, and pineapple. Concomitant medication included zinc taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10) taken for an unspecified indication, start and stop date were not reported and prenatal vitamin. No other vaccine in four weeks. No covid prior vaccination. The patient was not covid tested post vaccination. It was reported that it was unknown if patient was pregnant at the time of vaccination. The patient experienced vaginal spotting at 18 days into her cycle, had menstrual cramps, sweating, and insomnia on 12Jul2021 20:00. Patient did not receive any treatment for the events. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected
Pt had a fever of 103, whinnying & fretful, coughing, rhonchi & chest congestion, Tachycardia, temp above 104;
ear itching; Ear burning; mucus in eyes; swollen eyes; difficult breathing; rash on neck, chest, legs, arms; red dots, lines moving across body; hives on face, hair and eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on face, hair and eyes), EAR PRURITUS (ear itching), EYE DISCHARGE (mucus in eyes), EYE SWELLING (swollen eyes) and DYSPNOEA (difficult breathing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (shell fish can cause rash.).    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced URTICARIA (hives on face, hair and eyes), EYE DISCHARGE (mucus in eyes), EYE SWELLING (swollen eyes), DYSPNOEA (difficult breathing), RASH (rash on neck, chest, legs, arms) and ERYTHEMA (red dots, lines moving across body). On an unknown date, the patient experienced EAR PRURITUS (ear itching). At the time of the report, URTICARIA (hives on face, hair and eyes), EAR PRURITUS (ear itching), EYE DISCHARGE (mucus in eyes), EYE SWELLING (swollen eyes), DYSPNOEA (difficult breathing), RASH (rash on neck, chest, legs, arms) and ERYTHEMA (red dots, lines moving across body) outcome was unknown. Not Provided      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.