chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received both doses 3 years ago, at the end of June 2021 had a shingles outbreak/ Suspected vaccination failure; June 2021 shingles outbreak on lower left back; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). In June 2022, the patient received the 1st dose of Shingrix. On 27th June 2021, more than a year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, 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.     Linked case(s) involving the same patient:  US2022AMR099103   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient received both doses of Shingrix about 3 years ago (not sure of the dates) from reporting. Received 2nd dose on unknown arm.  The reporter stated at end of June 2021 she had a shingles outbreak on her lower left back, healthcare professional verified it was shingles. The patient report shingles outbreak last Friday 24th June 2022 in the same spot on the lower left back.  Healthcare professional verified and started her on Valtrex. The reporter did not consent to follow-up her and her healthcare professional. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. For tolerance of Valtrex, refer case US2022AMR099103, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099103:Same patient, same reporter, different product
Urticaria (hives) appeared on upper body (no localized injection site hives).
Patient experienced a syncopal episode within a few minutes after administration of immunizations.  He received Gardasil, Havrix, and Menactra.  After leaving the exam room, he experienced an acute syncopal episode in the hallway.  I evaluated the patient immediately afterwards and he regained consciousness within seconds and was able to ambulate back to the exam room within a few minutes.  There was no associated chest pain, shortness of breath, abdominal symptoms, throat symptoms or difficulty swallowing.  I conducted an exam of the patient and kept him in the room monitor.  We observed him for about 30 to 40 minutes with frequent checking in. He reported complete resolution of symptoms and was doing well.  On further questioning, he had stated that he is experienced previous episodes similar to this with donating blood, cuts, and immunizations.  In addition, reported not having had p.o. intake since dinner last night.  Vitals taken by me after patient was observed for 30 minutes in a standing position BP: 106/71. HR: 77.
She felt like she had the flu; extreme fatigue; This is a spontaneous report form a contactable consumer (patient daughter). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on unspecified date for COVID-19 immunisation. Consumer stated her mother who had received both doses of Pfizer's COVID vaccine has still not recovered from her second dose. It has been well over a month. Caller states She felt like she had the flu for 3 weeks and she's still suffering from extreme fatigue and is not able to get on with her regular activities. She has not recuperated. The outcome of the events was not recovered.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
a physician reported that his 33 year old asplenic daughter received an injection of Pnu-immune 23 in 01/99 following a case of pneumoccal sepsis with disseminated intravascular coagulation. On 10/23/99, she felt achy anf developed shakes and a fever of 103 degrees F.  She was hospitalized with a diagnosis of pneumococcal sepsis (serotype not provided). Upon internal review on 01/29/02, this case will be redistributed to reflect change in code from vaccination failure to drug ineffective.
arm sore and heavy, worst day was 1/9/21, getting better now. Trouble moving arm. Patient has taken Tylenol for the soreness. Pain is more focused on the injection site but patient has heaviness in the arm.
pt recvd vax & was driving car & w/in 6min stated "I'm sick"-grandparent instructed pt to stop car;pulled over & lay down on front seat;pt was cold,clammy & diaphoretic,lips white;trouble getting radial pulse but breathing okay;came to
Presented to urgent care with 5"x4" area of blanching erythema, swelling minimal. No fevers, chills or streaking. Treated for cellulitis with Keflex.
Red, indurated, hot touch left upper arm 5 1/2 x 3 1/2 DTap.
sore arm; headache; joints kind of hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Infection (it was something that the patient had for a while. The patient had to take 3 types of medications because of infection.) and Stomach inflammation (it was not confirmed if the patient had polyps or ulcers).    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting). The patient was treated with DOXYCYCLINE on 23-Nov-2021 for Adverse event, at a dose of 100 milligram twice a day; OMEPRAZOLE on 23-Nov-2021 for Adverse event, at a dose of 40 milligram twice a day and METRONIDAZOLE on 23-Nov-2021 for Adverse event, at a dose of 500 milligram three times a day. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and ARTHRALGIA (joints kind of hurting) outcome was unknown.            The patient took unspecified concomitant medications for other health conditions. The patient had an appointment to get the booster shot, which was scheduled for 30-Nov-2021. The pills information (taken for infection) revealed that the patient could not take any vaccines while taking the medications.   This case was linked to MOD-2021-397027 (Patient Link).
Right Arm very tender to the touch, very painful, swollen, has a knot in the center.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was vaccinated intramuscularly with 0.5 ml dose of PNEUMOVAX 23 (lot number KK004542 and expiration date 19-AUG-2015) after the expiration date. Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 35 year old female with a history of papilloma viral infection who on unspecified dated, was vaccinated with the first and second dose of Gardasil. 04-APR-2007, the patient was vaccinated with a third dose of Gardasil (lot # 654702/0011U) 0.5 ml IM into the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN, and ALLEGRA-D. On 05-APR-2007, the patient sought medical attention by contacting the physician's office. The patient reported that on 04-APR-2007, immediately after being vaccinated with the third dose of vaccine, she noticed symptoms. She had severe shoulder pain. The patient could not lift her arm laterally and could not sleep due to the pain. The patient was ordered MEDROL DOSE PACK, heat, and LORCET PLUS. The patient had also been seen at an orthopedics office. She was given 2 steroid injections and she is being set up for physical therapy. The patient did not have any symptoms with the first two doses of vaccine. At the time of reporting, the patient had not recovered. No further information was available at the time of reporting. The reporter felt that the events were disabling. Additional information has been requested.
a patient was given an expired dose of Pentacel with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse and transmitted to Sanofi on 27-Jul-2020.  This case involved an unknown age patient for whom it was reported that a patient was given an expired dose of pentacel with no adverse event (Expired product administered), while patient was received vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On 23-Jul-2020the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot: unknown and Expiration date: 22-Jul-2020) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) it was reported that a patient was given an expired dose of pentacle with no adverse event (Expired product administered).  No relevant laboratory data was reported.  Action taken, corrective treatment and event outcome were not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
There was a vaccine administration error - my son, who is 12 years old, received the Moderna shot.  Confirmation when making appointment and paperwork provided was for Pfizer, but the facility administered Moderna.   At this time, there has not been an adverse event associated with the error, but according to modernatx.com; a report should be completed for a vaccine administration error.  Website also states to include the words "Moderna COVID-19 Vaccine EUA" -
Approximately ten minutes after administering the VARIVAX vaccine child had a red area around vaccine site. The area was approximately an inch by a half an inch in size. He was watched for 20 minutes. Area was less red and looks like it may bruise. Mom had BENADRYL and 3/4 teaspoon was given.
PATIENT EXPERIENCED - CHILLS, SLEEPINESS, LOSS OF APPETITE AND HOTNESS OF STOMACH 3 DAYS AFTER THE ADMINISTRATION OF VACCINE. EXCEPT FOR THE HOTNESS OF STOMACH AND LOSS OF APPETITE, OTHER SYMTOMPS GOT RESOLVED IN 24 HOURS.
Series of symptoms resulting in sinus tachycardia confirmation through EKG on 12/3/21. 11/29/21 - Moderna Booster at 3:00 pm, sore arm began at night 11/30/21 - Only sore arm until about 3:00 pm, started to feel off around then. By 6:00 pm terrible headache, chills, 100.4 temperature, muscle soreness, heavy cough. Symptoms lasted through the night. Took Ibuprofen PM. 12/1/21 - Lymph node under my left arm had increased to a size of a tennis ball, pain in my left breast area.  Fatigue continued and headache off and on all day. Muscles slightly ached. Cough. Took Ibuprofen. 12/2/21 - Around 8:00 pm, heart fluttering began as I laid down. I sat up and then they passed shortly.  Fatigued. Cough continues. 12/3/21 - Around 4:30 am, heart fluttering again.  Palpitations continued on and off during the day.  Heart rate felt increased. Went to primary care doctor around 3:00 and EKG reported sinus tachycardia.  Still had palpitations during the evening. Fatigued.   Cough continues. 12/4/21 - Still experiencing heart palpitations and fatigue today.  Headache all day at the time of this report.  Took Tylenol early this morning and followed up with Ibuprofen in early afternoon. Cough seems to be improved as of today.  I still have not taken the prescribed cough medicine from my primary care physician office.  May not take it as it does not seem necessary.
Very mild side effects. Mild soreness in arm night of vaccination and following AM. Fatigued next day.
ACUTE NON ST ELEVATION MI 6/1/2021    HYPOTENSION 7/1/2021    ACUTE RESPIRATORY FAILURE 5/27/2021    CHRONIC RESPIRATORY FAILURE 7/1/2021    CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021    CARDIOGENIC SHOCK 6/1/2021    ACUTE NON ST ELEVATION MI 6/1/2021 HYPOTENSION 7/1/2021 ACUTE RESPIRATORY FAILURE 5/27/2021 CHRONIC RESPIRATORY FAILURE 7/1/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIOGENIC SHOCK 6/1/2021 ACUTE NON ST ELEVATION MI 6/1/2021 HYPOTENSION 7/1/2021 ACUTE RESPIRATORY FAILURE 5/27/2021 CHRONIC RESPIRATORY FAILURE 7/1/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIOGENIC SHOCK 6/1/2021 ACUTE NON ST ELEVATION MI 6/1/2021 HYPOTENSION 7/1/2021 ACUTE RESPIRATORY FAILURE 5/27/2021 CHRONIC RESPIRATORY FAILURE 7/1/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIOGENIC SHOCK 6/1/2021 ACUTE NON ST ELEVATION MI 6/1/2021 HYPOTENSION 7/1/2021 ACUTE RESPIRATORY FAILURE 5/27/2021 CHRONIC RESPIRATORY FAILURE 7/1/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIOGENIC SHOCK 6/1/2021 ACUTE NON ST ELEVATION MI 6/1/2021 HYPOTENSION 7/1/2021 ACUTE RESPIRATORY FAILURE 5/27/2021 CHRONIC RESPIRATORY FAILURE 7/1/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIOGENIC SHOCK 6/1/2021
Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Apr-2021 and Pfizer on 09-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose on the20-Apr-2021 and booster dose on 07-Sep-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known allergies. Acute illness and Chronic illnesses at the time of vaccination and up to one month before was reported as unknown.  Concomitant medications details were not reported by the reporter.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as none.  It was reported that patient had received three doses of Moderna and two doses of Pfizer one day after and wants a booster dose. The patient had received first dose of the Moderna on the 18-Mar-2021, the second dose on the 20-Apr-2021. And then a first Pfizer dose on the 21-Apr-2021, a second Pfizer dose on the 09-Jun-2021, and a first booster dose of Moderna on the 07-Sep-2021.  Treatment details were not reported by the reporter.
received the shingrix vaccine dose #1 in October 2019 / wants to know if he can get dose #2 now; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in October 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 patient reported the case for himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know if he could get dose now or if he need to start the series again. The reporter consent to follow up.
Pt recvd a series of 3 Engerix-B, serology done (about 1 month /p 3rd dose) indicated that pt failed to develop titers, revax series (3 doses) started 12Sep90 /w Engerix B Lot # 618A4, and 15Oct90, no treatment has been required
stroke; This is a spontaneous report from a contactable consumer or other non-health care professional. The reporter reported for 2 of his neighbor. This report is for the 1st neighbor. A 60-year-old male patient received 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 medical history and concomitant medications were not reported. On an unspecified date the patient experienced stroke, the same day of vaccination. Reporter mentioned were the most affected by the shot but did not give any specifics. The event was medically significant. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
One week after receiving HiB + IPV vaccines, pt began vomiting formula, which lasted for 3 days. Diarrhea was also present during this time, though not as frequent as the vomiting. She was able to keep down Pedialyte and slowly began keeping down 1/2 strength formulation by 3/5/07. She was not exposed to any other illness before or after the vaccinations and had no fever during the time of this possible reaction. She now seems fully recovered, though I will continue watching her for problems.
Around  April 18th, 2022 I noticed I was scratching my neck and face. It kind of looked like a rash, but not raised or hot. Might have been from scratching but it was very itchy and extended from my cheek to my neck. I was subconsciously scratching so I started t pay attention to it and it would grow a little at a time. After 7 days, around April  27th, 2022 I started taking Allegra and it would help. If I stopped taking it, it would flare back up.  It eventually started to subside sometime in May but I still take it because it comes back if I don't.   I did not seek medical attention for this event. I self treated. I mentioned it to her recently when I was seen for COVID-19 symptoms.
Information has been received from a physician concerning a 16 year old male who on 31-MAY-1995 and 01-FEB-2008 was vaccinated with the first and second doses of MMR II (lot not reported). On 30-NOV-2009 the patient had a fever and his body temperature was tested as 103F. On 21-DEC-2009 the patient experienced parotitis. At the time of the report, the patient's outcome was unknown. Follow up information from the physician indicated that the patient experienced mumps on 26-DEC-2009. On 28-DEC-2009, the patient was diagnosed. The patient was afebrile and had right parotitis. On the same day, a first blood work was performed and showed that: IgM, <1.10; IgG 3.34; serum amylase, 35. No further information is available.
Disrupted menstrual cycle: 4/11/21 - 4/15/21: First period  was very heavy with painful cramps. 6/2/21 - 6/9/21: period was 8 days long. Usually they are 5 days.  7/17/21 - 7/31/12 - Cycle was 18 days and started bleeding early. Bled continuously for 15 days.  8/17/21 - 8/21/21 - Cycle was 31 days long. Bled for 5 days. Blood was normal colour and consistency. Very painful cramps though.   Things to note:  Average cycle length - 25 days Average period length - 5 days I track all symptoms and flow information in detail and have 19 months worth of data.
haven't had the flu since I quit getting flu shots over 20 years ago; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown age and gender) who experienced "haven't had the flu since I quit getting flu shots over 20 years ago" (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious "haven't had the flu since I quit getting flu shots over 20 years ago" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
1-28-2021 to 1-30-2021 very sore arm at injection site. 1-31-2021 to 2-2-2021 very itchy and hot arm at the vaccine site. Needed to use hydrocortisone, 2-8-2021 developed large rash around injection site area. It was hot to the touch and intensely itchy. It was gone on morning of 2-9-2021.