chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Goth both doses, year later shingles; Shingles came back, 12th time; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included blood cholesterol increased (High cholesterol).   In JUL-2020, the patient received the 2nd dose of Shingrix. In MAY-2020, the patient received the 1st dose of Shingrix. In JAN-2021, between 5 and 6 months after receiving Shingrix and between 7 and 9 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Goth both doses, year later shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles came back, 12th time). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023042079   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was patient's wife. The reporter reported that patient received both doses of Shingrix, shingles came back one year later. The patient had 12th time Shingles. The reporter was consented to follow up. This case was considered as vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming influenza were unknown at the time of reporting. This case is linked with case US2023042079 reported by same reporter.; Sender's Comments:  US-GSK-US2023042079:Same reporter
Cold chills/sweats in the middle of the night, headache in the morning, muscle aches (not just in the arm of injection), and congestion
Vaccine give at 12:16pm. Patient developed vomiting at approximately 3:15pm and his throat felt sore/tight. He vomited 2 more times that evening & developed a fever of 100.0 degrees. Patient took TYLENOL but fever remained approximately 100.0 degrees. The patient went to bed and slept it off. Patient stated he was fine the next morning.
I had abdominal pain with blood in stool. I went to the ER. They did a blood work and MRI. I was diagnosed with DVT. On Tuesday, I was diagnosed with a UTI.
arms are itching a lot no; minor itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (minor itching) and PRURITUS (arms are itching a lot no) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (minor itching). In August 2021, the patient experienced PRURITUS (arms are itching a lot no). At the time of the report, PRURITUS (minor itching) and PRURITUS (arms are itching a lot no) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
25JUN98 pt devel soreness of lt arm next day 26JUN98 arm red, swollen, pruritic also warm;26JUN98 exam deltoid region w/erythema of 9x6cm;warm to touch, sl indurated;non-tender w/no edema noted;
No adverse event; 9 patients received Moderna Covid-19 Bivalent vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine past the 30 day beyond use date).    Patient have received other vaccines in the 4 weeks prior to COVID-19 vaccine. The vaccine was delivered to the hospital on 20-Sep-2022.  No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 05 out of 09.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:Master case
After the vaccine, I just had pain that evening and the next day on the injection site. But I went to my midwifery appt and my baby was SVT - I got admitted to hospital last Tuesday 13th and I've been here since. I had COVID virus in August 2020.   Pregnancy History - this is my first pregnancy; estimated date of delivery - it was June 18th originally. I'm 32 weeks tomorrow.
Patient was overwhelmingly nervous about needles. After injection, he felt faint, he became unresponsive, his head fell back and he was sliding down the chair.  In moments he came to, and wanted to lie on floor, we moved him to the floor.  Paramedics were called.  He was pale and sweating on the floor.  He stated his neck was stiff and face was tingling.   Paramedics came and evaluated him.  The patient chose not to go to the hospital. This was approximately over a 30 minute period.
to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb; Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 14:30 as a single dose (at the age of 40-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The day after (13Mar2021 05:00), the patient began to feel a tingling sensation on the outside of her arm through to her fingertips. Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off, it went away after a few hours and taking Advil. Day 2 (14Mar2021), the tingling was back, but on the inside of her arm, mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb. The outcome of the events was not recovered.
flu-like symptoms; it was hard; extremely itchy; soreness; redness to the area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL COLD & FLU [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Flu-like symptoms, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) on 04-Jan-2021 at a dose of 20 mg. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (it was hard), VACCINATION SITE PRURITUS (extremely itchy), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness to the area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-003367 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Upon review, start date of the vaccine was not provided, so it was updated to regulatory authority. On 04-Jun-2021: Follow-up via telephone received from patient. No new information for coworker. refused to fill out form.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
C/O rash to both arms and redness at injection site, w/itching few hrs. after TDAP administration. Exam, macular rash scattered bilt. arm of mild erythema, no vesicles. Erythema also at injection site (left deltoid) no blisters. Tx: Antihistamine oral, hydrocortisone topical. Started tx today 6/1/16.
pt recv vax & began to have tinnitus, vertigo & could not heat w/hearing aids;nurse instructed pt be taken to MD immediately;pt taken to urgent care then to ENT specialist;pt being sent to a second specialist 23MAR98;
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Had pt. lay down for 15 minutes; obtained VS
Tinnitus (hissing and high frequency ringing) in both ears.  Symptoms have persisted for over 4 weeks.
Hrs after Pediarix vaccine left delt - developed pruritic papules and quarter-size surrounding redness on arms, trunk. Left deltoid became inflamed. No systemic symptoms such as fever, cough, chills. Resolving with Benadryl. Still present - papules - 1 week later.
Diarrhea; Headache; queasiness; fever going up and down between 99-100.8; problem breathing; sore arm; Vomiting; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 301558A) via an unspecified route of administration, administered in right arm on 05Oct2021 at approximately 11:00 (age at the time of vaccination was 55-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included covid-19 (he already had covid, he already gave blood to senior homes for people that did not have antibodies), obesity and overweight from unknown date and unknown if ongoing. Concomitant medications included vitamin D, Vitamin C and Zinc. No prior vaccination within four weeks. On 05Oct2021, from 7 pm he started experiencing diarrhea, headaches, queasiness, his fever goes up and down between 99-100, he had a problem breathing, he had to stand up and try to stretch to catch his breath, soreness of his injection arm and he vomited last night as well but hasn't since. He did a thermometer check and his temperature was 100.8. The lowest reading, he got last night was 99.3, and this morning it was back at 100. He had diarrhea two times late at night, and early in the morning. He just recently a little more. It was thicker than in the past. He had vomiting and injection site pain described as a throbbing pain in addition to the other reported side effects stated was like his body is acting like it is fighting the virus all over again. Patient asked are these side effects because he already had the virus, and it was overdriving his system making it like he had covid again. Patient took Tylenol for headache and queasiness and his breathing issue went away last night after using the restroom, stretching, and using nasal spray. The patient underwent lab tests and procedures which included body temperature resulting going up and down from 99 to 100.8 on an unspecified date (a fever going up and down from 99 to 100.8), body temperature resulting 100.4 and 100.8 on 05Oct2021. outcome of the events problem breathing, and vomiting was recovered on and unspecified date in Oct2021, outcome of fever was not recovered, diarrhea and headache was recovering and rest all events outcome was unknown at the time of reporting.  Follow-up attempts are completed. No further information is expected.
her bloodwork showed a low platelet count/the vaccine can cause thrombocytopenia; This is a spontaneous report received from a contactable consumer (reporting on herself). A 73-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The historical vaccine included first dose of BNT162B2 received on an unspecified date for COVID-19 immunization. The patient's concomitant medications were not reported. It was stated that on 25Mar2021, patient received her second dose of the BNT162B2. Then states she had to have bloodwork drawn for an oral surgery on 31Mar2021. She states that the results of her bloodwork showed a low platelet count. Patient states that she has read online that the vaccine can cause thrombocytopenia and would like to know if we have any information regarding this. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Rash on arm near injection site-developed. Rash on trunk, forehead scalp. Patient received vaccination 9/21/2017. On 9/28/17, she began developing a rash on her trunk, forehead and scalp. Trunk lesions-0.5 to 2.0 cm macules-red with central cleaning. Has significant itching. One of the macules is on (L) deltoid region at site of injection. Total of six lesions on truck. Forehead and scalp-diffuse maculopapular rash, flesh colored; covering entire forehead, scalp, back of neck; very itchy. As of date of the report, the rash is unchanged but has not worsened.
last night body pain and chills around 9:00 pm this morning , body pain ,chills, fever 100.08 around 7:30 am 9:20 am fever went down to 98.6 after taking Tylenol at 7:30 am
A report has been received from a physician concerning a patient of unknown gender, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started during 2014. The patient received expired FLUMIST during 2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Vaccine at 520 pm.   Then at 530 pm my   Rt arm got heavy and then my head got tingly and cold and I felt like I was going into a dark tunnel and I said to nurse oh no I don?t feel good and I?m gonna pass out.   Started to pass out but did not all the way. Provider there encouraged me to breath in and out for awhile and gave me apple juice.    Legs and arms felt very heavy and weighted down.   Hard to walk at first as legs felt heavy ,felt nauseated
vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 001B21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021 at 9:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 9:28 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022 at 7:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 19-Jan-2022 and vaccine administered after 30 day use by date) outcome was unknown.        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.  The vaccines were initially placed in the refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received and contains non significant information.
Moderna COVID?19 Vaccine EUA - had mild swelling of right eye about 30-45 min after injection - later that day had headache, fatigue and mild dizziness.  For 24-48 hours after injection had nausea, fatigue, dizziness off and on - swelling of right eye about the same. 72 hours after injection noticed moderate swelling of both eyes, right worse than left and swelling of upper lip. Also had some numbness and tingling to upper palate and back of throat.  Took 3 doses of benadryl that day and have continued to take zyrtec daily for 5 days - swelling has improved quite a bit but still noticed in right eye.  Swelling of lip and numbness and tingling of throat resolved after 2-3 doses of benadryl.
From faxed information received at manufacturer on 1/13/03 it was reported: this is in follow up to a report(s) previously submitted on 8/11/02 and 10/12/02. Information has been received from a registered nurse concerning a 50 year old white male who on 10/02/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot # 641116/1160L). On 10/3/02, the patient was vaccinated IM in the left deltoid with a second dose of concomitant suspect therapy influenza virus vaccine (FLUZONE) (lot #U0911AA), which was last administered in 2001. On 10/3/02, the patient's arm became extremely swollen and painful. The registered nurse reported that the patient was instructed to seek medical attention. The patient was treated with amoxicillin trihydrate (+) clavulanate potassium (Augmentin), 500mg, acetaminphen (Tylenol) and moist heat. The patient continued to be in pain and became very weak. The patient was admitted to the hospital for three days (dates not reported, and was treated with IV antibiotics. The registered nurse reported that the patient had recovered from the experience. No further information is expected. The case is closed. A 15-day follow up report received 7/16/2003 adds: 06/25/2003: Administrative case closure (no additional info anticipated). 07/07/2003: This version was created to correct the dates that this case was previously submitted by manufacturer to 11/08/2002 and 12/10/2002 (the dates were incorrectly typed as 08/11/2002 and 10/12/2002); and to correct the lot number for PNEUMOVAX 23 in Box 14. The correct lot number is 641116/1160L. From additional info received on 7/14/03, it was reported "this is an amended report. The adverse event onset date and time have been updated and the date and time of administration of secondary suspect vaccination has been updated. The case is closed, no additional info is anticipated."
Started with runny nose and "cranky", felt a little warm, remained with mild symptoms through the week but by Friday late afternoon had fever of 103.5 axillary temp. Treated with Motrin and brought the temp down, but still febrile Saturday AM. Went to ER, Dx'd with Bilateral Otitis Media and placed on Amoxicillin, Rash began Saturday night, Mom describes it as a mottled look on trunk which which progressed over the weekend to a bumpy rash. Maculopapular in nature. Saw Dr Monday afternoon. Switched antibiotics. Dr felt the rash and fever were reactions to the MMR vaccine received 9/23/2010. Otitis improved by the appt, but still running a low grade temp. Rash located face neck and trunk and gradually improved till unnoticeable 10/7/2010. Fever is also resolved. Remains on antibiotics till course is finished 10/13/2010. No diarrhea or vomiting and no one else sick in family.
This spontaneous report was received from a back office lead and refers to a 34 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
t103 hives all over body; itchy rt arm swollen & red @ inject site; sx lasted 24-48 hrs; no facial swelling or difficulty breathing;;
The pt developed speech problems, regression, and developmental delay. Diagnosed with Autistic Spectrum disorder. A follow up report received 5/17/2002 adds: Developed fever and screaming syndrome 1 day after vaccine. Behavior changes began.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the VARIVAX underwent multiple supported temperature excursions. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. This is one of the many reports from the same source. Additional information has been requested.