chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash/ it' was horrible and hurt so bad; Itches so bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A, 0321A and 0321A) for COVID-19 vaccination.     The patient's past medical history included Brain operation (2 brain surgeries). Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Stroke (strokes), Aneurysm, Blood pressure high, Seizures, Diabetes and Hip fracture (Broke her hip). Concomitant products included LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) for Diabetes, LACOSAMIDE (VIMPAT) for Seizures, MENADIONE (KAPPA), CLOPIDOGREL BISULFATE (PLAVIX), MONTELUKAST, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash/ "it's horrible and hurts so bad") and RASH PRURITIC (Itches so bad) had not resolved.            The patient received her vaccines in both left and right deltoid muscle. The patient has no allergies, never tested positive for Covid-19. Treatment medications also included an unspecified lotion.   This case was linked to MOD-2022-538662, MOD-2022-538663 (Patient Link).
A 32 years old female present with nauseas in the recovery area. She pass with the paramedic  and she vomit once and she tell to paramedic that she feels fine. Patient denies  blurry vision, dizziness or headache. Patient vitals was Bp: 110/70mmhg, %O2 98%, Hr: 93bpm, Temp: 35.8C and Sugar: 111dl/mg
ADMINISTRATION ERROR:   The vial had the expiration date for ultra cold storage on the vial and was used as the expiration date for the medication.  The vial was stored in the refrigerator and was due to expire before the date given.  Patient reported no ill effects from the vaccine other than coughing and some mucous later that day.
Severe burning on top of shoulder within 15 minutes progressing to burning pain down arm to elbow.  Applied ice packs and took Advil alternating with Tylenol with no effect.  I was not able to move  my shoulder or arm for over a week.   Had an MRI of shoulder done on  11/18/2021. After almost a month, I am  able to move my arm but not without pain.  Still inflamed at injection area.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden. On 23rd November 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unchanged. The reporter considered the pain in arm an injected limb mobility decreased to be related to Influenza vaccine Quadrivalent . Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient was administered a Glaxo Smith Kline's Quadrivalent Flu vaccine in her left arm but it was not known which flu vaccine was given. Within a week, the patient's arm was sore and tender. The problem with the patient's arm was worsened. Within three weeks, the patient was unable to lie down on her left arm. The range of motion for her arm was decreased and she had difficulty in reaching. A 25mg gauge needle was used. Due to the continuing problems with the arm, the patient's primary doctor had referred her to an orthopaedist and classified it as an injury to her arm. The patient worked in the doctor's office. The sales representative could not provide the health care professional's address, lot number, expiration date or any additional information. The representative stated that she spoke to medical information on behalf on this doctor at the time of reporting but did not report the adverse event to them.
Patient right shoulder and right deltoid, red, swollen, hard and warm to touch. Denies pain or fever at this time. Began 4/11/09 and continues today 4/13/09.
slept all day; changes with blood pressure; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 13:15 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thalassaemia" (unspecified if ongoing), notes: She states she has thalassemia anemia; "anemia" (unspecified if ongoing), notes: She states she has thalassemia anemia; "blood pressure", start date: 2020 (unspecified if ongoing), notes: She has been checking her blood pressure since 2020. It is usually around 155/68.; "Asthma" (unspecified if ongoing); "Heart murmur" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM taken for blood pressure abnormal (ongoing); SALMETEROL AND FLUTICASONE taken for asthma (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac murmur (ongoing). The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset 09Mar2021, outcome "not recovered", described as "changes with blood pressure"; ASTHENIA (non-serious) with onset 09Mar2021, outcome "recovering", described as "Weakness"; SOMNOLENCE (non-serious), outcome "unknown", described as "slept all day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient was using concomitant product fluticasone-salmeterol from over 10 years. Had no Prior Vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient; It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient; Syringe Connection Issue; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue) in a 55-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication was provided
Flu vaccine licensed for 18 yrs and up was given to an 8 year old. No signs of symptoms noted.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with 10 doses of PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported) which had been improperly stored. No adverse effects reported. Additional information has been requested.
Headache, fever, fatigue, swelling, pain, rash and itching at injection site
Patient presented to the ED with nausea, vomiting, diarrhea and cough for 3 days. She tested positive for COVID-19. She was found to have acute on chronic renal failure secondary to vomiting and diarrhea. She was admitted for rehydration. She was discharge 2 days later in stable condition.
Very flu-like. Muscle and joint aches, nausea (no vomiting), severe headache, extreme fatigue, constipation for about 60 hours - 36 hours were serious.
Headache, Myalgia, body aches headache weakness cold sweats felt hot Narrative:
ABDOMINAL PAIN; This spontaneous case (PVX2019-1395) report was received from a nurse on 31-May-2019. It describes a male consumer who experienced abdominal pain, after the administration of Vivotif (lot no: 3003253) for an unknown indication.  Case report: The consumer experienced abdominal pain after the first dose of Vivotif.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer had abdominal pain, after the administration of Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had abdominal pain, after the administration of Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
ADMITTED TO HOSPITAL, CURRENTLY STILL ADMITTED AS OF 3/21/22.
Swelling, pain, itching and heat in the arm @ 2" below the injection site at the site of the small pox vaccine I had as a child.  presents like cellulitis but no fever.
Right arm - at site of VARIVAX injection redness, swelling and discomfort at injection site; warm to touch. Was still worsening on day #3. Treated with KEFLEX for 7 days; also BENADRYL and ice.
MONOVALENT VACCINE WAS ADMINISTERED IN ERROR FOR A BOOSTER DOSE. ADVISED FACILITY TO NOTIFY MEDICAL DIRECTOR AND DETERMINE IF HE RECOMMENDS THE PATIENT RECEIVE A BIVALENT BOOSTER DOSE OR NOT.  ADVISED NOTIFY PATIENT/SPONSOR OF ERROR AND DECIDE IF THEY WISH TO REPEAT BASED ON CDC AND MD RECOMMENDATION.  CAN REPEAT IN 2 MONTHS FROM DATE OF WRONG DOSE WITH BIVALENT BOOSTER.
Arm swelling and soreness at vaccination site onset 1-2 hours after administration. Chills and body aches with onset about 12 hours after vaccine that continued until following morning. Headache off and on with chills that persisted up to 24 hours after injection.
body aches, headaches, dizziness, muscle aches in one or both legs, tiredness all the time,
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. The patient's past medical history included heartbeats increased (she had a history of rapid heartbeat with other immunizations). On 26th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the injection site swelling, feeling unwell, injection site erythema, nausea, fever and heartbeats increased were recovered/resolved and the outcome of the injection site itching and generalized muscle aches were unknown. It was unknown if the reporter considered the injection site swelling, feeling unwell, injection site erythema, nausea, fever, heartbeats increased, injection site itching and generalized muscle aches to be related to SHINGRIX. Additional details were provided as follows: The caller who was the office manager for physician office. The patient received SHINGRIX in the left arm and experienced arm swelling and redness the same day and nausea that night. She noted she felt sick had a low-grade fever the next day, her muscles ached all over, which she took ADVIL and TYLENOL for alternating. She experienced rapid heartbeat about 3 hours after the shot. She still has itching and swelling the size of a 50 cent piece at the site. She noted the redness and swelling had gotten to a 3 inch circular area. All other issues have resolved.
Initially patient had SIRS reaction that lasted for few weeks then was followed with thrombocytopenia that later developed into pancytopenia and possibly a plastic anemia versus myelodysplastic syndrome that is currently being investigated by hematology
On 6/20/99, the pt experienced an erythematous papular rash, fever of 102.6F and a ear infection. The pt was taken to the ER, where she was treated with Suprax for the ear infection. Follow-up was received from a LPN. The pt recovered from her symptoms. No further information is available.
Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.   Before use date reported was 17-Nov-2022.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416, US-MODERNATX, INC.-MOD-2023-704473 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up information included patient and vaccination details updated. On 24-Jan-2023: Follow-up document included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case US-MODERNATX, INC.-MOD-2023-704473:dose 1
Red, itchy lump at vaccination site.  Went away after 3 days.  Date of vaccination was actually 01/07/2021.
Chest pain developed while sleeping. Awoke at 0130 with 5/10 retrosternal chest pain. Had vaccinia vaccine on 4/10/06.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), on 27Jan2021 as dose 2, single (Lot number: EL3246), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 04Feb2022 as dose 4 (booster), single (Lot number: FL3209) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 22Aug2022, outcome "recovered" and all described as "COVID-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2022) Positive, notes: she had covid on 22Aug2022, tested positive. The clinical course was reported as follows:  on 22Aug2022 of this year, she tested positive for COVID-19. For 19 days, she tested positive, and she is calling to find out how long she will be protected and when can she get the booster dose. So, I have all of the dates of the doses that she received. Her first dose, and they are all Pfizer COVID-19 Vaccines. First dose was 08Jan2021 with LOT# EL3246. Her second primary dose was 27Jan2021 with LOT# EL3246. Her first booster dose was 23Aug2021 and the LOT# is FC3180 and her second booster, the last booster was 04Feb2022 this year and that would be LOT# was FL3209 and like I mentioned, on 22Aug2022 she tested positive after this. No follow-up attempts are possible. No further information is expected.
Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin; Stomach upset,GI discomfort,queasy stomach; Move her bowels and her stools, patient noted are looser that normal; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach), DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal) and NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Previously administered products included for Flu vaccination: Flu vaccine (last year 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Childhood asthma, Bronchitis (Continuing bouts of bronchitis but the last time she got sick was fall of 2-19 before the pandemic.), General anesthesia (nausea and vomiting), Drug allergy (cortisone shot), Drug allergy (Allergic to doxycycline (severe diarrhea),), Drug allergy (Allergic to vibramycin (difficult of breathing)), Drug allergy (Allergic to markain (difficult of breathing)) and Adhesive tape allergy (surgical tape).   On 08-Sep-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. On 14-Sep-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin). In September 2022, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach) and DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach) and NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin) had not resolved and DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal) was resolving.            Concomitant medication details were not reported by the reporter.  On 18-MAR-2021, Patient received 1st dose of Moderna COVID-19 Vaccine with lot number 029A21A. On 21-APR-2021, Patient received 2nd dose of Moderna COVID-19 Vaccine with lot number 046A21A. On 10-Nov-2021, Patient received 1st booster dose of Moderna COVID-19 Vaccine with lot number  058F21A. On 09-MAY-2022, Patient received 2nd booster dose of Moderna COVID-19 Vaccine with lot number  004M21A. Treatment received antacids for unknown indication.   This case was linked to MOD-2022-647566, MOD-2022-647558 (Patient Link).
About 14 hr post vaccination fever, nausea, generalized body aches. Fever continues, dehydration, nausea, redness of face (flushing) and severe headache seeing visual spots/blurry. Treated urgent care 4/10/11.
Patient was administered age 5-11 year dosing of Pfizer COVID vaccine; patient is 13 years of age.  Patient tolerated vaccine well, and error was not realized until after administration to left deltoid.