chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent for 6 to 12 years instead of the bivalent for 6 months to 5 years; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent for 6 to 12 years instead of the bivalent for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent for 6 to 12 years instead of the bivalent for 6 months to 5 years) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent for 6 to 12 years instead of the bivalent for 6 months to 5 years) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent for 6 to 12 years instead of the bivalent for 6 months to 5 years).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
My son felt fine but then developed intermittent chest pain 1-14 days after the vaccine. The chest pain was right over his heart and would come and go.
Injection site pain, tenderness, swelling, tight, redness, hot.  These symptoms did not show up until 13 days after injection.
Pains from the top of her shoulders to her fingers; Neck hurts; Upper arm hurts; Shoulder hurts; Lymph node hurts; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains from the top of her shoulders to her fingers), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), VACCINATION SITE PAIN (Soreness of arm) and ARTHRALGIA (Shoulder hurts) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type II diabetes mellitus, Hypertension, Osteoporosis, Arthritis, Fibromyalgia and Neuropathy.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness of arm). On 14-Feb-2021, the patient experienced NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), ARTHRALGIA (Shoulder hurts) and LYMPHADENOPATHY (Lymph node hurts). On 28-Feb-2021, the patient experienced PAIN (Pains from the top of her shoulders to her fingers). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain management, at a dose of 1 dosage form. At the time of the report, PAIN (Pains from the top of her shoulders to her fingers) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown and NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Upper arm hurts), ARTHRALGIA (Shoulder hurts) and LYMPHADENOPATHY (Lymph node hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
This spontaneous report was received from a medical assistant who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # M013156, expiration date on 15-OCT-2017 (dose and route of administration were not reported), for prophylaxis. The medical assistant stated that PNEUMOVAX 23 did not experience any temperature excursions prior to administration. No adverse symptoms were reported.
Increased size from 1.5 in diam to 2.5 in diam. Feeling tired, lethargic, mild nausea. Pt had been alternating Ibuprofen and TYLENOL. Tried ice - didn't make a difference. Prescribed cephalexin 250 mg, 21, 1 tab(s) 3 times a day for 7 days. Got better after 24 hours of antibiotics.
Patient states she was sick for two days in bed after the vaccines and her arm has been sore since.
This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 17-MAR-2014, the patient was vaccinated with second dose of ROTATEQ, lot #J008735; expiration date: 24-MAR-2015 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Felt more weak and wobbly until I was unable to walk. Emergency room physician diagnosed urinary tract infection and sent me home. Went back following day and was admitted
several pt from this facility recv inj & devel inj site rxn characterized by swelling & pain;
Patient received MMR/ V instead of DTAP/ IPV  on 4/8/22 Last MMR/ V given 3/7/22 Site redness / fever  on 4/12/22
cellulitis; This spontaneous report was received from a consumer who was referring to herself, a female patient of unknown age, via Pfizer (manufacturer control #2019391227). There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported).        On an unknown date, the patient experienced side effects from pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) such as cellulitis and wanted unspecified medical information.  The outcome of cellulitis was unknown.    The reporter considered cellulitis to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).     Upon internal review, cellulitis was determined to be medically significant.
Information has been received from a consumer concerning a female patient who on an unspecified date was vaccinated with an adult dose of RECOMBIVAX HB. The consumer reported that my baby's mother ended in the hospital with multiple sclerosis 6 months after the shot. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Moderna booster given at 11:00 AM, 11/03/2021.   At approximately 8:00 AM, 11/04/2021 had dizziness while returning to bed.  Experienced  6-10 second syncopal episode with up to 30 seconds of antegrade amnesia. During syncope,  respirations were unlabored and the return to consciousness was prompt.  Pulse was regular (approx 80 beats/min) immediately after awakening. (Observant of the episode was a retired physician.)
Local reaction at injection site. Treatment-BENADRYL. Arm red and swollen.
Tip of tongue and upper and lower lip fell numb and tingly. Alleviated with Benadryl 50mg orally.
Heart beating really fast, and it lasted a few minutes before it went away. She said when she got home, it happened again and it lasted longer; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 58-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date in Sep2021 as dose 1, single for covid-19 immunization. Medical history included allergies to certain medications, bee stings, and "all kinds of stuff". The patient's concomitant medications were not reported. On an unspecified in Sep2021, she had the vaccine about 2 and a half weeks ago, the 1st dose, and right after she had it and was sitting there she felt her heart breathing really fast, and it lasted a few minutes before it went away. Patient also reported that they made her stay for 30 minutes and it lasted a few minutes. She said when she got home, it happened again and it lasted longer. 2 hours later, it happened again and it lasted for 10-15 minutes. Consumer said she was scared it would happen again with the 2nd dose. She wanted to know if she should go ahead and proceed with getting her 2nd dose. Outcome of the event was recovered on an unspecified date in Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Metallic taste after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste after the 2nd dose) in a female patient of an unknown age 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste after the 2nd dose). At the time of the report, DYSGEUSIA (Metallic taste after the 2nd dose) outcome was unknown.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.
most of the vaccine ran down outside; one of the needle was not completely tight; one of the needle was not completely tight; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside), UNDERDOSE (one of the needle was not completely tight) and DEVICE CONNECTION ISSUE (one of the needle was not completely tight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside) and UNDERDOSE (one of the needle was not completely tight). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (one of the needle was not completely tight). At the time of the report, INCORRECT DOSE ADMINISTERED (most of the vaccine ran down outside) and UNDERDOSE (one of the needle was not completely tight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Muscle tenderness over injection site/minimal red/NO induration/not hot over area.  Normal ROM, muscle strength. Diphenhydramine and Ibuprofen prescribed at time of visit for immunization reaction.
PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 FEVER ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 FEVER PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA PULMONARY EMBOLISM, UNSPECIFIED. 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES 12/1/2021 ACUTE IDIOPATHIC THROMBOCYTOPENIC PURPURA
Patient experienced swelling and redness at injection site approximately 4 inches in diameter. Pain and heat accompanied at injection site.
Couldn't left my right arm at all on Mon. then started with severe headaches, loose stools, chills, nausea continued  for 2 weeks, jest started to feel better now
In the evening started arm pain. At 2:30am, woke up with chills, temp at 100.1.
poking needle sensation; I had the booster Pfizer vaccine and developed a rash all over my face; It is unusually red with small 'hives."; It is unusually red with small 'hives."; my skin is very sensitive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Dec2021 (Lot number: FL3198, Expiration Date: Jun2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "poking needle sensation"; RASH (non-serious), outcome "unknown", described as "I had the booster Pfizer vaccine and developed a rash all over my face"; ERYTHEMA (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "It is unusually red with small 'hives.""; SENSITIVE SKIN (non-serious), outcome "unknown", described as "my skin is very sensitive".  Additional Information: Customer Verbatim: After a Booster shoot (Pfizer/BioNTech, Lot: FL3198, Exp: Jun2022) On 21Dec2021, I had the booster Pfizer vaccine and developed a rash all over my face. It is unusually red with small 'hives." The rash is not itchy, but my skin is very sensitive. If I scratch, it feels like I am being poked with a small needle. It has been over one month, and the rash and the poking needle sensation has not disappeared. How long is this going to last, should I be concerned, and do I need to see my doctor?  Follow-up attempts are completed. No further information is expected.
15mins post vax pt became dizzy, eyes dilated & was pale;pt went to Er;pt had no further problems;pt's mom stated pt felt bad for a total of 45mins;
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report was received from a caregiver (PVX2019-192) on 18-Jan-2019. The report describes a 20-year-old female consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003240) for trip.  It was reported that the consumer took four doses of Vivotif in an inappropriate way. She took it on day 1, 3, 6, and 8 respectively.   The action taken with Vivotif with respect to the event "did not take Vivotif according to schedule" was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Patient came in complaining of new onset of menstrual irregularities, break through bleeding and chronic, non-productive cough, which she states began within days of receiving the vaccine. Referral to OBGYN was initiated after a pelvic ultrasound was significant for bilateral ovaries with multiple follicular cysts. At the time of presentation, and on follow up, the patient denies history of PCOS or other menstrual irregularities and clinical presentation at that time was incongruent with PCOS diagnosis. Patient was treated for reported cough. At follow up, the patient reported that cough was still persistent and additional  imaging was ordered at that time. Patient has not yet pursued the imaging as of this time.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vaccine was placed in refrigerator on 17-Nov-2021. The vaccine did not go any temperature excursion and does not experience adverse event. No treatment information was provided.
Fever/chills. Radiating pain in arm, unable to raise arm/bend. Swelling at site. Nausea.
Information has been received from a registered nurse concerning her 6-year-old daughter with no pertinent medical history and no known drug allergies, who on 06-JUL-2006 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included poliovirus vaccine, measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The first dose of varicella virus vaccine live (Oka/Merck) was given on 17-SEP-2007 with concomitant vaccinations Prevnar and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). On15-Nov-2007, the patient broke out in chickenpox all over her body, (head, neck, hair, in one ear and trunk). The child had a fever for 4 days of 102F, vomited for 3 days and a cough. No medical attention was sought, the mother monitored the child's condition at home and administered Tylenol and ibuprofen. The child is recovering but the cough persisted. No product quality complaint was involved. Additional information is not expected.
Patient began use of oral typhoid on 4/21/2014 in preparation for upcoming trip. She took her second dose on 4/23 and will take 3rd dose tonight (4/25) and final dose on 4/27. Approximately 24 hours after 1st dose (4/21) she began to experience a mild headache with stomach cramping. After her second dose, her headache worsened and she took her MAXALT w/o relief of 6/10 headache. Her stomach ache continued and she has urge to have a BM but cannot. She reported to medical this morning (4/25) due to persistent headache (throbbing ache around head) and no BM in 3 days and some sharp diffuse mid/lower abdominal pains. Headache is similar to past migraine but MAXALT typically resolves -this one is not. She believes this is just the side effects from the vaccine she was advised about. She advised she was told to come to VHC by sick-call provider for further evaluation.
This spontaneous report has been received from a nurse prescriber via a field representative concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date were not reported ) subcutaneously for prevention of shingles. On an unknown date, the patient developed shingles. It was not known by the primary reporter if treatment was provided. At the time of the report, the outcome of the event was unknown.
Received call from attending physician of patient.  Dr. says his patient has vaccine related rash & believes it is shingles which became apparent within 48 hours after receiving the vaccine.  I called the manufacturer requesting more info regarding Zostavax.  Medical dept (Merck) says they are willing to test sample from rash to see if the rash is related to vaccination.  This info. was relayed to patient's doctor & other for user.
Dose #3 administered at 2:30-3pm.  Soreness at injection site and then body aches, nausea, and headache at 6am on 05/23/06.  Event reported to MD administering vaccine.  MD advised pt to report to Public Health and Env Services.  Pt again advised to have MD report event since additional details unknown to health department.
BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On Mar-2021, the subject experienced fever, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reported. This report was non-serious.
about 5 minutes after vaccine administrated, pt "felt bad" and moments later passed out, her bp was checked and was slightly low but patient was still feeling bad so we called 911 and the emt came and checked her as well, bp lower this time and pt passed out again, emt started an iv and gave the patient Zofran and she was transported to the hospital