chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors for HBV transmission, and transmission rates. Tests for HBsAg(HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012. All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. This is one of 25 reports from the same source. Additional information has been requested.
Initially I only had pain at injection site. Several days later I broke out in rashes that at the time I thought was poison ivy. I went to a clinic where the nurse practitioner informed me of a temperature of 100.7. Since I never had poison ivy before and she was unsure how allergic I was, she decided to prescribe prednisone but told me also that fever is rare with poison ivy. At the time I didn't even think it was possible since I had several days where I felt fine. It wasn't until late last night when my temperature on two separate thermometers was 95.9 where I became concerned and started doing my own research. Today the rashes are almost gone and we're never as itchy as poison ivy is described. I will be going to the hospital today for bloodwork to determine whether it's a reaction or a form of pneumonia. Other symptoms include rash on left side of neck and arm as well as my back. Chills, sweating, fever, low temp 2 degrees below normal, elevated heart rate and joint pain. Also temporary numbness in left leg.
Significantly redder and as big as can of coke; Really itchy; Slight pale rash; Skin would feel itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Skin would feel itchy at injection site), VACCINATION SITE PRURITUS (Really itchy), VACCINATION SITE RASH (Slight pale rash) and VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin (The patient stated that she get rashes and itchiness very easily.). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), LOSARTAN, ESTROGENS CONJUGATED (PREMARIN) and PREDNISONE ( same dose since 5-6 years) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Skin would feel itchy at injection site) and VACCINATION SITE RASH (Slight pale rash). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Really itchy). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke). At the time of the report, VACCINATION SITE PRURITUS (Skin would feel itchy at injection site), VACCINATION SITE PRURITUS (Really itchy), VACCINATION SITE RASH (Slight pale rash) and VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included body lotion. Patient reports "I'm putting lotion on it and its still the same"
This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical conditions was reported. On 31-JUL-2015 the patient was vaccinated with improperly stored dose of GARASIL, lot # K023432, expiration date: 18-JUN-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA00124). Additional information has been requested.
Right arm immunization site reaction 4cm X 6cm erythematous area on upper right arm. Warm, clearly demarcated area, tender to touch, no streaking. Similar 1X1 cm area on upper left arm. Augmentin X 7 days.
Delayed fatigue, lingering as of 8 days post vaccine. Headaches off and on, lack of appetite and nausea after eating
Rash on back and stomach on 10/04/08-10/06/08 11 days after immunizations (9/23/08) Mother noticed left leg lump on 10/08/08 and says patient has had an on and off occuring fever and low appetite.
Information has been received from a registered nurse concerning a male who on 07-SEP-2007 was vaccinated PO with a single dose of Rotateq. In September 2007, the patient experienced vomiting and reflux (development unclear) and tested positive for rotavirus in the stools and was hospitalized. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Shaky and cold, 12:00 midnight stomach upset and nausea, 01/17/2013 6:30 AM headache and ongoing nausea and shakiness. Arm is very sore and a bit swollen but does not appear red. Bicep sore below injection site (shoulder).
First dose was given on 20Aug2019 / Second dose had not been administered at time of call; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082156:same reporter
No symptoms reported; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; This spontaneous report has been received from a medical assistant concerning to a female patient of unknown age.   The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient received a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 26-NOV-2019, the patient mistakenly received a fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) subcutaneously (inappropriate schedule of product administration) (incorrect route of product administration) (extra dose administered) (anatomical location was not reported) (lot#: S006472, expiration date: 16-JAN-2022). No product quality complaint was reported. No symptoms were reported.
Inappropriate schedule of drug administration; Extreme diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea). At the time of the report, DIARRHOEA (Extreme diarrhea) had not resolved. Not Provided          Treatment Medication for Diarrhea    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No specific follow-up information recorded.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Additional Details: pt. diagnosed with bilateral large pulmonary embolism and large left pulmonart infarct. pt. is sitll in the hospital and is recovering
8JAN97 pt started w/high pitch cry-2hr-left thigh very red swollen hard almost purple;t101 by morning t103;called MD took to office inc APAP, cool bath & no more DTP;
Diarrhea every 15 minutes for 4 hours straight.  Starting on 1/21/11, diarrhea every 2 hours for 24 hours.
Tachycardia and sensation in throat 15-30 minutes after vaccination.  HR-140 BP-180/120 HR went back down to 115 and BP 136/67. Received Solu Medrol for reaction. Advised not to received 2nd dose per CDC guidelines.
I experienced a lot of soreness around neck, shoulders, upper back that last a few minutes. The next morning, it started up again, much more severe that did not go away and had to go to the emergency room, medication, and a hospital stay for 6 days. Pericarditis, heart inflammation, irregular heartbeat. A heart attach that caused no permanent damage so I was fortunate.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-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.   Concomitant medications were not reported.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Included patient details updated
First vaccine - left arm swelling, hot, itchy, painful, couldn't raise arm. Second vaccine - extreme fatigue, slept for 36 hours straight, pain, swelling, hot, itchy, can't raise arm and location of first vaccine in left arm swelled, got hot red and itchy again, couldn't raise left arm.
March 20  mild dizziness  lasting for 2-3 hrs March 21  Increased dizziness lasting about half day March 25  mild dizziness  lasting all day but able to function .  Sudden movement trigger slight increase of dizziness.
About 15 minutes after injection, head felt heavy and she felt weak and throat was closing. She received Benadryl and her symptoms resolved before she left vaccine clinic.   Recommended not to take #2 dose until she sees an allergist and gets their opinion.
2 days post vax, left thigh had swelling, warm, and redness. Treated with Benadryl.
On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my chest.  The next day (1/27) I woke with chills and fever ranging from 99 to 102.4 degrees.  And a severe headache., also very tired....Stayed in bed most of the day.  On 1/28 I broke out in hives on my chest and stomach.  Also have very sore muscles, especially in my legs, and shortness of breath.
The patient has not shown any symptoms as of yet; Gardasil 9 was accidentally give to a 6 month old.; Gardasil 9 was accidentally give to a 6 month old.; This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The case concerns 1 patient and 1 combination product. On 26-MAR-2020, the patient received accidentally a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S008154, expiration date 20-NOV-2021 (exact dose and injection site; route of administration was reported as injectable) for prophylaxis (indication was also reported as accidental exposure). The patient had not shown any symptoms as of report time, but was also no longer at the facility. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S008154; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness, swelling and pain Rt upper arm.  4/15/08 Reviewed hospital medical records for 4/11-4/12/2008. FINAL DX: no d/c available; admit dx acute cellulitis Records indicate patient experiencedswelling, redness & pain RUE since vaccination on 4/8/08.  Seen by PCP & tx w/antibiotics.  Returned to PCP with markedly increased swelling, tenderness & induration; no fever.  Sent to hospital for admission.
Beginning 24 hours after lasting for 48 hours - flu like symptoms & difficulty breathing.  1 week after - temporary dark brown vaginal discharge (lasted a few hours, no menstruation occurred) this is abnormal for me/ has never occurred before.
Patient mentioned he had a cramp in his left thigh. Declined pain medication. Took blood pressure. Offered patient cold water. Advised to be observed for additional 30 minutes.  Patient felt better and was cleared by Nurse.
pain all over his body/pain in my joints and all over my body; pain all over his body/pain in my joints and all over my body; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. About 4 days later (27Mar2021) of receiving 2nd dose of BNT162B2, patient got the pain in joints and all over body. Outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
contracted COVID-19 a mild case; numbness on her face for several days; muscle pain in legs,muscle pain in jaw; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (numbness on her face for several days), COVID-19 (contracted COVID-19 a mild case), CHILLS (chills) and MYALGIA (muscle pain in legs,muscle pain in jaw) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced CHILLS (chills). On 24-Aug-2021, the patient experienced HYPOAESTHESIA (numbness on her face for several days) and MYALGIA (muscle pain in legs,muscle pain in jaw). On 26-Aug-2021, the patient experienced COVID-19 (contracted COVID-19 a mild case). At the time of the report, HYPOAESTHESIA (numbness on her face for several days), COVID-19 (contracted COVID-19 a mild case), CHILLS (chills) and MYALGIA (muscle pain in legs,muscle pain in jaw) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: positive Positive.     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.   Her concerned is about getting the second dose because she had COVID.  Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced non serious unexpected events of  hypoesthesia, COVID-19 and expected events of myalgia and chills. The events occurred 3-7 days after the first dose of Spikevax. Rechallenge was unknown since information about second dose and reoccurrence of the event was not provided. The benefit-risk relationship of drug is not affected by this report
paralyzed from his arm down; This case was reported by a consumer via call center representative and described the occurrence of monoplegia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced monoplegia (serious criteria GSK medically significant). On an unknown date, the outcome of the monoplegia was unknown.   It was unknown if the reporter considered the monoplegia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter saw on a national news broadcast a man who became paralyzed from his arm down following Shingrix vaccine.
Large red rash on arm appear a week after getting my first vaccine.  Itchy and sore.  Arm was sore for two/three days after shot and I was extremely tired for a day or two after the first shot.  Scheduled to get next dose on July 7th
she had abdominal surgery; bruising; swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A 57-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced she had abdominal surgery on 01Apr2021, bruising and swelling on an unspecified date in 2021. The patient stated that, she was scheduled to have the second vaccine today and she underwent surgery on 01Apr2021. She just wanted to make sure the vaccine would not interfere with her healing. She had swelling and bruising. She stated the surgery was scheduled after the first dose. It was abdominal surgery. She did not wish to provide any further details about the surgery. No further details provided. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash seen on arm after first and second shot.  After first shot rash appeared several days later and covered a smaller area.  After second shot rash appeared next day and covers more of upper arm.
Symptoms started on the 21st of February and by the 24th my glands were swollen, my head and nose hurt, and I developed a cough sporadically and I wouldn't be able to stop. I had green phlegm so it was obviously an infection. I went to Urgent Care and they said it was an infection and he prescribed me an antibiotic, Flonase, and a cough syrup. I lost my voice in the process, he said it was sinuses, ears, and chest. I've never had any type of sinus infection before so this was all new to me. Its been about two weeks now and my ears seem clear but one ear seems a little bit sore still, my cough is almost completely gone, my voice is hoarse, and my chest feels a lot better.
A 15 year old patient the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 22-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The reporter asked can patient receive the 2nd dose of the Pfizer vaccine or not.
her arm was itching; arm is swollen and warm; her arm is warm; the injection site was red the redness progressed down her arm 4 inches long; her arm a little sore; her arm warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm a little sore), SKIN WARM (her arm warm), PRURITUS (her arm was itching), PERIPHERAL SWELLING (arm is swollen and warm) and SKIN WARM (her arm is warm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.  Concomitant products included SPIRONOLACTONE, FUROSEMIDE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm a little sore) and SKIN WARM (her arm warm). On 21-Apr-2021, the patient experienced PRURITUS (her arm was itching), PERIPHERAL SWELLING (arm is swollen and warm), SKIN WARM (her arm is warm) and VACCINATION SITE ERYTHEMA (the injection site was red the redness progressed down her arm 4 inches long). On 14-Apr-2021, PAIN IN EXTREMITY (her arm a little sore) had resolved, SKIN WARM (her arm warm) had resolved with sequelae. At the time of the report, PRURITUS (her arm was itching), PERIPHERAL SWELLING (arm is swollen and warm), SKIN WARM (her arm is warm) and VACCINATION SITE ERYTHEMA (the injection site was red the redness progressed down her arm 4 inches long) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Eye drop for glaucoma. Treatment included Cortisone cream.