chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from Pfizer, Inc. (manufacturer report# 2016466823) on 27-OCT-2016. Reporter had a 62 year old female with an adverse side-effect from Pneumonia inspection from a pharmacy. Reporter was not sure of the vaccine, but it's the Streptococcal Pneumonia Vaccine given out at pharmacy to prevent pneumonia. Patient had shoulder pain, injection site pain and restricted movement of arm, but it looks like intense pain apparently. The vaccine was administered today (03-OCT-2016) and the side effect was not immediate, but it was into the evening and now at this point, at the middle of the night at 2:30 AM the patient was moaning at the middle of the night. Start date was not captured for moaning as it started in the middle of the night and date was not probed for it separately. Outcome for shoulder pain, injection site pain, restricted movement of arm and moaning was reported as ongoing and worsened. Reporter was not sure of the dose: it was just the syringe at the store. Reporter asked if there were any relief clues or things that he could know that would make the pain less or something to have or this was a common thing. Reporter provided the complete name of the product as PNEUMOVAX 23 Inj 25mcg/0.5ml PF SYR. Reporter did not have the product details with him (LOT#, NDC#, UPC# and expiration date). Other medical conditions were not reported. Reporter did not know if patient was on other medications. Reporter was unsure about any laboratory work. Additional information is expected.
Lethargic; Vomiting; Nausea; Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced lethargy, vomiting, nausea, chills and fever. On an unknown date, the outcome of the lethargy, vomiting, nausea, chills and fever were unknown.   It was unknown if the reporter considered the lethargy, vomiting, nausea, chills and fever to be related to Shingrix.  Additional details were provided as follows: The expiry date was updated from 26th March 2020 to 26th March 2022, as per sales data sheet. The age at vaccination was not reported. The Caller was the pharmacist reporting the AE for a patient.  The patient received Shingrix and had lethargic, had fever and chills, and nausea and vomiting. Limited information was known about the resolution of the symptoms. The HCP information not provided. This case linked with US2020173751, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020173751:same reporter
Received my second dose at 2:00 pm and woke up at 3:00 am with severe muscle/bone pain throughuot my hips, buttox, legs, knees and ankles.  Had constant headache from 3:00 am till 5:00 pm.  Constant chills throughout the day and into the evening.  Was unable to rest/sleep do to pain lasting 20 hours.  Had blurred faresighted vision throughout the day.  Had mild headache lasting 5 hours the second morning after the shot.
After taking my 2nd Shot for Booster on the morning of Friday the 5th of 2021. I ate and hydrated for the day. At home I was resting when standing up I was overwhelmed with dizziness, nausea, sweats, and then the chills and heat hit. My inner core felt frozen. I couldn't move after standing up and the chills locked every bone in my body I couldn't breathe. Terrified doesn't cover how afraid I was at that moment. Teeth chattering, fingers rigid, and my back was solid. After moments in this state, I put on layers of sweaters to warm myself. The outside temperature was 65-70*C. So not that bad. I was in shock and not long after putting on my sweaters. My skin felt like it was sun burned and all the weight of the clothing was painful.  I could not lay down, or even roll on my side for rest. Even standing up made my spin hurt.  The muscles in my lower back seized up and the pain was right in the middle of my spin. (The ER Doctors checked and I do not have kidney stones.) I was fighting 99.3+ temp and rising. (This temp is accurate. I have phot evidence.)  There was no sleep that Friday night.  Saturday morning I called the first available chiropractor and went to that appointment at 2pm.  As a new client they don't want to go all out in the first session, but I was in pain with every breathe.  Hyperventilating and over breathing was causing issues with my head and stomach.  The session was amazing, electro therapy mixed with heavy cracks worked on by a professional did help, but only for a brief period of time. Walking away from the building I was still in more pain than ever.  My dad arrived to take me to the ER at roughly 6pm.   Doctors gave me fluid and anti inflammatory drip. Potassium and Tylenol.   It worked. The pain was unreal and I welcomed anything to end the suffering.
sore throat; upset stomach; achy; Fever; fatigue; headache; chills; Age at vaccination: 9 years; Age at vaccination: 9 years; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 9-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182; Expiration date: not provided) via an unspecified route of administration on 12May2021 (age at vaccination 09-year-old) in right arm as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, the patient experienced fever, fatigue, headache, sore throat, upset stomach, achy and chills. The patient received treatment of tylenol for true events. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
I started spotting less than 24 hours after my second dose, it is very abnormal for me to spot before my regular period. Spotting lasted 6 weeks. I then stopped spotting for 2 days and then I started bleeding very heavily for 7 days. I was bleeding a total of 7 weeks. I stopped bleeding finally and started getting headaches and my face started breaking out like I was a teenager again. I am now struggling with skin issues that I should not have at my age. I have also been emotional more than usual, this vaccine has messed with my hormones. I am seeking help from an OBGYN.
Patient was given a dose from an expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.
About six weeks after the vaccination I noticed a rash on my back about 1.5" long  by .75" wide. When I went to my dermatologist, the PA looked at the rash and called it a yeast infection. He prescribed Econazole Nitrate Cream which I used twice a day for over six weeks before the rash disappeared completely.  I wonder if the rash could be a result of the vaccine since I had never had a yeast infection on my back prior to this time.
Information has been received from a registered nurse concerning her 17 week old grandson with no pertinent medical history who on 07-OCT-2008 was vaccinated oral with the first dose of ROTATEQ on approximately 10-DEC-2008, the patient was vaccinated oral with the second dose of ROTATEQ (LOT # 661428/0898X).  There was no concomitant medication.  In less than 24 hours after received his second dose of ROTATEQ, on approximately 11-DEC-2008, the patient developed hives.  The hives began on his feet and legs and spread upwards to his chest, arms and then his face.  No fevers noted.  The rash lasted for 4 days and on 15-DEC-2008 disappeared in the same pattern of how it appeared (from his feet up).  The patient was seen by the physician and the physician felt that it was viral and not a reaction to the vaccine.  Subsequently, the patient recovered from the adverse event.  The patient did not experience any difficulties after the first dose.  It was reported that the patient sought medical attention: office visit.  Additional information has been requested.
She was urinating very frequently in the course of a 30 minute program she went five times, she had some burning also. We took her to the local urgent care where they did a urine sample and prescribed an antibiotic for 10 days.
8/20/12 - father of child called to report child developed generalize rash later in the day after receiving her immunization. He reported child is alert, active and without fever. States plans to take infant to doctor today.
This spontaneous report as received from a registered nurse refers to three unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23, lot # M006139, expiration date 13-MAY-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; chills; very tired; joints hurt; 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 DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt). At the time of the report, DIARRHOEA (diarrhea) had not resolved and CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt) outcome was unknown.            No concomitant medication or lab results were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
massive rash that burned and Itched; muscle contractions in hands; nervousness; dizziness,; bruising on my calves; horrendous reaction; massive rash that burned and Itched; massive rash and swelling all over neck, face and ears; massive rash and swelling all over neck, FACE AND EARS; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,) and CONTUSION (bruising on my calves) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Causes itchiness all over body).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 60 UNK. At the time of the report, BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: less than 10 (Low) low and 139 (Low) After three days, my platelet count was up to 139.         No concomitant medication were not provided.  Treatment medication includes 60 mg of steroids    Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021.Updated lab data. Added event horrendous reaction.
Administered vaccine on 16-Dec-2021, from vial stored in refrigerator on 16-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 16-Dec-2021, from vial stored in refrigerator on 16-Oct-2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine on 16-Dec-2021, from vial stored in refrigerator on 16-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 16-Dec-2021, from vial stored in refrigerator on 16-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was reported.  Date placed in refrigerator16-Oct-2021. No adverse events were reported. No temperature excursion of the product was reported.  Treatment information was not provided.
Fever, paleness, difficulty breathing, fast heart beat, disoriented, confusion, weakness, swelling of glands all within minutes of getting the shot.
Information has been received from a health professional concerning a 15 month old female who on 12/7/01 was vaccinated with MMRII (lot 639916/0903L). The LVN reported that in approx. 12/01, the pt subsequently experienced a rash "all over". Unspecified medical attention was sought. Additional information has been requested.
AREA IS RAISED, RED, SORE, AND HOT UNTILL 1-16 WITH NO SIGN OF GETTING BETTER. FEVER AND CHILLS THE NIGHT AFTER, FEVER REMAINED FOR A FEW DAYS.
hot rash that expanded and now it went away except for the vaccination arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Pregnancy (The patient planning for pregnancy.). Concomitant products included CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm). At the time of the report, PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073882 (E2B Linked Report).; Sender's Comments:  MOD-2021-073882:Crossed linked
day 18 post vaccine: patient describes pain in chest. day 22 post vaccine: patient has lesions in right breast area.  Given neurotin and valtrex. day 27 post vaccine: lesions drying.  Culture sent off for viral and DFA.  condition has resolved.  Lab cultures not back yet.  Digital photos were taken and sent to CIL.
Swollen Lymph nodes around ears when exposed to cold wind.  Swelling increases gradually over next two days. When Ibuprofen 2 tablets was used about every 8hrs, swelling reduced after about 3-5 days. If exposed to cold again, swelling returns. Cold weather started after about a month after 2nd dose; that when the side affects started. Till dates it started in near one ear and then second with the other ear and then again with first one in a span of about 3 weeks.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product APIXABAN (ELIQUIS) for an unknown indication.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has high blood pressure and it's under control on medication. Caller also has Afib and is taking Eliquis.  The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Blood pressure high.   On 10-Jun-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started APIXABAN (ELIQUIS) (unknown route) at an unspecified dose. On 10-Jul-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication or treatment medication not provided.
53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (53 doses of the booster of the Moderna COVID19 vaccine were given lot 009c21a with expiration date Oct 15 2021,Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.  On 27-DEC-2021, upon internal review, case MOD-2021-421914  was merged with case MOD-2021-418891  as case  MOD-2021-418891  was  determined to be the master case and duplicate case as well.   This case was linked to MOD-2021-421942, MOD-2021-421985, MOD-2021-422051, MOD-2021-422057, MOD-2021-422061, MOD-2021-422069, MOD-2021-422084, MOD-2021-422088, MOD-2021-422090, MOD-2021-422101, MOD-2021-422108, MOD-2021-422119, MOD-2021-422129, MOD-2021-422136, MOD-2021-422139, MOD-2021-422143, MOD-2021-422146, MOD-2021-422148, MOD-2021-422166, MOD-2021-422175, MOD-2021-422188, MOD-2021-422190, MOD-2021-422191, MOD-2021-422192, MOD-2021-422194, MOD-2021-422197, MOD-2021-422201, MOD-2021-422202, MOD-2021-422205, MOD-2021-422208, MOD-2021-422210, MOD-2021-422212, MOD-2021-422213, MOD-2021-422215, MOD-2021-422218, MOD-2021-422222, MOD-2021-422223, MOD-2021-422224, MOD-2021-422225, MOD-2021-422227, MOD-2021-422228, MOD-2021-422229, MOD-2021-422230, MOD-2021-422231, MOD-2021-422232, MOD-2021-422233, MOD-2021-422235, MOD-2021-422236, MOD-2021-422238, MOD-2021-422239, MOD-2021-422241, MOD-2021-422243 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow Up contains NNI On 20-Dec-2021: Case made valid upon Follow up received, on 20-Dec-21 includes Significant information : Patient Demographic information updated. On 20-Dec-2021: Significant Follow up- Date of event received, patient identifiers updated On 22-Dec-2021: Follow up received on 22 Dec 2021,contain non significant info
pt noted redness in LOA of left deltoid in evening of 3/1/06 day of administration. Swelling noted by mother on 3/2/06 redness had increased. Today 3/3/06 color and swelling subsiding. Child c/o some itching at site. Mother gave TYELNOL x 1 last evening. Child offers no other complaints, nor does mother. Child anxious to return to her school at this time.
Patient had chills and at one time registered a temperature greater than 101 degrees. Fevers began improving through the day on Friday, 08/13/2021 and were gone by Monday, 08/16/2021.
Arm swelled, became red & inflamed. Area was hard & sore. Inflammation lasted for 5 days.
Pain in left back/rib cage radiating to front of chest.  No blistering rash yet. Patient also reports itching and burning sensations in affected area.  Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
Just now coming out of having Covid; Just now coming out of having Covid; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that the patient received the first dose of the vaccine on 14Mar2021 and scheduled for the second dose on 14Apr2021 but just now coming out of having Covid and was curious if they need to postpone her second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.