chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TIGHTENING OF MUSCLES ABOVE EAR AND SHOULDERS; HURTS TO TURN NECK; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21/H21H, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tightening of muscles above ear and shoulders, hurts to turn neck, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tightening of muscles above ear and shoulders, hurts to turn neck and slight headache was not reported. This report was non-serious.
# AKI with non-nephrotic range proteinuia and microscopic hematuria  # Neutrophilia  # Fevers  # Normocytic anemia # Thrombocytosis   # Coagulopathy # RUE Superficial venous thrombosis  # Subconjunctival hemorrhage  # Flame hemorrhage R fundus  # Mild iridocyclitis # CRP elevation  # Procalcitonin elevation  # D Dimer elevation  # Anasarca  # Elevated BNP  # Hypoalbuminemia # Small pericardial effusion  # Elevated alk phos, bilirubin (direct predominant), and AST  # Elevated lipase  # Hypocomplementemia with low CH50 # Elevated IL2 Receptor (8540)  # Aseptic meningitis w CSF with lymphohistiocytic predominant pleocytosis (25 nuc cells with 49% lymphs, 35% histiocytes, 16% pmn, glucose 41, protein 155 with neg meningoencephalitis panel)
Nausea, vomiting , and dry heaving every 20-40 min- this only happened w/ 2nd shot  Moderna Arm after 1st shot (started 7 days after shot and lasted 6 days or so)
We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive.  Clinical course: The patient tested positive for Corvid and her all family member went for testing and also tested positive. They all had received Pfizer inoculations and boosters and although their tests are positive, all are functioning very well.  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-202200676409 Same product/reporter/AEs, different patient
Systemic: Felt lightheaded, but resolved after 10 minutes; BP 112/60; Temp. 97.9-Mild
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L047307, expiration date: 23-MAY-2017 (dose, therapy type and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 20 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
All over body itching but no rash or swelling; Extreme fatigue; Change in menstrual cycle; This is a spontaneous report from a contactable other hcp reported for herself that. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 19Aug2021 (Batch/Lot Number: EW0183, expiry date: unknown) as dose 2, single for COVID-19 immunization (age at vaccination:41-Year-old). Medical history included anxiety, obesity, and allergy to Penicillin. Concomitant medication included sertraline hydrochloride (ZOLOFT) 150 mg daily taken for an unspecified indication, start and stop date were not reported (medications within 2 weeks prior to the vaccination). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 15Jul2021(Batch/Lot Number: EW0183, expiry date: unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with covid-19 before vaccination, and not tested post vaccination. On 20Aug2021 the patient experienced all over body itching but no rash or swelling, extreme fatigue, and change in menstrual cycle. The patient had not received treatment for the events. The outcome of the events was recovering.
Pericarditis one week, spoke to cardiologist about the events, shortness of breath, pain first left shoulder blade muscle several days then sternum several days & finally right shoulder blade muscle before eventually clearing up after 7-10 days total.
101-102°fever; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The patient was in bed with 101 to 102 degree fever for 3 days after shingrix shot. The patient reported that, he or she should not have listened to the pharmacist and a nurse who said it was fine to get the Shingrix shot one day and flu vaccine the next.  The patient  got the 2nd dose with no ill effects. For tolerance refer linked case US2021AMR202746, same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202746:same patient US-GLAXOSMITHKLINE-US2021AMR202852:same patient
09:55 --pt received injection (pt has hx of nausea but no vomiting with any needle injection including blood draw) 10:00--Pt reports nausea and dizziness ---Paramedics called.  Pt refused IV fluid --so no IV was inserted.  10:04---Pt vomits.   No blood noted. (B/P = 110/60, o2=99%, pulse = 80, R20 10:07--Paramedics arrived--Pt refused Paramedics.  B/P93/61 (pt reports that B/P is normal for her.  10:19 ----pt states that she feels better after the vomit --Discharged.  pt ambulated with no assistance.  denied any dizziness or nausea.
Developed upper extremity Deep Vein Thrombosis (DVT) with complete occlusion of the Axillary and SubClavian veins of the right arm. Swelling, redness of the right arm and hand. Pain in the right axilla. Visibly distended veins near the right clavicle, upper arm, forearm and hand. This occurred 2 weeks following 2nd dose of COVID vaccine. Patient has no risk factors or other known causes of DVT.
patient passed out on floor and appeared to have seizure like symptom. Felt faint , dizzy, and flushed.  called 911. Medical team arrived and patient proceeded to get nauseated and throw up.
Patient was tired the next day; sore left arm, not as bad as the first two shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 008B21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots). On 29-Oct-2021, the patient experienced FATIGUE (Patient was tired the next day). At the time of the report, VACCINATION SITE PAIN (sore left arm, not as bad as the first two shots) and FATIGUE (Patient was tired the next day) outcome was unknown.      Concomitant medications included unspecified High cholesterol medications.  No treatment medications were reported.   This case was linked to MOD-2022-666798, MOD-2022-666783 (Patient Link).
Patient can not move his left arm; pain in the left arm at the injection site; vaccination experienced headache; Left shoulder joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can not move his left arm), VACCINATION SITE PAIN (pain in the left arm at the injection site), HEADACHE (vaccination experienced headache) and ARTHRALGIA (Left shoulder joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can not move his left arm), VACCINATION SITE PAIN (pain in the left arm at the injection site), HEADACHE (vaccination experienced headache) and ARTHRALGIA (Left shoulder joint pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can not move his left arm), VACCINATION SITE PAIN (pain in the left arm at the injection site) and ARTHRALGIA (Left shoulder joint pain) outcome was unknown and HEADACHE (vaccination experienced headache) had resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to events was not applicable.
Patient was vaccinated with Moderna Covid Vaccine on Thursday, May 6, 2021.  We were informed the following Monday that the patient had passed away unexpectedly on Friday, May 7, 2021.  Family members did not reach out to us to ask any questions or to let us know what had happened.  We do not know that this patient passed away due to vaccination with the Moderna Vaccine.
Woke up in the middle of the night with aching leg muscles and stomach discomfort. Had pain at injection site from the beginning. 7 days later I had shivering which rotated with fever, also had fatigue, headache, stomach bloating, dizziness, and had 3 spots on my face - these all continued through day 12.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Received Paxlovid treatment from 22Sep2022 to 26Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
48 hours after first Pfizer COVID vaccine, she developed numbness in right leg and left toes, and vaginal warmth. Symptoms lasted less than 24 hours. Was seen in ER.
patient was administered vaccine which had undergone several temperature excursions.; No adverse event; patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if  the patient ever been diagnosed with/ tested positive for COVID-19.     On 22-Sep-2022 at 12:59 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 12:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.).    Concomitant product use was not provided by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department made aware of the situation.  The vial size was reported as 5.5ml.  Treatment information was not provided.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)". Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA003169: Original Case: 1710USA003115, US-009507513-1710USA003166: Original Case: 1710USA003115, US-009507513-1710USA003167: Original Case: 1710USA003115, US-009507513-1710USA003168: Original Case: 1710USA003115, US-009507513-1710USA003164: Original Case: 1710USA003115, US-009507513-1710USA003163: Original Case: 1710USA003115, US-009507513-1710USA003165: Original Case: 1710USA003115.
Severe itching and not just at the injection site the itching was particularly bad in hands and feet but arms and legs as well. I scratch so hard I tore open skin. I was seen in urgent care on 929 and had oral dexamethasone and I also had another 10 mg of oral prednisone on 9-28-2021 (30 mg daily for three days was prescribed but the OT hing had improved somewhat and I didn?t want to rusk additional side effects from prednisone) and I started on Zyrtec twice a day for a week and triamcinolone cream. The itching is getting better.
Pt had swelling and redness a few days after having vaccine administered. She went to doctor's office, who thought it may be a bacterial infection. They gave her antibiotics, and she let me know what happened when she picked up her rx. Alcohol swab and sterile needle were used, as well as individually wrapped bandaid. (Not sure exactly why doctor thought bacterial infection over allergic reaction.)
Vaccine not indicated for patients younger than 18. First dose was administered 2/19/21. CDC recommends continuing series despite patient being younger than 18 years of age. Per patient and patient's father there were no side effects from receiving first dose.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a flu shot about 10 years before the time of reporting (name of flu shot formulation unknown) and she experienced flu like symptoms for 2 days.   No further information was available. The reporter did not consent to follow-up.
Suspected Vaccination failure; had it couple years ago some doesn't go away; scratch my back; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and experienced shingles couple of years ago and thought some doesn't go away. The patient stated that if only someone could scratch his/her back. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with case US2021AMR179447, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179447:Same reporter
Difficulty breathing, no oral swelling, stridor, altered mental status. Bag valve mask ventilate. IM epi.  Initial care by MD and nurse. 911 ACLS called, transported to ER.
sore arm were I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm were I got the shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm were I got the shot). At the time of the report, VACCINATION SITE PAIN (sore arm were I got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take any regular medications. It was reported that, the reporter was on his 60s, may be the year and the month was march but the date was missing. Treatment information was not provided.   This case was linked to MOD-2021-400033, MOD-2021-400048 (Patient Link).