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.
I started with a severe headache, which I get after every vaccine, and I used an ice pack to help. Around 8 AM, I started to vomit fluid/liquid, but then I started dry heaving. After that, it started to turn to bile. It was yellow/green and started burning. I called my niece, who is a RN and she recommended promethazine. I called the pharmacist from where I received the vaccine and he said that I could take it. I took the promethazine around noon. I vomited about two more times and by 4 PM, it stopped. Around 6PM, I was able to eat ice chips, ginger ale and eventually able to eat crackers. I'm also experiencing tenderness around my lymph nodes in my left armpit.
A-Fib exacerbation; This case was reported by a other health professional via call center representative and described the occurrence of atrial fibrillation aggravated in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation aggravated was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 72 or 71 years old at time of vaccination. The pharmacy intern stated that the patient with history of rate-controlled A-Fib. The patient received the first dose of Shingrix and then experienced an exacerbation of the A-Fib. The patient had to be rate-controlled for two weeks, and then the episode resolved. The reporter was consented to follow up. No further details available to pharmacy intern at the time of this call.
stiffness; barely able to move; muscle aches; fever of 100.6; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.6 (Inconclusive) 100.6.         No treatment information was provided.  No concomitant medications were provided by the reporter.
Covid shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid shoulder). On 21-Jan-2021, VACCINATION SITE REACTION (Covid shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-023511 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information include email details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1/2/2021: In the evening, I  started experiencing swelling (felt like a hard knot under the skin), itching, redness, and heat at the injection site. Earlier in the day I noticed a little pain discomfort in my right arm pit. As the day wore on, I noticed swelling in my lymph nodes and the level of discomfort increased to the point that it disturbed my sleep. 1/3/2021: The pain and swelling at the injection site and armpit continued to be the same. I took ibuprofen to try and alleviate the level of discomfort. That evening before bed also took Benadryl to see if it would help with the injection site reaction. I also started experiencing a dull shooting pain and tingling from my armpit down to my wrist on my right arm. 1/4/2021: The injection site improved, no more knot, heat, or itching. It still remained a little swollen. Lymph nodes were still swollen throughout the day, but manageable with ibuprofen. Shooting pain and tingling still occurring sporadically throughout the day. 1/5/2021: Still a little discomfort in the armpit, but seems to be improving.
Initially patient had a red, swollen, warm to the touch area where the varicella was given in the back of her left arm, that lasted about a week. Starting on 7/7/09 she had a rash across the top of her back, then within 2 days or so it was on her entire back and her chest and stomach. As it seemed to start to fade/go away (which was at least a week or so) then it spread to her upper arms and upper legs, then as it started to fade it went to her lower arms/hands and lower legs/feet, which she still has. It itches occasionally throughout the whole process, sometimes seems "more inflamed" than other times and is warm to the touch. The appearance of the rash the best I could find almost looked like a measles rash. Her doctor did look at the rash and stated that she was unsure what it is, it is probably/could be a vaccine reaction, due to the timing of the vaccines and then the rash.
Pt recvd 3 doses of Engerix-B; titer checked 5 months p/3rd dose; titer was neg;
Subcutaneous administration of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date 11th June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details reported were as follows: The patient received Shingrix subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. The reporter did not consent to follow up.
Rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. Very very itchy, dots and kind of scabby.; Very very itchy, dots and kind of scabby.; Rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. Very very itchy, dots and kind of scabby.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) reported for herself. A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration, administered in left arm on 05May2021 at 20:45 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. No other medical history was reported. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced rash from my hips up to my neck and back of ears covering my entire back, arms, torso, breasts, neck. very very itchy, dots and kind of scabby on 16May2021 at 18:30. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the events. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Vaccines given at 10:35 - Pt was sitting for her 15 min. post vaccination per protocol for HPV. At approx 10:40 she became faint-like & clenched her arms & hands up toward her face - she got slightly diaphoretic & c/o numbness & tingling in her hands & face - 5 min later the face was better, hands same then 5 min later c/o numbness & tingling in her feet.
overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
Mother reports PT to develop "hives" 2 hrs post vax the ??? affecting feet and HE. Mother reports rash would resolve spontaneously only to return. Mother brought PT to ER after noticing lesion to affect entire body. PT with good appearance and acting. (+) no fever & several hours. The follow up states per TC 4/8/03 to MD's office hep B manuf and lot #.
This spontaneous report was received from the registered nurse regarding a 9 years old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On an unknown date in July 2018, the patient was vaccinated with VARIVAX lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes(product storage error). There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. The patient received VARIVAX the week immediately following the product storage error. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several reports from same reporter.; Sender's Comments: US-009507513-1807USA011693:
This spontaneous report as received from an other health professional (Office manager) via Poison & Drug Center (PDC) refers to a currently 6 years old male patient. The patient's concurrent condition included allergy to amoxicillin. On 15-FEB-2013, the patient was vaccinated with first dose of VARIVAX 0.5 ml (Lot # N022983, Expiry date: 23-AUG-2018) (route of administration was not reported) for prophylaxis. On 05-DEC-2017 the patient was vaccinated with second dose of VARIVAX (Lot # and expiry date was not reported) that had undergone an excursion for prophylaxis. The patient had no relevant concomitant medications. The office manager reported that over the years the patient had been seen for upper respiratory infections. On an unknown date in 2017 (reported as for about a month), the patient had a rash on and off around the gluteal area. The physician ordered triamcinolone ointment for the rash. It was unknown if there was relevant lab work performed. It was reported that as of 05-DEC-2017, it was unknown if the patient will receive further doses of VARIVAX. The outcome of the events was unknown. The reporting office manager did not provide the causality assessment for the events.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 58-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 17 September 2008, 20 October 2008 and 22 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg/mL, left deltoid). 22 January 2009, the subject experienced drug dose administration interval too short. On 16 March 2009, 53 days after vaccination with the third dose of Engerix B, the subject experienced decreased therapeutic response. On 16 March 2009, hepatitis B surface antibody was low at 7.2. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778216A, A0778217A and A0778220A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Statement: Engerix vaccine lot numbers AHBVB703AA, AHBVB584AA and AHBV670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
The night after vaccine my left arm was sore and armpit was painful for a good 30 hours. It was swollen and it hurt without touching it. 01/19/22 Covid-19 symptoms started. Tested positive on 01/20/22. I had two days of burning throat with very little relief. No fever, no loss of taste or smell, no chills, but I was tired and slept alot. I had decreased appetite and congestion that later developed into a cough. I never had a headache either. Symptoms lasted for 2 days for sore throat, and the cough lingered for 8-9 days. I went back to work after a week.
Parotid swelling - left cheek anterior to pinna.  Displaced pinna up & out.  Fever 101.
This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient had no pertinent medical history and there were no drug allergies/drug reactions reported. The patient reported that she was vaccinated with an unspecified flu vaccine on an unspecified date in September 2015. On 13-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route of administration and anatomical location were not reported). There was no concomitant medication reported. On 14-NOV-2015, the patient experienced injection site nodule which was red and sore and injection site inflammation. No treatment was given to treat the injection site nodule and inflammation. Additionally, it was reported that on an unspecified date in November 2015, the patient called to the pharmacist for medical attention. At the reporting time, the outcome of injection site nodule and injection site inflammation was reported as not recovered/not resolved. Additional information has been requested.
Pt developed erythema, swelling, and tenderness to injection site. Treated with Ibuprofen and/or TYLENOL, and cold compress.
This case was reported by a healthcare professional and described the occurrence of a male subject of unspecified age testing hepatitis B antigen positive following vaccination with Engerix B for prophylaxis. On unspecified dates the subject received 1st and 2nd doses of Engerix-B. At an unspecified time after the 2nd vaccination with Engerix-B, the subject tested hepatitis B antigen positive. He had no symptoms of hepatitis and his liver enzymes were normal. Prior to receiving Engerix-B, the subject was hepatitis B antigen negative. Follow-up was received from the reporting healthcare professional. The subject received the 1st dose of Engerix-B on 06 November 2006. On 08 November 2006, two days after receipt of the 1st dose of Engerix B, a hepatitis B surface antigen test was positive. On 10 November 2006, a repeat hepatitis B surface antigen test was again positive. On 16 November 2006, the subject was again retested with "a different lab" and was hepatitis B surface antigen negative. The healthcare professional stated that the subject tested positive for hepatitis B surface antigen due to "lab error, not because of the vaccine."
Chills; Fever; Tiredness; Shaky; Muscle pain; Groin pain; Feeling not well; Injection site swelling; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 mentioned wanted to know, patient having some reaction to COVID, Pfizer shot. The patient wanted to speak to someone. The patient provided the reactions had on this past Tuesday, the shot my second. The patient experienced chills, fever, tiredness, shaky, muscle pain, groin pain, feeling not well and Injection site swelling. And also wanted to know, how long these symptoms will last. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Full body hives occurred about 27 hours after the first dose. These lasted for 1 week.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. 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.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-405897 (Patient Link).
pt recv vax 30MAY95 & 8JUN95 pt was seen by MD & had fifty lesions & a low grade temp; @ time of report, pt had approx 150 lesions consistent w/chicken pox including both vesicular & pustular lesions;
Missed 2nd dose on due date; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date). On 03-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose on due date) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient missed the 2nd dose which was scheduled on 03-04-2021   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up information received captured no new information.
hyporesponsive rxn, pale color for 5 minutes, 3 hrs p/DTP vax;
Per pt after receiving 2nd dose of covid vaccine experienced fever, chills, and sore throat.
also cannot breathe well; snotty nose; tingling all over her body/whole body tingles; This is a spontaneous report from a contactable consumer or other non health care professional. A 15-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at the age of 15-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety: Chronic anxiety (Diagnosed 3-4 months ago). Concomitant medications included fluoxetine indication for chronic anxiety from 15Jul2021. On 16Jul2021, the patient experienced tingling all over her body/whole body tingles. On 17Jul2021, the patient could not breathe well and snotty nose. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.