chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient's age was reported 81 years 10 months.  No concomitant medications were reported.  The reporter informed that, the expired Moderna vaccine was administered to the patient between 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
Lack of drug effect; tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Nitrous Oxide).   On 15-Apr-2021 at 10:44 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021 at 10:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a 48-year-old, female patient, with no relevant medical history reported, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive which occurred 6 months 2 days after the first dose of mRNA-1273. Drug ineffective was an additional event. SARS-CoV-2 test was positive as on 17-Oct-2021.Ongoing pandemic of COVID-19  remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538939 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient, with no relevant medical history reported, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive which occurred 6 months 2 days after the first dose of mRNA-1273. Drug ineffective was an additional event. SARS-CoV-2 test was positive as on 17-Oct-2021.Ongoing pandemic of COVID-19  remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
1000: APPREHENSION AND WORRY 1001: DIZZINESS : GAVE BENEDRYL 20 MG, GAVE THE PT WATER AND LOWERED PT TO GROUND, BP TAKEN: 120/86, 65 HR, 16 1005: PERIPHERAL EXTREMITY PARESTHESIA  IN HANDS, SLOWED THE BREATHING WITH GUIDED COACHING 1006: VISUAL CHANGES "FEELING VISION IS DISTANT AND UNCLEAR", OBJECTS ARE FAR AND UNCLEAR.  BP: 120/86, UNCHANGES RR: 20 1008: PT STARTED TO VOMIT CLEAR SPUTUM 1008: 911 CALLED,  1010: CONTINUED TO MONITOR AIRWAY AND COMFORT PT.   1014: PT SAT UP "I CANNOT BREATH".  EPINEPHRINE 0.3 MG TO RIGHT THIGH 1020-1024: FIRE DEPARTMENT AND PARAMEDIC TRANSPORTED PT TO HOSPITAL  1011: CONTINUED TO ASSESS, PT REPORTED SOB AND DIFFICULTY GETTING BREATH
Information has been received from a registered nurse referring to a female child of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On 07-JUN-2014, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot #, expired date, strength, dose, route and frequency were unknown). On 14-AUG-2015 the patient was vaccinated with the second dose of PROQUAD (Merck) (lot #, expired date, strength, dose and frequency were unknown) intramuscularly (inappropriate schedule of vaccine administered) (subcutaneous injection formulation administered by other route). No concomitant medication was reported. No adverse effects reported. Additional information has been requested.
Back ache; some soreness in his arm; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 09:15 at single dose in the left arm for covid-19 immunisation.  Vaccination Facility Type was Hospital. Medical history included prostate cancer from 3 years. Having aches and his back bothering him predates taking the vaccine. A while ago he blew out his knee and his shoulder and three years ago he started having trouble with his back. Family Medical History: heart disease.There were no concomitant medications. He had the flu vaccine from the VA and it can be a little bit of a thing but the last one it ached, made his shoulder worse; the ache lasted six months but it might have been the way it was administered. He has no product or information to provide NDC, lot or expiration date for the flu vaccine he received about two years ago. Mentions he swore off the flu vaccine after that. He was at the VA yesterday for some other business and they told him the shot was available to him so he had it. He is planning to get the second dose on 02Feb2021. He used to take blood thinners and he imagines, like with the blood thinners, that they wouldn't want him to stack Tylenol on top of the vaccine. He has a few aches and his back is bothering him; which is normal for him; but he would like to know if he can take Tylenol for his back. He noticed some soreness in his arm, a little, when he got home two or three hours later. His sister said to rub it to disperse the medication, so he did. Adds it is not a big deal. Recently he has not been sleeping well; which is also normal for him; so today he slept in; he may have slept too long on his back but his back is aching and he wanted to take some Tylenol for his back. The patient experienced some soreness in his arm on 12Jan2021 with outcome of recovering , back ache on 13Jan2021 with outcome of not recovered.  Treatment received for the event. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none.  Information about lot/batch number has been requested.
Info has been received from a physician concerning a male in his thirties who was vaccinated, SC, with an 0.5 ml dose of MMRII. Subsequently, the pt developed a rash. The physician dx'd the rash as measles. It was noted that the pt had no complications. Unspecified medical attention was sought. Subsequently, the pt completely recovered. No product quality complaint was involved. Additional info has been requested.
No first hand knowledge of event. 14 days post immunization, patient's wife presented to report an ER visit following immunization. No details available to me first hand. No first hand knowledge of event.
pt recv vax 15FEB96 & 4MAR96 pt devel one vesicle near the inj site on rt leg;it was reported that the pt sister (WAES96030580) also devel one vesicle @ the inj site on the same day;
This is a spontaneous report from a contactable Pharmacist who reported for patient. The Pharmacist mentioned that she had called earlier as well. A 67 year old female patient received PREVNAR13; lot H86212, expiry date 31OCT2015) on 11OCT2014, at 0.5 ml single. Medical history and concomitant medications were not provided. On 11OCT2014, the patient experienced pain in left arm, sore in left arm, could not lift her arm without pain and swelling at injection site. The Pharmacist mentioned that she administered the vaccine on 11OCT2014 and all the symptoms started on the evening of 11OCT2014. The swelling resolved on unknown date but the pain continued to worsen. Event "could not lift her arm without pain" outcome was unknown. The reporter thought that all those symptoms were due to administration of PREVNAR13. Follow up (13JAN2015): Follow-up activities closed. F/U response received from HCP. Follow up attempts completed. No further information expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  TRANSIENT CEREBRAL ISCHEMIA
I got the GARDASIL/HPV vaccination in 11/2014, 2/2015 and 8/2015. In summer, 2016, I began to suffer a strong pain in my left forearm, the pain last for 2-4 weeks and occurred repeatedly in both forearms. Few months later, I began to feel strongly painful in my leg muscles and had difficulty to walk. During the late 2016, I saw many doctors but no one could tell what disease I have had. The symptoms persisted and intensified during 2017, which made me hardly to walk and seriously affected my work and life. In November, I was diagnosed with an immune related disease which expressed as myofasciitis. Since November, 2017, I have been taking Glucocorticoid to restrain the pain and disease, the side effects of the drugs are also destroying my health. But unfortunately, the pain of myofasciitis always recurs and could hardly be completely cured.
On day 5 of my period in the evening, my period flow significantly increased. Normally I do not fill a Junior Lite tampon in 8 hours. I never have a heavy period on day 5. The night after my shot, I filled a Junior lite tampon. Sunday morning I filled a regular tampon and in the afternoon a lite tampon. Overnight Sunday-Monday I filled a Super tampon. Monday during the day the menstral flow subsided to almost nothing.
Patient reports reaction around injection site including: redness, swelling, and soreness. Symptoms began the day after getting the and have not gotten any better over a 48 hour period
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/21/2023.
dizziness 2-12/14-10: swelling where shot was given 2-12/14/10; severe headache 2/12 p.m. until 2/14 pm; 102 degree temp. late p.m. 2/12 thru 2/13 p.m.; nausea, no appetite, pain in arms, legs and head 2/12 - 2/14; took TYLENOL extra strength (scheduled for cataract surgery 2/16/10)
numbness on right side of face spreading to head and neck. prescribed prednisone, valcyclovir. multiple MRI with no conclusion
I had some itchiness on my body ( hands) and then I had explosive diarrhea. This happened about 8 days after vaccine was given. Then I noticed a rash starting on my body. It was on my back, chest. Also. Seemed to start in genital area. Because of this I went to gyneco.ogist and GI APRN because of swelling and severe itch. Also went to Urgent Care where I was given Prednisone for 7 days. GYN GAVE cream to apply(Clortrima/BetaMeth. Later test revealed No yeast infection.
Area around injection site firm, red and tender and remains that way as of 04/04/2021. Also had joint pain and fatigue.
On Thursday February 18, 2021 around 9 am I began feeling chills, body aches, extreme nausea and experienced one of the worst headaches I have ever had in my life. I left work after a noon meeting and was on the verge of asking my husband to take me to the ER while I waited to hear back from my neurologist. I sent a message to my neurologist and inquired as to whether or not it was safe to take a dose of the regular migraine medication I have to treat this headache. The response I received from his office was that it was safe to take my abortive migraine medication which I did and within a couple of hours I began to feel better.
An adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (An adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (An adverse reaction). At the time of the report, ADVERSE REACTION (An adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
8/9/21 hx of HTN, DM type 2, who presented to ED for evaluation of abnormal labs
first dose on 3/4/2020, not yet received second; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th March 2020).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 5-MAY-2022 Reporter's Comment: The reporter was a pharmacy intern. The patient had not yet received the second dose of Shingrix. The reporter consented to follow up by safety via telephone only. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Experienced swelling of tongue, difficulty swallowing, feeling hot, feeling of elevated heart rate. Administered 25mg Diphenhydramine with improvement. Patient sent home at 1500 with significant other and instructions to go to the ED if symptoms persist or worsen.
After each vaccine I had temperature, nausea, stayed in bed for one day, chills and headache. I took TYLENOL. On the 28 I tested Positive for COVID-19. I called my doctor and he prescribed Paxlovid, after I finished the dose, one/two days after I got sick again, I tested again for COVID-19 and it was Positive, I had temperature, my doctor said not to take the medicine again, it was worse than before. Last Wed and Sat I tested again, and it was Negative. My nose still running.
Redness at injection site, swollen armpit, sore jaw on left side, sore left shoulder, sore left breast, lower left arm soreness  Left arm and shoulder still aches, left breast still sore
Sore arm; More tired than usual; A spontaneous report was received from a consumer concerning a  60-year-old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm/injection site pain and was more tired than usual/fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, after receiving the vaccine, the patient experienced sore arm and was more tired than usual. She stated that her symptoms did not last longer than 24hrs.  Treatment for the events included Motrin.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, injection site pain and fatigue were  recovered/resolved.; 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. Further information has been requested
Cellulitis of upper arm less than 12 hours after injection, treated with cephalexin.
gave a 17 year old Quadracel instead of Gardasil; gave a 17 year old Quadracel instead of Gardasil; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5497AA via intramuscular route in the left deltoid on 08-Aug-2019 instead of GARDASIL.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Documents held by sender: none.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck), 0.5 ml, subcutaneous (lot # not reported). On an unknown date the PROQUAD was exposed to a highest temperature of 11F for 2 hours total over four different excursions. There was no adverse effect reported. This case is linked to MARRS # 1406USA000368 (same reporter link). Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
Parent called to report, after her child had received Hep-B at 09:30. He went to school and completed a day of school but told parent he "felt weird; not like himself" all day. He complained of loss of memory, shakiness and spilling liquids while at school. By 19:30, he complained of itchy eyes and loss of appetite. He went to ER and his only treatment was to take Benadryl po.
on 02/15/2001 the patient developed a generalized rash. The patient sought unspecified medical attention. It was reported that the patient recovered from the rash. Additional information has been requested.
Right forearm noted with quarter size redness with pea size raised area. Denies any discomfort at this time.
Patient reports that approximately 2 hours after receiving her 2nd dose of Shingrix, she developed vomiting, diarrhea, body aches, chills, sweats, Left Arm soreness, extreme fatigue, loss of appetite and she does not remember much after her appointment that day.
Developed rash and joint swelling the next day. Also with swelling of the lips. No fever. Rash was itchy and on arms and legs.  No joint swelling resolved after 48 hours. Still with pain of feet with walking on 7/9/21
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-MAR-2017, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
First of all, What I am going to report is not the adverse effect of the vaccine. Instead it is the good effect of the vaccine. I was diagnosed as Malt Lymphoma in Sept. 2019. I believe the two doses of the Pfizer vaccine cured my lymphoma.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30(at the age of 68-year-old) as a dose for COVID-19 immunisation. Medical history included malt lymphoma. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has experienced unexpected therapeutic benefit from both the doses. On an unknown date the patient reports that "first of all", what she reported was not the adverse effect of the vaccine. Instead, it was the good effect of the vaccine. The patient was diagnosed with malt lymphoma on an unknown date in Sep2019. The patient believed that the two doses of Pfizer vaccine cured her lymphoma. On the report date(14May2021) she got her latest PET scan result which showed that lymphoma in her rectum was gone. She has never had any treatment for the lymphoma. The only symptom she had been had was the tender/pain in the lymphoma location in her lower ab. After the first dose of vaccine, she could feel that the pain was reduced. The patient developed multiple lymph nodes swollen, shortness of the breath, and night sweat etc. which were typical lymphoma symptoms after the second dose of the vaccine. At the same time, the pain at the lower ab had been significantly reduced. Also, her appetite had been improved a lot which made her to gain 4 lbs since 30Mar. This means a lot to the patient since she had lost the appetite and kept losing weight in the last few years. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. On an unknown date, the patient underwent positron emission tomography (PET) scan which showed that lymphoma in her rectum was gone. The clinical outcome of the event unexpected therapeutic benefit was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.