chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnant patient received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant patient received vaccine) in a 37-year-old female patient (gravida 7, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Secondary infertility (female), Hyperemesis (Pregnancy history) on 04-Jun-2019, Hyperemesis (Pregnancy history) on 25-Jan-2017, Hyperemesis (Pregnancy history) on 03-Jan-2014, Torn muscle (unclear if torn back muscle was maternal medical history during pregnancy or infant) on 03-Jan-2014 and Spontaneous abortion (genetic abnormality, chromosomal issue with fetus.) on 28-Dec-2012. Concurrent medical conditions included Seasonal allergy (seasonal-grass), Topical adhesive allergy (adhesives), Allergy (cedar), Hypothyroidism, Osteoarthritis, Irritable bowel syndrome and Asthma (Asthma post-partum). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, L-THEANINE, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Sep-2020 and the estimated date of delivery was 04-Jul-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant patient received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 03-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Pregnancy test: (Positive) Pregnancy test positive. On 12-Dec-2020, Cytogenetic analysis: (normal) Genetic testing normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Doctor's office 12/14/04 : states infected. Advil: warm compresses, red, hot arm. No temperature.
Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL 0.5 mL injection.  The patient did not experience any adverse experience after the first dose.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL 0.5 mL injection and developed hives.  On an unspecified date the patient was vaccinated with a third dose of GARDASIL 0.5 mL injection and developed a rash.  Medical attention was sought.  At the time of reporting the patient had not recovered from the hives or rash.  No further information was provided.  Additional information has been requested.
I began to feel faint; rapid increase in heart rate; shortness of breath; This is a spontaneous report from a contactable consumer (patient).  This 42-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EW016) on 16Apr2021 at 10:00, at the age of 42 years, as the first single dose, in left arm, for COVID-19 immunisation. Medical history included COVID-19. There were no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 8 minutes after the first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath. Major symptoms subsided after a couple of minutes. The events resolved on 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101060826 same patient, different vaccine dose and events
Hives ->BENADRYL, temperature ->Unknown, Neck/Back ache.
Pt developed body aches, chills, sore throat and increasing difficulty swallowing with swelling of lip, 1 day after receiving influenza vaccine injection and about 8 weeks after beginning Allopurinol (history of receiving influenza vaccine yearly without reaction; Allopurinol initially 100mg OD but increased to 300mg several weeks later). Pt had 80% to 90% body surface area sloughing (Toxic Epidermal Necrolysis). Admitted to the hospital, 1 day after development of above mentioned signs and symptoms; allopurinol discontinued and treated with antibiotics and steroids. After 16 days in the hospital, he was transferred to another hospital service where steroids were discontinued; treated with IVIG, silver nitrate topical. Wounds continued to slough and pt expired on 5th hospital day.
arm was warm; feels like there is a lump - front of injection site; FEELS HARD- front of injection site a little bit; feels like picking; arm was so itchy - front of injection site a little bit; not real red; had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, VACCINATION SITE WARMTH, VACCINATION SITE MASS, VACCINATION SITE IRRITATION, and VACCINATION SITE PRURITUS in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included BABY ASPIRIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE MASS, VACCINATION SITE IRRITATION, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA, and PERIPHERAL SWELLING. The patient was treated with DIMETICONE, MENTHOL, PRAMOCAINE HYDROCHLORIDE ongoing since an unknown date for Itchy, at an unspecified dose and frequency; VASELINE ongoing since an unknown date at an unspecified dose and frequency and HYDROGEN PEROXIDE ongoing since an unknown date at an unspecified dose and frequency. On 14-Jan-2021, PAIN IN EXTREMITY (had a sore arm) had resolved. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE MASS, VACCINATION SITE IRRITATION, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA, and PERIPHERAL SWELLING outcome was unknown.            Reporter did not allow further contact
Soreness at Covid-19 vaccination site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at Covid-19 vaccination site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Patient had a febrile seizure 5 days after receiving MMR, VZV, Comvax vaccines. Temp. was 103.8. Seizure lasted 2 minutes. No source of fever discovered.
burning pain; bone pain; old shoulder injury and that hurt worse; Tired; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired). At the time of the report, BURNING SENSATION (burning pain), BONE PAIN (bone pain), ARTHRALGIA (old shoulder injury and that hurt worse) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was  not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-063219 (Patient Link).
screaming, loud, began 3 1/2hr p/vax;lasted 3 hours;mom described irregular breathing,sl jittery, next day;
Systemic: Dizziness / Lightheadness-Mild, Systemic: sweating-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After administering the Pfizer vaccine, in 2-3 minutes patient became light headed, had vision changes, lost her voice, and was sweating. Patient put her hands in her head and began to regain her vagal functions. The patient never lost consciousness and always had a pulse. She was given a bottle of water, an icepack, and a protein bar. Patient was monitored for more than 30 minutes to make sure she was ok by the pharmacist and technician who sat with her the whole time.
Tongue tingling around 3pm on 4/14/21.  Extreme headache 7am on 4/15/21.  Extremely hot from 7:40am-9am.  4/15/21 injection site is sore, red, swollen, and hard.  Ringing in my ears started around 2pm on 4/15/21.
Information has been received from a registered nurse concerning a 14 year old female pt who was vaccinated with Hep B. Subsequently the pt experienced flu-like symptoms that consisted of nausea, dizziness, fever of 101 and lightheadedness. Approximately one week post onset, the pt recovered. Additional information has been requested.
The rash was sore and warm to touch; Within 24 hours she had a huge red rash the size of a baseball on her left arm; The rash was sore; Within 24 hours she had a huge red rash the size of a baseball on her left arm; fatigue for 24 hours after her second shot. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The rash was sore and warm to touch), RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm), VACCINATION SITE PAIN (The rash was sore), VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm) and FATIGUE (fatigue for 24 hours after her second shot.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (hives from Iodine contrast dyes and other sources). Concurrent medical conditions included Iodine contrast media allergy (hives from Iodine contrast dyes and other sources.).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue for 24 hours after her second shot.). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (The rash was sore and warm to touch), RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm), VACCINATION SITE PAIN (The rash was sore) and VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm). In January 2021, FATIGUE (fatigue for 24 hours after her second shot.) had resolved. On 09-Feb-2021, VACCINATION SITE PAIN (The rash was sore) and VACCINATION SITE RASH (Within 24 hours she had a huge red rash the size of a baseball on her left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (The rash was sore and warm to touch) outcome was unknown and RASH ERYTHEMATOUS (Within 24 hours she had a huge red rash the size of a baseball on her left arm) had resolved.            No concomitant medications were reported.  The patient received her second Moderna Covid-19 vaccine and expiration date is not available. The patient received the vaccine in her left arm shoulder deltoid muscle.   It was reported that within 24 hours patient had a huge red rash the size of a baseball on her left arm. The rash was sore and warm to the touch. The rash lasted for 2 weeks. The patient had fatigue for 24 hours after her second shot.   No treatment details were reported.   This case was linked to MOD-2022-546786, MOD-2022-546931, MOD-2022-546935, MOD-2022-546503 (Patient Link).
Heavy rash taking over my skin on my right arm bringing discoloration to my skin and it?s spreading
PARENT REPORTED TO SCHOOL NURSE LEADER THAT LATER THAT DAY CHILD DEVELOPED "HIVE LIKE" RASH AROUND INJECTION SITE [MOM DESCRIBED LOOKING LIKE MOSQUITO BITES]. NO HIVES ELSEWHERE, NO BREATHING DIFFICULTIES, FLUSHING, PROJECTILE VOMITING, LARYNGOEDEMA. 'HIVES' AROUND INJECTION SITE RESOLVED SPONTANEOUSLY.
Patient received the Pfizer vaccine on 3/18/21 and 4/8/21 so was fully vaccinated when they tested positive for COVID-19 on 9/17/21.
This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. Concomitant therapies included sterile diluent (MERCK). The patient's concurrent conditions and medical history were not reported. In approximately March 2018, reported as "about 3 months ago", the patient was vaccinated with a dose of VARIVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) and in approximately 2018, reported as "one week later", the patient was administered a dose of M-M-R II for prophylaxis (strength, dose, route, frequency, therapy type, lot/batch # and expiration date were not reported). No adverse effects were reported.
This spontaneous report was received from a registered nurse referring to a 46 year old female patient. The patient had a known allergy to penicillin. The patient had no pertinent medical history or concurrent conditions. The patient's concomitant therapies included vitamin D3, folic acid and unspecified multivitamins. On 08-JAN-2018, the patient was vaccinated with the 1st dose of varicella (Oka/Merck) VARIVAX, subcutaneously (lot # and expiration date were not provided) for prophylaxis. On 10-JAN-2018, the patient developed red, raised bumps on her chest, back and side (rash erythematous). Furthermore, the patient developed 2 bumps on the inside of her tongue following (tongue disorder). The patient sought for medical attention, however no treatment was provided for her symptoms. No laboratory diagnostic procedures were performed. At the time of the report, the outcome of tongue disorder and rash erythematous was reported as not recovered. Additionally, a causality between the adverse events and vaccination with Oka/Merck VARIVAX was not provided.
Mom reports area of redness up to 3" - red and warm to the touch - no fever - redness and slight swelling on Friday but got worse on Saturday - place at injection site 1/2" now - advised to use cold compress and anti-inflammatories.
At approximately 6:47pm we gave a Janssen COVID vaccine to the patient. After a few minutes the patient became noticeably sweaty with pallor. I talked with him and he said he was dizzy as well. He stated that it is due to anxiety. I checked his blood pressure and it was 124/94 with a pulse of 83. We gave him a cold pack to use on his wrists and neck. We watched the patient for any worsening of symptoms. After a while the patient stated he now felt  fine with no symptoms and left with no issues.
Immediate dizzy light headed, stayed an extra 30 min.  More tired, breathless, getting progressively worse.  July 2021, passed out and lightheaded dizzy, went to hospital.  Ran tons of tests, chest pain, right side numbness and pain from shoulders to feet.  Fatigue trouble breathing, on oxygen.  Panic and Anxiety attacks constantly at night.  Went to neurologist, gastro doc and cardiologist.  Oct 8th going to see pulmonologist.  Sick, tired, hard to breathe since 2 weeks after the 2nd shot
Itching Rash; This is a spontaneous report from a contactable nurse. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an intramuscular route of administration in the right arm on 01Apr2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included end stage renal disease (ESRD). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 02Apr2021, the patient experienced itching rash. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with antihistamine (unspecified) and cortisone cream (MANUFACTURER UNKNOWN). The clinical outcome of event itching rash was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.   The patient's past medical history included Exposure to chemical pollution (exposure to Agent Orange) and Open heart surgery. Concurrent medical conditions included Hypertension.  On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle) outcome was unknown.  Concomitant medication of the patient was not reported.  The patient received his second vaccine in his left arm shoulder deltoid muscle.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-461985, MOD-2022-462001 (Patient Link).
tongue swelling; lips swelling; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were provided by the reporter.
This 36  year old   female received the Pfizer Covid shot on 4/17/21    and went to the ED on  4/20/21     and was admitted  on 4/20/21 with the following diagnoses listed below. I63.9 - Cerebral infarction, unspecified I63.9 - CVA (cerebral vascular accident) (HCC)
Cough; This is a spontaneous report from a non-contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 15Jun2021 as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that last week (Jun2021), the patient started coughing and reported that this might be a problem after taking the first dose of Pfizer COVID-19 vaccine. The consumer cancelled the appointment for the 2nd dose due to cough which the patient was supposed to get on 06Jul2021. The patient just had cough a little bit now. The consumer wanted to know if it was safe to go if he was coughing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received a second dose of the pfizer bivalent vaccine which is not within guidelines.  Patient has reported no adverse event.
1st dose on 4/29/21 Lot number N/A. Cellulitis given PREDNISONE for 9days. Recurred and patient saw PCP dx contact and cellulitis Rx BACTRIM AND PREDNISONE for longer taper which was then extended by consulting dermatologist. PERMETHRIN given to cover scabies too. Rash involves 90% BSA, affecting palms, and soles and requiring 2 weeks out of work. Patient on long term PREDNISONE and immunosuppressant MYCOPHENYLATE MOFETIL as of early September. Patient history of elevated PSA, insomnia, hyperlipidemia, history of kidney stones, and multiple joint arthritis.