chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flushing, rash, itching to face and neck, swelling of lips treated with PO Benadryl when event reported, continued to use Benadryl until 9/24 when felt recovered
Information has been received through Merck pregnancy registry from a pharm D. concerning a 33-year-old pregnant female (LMP 20-MAY-2007) with no pertinent medical history or allergies who on 04-OCT-2007 (also reported as 05-OCT-2007) was vaccinated intramuscularly with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included prenatal vitamins (unspecified). On 04-OCT-2007 the patient came to the emergency room for vaginal bleeding and the physician noticed that her children had chickenpox. The physician was thinking of administering immunoglobulin to the patient but realized that she was "outside the criteria" and decided against it. A nurse who was not aware of this decision administered varicella virus vaccine live (Oka/Merck) intramuscularly thinking that it was immunoglobulin. Pharmacist stated this was not a situation of product confusion. The patient had a pregnancy test, genital wet mount (negative for trichomonas), chem panel and ultrasound performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow-up information received on 27-MAY-2009 indicated the patient was homeless and the reporter was unable to obtain additional information at this time. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (strong headache), MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEADACHE (strong headache). 13-May-2021, the patient experienced MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (strong headache) had not resolved and MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Patient had her second vaccine shot around 2:00 pm. Patient reported that she was taking rest. No concomitant medications were reported. This case was linked to MOD-2021-127514 (Patient Link).
2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided.
Patient said she was fatigued and had to sleep all day. She was also confused and disorient. She could not remember where she was and forgot to take her medications. Her family almost called 911 because they were very concerned. She said her experience lasted for 24 hours.
Body aches; Nausea; Vomit; Diarrhea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 09Apr2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included estradiol, progesterone (BIJUVA; hormone replace therapy) from an unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 19Mar2021 at 13:45 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:30, the patient experienced nausea, vomit, diarrhoea, body aches, and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of nausea, vomit, diarrhoea, body aches, and chills which included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of nausea, vomit, diarrhea, body aches and chills were recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I woke up the morning after getting my first shot with a 100.3 fever, very lightheaded, and had muscle aches. Lasted for one day and then I felt back to normal. A week after the first shot I woke up with intense pain at the injection site on Thursday and Friday.
Suddenly died from a heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Suddenly died from a heart attack) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced MYOCARDIAL INFARCTION (Suddenly died from a heart attack) (seriousness criteria death and medically significant). The patient died on 04-Jan-2022. The reported cause of death was suddenly died from a heart attack. It is unknown if an autopsy was performed.            No concomitant medication details was provided. The patient was  died from unexplained experimental mRNA technology which was seen result in massive wave  of youth illness and death. No treatment medication details was provided. Company comment:This case concerns 13-years-old, male patient with no reported medical history, who experienced the unexpected Fatal AESI event of Myocardial infarction event (seriousness criteria death and medically significant). The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns 13-years-old, male patient with no reported medical history, who experienced the unexpected Fatal AESI event of Myocardial infarction event (seriousness criteria death and medically significant). The event occurred approximately 7 months after the second dose of mRNA-1273 vaccine. At the time of report, very limited information has been provided about the patient and about the event leading to the fatal outcome. It is also unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Suddenly died from a heart attack
Pt states her lips were tingling after the vaccine. Took benedryl. Went to ER on the evening of 9/24. Had dizziness but no itching, swelling, or trouble swallowing. Experience mild breathing difficulties. Symptoms started 5-10 minutes after shot was given. Once going to ER the next day, Pt informed staff she has had anaphylaxis in the past (7-10 years ago).
High temperature, high blood pressure, vision loss, possible glaucoma, muscle ache, anxiety, depression.  11/16/06 Received medical records from VAMC which reveal patient seen 9/03 for acute supurative conjunctivitis.  No other problems noted until 6/05 when eval by neurosurgeon for neck & back pain after falling from truck on deployment 2004.  Disc bulging noted at that time at C4-5, C5-6 &  C6-7.  HNP t L5-S1.  Had received 2 epidural blocks for lumbar pain with some resolution.  Next seen 8/06 by neurosurgeon still c/o LBP & neck pain.  Was receiving PT.  Felt that surgery would not benefit patient & he was to continue PT & meds.  Vaccination record also included with records.
Started itching in administered arm - then rash on arm which spread to trunk and whole body took BENADRYL and used Aveeno - was on chemo - steroid medicine helped.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 002az1a), in left arm and on 13Jun2022 as dose 4 (booster), single (Lot number: 056m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high bp" (unspecified if ongoing); "high cholesterol" (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 Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Plaxovid from 26Jul2022 to 30Jul2022.  Clinical course: Patient had no known allergies.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: 10 minutes after vaccination, patient began to sweat then passed out and unresponsive for about 30 seconds or so (shook a few times) & then came to with continued sweating.  EMS was called who checked him out but he did refuse transport and left later on his own after about 45 to 60 minutes .
left arm was red and itchy. patient is using benedrly started 3-4 hours after immunization and is still currently red and itchy on 11-4-19
Information has been received from a nurse practitioner concerning a 3 year old female patient with no reported medical history who on 01-AUG-2005 was vaccinated with a dose of hepatitis A virus vaccine inactivated (Lot# 649453/0132R). There was no concomitant medication. The patient developed a severe local reaction after receiving a hepatitis A virus vaccine inactivated. The child developed a fever and vomiting within the first 24 hours following the vaccination. Then her arm turned red and was warm to the touch. The child was seen in the office in on 04-AUG-2005 and her father called because the swelling got worse during the past few hours. The reported indicated that it may be cellulitis and that the child had an appointment for 05-AUG-2005. At the time of this report, the patient had not recovered. There was no product quality complaint involved.  Additional information has been requested.
2 days /p receiving Rabies vax booster, pt's skin became red & flushed /w severe urticaria.  No respiratory distress-given Benedryl & Epi
Aplastic anemia; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Aplastic anemia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination.     Patient had no medical history of allergies and not had COVID plus test or diagnosis. No acute and chronic illnesses at the time of vaccination was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced APLASTIC ANAEMIA (Aplastic anemia) (seriousness criteria hospitalization and medically significant). At the time of the report, APLASTIC ANAEMIA (Aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: low blood cells (Low) low blood cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  Patient visited his primary doctor and he did a blood test, where they found out he had low blood cells, he was admitted at the hospital that day, but because his case was complex, they had to refer him to another hospital. He was currently admitted in the hospital receiving treatment and blood transfusions forhis aplastic anemia.  He was in the hospital receiving treatment for his aplastic anemia. Medication and blood transfusion for the aplastic anemia was reported.  Company Comment: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected serious event of Aplastic anemia. The event occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine and resulted in hospitalization. The patient is currently admitted in the hospital receiving treatment and blood transfusions for his aplastic anemia. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected serious event of Aplastic anemia. The event occurred approximately 2 days after receiving the first dose of mRNA-1273 Vaccine and resulted in hospitalization. The patient is currently admitted in the hospital receiving treatment and blood transfusions for his aplastic anemia. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a physician's assistant via company representative refers to a 61 year old female patient. On 23-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # J004310, expiration date 12-JUL-2014, 0.65 ml dose, subcutaneous. It was reported that the patient experienced shingles a year after receiving ZOSTAVAX (adverse event onset date reported as 07-JUL-2014). On 07-JUL-2014, the patient saw physician for a rash on the right arm and was treated with bacitracin. On 22-JUL-2014, the patient was seen by the nurse practitioner and received VALTREX. On 01-AUG-2014, the patient saw physician for follow-up and received calamine lotion. On 15-SEP-2014, the patient was seen by nurse practitioner for a spot in same area where the rash had been on the right arm, and no treatment was given. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Morning after shot, arm was slightly sore when lifting, with small (pea sized) red spot at injection site.  Arm remained slightly sore ; then. 3 days  after the injection, noticed well-defined,  red, warm, slightly raised, itchy triangular area about 6 inches below injection site. Next day (today) area is less well-defined, slightly larger, less pink, but still itchy. Appears to be slightly further down arm toward inside of elbow. I experienced this precise phenomenon after the first booster although  the area was oval. The first two shots I had extreme soreness  and hand-sized red raised welts at and below injection site. The two boosters have red itchy areas completely separated from the injection site below on the same arm.
Pt had bilateral cold, black hands approximately 12 hours after receiving her 3rd moderna vaccination. She put them in warm water and side effect resolved within 5 minutes and did not return.
Generalized tonic clonic sz, lasted 2-3 min; Initially postictal, but normal neuro exam afterwards; no fever;
Patient experienced redness and swelling at the injection site about the size of a small ball (in between a grape and a golf ball). The swelling is reduced and only some bruising remains about three weeks later.
DIAPHORETIC, NAUSEA,SYNCOPE,PALE CLAMMY. PT HAD SUDDEN ONSET OF THESE SYMPTOMS. WAS PLACED IN SUPINE POSITION WITH LEGS ELEVATED. TOOK APPROXIMATELY 30 MINS TO RECOVER LEFT WITH RESIDUAL WEAKNESS  FOR REMAINDER OF THE DAY.
Client received vaccine through a drive through clinic. He was in passenger side of car. His mother was driver. Immediately after receiving the J&J vaccine he reported pain in his arm after vaccination and then he developed nausea and dizziness . No syncope noted. Immediately upon start of symptoms, a EMT was on site and assessed client. He was provided with water and his symptoms resolved within 10 minutes of start of symptoms. Client stayed for his 15 minute observation time and was able to leave after the 15 minutes with his mother.
I had severe bells palsy in 2014 & since then I have had deep crease above the length of right eye brow & forehead & eye brow were frozen.   on 3rd day of 2nd vaccine (3/18) , I had 3 short wrinkles lines above inside of eyebrow & 1 long ling wrinkle from eyebrow to forehead which lasted till next day.  Following week, I noticed the solid line/wrinkle since 2014 was half it size.  As week went on I could slightly raise eyebrow , fine line appeared on forehead that matched the left side and I could slightly frown.  Eyebrow'/forehead are still evolving with slight swelling (like a welt w/out redness) from arch of eyebrow to end of eyebrow toward hairine.  I have already reported previous unusual symptoms.
On 7-25-11 child developed a few fluid filled red spots on the knee, back of arm & face. On 7-26-11 rash spread all over body (chest, back, face, arms, legs). Child had a fever 100.7 degrees F & had vomited 2x on 7-25-11, 2x on 7-26-11 and 1x on 7-27-11. Mom called MD office & spoke with nurse who told mom child had a flu like illness in addition to having a vaccine reaction. Child is in daycare & mom said children have recently been sent home with vomiting & diarrhea illness advised mom that child should avoid contact with susceptible of immunocompromised people until rash has resolved. Will conduct a f/u phone call. 7/29/11 FU phone call - plans to go to MD tody. Rash & N & V persist. 8-1-11 T.C. to mom. Per mom, child is better & rash has faded. No N/V, no fever. Still decreased appetite but child is active. Child was seen by MD on 7-29-11. Per mom doctor thought child had a flu like illness and the rash was "nothing" to worry about". No further f/u.
This spontaneous report was received from a registered nurse, concerning a 6 month-old infant of unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates; at 3, 6 and 8 months of age, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint was involved (PQC). Additional information has been requested.
This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 13:45 (Lot number: EN6203) at the age of 40 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE; VELIVET; ZOLOFT; PLEXION SCT; NASACORT; CENTRUM A TO ZINC; VITAMIN D 3. The following information was reported: HEADACHE (non-serious) with onset 03Mar2021, outcome "recovering", described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Mar2021, outcome "recovering", described as "stomach cramping". Therapeutic measures were not taken as a result of headache, abdominal pain upper. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient had no allergies to medications, food, or other products.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101654777 same patient/drug/event, different vaccine dose;US-PFIZER INC-2021352149 same patient/drug, different vaccine dose/event
One hour after receiving the first shot I became dizzy and body aches all over my body with a sore throat and terrible headache.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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.