chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on his stomach and left arm; his left arm and back is itching,specially his left arm; rash on his stomach and left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm). At the time of the report, RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Site: Pain at Injection Site-Medium, Additional Details: Pt has had pins and needles in left arm and pain in left shouder and back since getting vaccine on August !st. Finally went to Dr on September 13th.  Getting a bit better but still haa pins and needles on left arm and pain in back and shoulder when sleeping.
an expired vaccine was administered to pt.  notified my supervisor and the lead immunization coordinator  and the provider of the incident provier of pt told me she would call the pt
OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
No adverse effects reported; two patients were administrated an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S013489, expiration date 06-MAR-2021 (strength, route of administration and exact dose were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of above 9 Celsius degrees (also reported as 16.8 Celsius degrees) for 3 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.; Sender's Comments:  US-009507513-1909USA007126:
Administered a vaccine after it expired.  Was opened at 9:00 am 10/6 and administered at 12:30 on 10/7.
Patient received Influenza vaccination in the deltoid of the right arm on 9/11/2020 in the am. MD indicated she presented today with an injury in the arm. Patient claimed shot was delivered intravenously in the elbow and was having a reaction on 10/7. MD indicated that the patient was ok and recovering with treatment. I indicated I would report and investigate the incident.
Symptoms started 11/11/21. Have been in the ED and hospital twice for tachycardia, arrhythmia, chest pain, shortness of breath and weakness. Symptoms have persisted for a month. Cardiologists suspect myocarditis or pericarditis, but I am unable to get the cardiac MRI until 1./20/22 to confirm.  Echocardiogram showed abnormalities.  Pulse rate elevates with minimal activity. Had an arrhythmia on 11/11, which initially sent me to the ED. I was hospitalized again 12/10-12/11 for chest pain, shortness of breath, weakness and episodes of tachycardia. No confirmed diagnosis at this time, but two Cardiologists suspect myocarditis or pericarditis.
After giving the vaccine patient complained of light headed and also his left hand where he got the shot was numb for a while. asked him to stay some more time to monitor. He did stay for an extra few minutes and left saying he is feeling better and no symptoms.
Ten days after vaccination I developed a hot, red spot at the site of injection. This spot grew larger, eventually taking up the top part of my arm, for the next 3 days until I began taking an antibiotic (Keflex) prescribed by my PCP. The red spot is still there (I have taken 5 pills in the course of two days) but has finally started to appear less red and feel less hot.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 02/17/2021 and 03/17/2021.   They tested positive for COVID-19 on 09/29/2021, and were admitted to hospital on 09/29/2021. They were hospitalized and discharged several times over course of the next 5 weeks after the positive test. They were hospitalized 09/29/2021-10/03/2021, then at a different hospital 10/09/2021-10/14/2021, and again at a third hospital 10/14/2021 until their death on 11/01/2021 (although one clinical note states date of death is 11/02/2021, the death certificate has 11/01/2021).  The individual had several underlying medical conditions, and this made medical management of the situation difficult. They were found to have acute hypoxic respiratory failure, COVID-19 pneumonia, and to be in A-fib. The individual was transitioned to comfort care after lack of improvement in condition. They died on 11/01/2021.
COMPRESSION RIGHT AT THE SOLAR PLEXUS; WOKEN UP FROM SLEEP; MAJOR HEART BURN; LEFT LEG SWELLING; FELT LIKE DRUNK; SEASICKNESS; FELT NAUSEOUS; FELT TIRED; FELT JET LAGGED; HOT OIL BEING INJECTED INTO ARM; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included alcohol user, and concurrent conditions included non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. the patient was not relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cyanocobalamin for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and for drug used for unknown indication.  On 09-APR-2021, the subject experienced hot oil being injected into arm. On 10-APR-2021, the subject experienced felt jet lagged. On 10-APR-2021, the subject experienced felt tired. On 11-APR-2021, the subject experienced seasickness. On 11-APR-2021, the subject experienced felt nauseous. On 12-APR-2021, the subject experienced felt like drunk. On 15-APR-2021, the subject experienced left leg swelling. On 01-MAY-2021, the subject experienced major heart burn. On an unspecified date, the subject experienced compression right at the solar plexus, and woken up from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like drunk, felt jet lagged, seasickness, left leg swelling, hot oil being injected into arm, felt tired, and felt nauseous, had not recovered from major heart burn, and the outcome of compression right at the solar plexus and woken up from sleep was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VAQTA and a dose of M-M-R II (strength, lot number, expiry date, route and dose were not reported for both vaccines), which were improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reporter. (Linked to 1501USA008154, 1501USA012474, 1501USA012475, 1501USA012476). Additional information has been requested.
Fatigue, chest pain that will not go away and can't find out what is causing it.
5-7 DAYS FOLLOWING MMR VACCINE, I DEVELOPED PAIN, SWELLING, AND NUMBNESS IN MY FINGER, KNEES, ANKLES, AND MY ARM.
had induration; This case was reported by a physician via sales rep and described the occurrence of induration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced induration. On an unknown date, the outcome of the induration was recovered/resolved.   It was unknown if the reporter considered the induration to be related to Pediarix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Pediarix and experienced induration which lasted approximately 2 weeks. The reporter did not consent to follow up.
Information has been received from a physician concerning a 4 year old male who was vaccinated with a second, single dose of Varivax. Concomitant vaccines administered on the same day included MMR. The patient developed a 4 inch area of soft, pink swelling below the injection site with injection site tenderness which caused the patient to limp. A chest x-ray was normal and the patient was afebrile. Unspecified medical attention was sought. No product quality complaint was involved. This was considered a significant disability or incapacity by the reporter as the patient was limping because of the swelling. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 11-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist at the pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine on 28-JAN-2022; This spontaneous report was received from a Medical Assistant and refers to a 4-year-old female patient. The patient's medical history included frequent chronic ear infections. The patient's concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 28-JAN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot #U002532, expiration date: 24-JUL-2022, administered subcutaneously (anatomical location: right thigh) for prophylaxis (strength was not provided).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in temperature - 12.3 degree Celsius for 1 hour (product storage error). Previous temperature excursion were reported as follows: -13.3 degree Celsius for 30 minutes; -11.1 degree Celsius for 1 hours 15 minutes; -8.9 Cdegree Celsius for 1 hour 30 minutes; -14.4 degree Celsius for 6 hours. No adverse effects were reported.
This patient is an 83-year-old male with a history of hypertension, diabetes, atrial fibrillation, and congestive heart failure who was recently in the hospital for atrial fibrillation and a fall.  He was discharged to an extended care facility.  The staff from care facility state that he has had increasing pedal edema since he arrived there. They did administer an extra dose of Lasix yesterday.  In addition they noticed a rash on his abdomen, back, and feet over the past 2 days.  He has had no reported fever
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), unknown MMR vaccine and unknown VARIVAX vaccine. FLUMIST quadrivalent (intranasal) started on 13-Nov-2015, MMR started on 04-Dec-2014 and VARIVAX started on an unknown date. Nurse reported that patient received a dose of MMR  FLUMIST and VARIVAX less than 4 weeks apart from another live vaccine called FLUMIST quadrivalent. The outcome of the event of FLUMIST quadrivalent administered with MMR and VARIVAX is unknown. The report was considered to be non-serious. Corrected report on 25-Nov-2015: Key ingredient updated.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Pregnancy; Initial Report Received on 23-Sep-2022 and 07-Oct-2022 (Safety received 14 Mar 2023)   A nurse reported to the pregnancy registry that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site were not provided.   The nurse provided the Registry contact number to the participant and the potential participant seemed interested in enrolling, but the patient was not actually a patient in her department. The Pregnancy Registry made several attempts to the reporter on 20 Oct and 09 Nov 2022 to follow-up on the potential participant, but was told the reporter was not there.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
On the morning of September 4th, patient woke with a fever, swollen left hand and fore-arm with peripheral neuropathy. As the progressed these same symptoms affected the right hand and right fore arm. Starting distally in the fingers and moving proximally up the arm. Late that evening both upper legs showed signs of numbness and burning, ice packs were applied to alleviate the pain and burning feeling.
Day 1 late afternoon: noticed swelling and broken blood vessels around bridge of nose.  Awoke day 2 7am with numbness of whole nose.  Numbness spread to palate, tongue & lips by late morning. Felt ill and shaky.  Spread later to sides of face around jawline. Checked myself for stroke. Blood pressure was elevated 140/100, came down near normal by end of the day 110/80.  Day 3, numbness reduced in nose, still in tongue and lips.  Day 4: saw family doctor, tested for stroke: negative. Took blood for testing, don't have results yet. Blood pressure back to normal: 100/60. Still have a little intermittent numbness in tongue and lips.
On 10.23.08 an area approximately 11/2 by 11/2 oblong on left latersl arm noted. Arm warm to touch reddened area. vaccine administered on 10/21/08. Advised to take an antihistamine at night. will continue to monitor untill resolved
Red rash that appeared on the back of her neck the evening after the vaccine.  The rash then expanded to the front of her neck as well.
Brought me out of years of menopause and I had a menstrual cycle for a full week; All my bones ache more; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 59 years old) via an unspecified route of administration, administered in Arm Right on 22Apr2021 (Batch/Lot Number: EN6199) as dose 2, single for covid-19 immunisation. Medical history included known allergies: Penicillin. There were no concomitant medications. The patient had no covid prior vaccination, not other vaccine in four weeks and no other medications in two weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 59 years old) via an unspecified route of administration in the right arm on 25Mar2021 (Batch/Lot No: EN6199) for Covid-19 Immunization. The patient reported that on 25Apr2021, it brought her out of years of menopause, and she had a menstrual cycle for a full week. All her bones ache more. She has been to the doctor and they couldn't find anything wrong. So, the patient would like to know how it changed her system when they said it doesn't affect DNA. The events were treated on check-up. The patient was not tested for covid-19 post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
include congestion, fatigue, headache, chills, body aches. starting 11/30/21
Below injection site there is a rash that looks like a burn that is the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 14-Apr-2021, the patient experienced VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter). At the time of the report, VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report was received from a registered nurse via company representative regarding a 14 months pediatric patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with VAQTA for prophylaxis (dose number, frequency, route, anatomical location, lot # and expiration date were not provided). On an unspecified date, the patient received a dose regiment of VAQTA too soon at 14 months instead of the 16 month and the patient experienced an adverse reaction. At the reporting time, the outcome of adverse reaction was unknown. The reporter did not assess the relatedness between VAQTA and the reaction.
77-year-old male with past medical history of stroke, hyperlipidemia, diastolic heart failure, diabetes mellitus, and hypertension presents ED for evaluation of sudden onset of dizziness.  Reports his dizziness started today early in the morning while he was outside taken to trash.  He later went to his house and sat down but his dizziness did not go away.  His dizziness only resolved after arriving to the ED.  Denies loss of consciousness.  Did not fall. Has only eaten tangerines today