chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have shingles, had vaccination years ago/Suspected vaccination failure; shingles, lower back to belly button; 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. 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 Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had shingles vaccination many years ago.  The patient had shingles at the time of reporting affecting lower back going to the belly button . The patient stated that, it was absolutely awful and Keep him/her in prayers .  The patient further stated that, guess he/she should have taken another one. 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 possible as no contact details were available.
Client received Hep-B #1 (Recombivax) LDT and PPD-TB (Tubersol) in RFA and 10 minutes later, developed rash on neck and a scratchy throat. Went to ER experiencing breathing difficulties. Received Epinephrine and injection of Benadryl and recovered within minutes.
Vasculitis Both Lower Legs -  Red Rash and Red Spots Warm to Touch
Aching like arthritis in my knees and legs; Aching like arthritis in my knees and legs; This is a spontaneous report from a contactable physician, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 11Mar2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID), taken from an unknown date. 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. On 18Mar2021, approximately one week after vaccination, the patient experienced aching like arthritis in the knees and legs which had lasted approximately two weeks. It was reported that the patient never had arthritis before. The clinical outcome of the event aching like arthritis in the knees and legs was resolved on 01Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Felt dizzy/lightheaded after receiving IM injection-laid down x 10 min in observation then x 15 min in clinic. Ate crackers and drank water then felt better, return to class, mom notified.
17JUL95 grandma called clinic spoke w/RN stated her daughter called & said both twins were screaming asked what to do, urged to go & check on twins, call PMD having non characteristic screaming;19JUL95 attempted tc d/c;19JUL95 home visit
Please help. I received the moderna vaccine on Dec 30th (health care professional) today is January 9th. I have a baseball size rash, hot to touch, not painful that started last a Tuesday (six days after injection). At first my arm was a bit sore but nothing more than the flu vaccine. I have drawn a circle around the mark to see if it is increasing in size, it has been increasing each day. I went to dr and they. Told me they don?t know what is causing this but put me on an antibiotic. I am scheduled for second vaccine on Jan 25th. Not sure if I should still get this.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 2 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006259, 1210USA006260, and 1210USA006262) and 1 patient who received incorrectly stored M-M-R II (case ID 1210USA006263), all on the same day. Additional information has been requested.
We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.; Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was initially stored in the refrigerator on 31-Mar-2022. The vial did not undergo temperature excursion.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received included no new information.
Local erythema, color and pruritus symptoms induration.  Both arms-  No Rx
Well I got the vaccine and had cold like symptoms and then on Wednesday I went into A-fib and went to urgent care. It is hard to say if it is the vaccine or Covid itself. I had lots of fatigue, a headache and a fever of 99.5. The ER prescribed metoprolol and I have been referred to a cardiologist. Other than that I have just been quarantined at home.
rash upper arms; Itching; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on the left arm, at the age of 78 years, on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from 1980 to an unknown date and rheumatoid arthritis from 1980 to an unknown date. The patient's concomitant medications included an unspecified flu shot in Nov2020. The patient experienced some rash in the upper arm and itching on 20Jan2021 which has gotten better (she added that she did not take anything medical for this, just a night cream). She added that she was allergic to epinephrine which she mentioned during her first shot. She was asking if it was okay to proceed with the second dose. The patient said that she got the first dose injected on January 20th to her left arm, and that evening she had the rash. She says she didn't really treat the rash, she just used cream for the itching. She says the rash was that she broke out on the upper part of both of her arms. She says that the itching did get better. Therapeutic measures were taken as a result of itching (pruritus). The outcome of the events was unknown.
Redness warmth at GARDASIL injection site - Full tongue itchy HARDPALATE - NO SOB No Wheezing
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 28-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sudden onset of violent shivering and nausea around 9:30-10pm. This lasted through the night and continued through the next day with a fever, bad headache, moderate body aches, muscle weakness. I slept 2 days straight and have had no appetite and unable to eat or drink much (have to force down water). Last night I woke up soaked in sweat. Starting to feel better today (day 3 I guess) but still recovering, weak, headache, tired. Today is 11/3 at 3pm.   I was pretty scared with the shivering and would have gone to the hospital but I was out of town .  I made my husband wake up to check on me every hour to make sure I was still alive.
1 of 5 pts immunized from the same lot# who exp an adverse event;pt devel erythema,swelling & fever;fever subsided p/2days;other sx also resolved;pt also had URTI/bronchitis @ time of immunization;given Zithromax 5-day course;sx resolved
Pfizer-BioNTech COVID-19 Vaccine EUA. 5 minutes after vaccination patient felt warm, light headed, left arm pain, and blurred vision. Lasted about 3 minutes and gradually was gone by 5 minutes.
The day following the vaccine, the patient complained of throat issues and anxiety.  This was not new... however .  That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative.   On 12/30/2020, patient complained of sternal pressure and was transferred to the hospital.  The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction.
Right side of the neck became tight; Lymph nodes on the right side of the neck became swollen; Possibly a reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Right side of the neck became tight), LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) and VACCINATION COMPLICATION (Possibly a reaction) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced MUSCLE TIGHTNESS (Right side of the neck became tight), LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) and VACCINATION COMPLICATION (Possibly a reaction). On 03-Jan-2021, MUSCLE TIGHTNESS (Right side of the neck became tight) and LYMPHADENOPATHY (Lymph nodes on the right side of the neck became swollen) had resolved. At the time of the report, VACCINATION COMPLICATION (Possibly a reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  After few minutes of vaccine administration the patient experienced the right side of the neck became tight and the lymph node on the right side of neck became swollen. Treatment information included diphenhydramine and ibuprofen.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  The initial report of "possibly a reaction" likely refers to the later report of tight neck and lymphadenopathy, but this is not specified so agree with retaining the general event of vaccination complication   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Patient age, Batch number, events including outcome, and treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  The initial report of "possibly a reaction" likely refers to the later report of tight neck and lymphadenopathy, but this is not specified so agree with retaining the general event of vaccination complication
Her foot is tingling and numb; Her foot is tingling and numb; Can barely walk; Getting pain in her right leg from the knee down into her foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Getting pain in her right leg from the knee down into her foot), HYPOAESTHESIA (Her foot is tingling and numb), PARAESTHESIA (Her foot is tingling and numb) and GAIT DISTURBANCE (Can barely walk) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Getting pain in her right leg from the knee down into her foot). On an unknown date, the patient experienced HYPOAESTHESIA (Her foot is tingling and numb), PARAESTHESIA (Her foot is tingling and numb) and GAIT DISTURBANCE (Can barely walk). At the time of the report, PAIN IN EXTREMITY (Getting pain in her right leg from the knee down into her foot), HYPOAESTHESIA (Her foot is tingling and numb), PARAESTHESIA (Her foot is tingling and numb) and GAIT DISTURBANCE (Can barely walk) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up received on 28-MAY-2021 and not patient feel fine now. Outcome of the event updated.
Moderna COVID?19 Vaccine EUA circular rash about 3 inches in diameter; slightly raised; firm Started 8 days after the shot and still continuing as of 10 days after the shot
Swelling in groin area noted 12/16/2021; Two red raised bumps at injection site noted 12/22/2021
Pt reports pain in the (R) arm that was very bad Thursday after receiving the vaccine-she reports redness and some swelling. She advised that it has gotten better. This pt called 2/17/15-PM. I have advised the pt to follow-up with her primary care provider, she advised she was going to call him today.
Today at 12:42 patient?s companion flagged nurse down that the pt wasn?t feeling so good. Pt reported that she was feeling dizzy and was seeing flashing lights. Pt reported that she hadn?t eaten any breakfast this morning prior to getting her vaccine. Pt reported that she only had a cracker and hadn?t had water/fluids to drink today. Pt reported that she received her first Moderna vaccine today at 12:24 pm. Pt was offered some fruit to eat and tolerated food well. Pt reported she was starting to feel much better. Pt reported that her symptoms had subsided and she felt okay to leave. PHN advised pt to at least wait 30 min in total to assure that she was okay. Pt verbalized understanding and remained seated until 30 minutes passed. Pts vitals at 12:43 were 130/84 blood pressure, saturation at 96%, respirations 17, and 84 bpm. Vitals were taken again at 12:57, 122/78, 99% saturation, 80 bpm, and respirations 18. At 13:10 pts vitals were taken again, blood pressure 118/70, 97% saturation, respirations 18, and 83 bpm. Pt reported that she does not take any medications on a daily basis, but did take Tylenol this morning for a HA. Pt denied any supplements or herbal remedies. Pt denies that she has any chronic health conditions. Pt denied ever having Covid. Pt reported that she was feeling much better. Pt denied any symptoms and that her symptoms have subsided. Pt was offered some water, but stated that she had water in her car. Pt was released to go home, vitals were within normal limits, and pt was no longer having any symptoms. Pts left with her companion. Pt signed the reporting form that she was okay. PHN advised that if pts symptoms return or if she doesn?t feel well after leaving to seek immediate medical attention and/or can follow-up with her primary care provider. Pt verbalized understanding.
On Thursday night I had a sore throat, head congestion, excess mucus. I called the doctor, had a telehealth visit and described my symptoms. He prescribed a Z-pak, that did help break up the congestion and mucus for me to cough up. This has now progressed to my lungs. I called the doctor today, 03/13/23 for another telehealth visit. My doctor ordered a chest x-ray and asked that I do a home COVID-19 test that did come back negative.
Upper Respiratory Symptoms post vaccination; COVID Rapid Test was Positive post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination). At the time of the report, RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow up received on 08-JUL 2021, Event  outcome updated. second dose added
pt recv vax; 27 hr p/ vax; sz w/ "foaming from mouth & head turned to the side"; to er;found to have low dilantin level;MD inc dilantin & advised family no relation to HBV;further doses not contraindicated;
fever, chills, body aches, massive migraine, extreme fatigue for 36 hours.
55-year-old female presented to urgent care on 1/13/2021 with headache, body aches, temp up to 100.2 Fahrenheit, sore throat, and some left axillary lymph node swelling. She also had some erythema and edema to the vaccination site.  She received this vaccination on January 11.  Her symptoms started January 12. On January 14, 2021, patient returned to urgent care for worsening erythema and discomfort at injection site. Patient was given supportive care and discharged home.
41 hours after injection given the injection site had a 2 inch diameter welt, red, raised, inflamed, warm to touch, and soreness at the site.  Tylenol 1 gm given every 8 hours & an ice pack to site for 20 minutes twice day done the day of the findings and the day after. No change in the welt & it continues to be sore & feverish. The symptoms are local at the injection site currently. As of today while reporting the finding no change in the injection site it continues to be a 2 inch diameter, red, raised, very warm to touch, and sore welt.
Severe headache intractable to NSAIDs and acetaminophen. Pain and swelling at injection site. Body aches and temp to 101.1
Local injection site pain; Myalgia; headache; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On 13th January 2020, 12 hrs after receiving Shingrix, the patient experienced injection site pain, myalgia, headache and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, myalgia, headache and influenza-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain, myalgia, headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about 12 hours later she started to experience local injection site pain, myalgia, headache and flu like symptoms. Reporter consented to follow up. Vaccination dates were reported as 13th and 14th January 2020, it was considered as 13th January 2020 as per source document.