chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was inadvertently administered varicella vaccination while on sirolimus therapy, and she developed a zoster infection; patient was inadvertently administered varicella vaccination while on sirolimus therapy, and she developed a zoster infection; it was communication error between physicians; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age (reported as child or infant) with pulmonary vein stenosis (PVS). The patient was on sirolimus therapy administered as pneumocystis pneumonia (PCP) prophylaxis.  There was no information about the patient's allergies, drug reactions or medical history provided. On an unknown date, the patient was inadvertently administered varicella virus vaccine live (oka/merck) (manufacturer unknown) for prophylaxis  (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, she developed varicella zoster virus infection, grade 3 (also reported as mild). As treatment the patient received acyclovir. The outcome of varicella zoster virus infection was unknown. It was also reported that an communication error between the pediatrician and the cardiologist occurred and the patient should not had been given the varicella vaccine while on sirolimus therapy (product communication issue, contraindicated product administered). The authors considered varicella zoster virus infection to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).     The authors considered the event of varicella zoster virus infection to be medically significant.   Literature report: Systemic Sirolimus Therapy for Infants and Children With Pulmonary Vein Stenosis; Systemic Sirolimus Therapy for Infants and Children With Pulmonary Vein Stenosis;  A copy of the published article is attached as further documentation of the patient's experience
Information has been received from a 34 year old female with insulin dependent diabetes mellitus since 11 months old, hypertension, hypercholesterolaemia and no drug reaction or allergies who on 02-AUG-2004 at 13:15 PM was vaccinated in the left arm with a 0.5 ml dose of Pneumovax 23 (lot number 647029/0460P). Concomitant therapy included Humulin, Synthroid, Effexor, Lipitor and lisinopril. At the time of vaccination, she was on an insulin pump and was in good control. The pt reported that within days of the vaccination (reported as 05-AUG-2004 and 14-AUG-2004), she had swelling of the site on the arm. then hives all over her body. She returned to her doctor who sent her to an allergist. She was placed on therapy with several medications to control the hives including Allegra and Remeron. She was not getting any better. She subsequently developed angioedema in her eyes, lips, hand and feet. She reported that her "blood sugar control had been completely destroyed". She stated that she had missed a great of work due to this problem. She was in good control of her diabetes which she no longer had. She worked everyday, which she no longer could do. She indicated that the medications to keep her hives under control were so terrible on her blood sugars that she was not sure how much longer she would be able to take them. It was noted that there was no acute illness at the time of vaccination. At the time of this report, the pt had not recovered. Follow-up information reported that the pt's urticaria have become chronic. She is seen by local allergist/dermatologist at a hospital clinic. Urticaria is considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:18 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.34 for dose administered on 27-Feb-2021 and 79.42 for dose administered on 27-Mar-2021.   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit at 09:00 AM, 35 degrees Fahrenheit from 11:00 AM to 02:00 PM, 34 degrees Fahrenheit from 03:00 PM to 04:00 PM and 35 degrees Fahrenheit from 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 PM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.
Minutes after receiving vaccine, my daughter was walking out of the office with me and passed out. She was standing next to me one minute and on the ground the next. Unconscious for about 10-15 seconds then woke up sick to her stomach and threw up. After this, she stayed seated for a few minutes and drank some apple juice. About 5 min later, she was able to stand and walk. She complained of 'stuffy ears' and stomach ache most of the day.
Severe joint pain; vertigo; instability; muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12May2021 at 11:30, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously took haloperidol (HALDOL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 16May2021, 4 days after vaccination, the patient experienced severe joint pain, vertigo, instability and muscle weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe joint pain, vertigo, instability and muscle weakness were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The employee stated that he started feeling weird.  Lips tingling, flushed face, feeling "fuzzy" headed, dry mouth, unsteady when standing.  BP 130/94 pulse 60 ; at 12:20 Lips numb again and feeling fuzzy; Took to the ER In the ER, patient presented with lip numbness, diaphoresis, leg weakness.  Patient states that symptoms were alleviated by sitting down but that the lip numbness returned,   Administered- Solu-Medrol 125mg ivp once; Pepcid 20mg ivpb once ,Benadryl 25mg ivp once Discharged from ER at 13:52 with symptoms improved
Pain in her vaccinated arm, right after the vaccination; A spontaneous report was received from a consumer, who is a caregiver concerning a female patient of un unknown age, who received Moderna's COVID-19 Vaccine and experienced pain in the arm right after the vaccination.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in right arm for prophylaxis of COVID-19 for infection.  On 03 JAN 2021, the patient experienced pain in arm right after the vaccination.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event pain in right arm right after the vaccination was not reported.; Reporter'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.
Soreness, knot, itchiness, and heat at injection site, mild rash on both forearms and face.
vaccination site mass; vaccination site pruritus; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE MASS (vaccination site mass), VACCINATION SITE PRURITUS (vaccination site pruritus) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown.            No relevant concomitant medications were reported. Treatment details included rubbing alcohol and cortisone cream..   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient's race added. Dose 1 details updated. Dose 2 details added. Vaccination facility information added.
5 cm redness and warmth to injection site. Prescibred Keflex for 10 days on 2-22-02
"Patient received his first dose of the Pfizer COVID-19 vaccine.  He received this at approximately 2 PM.  Approximately 5 minutes after getting the first dose he felt lightheaded and had a racing heart rate and also felt nauseous.  This lasted for approximately 30 minutes.  All of his symptoms then resolved.  He came to the emergency department today for a further work-up and evaluation."
Rash on my chest and it itches really bad; Rash on my chest and it itches really bad; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 21May2021 as dose 1, single (at the age of 53-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in May2021, the patient experienced rash on my chest and it itches really bad and rash. The patient received Covid-19 Vaccine and she developed a rash on her chest and it itches really bad. She knew that it could be one of the side effect but she was wondering what would be the best treatment because she did not want to buy any ointment if it just going to continue to be more like this was the cause of it. The outcome of the rash pruritic was unknown while outcome of the event rash was not recovered.   Follow-up attempts completed. No further information expected.
Started getting muscle twitch in right side of neck and shoulder. It lasted from minutes to hours. Doctor suspected pinched nerve and recommended physical therapy. Started PT 4-28. Neck muscle twitch stopped after 2nd PT session on 4-29. Completed PT on 5-20. I am now getting muscle twitches in my back, left arm, left hand and left eye. The twitch is random and lasts about one to two minutes. As of this date (5-23) it has not resolved.
Mild headache, migrane, fast heartbeart, dizziness, fatigue, nausea,  vomiting, Depressive episodes lasting at least 2 days. Got 2nd dose  3/15/2021 (IM, RA) Same symptoms. Got Booster 11/13/2021 (IM, LA) Same symptoms. These symptoms have persistent for the last 7 months. Have been off and on, and is seriously affecting daily activities.
3-22 By evening was not feeling well, came down with a fever. Gave TYLENOL. 3-23 Had fever of 102 - 103 degrees all day. Had no energy, cried a lot, slept a lot, very runny nose, gave TYLENOL at different times. 3-24 was some better during the day. Still had a very runny nose. Didn't go to bed. Started golfing worked up and uncomfortable. From 9-10 pm had episodes of uncontrollable pain with short seizure like activity - lasting seconds at a time. Woke at midnight with similar episodes for 1/2 hour. 3-25 Alright during the day but very restless night and awake from 3-5:30 am. 3-27 follow-up with dr.
Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 88 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced chills on 11Feb2021 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
LEFT ARM (AREA OF DELTOID) BECAME SWOLLEN AND RED.  IT HAD FEVER IN IT AND WAS WARM TO TOUCH. IT ALSO BECAME ITCHY.
Suspected vaccination failure; Had the vaccine and still got them 4 times so far; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with benadryl (nos) (Benadryl Spray). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had vaccine and still got them 4 times so far. The patient used Benadryl spray. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Child received MMR. Few days later started having runny nose, then cough, fever, vomiting, red spots on face, body, buttocks, red eyes, breathing hard/noisy. Doctor diagnosed measles.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid from 20Jul2022 to 25Jul2022. The patient had no known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
SHE STATES THAT IT STARTED AT 2:00 PM ON 2/18/2018. HER LEFT UPPER ARM BECAME RED, SWOLLEN, HOT TO THE TOUCH AND VERY SORE. SHE STATES THAT THE PAIN IS INTENSE. WHEN SHE CAME INTO THE PHARMACY ON 2/19/2018 I OBSERVED THAT HER LEFT ARM WAS SWOLLEN FROM SHOULDER TO ELBOW AND HOT TO THE TOUCH.
Redness, scaling area at injection site. Affected area is slightly larger than dime size. Patient reports soreness, but unknown if it is from the shot or arthritis. No warmth reported by patient. No discharge.
Since June my menstral cycle has been extrememly off.  Prior to the vaccine I experieced normal, regular periods that were on time and the same lenght each time. But since the vaccine my periods have ranged from being longer than normal, or I'll have one and then I'll have a second one in the same month 1 week after what was my normal periods. I did bleed for 2 weeks straight in June and then in July I didn't have a period at all.  I've also experienced a 10lb weight gain since the vaccine without changing my diet or excercise regiment. I've been  very lethargic since the vaccine as well.   I've had a physical with labs done to make sure it wasn't something elese but all my bloodwork and hormone panels came back normal. No hot flashes so this has nothing to do with my age.
Itching/pruritis/itchy bumps; fever; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itching/pruritis/itchy bumps) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028120A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis and Surgery (Sigmoid colon resection) on 26-May-2021. Concurrent medical conditions included Asthma, Allergy, Penicillin allergy, Fish allergy (regurgitation requires hospitalization and IV's), Allergy (Pine nuts allergy cause swollen tongue and lips) and Drug allergy (Anti inflammatory drugs (Mobic, Advil) cause flu like sysmtoms). Concomitant products included CALCIUM CITRATE, COLECALCIFEROL (CALCITRATE PLUS D) for Calcium, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Nose congestion, BIFIDOBACTERIUM ANIMALIS, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS BIFIDUS) for Probiotic therapy, LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Itching/pruritis/itchy bumps). In March 2021, the patient experienced PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) (oral) in February 2021 for Fever, at an unspecified dose and frequency. On 24-Mar-2021, PRURITUS (Itching/pruritis/itchy bumps) had resolved. At the time of the report, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 160/80 (High) 160/80 mm/Hg. On 11-Mar-2021, SARS-CoV-2 antibody test negative: negative (Inconclusive) Vaccine provided no protection because no antibodies were found. On an unknown date, Body temperature: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (Itching/pruritis/itchy bumps) and PYREXIA (fever) to be possibly related.    Patient reported after the second shot on 17 Feb 2021, she had a fever that  lasted about 24-30 hours.  She took  Tylenol for it.  Patient reported she had three weeks of itchy bumps that started on 03 Mar 2021 after getting the second vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received and update relevant history ,lab data, concomitant medication and addition of second dose On 14-Jul-2021: Follow-up received and contain non-significant information. On 22-Jul-2021: Follow-up received and contain non-significant information.