chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having chest pains; Having difficulty breathing; Had back aches, body aches; Have headaches; Had back aches, body aches; Felt pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and MYALGIA (Had back aches, body aches) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to sulfa products).   On 11-May-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) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), MYALGIA (Had back aches, body aches) and HEADACHE (Have headaches). On 13-May-2021, the patient experienced CHEST PAIN (Having chest pains) and DYSPNOEA (Having difficulty breathing). On 13-May-2021, BACK PAIN (Had back aches, body aches) and MYALGIA (Had back aches, body aches) had resolved. At the time of the report, FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and HEADACHE (Have headaches) had not resolved.            Concomitant medications were not reported. Treatment information was not reported.
multiple pulmonary emboli; could barely breath; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder removal on 25-Mar-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue). On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary emboli) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and DYSPNOEA (could barely breath) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized for 3 days due to DYSPNOEA and PULMONARY EMBOLISM. On 13-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) outcome was unknown.            The doctors believed that her diagnosis was not a common side effect from the surgery and believed that the vaccine contributed to the diagnosis. She was treated with apixaban, omeprazole and aspirin 81mg (once daily).  The patient is scheduled to visit a hematologist after 6 months.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-081407 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested MOD-2021-081407:Crosslinked case; Dose 1
Patient reported rash, dizziness, double vision, extreme fatigue. Used bendaryl and hydrocortisone cream to alleviate issue
Staff reported that her arm swelled at the injection site left arm the evening of receiving the injection. Her arm was swollen (at the injection site, warm to touch with a hard knot.
Initial report received from other company (Novartis) on 05 March 2013. This case was initially reported by a healthcare professional. Other company reference number: PUS2013US011876. An 11-year-old female patient whose medical history and concomitant medications were not reported had received second dose of meningococcal vaccine (Mfr Unknown) (batch number, route and site of administration were not reported) on 20 November 2007. The patient had received first dose of MENVEO (Mfr: Novartis) (batch number, route and site of administration were not reported) on 21 June 2007. Thus the patient was administered an extra dose of vaccine. Laboratory details were not reported. At the time of this report, the patient did not experience any adverse reaction. List of documents held by sender: none.
Information has been received from a pharmacist who reported that his 18 year old daughter with no pertinent medical history and no drug reaction/allergies on 14-JUL-2008 was vaccinated with her third dose of GARDASIL. On 15-AUG-2008, the patient experienced muscle pains and joint pain and was hospitalized for 2 days. The patient's muscle pains and joint pain persisted. No adverse event was reported with the first and second dose of GARDASIL. Laboratory test include blood work and numerous other tests (results not provided). Follow-up information has been received from the patient's father who reported that his daughter had a spinal tap that did not confirm a specific diagnosis, and was negative for Guillain-Barre syndrome. The patient's muscle and joint pains persisted. Additional information has been requested.
Vaccination error: Vaccine was given outside 12 hour storage and handling guidelines. Moderna manufacturer made aware. No adverse reactions reported from patient.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/22/2021. They tested positive for COVID-19 on both 10/28/2021 and 10/29/2021 at the nursing home at which they were a resident. It was not known if they had a specific symptom onset date. They died on 11/03/2021. It seems they were not hospitalized related to this illness.
Vaccine was administered incorrectly into shoulder joint area instead of intramuscular. I had pain immediately the same day and the pain has progressed ever since causing serious mobility issues in my left shoulder and arm. A cyst developed in the exact spot that the vaccine was administered. My current treating physician confirmed that the incorrect administration of this vaccine is the cause of my pain and mobility issues and that he's had a minimum of four other patients with the same exact issue.
R09.02 HYPOXIA 4/19/2023 METABOLIC ENCEPHALOPATHY
Lump developed under axilla of left arm where vaccination was given.  Seen by physician.
Patient received second dose of moderna. Patient approached PHN in recovery after receiving vaccien to show PHN that left mid-arm was very swollen, far below injection site above crux  of elbow. PHN observed swollen area with Doctor. Doctor had patient wait for 30 minutes for observation and instructed to contact her doctor after she is done being observed.
On 21 October 2021, 53 year old female received 2nd dose of pfizer. Pt started having symptoms of itchiness around the local area after waiting for 15 minutes. Pt received 1st dose 28 September 2021 and states this happened when she received her first dosed. Pt was transported to ER. Pt did not receive EPI.
Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event; Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day) and NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine (1 booster dose) and Pfizer COVID-19 vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.   On 29-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day). On an unknown date, the patient experienced NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day) and NO ADVERSE EVENT (Not reported any adverse reactions to the two bivalent doses at this time/ 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 (Not reported any adverse reactions to the two bivalent doses at this time/ No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a Moderna bivalent booster and a Pfizer bivalent booster on the same day).    No concomitant medication reported.  The HCP reported that the patient received the Pfizer bivalent vaccine and a few minutes later received a Moderna COVID-19 bivalent vaccine on the same day. Patient had not reported any adverse reactions to the two bivalent doses at the time. The HCP wanted to know if there are any recommendations or guidance that can be provided for the patient.  No treatment medication reported.
Pt states she received vaccine in L arm. States it hurt immediately after the shot. C/o pain in L shoulder and states has limited mobility. States pain is not improving. Has Dr appt this week. Denies any external redness or swelling.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-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 11-Jan-2021 at 1:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.98 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature range of 35 Degree Fahrenheit from 09:00 AM. These vials were moved to fridge on 8-Jan-2021 and beyond use date for the vials was reported as 7-Feb-2021. Product moved to clinic on 11-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported
passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; washed in cold sweat; nausea; fatigue; vomiting; bad headache; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Blood pressure.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (tender arm). On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting) and HEADACHE (bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting), VACCINATION SITE PAIN (tender arm) and HEADACHE (bad 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.   Patient did not receive any treatment for the events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. stated he felt tingling in his tongue and lips 5 minutes after he got vaccinated.  No allergies known, no difficulty breathing.  At 1:10 pm pt. stated tingling is getting better.  At 1:23 pm pt. stated he is ok, and wants to go home.  At 1:27 pm pt. stated he barely feels tingling.  At 1:20 pm pt. went home.
Swelling in the arm (shoulder and bicep), redness, rash, itching, stiffening muscle
Pt states she received the immunizations on 9/30/19.  The next day she woke up and her right arm (the arm with influenza and PPSV 23) was red and painful.  She also states she has ran a low grade fever since she received the immunizations.  She states that there was a short time her fever went up to 102 but went back down.  Pt states she has used ice packs and ibuprofen.
(R) shoulder redness, swelling tense 12 cm x 13.5 cm.
Initial report of rt. arm numbness progressing to neck and shoulder later in the day.  By next day, experienced generalized body throbbing and aching, seeking medical attention.
joint pain, muscle aches, chills, fatigue Narrative:  Other Relevant History:
I had no adverse event to the vaccination. My symptom started with cold symptoms. I had sneezing, runny nose, and head ache. I had a high fever of 102. I spoke with my physician and was prescribed Paxlovid. My symptoms started to diminish after taking the medication. I could not taste my food while taking Paxlovid and very fatigue after finishing the dose I could taste my food again.
this patient received both vaccine shots 1-21-21 and 2-11-21. She then went on to become covid pos on 4-6-21
Today, day 15, got a  4" red rash which is a bit hot and hard on left upper arm .
CONTINUE TO FEEL PAIN AND SORENESS IN ARM ONE MONTH FROM ADMINISTRATION OF FLU SHOT.
3 days after the vaccine he broke out in hives from his neck down his torso and under his arms and on his arms. Extremely itchy. Lasted a couple of hours  Took benedryl. Helped with the itching
Expired vaccines administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported. Vial was initially stored in the refrigerator on 24-Mar-2022    This case was linked to MOD-2022-533485 (Patient Link).
Called provider at home. Went to ER for shortness of breath, hives and throat felt tight. After treatment signs and symptoms cleared.
Psoriasis on hands; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis on hands), PYREXIA (Fever) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free. On an unknown date, the patient experienced PSORIASIS (Psoriasis on hands), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PSORIASIS (Psoriasis on hands) had not resolved and PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number S033308, which has been verified to be valid, the expiration date was reported and validated as 08-APR-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:  manufacturerstate: ; manufacturercountry:; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001370: US-009507513-2104USA001371: US-009507513-2104USA001372: US-009507513-2104USA001376: US-009507513-2104USA001373: US-009507513-2104USA001392: US-009507513-2104USA001378: US-009507513-2104USA001390: US-009507513-2104USA001379: US-009507513-2104USA001387: US-009507513-2104USA001389: US-009507513-2104USA001393: US-009507513-2104USA001381: US-009507513-2104USA001394: US-009507513-2104USA001377:
vaccine accidentally given to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine accidentally given to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine accidentally given to a 17 year old). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine accidentally given to a 17 year old) had resolved.        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.   This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 037B21A, with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: no new information; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 037B21A, with no associated AEs.
Severe headache, confusion, unable to formulate sentences. Word finding difficulties. Mental fogginess. Eyes felt heavy and weak at the same time- tired eyes. behind the eyes headache. Memory problems and problems initiating words.