chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report has been received from a physician, referring to a 29 years old female patient. The patient's pertinent medical history did not include any historical or current medical condition, drug reactions or allergies. The patient had a history of 1 previous pregnancy and 1 live birth (reported as "a prior pregnancy"). The patient was taking unspecified "prenatal vitamins" concomitantly. On 29-MAR-2018, the patient was vaccinated with the first dose of VARIVAX, the physician reported that the reason for administration of VARIVAX series was that "after a prior pregnancy (unspecified date), the patient was varicella non immune and it was recommended to receive the vaccine postpartum" (prophylaxis) (route and anatomical site of administration, lot number and expiration date were unknown by the physician). Other suspect therapies included sterile diluent (STERILE DILUENT). The patient became pregnant with last menstrual period (LMP) of 20-MAR-2018. The physician reported that on 18-APR-2018, the patient "found out she was pregnant via urine pregnancy test".  Additionally, the physician reported that, on the same day, the patient "came into the office complaining of vaginal bleeding of 4 days (since 14-APR-2018) and loss of tissue through the vagina". The physician mentioned that a serum beta human chorionic gonadotropin (hCG) test (reported as "serum beta HCG") was performed to the patient, which resulted in 50 (units were not provided); based on this, the patient was diagnosed with a threatened abortion. The physician stated that, on 24-APR-2018, when the patient went back to the office "the bleeding had stopped, and the patient had shown no pregnancy symptoms"; therefore she was vaccinated with the second dose of VARIVAX (inappropriate schedule of drug administration). The estimated delivery date (EDD) was estimated as 25-DEC-2018. By reporting time, the patient was reported to be "still pregnant", however her gestational age was unknown and further information was not provided. The physician did not provide any causality assessment for abortion threatened in regards with VARIVAX and sterile diluent (STERILE DILUENT) administration. Upon internal review, abortion threatened was determined to be medically significant.
Prior of receiving my 1st dose of the full COVID-19 Moderna the COVIDF vaccine. I ask my primary care Dr. if there is any side effect from this COVID vaccine, Dr. informed me that there is NO side effect from this COVID-19 vaccine.  Well I signed up and got my 1st full dose of Moderna the COVID vaccine on 3/25/2021, couple days later my left leg calf swelled up so bad that I had a very hard time walking, and that I thought I develop a blood clot from the vaccine. I went out to Hospital. This is when the emergency room was experiences lots of people coming in with the same issues that I was having. An Ultra sound was done to see if there was a blood clot in my left leg.  This is when the doctor came into the room and informed me that they are seeing lots of patients that received the 1st full dose vaccine as a side effect causing their leg to swelled up. The next day I email my primary care CDr., about this. It took a while for the swelling to go down in the left leg. Then 2nd full dose of vaccine of Moderna on 04/22/2101, the same thing happened a couple days later left leg calf swelled up again. I email Dr. about this.  When they came out with the booster shots, I informed Dr. that I am NOT going through this and NO more of these COVID vaccine/boosters.  Dr. said the booster is half the dose over the full dose vaccine and will not have the side effect.  He advised me in getting the 1sst booster, received 1st booster on 11/03/2021 at pharmacy, and BINGO once again the left calf swelled up.  I informed Dr. this is it for me I'm NOT getting any more COVID vaccine/booster.  Well Dr. and Dr. (podiatric), told me to get the 2nd Booster since I was going in as outpatient for surgery on my right foot since COVID counts was so HIGH once again.  So, I went and got the 2nd Moderna booster on 06/20/2022, at Pharmacy. BINGO once again left leg calf swelled up. After this 4th COVID shot my left leg calf is still swallow and it has not gone down at all now the leg hurts.
Pre-diabetic; Ache; This spontaneous case was reported by a consumer and describes the occurrence of GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) and PAIN (Ache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) and PAIN (Ache). At the time of the report, GLUCOSE TOLERANCE IMPAIRED (Pre-diabetic) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Impaired.         Concomitant medication was not reported.  Patient reported that, the needle was going in with pen and prefers syringe. Patient was diagnosed as pre-diabetic and had ache. Treatment details not reported.  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.
Patient came  to ED with chest congestion, occasional cough, feeling weak in generalized body aches and loss of taste.  Patient admitted to hospital with pneumonia due to Covid, hypoxemia, and acute renal insufficiency.
patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular on 14Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included heart disease (unspecified). The patient is taking a lot of medication (unspecified). The patient had no prior vaccinations within 4 weeks. He tested positive yesterday, 20Jan2021, for COVID-19. His question was if he should get the second shot. The patient stated he had a sore arm on 14Jan2021, but really had no adverse reactions. The patient underwent COVID-19 rapid test: positive on 20Jan2021. The patient recovered from sore arm on 15Jan2021. Outcome of event "tested positive for COVID-19" was unknown.
itching on scalp; Vaginal itching; Itching on arm; Itching around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (Vaginal itching), PRURITUS (Itching on arm and scalp) and INJECTION SITE PRURITUS (Itching around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VULVOVAGINAL PRURITUS (Vaginal itching), PRURITUS (Itching on arm and scalp) and INJECTION SITE PRURITUS (Itching around injection site). At the time of the report, VULVOVAGINAL PRURITUS (Vaginal itching), PRURITUS (Itching on arm and scalp) and INJECTION SITE PRURITUS (Itching around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not taking Treatment information includes non-itch cream OTC
Patient felt lightheaded, diaphoretic. BP 79/47; brought to ED- Glucose 92; given 1 L NS and discharged.
This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with ROTATEQ, oral (dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored ROTATEQ on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2017US005441, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 15 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 04 Feb 2017, the patient experienced flu, fever, cough, headache, weakness. On 07 Feb 2016 the patient was diagnosed with flu type A. It was reported that cough lingered and the symptoms resolved. The outcome of events pyrexia and headache was reported as complete recovery on 09 Feb 2017 and for the event asthenia was reported as complete recovery on 10 Feb 2017. The outcome of the event cough was reported as condition improving and event influenza was reported as complete recovery on an unknown date. The seriousness and causality of the event influenza was not reported. The seriousness assessment of the events influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Received ProQuad vaccine on May 22, 2007 and presented at office with red, swollen area on right leg on May 2003, 2007. Was told by Dr to use cold compresses as needed and treat any pain with Motrin.
Narrative: An error occurred while administering the Moderna bivalent booster 10/5/22 at the facility, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml. Another COVID 19 Moderna Bivalent Booster 0.25 ml given 10/6/22 Left deltoid. Lot AS7146B Exp. 10/6/22
Swollen arm at Injection site; Pain at the site of Injection radiating to the back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications include birth control medication.
Body aches, muscle pain, headache ever since I took the shot, Goopy chest, red swollen hot rash at injection site, Fever, chills, sweating, 3 days with white blisters in back of mouth,
13FEB MMR & BHI administered; 22FEB elevated temp (not measured); 23FEB temp 105; 23 & 24FEB temp 106; 25FEB rash on trunk, face, & neck, red throat (negative for strep);
Chills; Fever at 102 F; Bad headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 102 degree Celsius (High) Body temperature-102 degree celsius.     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.   Concomitant medication details not reported by the reporter. Treatment included ibuprofen.; 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.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, 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), 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 included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Rebound covid symptoms (cough, rhinorrhea) after 6 days of testing negative; (13Apr2023) Negative, notes: Negative with symptom resolution starting 13Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient was treated with Paxlovid covid-19, treatment start date: 11Apr2023, Treatment stop date: 16Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE , COVID-19 and The suspected drug cannot be ruled out.
joint pain ("over whole body") 24hr p/vax;lasted 1wk;
High fever: 102.7, Shivering, Joint Pain, Muscle Pain,  Onset night of vaccination. Lasted 2 days. Took Tylenol and then Motrin. Stomach cramps, nausea, vomiting - Lasting 1.5 days. Onset on 3rd day.  Took Pepto Bismol. Nothing helped with the pain! Headache - From onset on night of vaccination & still have 4 days later. Tylenol & Motrin did not help.
Ovulation pain pain and fever, menstrual spotting after being in menopause for over 20 years.  Never had ovulation pain or spotting in that entire time.  This adverse effect resolved after 3 days.   Additionally, trigeminal neuralgia symptoms tic reported in VAERS 6/14/21  Temporary VAERS E-Report Number, have now advanced to facial pain.  This adverse reaction has not resolved and is getting worse.
all of a sudden I am having multiple teeth issues after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DENTAL DISCOMFORT (all of a sudden I am having multiple teeth issues after second shot) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DENTAL DISCOMFORT (all of a sudden I am having multiple teeth issues after second shot). At the time of the report, DENTAL DISCOMFORT (all of a sudden I am having multiple teeth issues after second shot) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
on the afternoon of 3SEP98 pt was noted to have collapsed @ daycare & had diff sitting, standing or walking;ataxia persisted over the evening accompanying signs of illness x/vomiting;no sz activity witnessed;gradually improving cerebellar
Suspected vaccination failure; shingles; This case was reported by a medical representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter could not remember any identifiable details other than female who got both doses Shingrix and still got shingles. This case was considered as suspected vaccination failure, as time to onset and laboratory confirmation test were unknown. The reporter consented to follow up.
On 1-25-18 arm sore by end of day, on 1-26-18 arm pain continued to increase as day went on. Arm swelling to elbow and turning red, then very red & hot. Bone in Lt. arm and muscle hurt. Even posterior ribs hurt by evening. Very painful to move fingers on left hand. At 10 PM had fever of 100.2 and chills. Legs were starting to jerk and cramps in my feet. 1-27-18 Deltoid area to elbow very swollen, red and firm. Increased pain on movement. Pain decreased over next few days, red tissue lasted about 5 days and pain when I would lift my left arm up. Took photo's.
18AUG93 recvd vax & 19AUg93 irritable, vomiting, high pitched crying;  afebrile; 19AUG93 ER visit; BS inc adm to hosp; dx diabetic ketoacidosis; new onset diabetes mellitus; r/o OM; nausea dx gastroenteritis; lethargic, dehydration, resp 40
Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K026666, expiration date: 20-OCT-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is a doctor as is her husband.  Her eyes and face swelled.  Eyes started first late in the evening 9/26.  By the morning of 9/27 her eyes and face were swollen.  She reports taking a Benadryl 25mg and Motrin 600mg every 6 hours.  She said the adverse effects slowly subsided.
Nothing for 8 days, then low grade fever, full body rash, leathery, poor appetite, swollen cheeks, reports of bone and joint pain, headache, tooth pain, cheek pain.
Right arm 20 x 11 cm erythema, below injection site right arm where pneumococcal was administered. Cleared by 3-8-2010.
AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient of an unknown age and gender  with no reported medical history, who experienced the serious (medically significant) unexpected AESI Atrial fibrillation, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender  with no reported medical history, who experienced the serious (medically significant) unexpected AESI Atrial fibrillation, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Events seriousness captured as per list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: pt's freind reported similar side effects for her and Pt. pt's friend claims that pt has generalized rash that started when she got hom. ras was on back, neck, buttocks, arms and legs. she claims that pt used benadryl otc and benadryl cream. rash resolved after aproximately 21 days
Woke the following morning with facial urticaria and complaints of abdominal discomfort and fatigue. No other symptoms and well immediately following immunization except for anticipated aching at injection site.  Reports no tongue or lip swelling/tingling, difficulty breathing, fever, arthralgia
Patient called me today and stated that she has flu-like symptoms, a fever of 102  F and arm soreness from the PNEUMOVAX 23 injection. Patient stated that it started in the middle of the night of 8/9/2017.