chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles symptoms, around the abdomen without an external rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not applicable. 3 weeks after receiving Shingrix, the patient had symptoms of shingles. The patient was asked regarding whether Shingrix vaccine was live vaccine or not. The patient enquired if there were any patients who after receiving the second dose complained of shingles symptoms, around the abdomen without an external rash.
fever in excess of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever in excess of 102 degrees Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from December 2020 to 28-Dec-2020.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (fever in excess of 102 degrees Fahrenheit). At the time of the report, PYREXIA (fever in excess of 102 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive in early Dec-2020. On 28-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 11-Jan-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Administration / scheduling error:  Vaccine given outside of recommended window of time - given too late after initial dose.  1st dose administered 1/20/2021.  2nd dose administered 3/30/2021.  60 days apart.  Timeframe is past window.
I got dizzy whole walking down the steps. I took a step down and felt dizzy and I think I blacked out and then all I knew I was laying on the bottom the steps on my face. I went to the doctor about a month later. I am 4 months from falling of being dizzy and I still have a bruise and lump on my face. The stairs are only 5 steps. I have a few other episodes of having dizziness. The second time was a few days after the initial spell and then the third was a few hours after that spell.
A 31-year-old female patient, whose had egg yolk allergy, hazelnut , PCN, bell peppers, received dose of INFLUENZA vaccine (batch number, route, dose and exact site of administration not reported) on an unspecified date in 2012 fall.  On the same day of vaccination, within an  hour the patient had shakes, fever, and nausea lasted for a week. The patient also had vomiting which lasted a week. Count not get out of bed. Missed work. Works in health care and was required to have the vaccine. Lab investigation and corrective treatment were not reported. At the time of this report, the patient was recovered. Documents held by sender: none
This spontaneous non-valid social media report was received from a patient of unknown age and gender reporting on themselves. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown) (exact dose, route, lot # and expiration date were not reported). Right when the sot went in, the patient experienced pain and his/her arm was sore for days. The patient went back to the doctor and complained about the soreness and decided not to continue with the doses of HPV (manufacturer unknown). The outcome of the events was unknown. The relatedness between the events and HPV (manufacturer unknown) was unknown, but the patient wished he/she was more informed about the vaccine and the possible side effects that could result. This is one of several reports received from the same source. Additional information is not expected as no contact details were provided.
pt recvd vax & 4 hrs p/vax exp lightheadedness & hot flashes; sx resolved w/in 24 hrs;
Upset stomach, muscle pain, nausea, light headed, tired, swollen red arm and 6 hives. Lasted for 72 hour.
01/02/2022:  Event occurred after 2nd vaccine. 83-year-old male history of CAD, multiple admissions for pneumonia, pulmonary fibrosis on 2 L nasal cannula hyperlipidemia presents to the ED today for shortness of breath. Started having shortness of breath 2 days ago and then it got progressively worse.  Episode nausea and vomiting.  Chest x-ray consistent with COVID-19 pneumonia.  Patient required increased oxygen.
pt recv vax 1APR97 & & 1/2hr p/vax pt exp paresthesia in lt shoulder which radiated to hand;exp numbness & tingling;h/a in middle of noc that woke pt up;SOB, warm flushing feeling;5APR97 exp burning sensation on feet;felt hot;neck pain
Pain developed in left bicep after injection. First day felt like inflammation and heat running down left arm. For two plus weeks pain still remains in left bicep and have not been able to lift anything with any kind of weight without pain associated with it.
Mother reports left arm swollen, hot and hard. Temperature controlled with Motrin. Previous rxn with DtaP as infant where leg was red and swollen for 1 mo and resolved.   Leg unable to move or bend (no injections given in leg or buttocks at the clinic) Dr office X-ray leg with no significant findings. Client to followup with orthapedic this month
testing positive for Covid-19 after they got their first dose of the vaccine; testing positive for Covid-19 after they got their first dose of the vaccine; This is a spontaneous report from a contactable pharmacist received from a Pfizer-sponsored program. This pharmacist reported same events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two patients who have been testing positive for Covid-19 after they got their first dose of the vaccine. The outcome of the events was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021460993 same reporter/drug/event, different patient.
Information has been received from a physician concerning a female patient "in her 40s" who "last week", on approximately 23-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23. The lot number was not available. Concomitant therapy included a dose of DTAP (manufacturer unspecified) and COUMADIN. The patient experienced serious swelling and redness in her arm and a temperature of 102 degrees after vaccination. On an unspecified date, the patient saw the physician. There were no lab studies performed. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Patient had her first Moderna COVID vaccination at 4:00 PM today and 5 min later felt dizziness, worsening, associated with headache, nausea, sore throat, hot flashes, and dizziness is from side to side when she looks at her phone, no dizziness when she does not look at it. Patient primary complaint is headache on bilateral temples. All other symptoms resolved, and no dizziness if not looking at phone.  Patient has history of headaches, similar in quality, but this is more intense (6/10 intensity, less than her scoliosis pains, but more than usual headache pain), but otherwise the same, pounding sensation, and she can feel throbbing. Headache is about the same currently. Started simultaneously as dizziness, immediately, unchanged. No changes in vision. Peak intensity of headache around 30 min after onset, peak at 4:30 or so.  Patient notified the vaccine clinic staff and was instructed to be observed in another area, and did not improve. Patient remembered that her initial blood pressure was low and it fluctuated. Patient was then sent to the ED.  Upon initial assessment in the Emergency Department 2 hours after her initial injection, the assessment is likely vasovagal near syncope with tension headache, rather than true allergic reaction. Given metoclopramide, diphenhydramine, normal saline, and obtained labs.
Fever Narrative: T 103, reduced with acetaminophen Followed up with OB/GYN doctor and recommended to complete covid 19 vaccine series. Currently working as rn in ED. Gravid 14 wks gestation, denies complications in pregnancy
soreness, swelling, red area, itching x 2 days later reduced sx remain-near inj site where pneumo vax given-not flu shot;
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN (intestinal discomfort) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN (intestinal discomfort) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN (intestinal discomfort) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-016906 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016906:
Redness; Itching; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching) and VACCINATION SITE PAIN (Soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy and Arthritis in 2017. Concomitant products included TELMISARTAN for Blood pressure high, AMITRIPTYLINE for Sleep disorder.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 2:05 AM, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itching). 02-Apr-2021 at 2:05 AM, the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and VACCINATION SITE PAIN (Soreness) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable   This case was linked to MOD-2021-031827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: ADR form - FU added
This spontaneous report has been received from a registered nurse referring to a 61 year old patient of unknown gender. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided. On 21-JAN-2019, the patient was inadvertently vaccinated with VARIVAX lot # R013302, expiration date 08-MAY-2020, intramuscularly for prophylaxis (strength, dose detail and anatomical location were not reported). The patient was supposed to receive SHINGRIX. No adverse effects were reported.
The patient had no adverse effects or symptoms following the PROQUAD administration.; The patient received a dose of PROQUAD on 9Aug2022 after having received a varicella vaccine on 29Jun2022.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 29-JUL-2022, the patient was vaccinated with varicella zoster vaccine (VARICELLA VACCINE) (dosage regimen, strength, formulation, lot #, expiry date, anatomical location, and route of administration were not provided) (manufacturer unknown) as prophylaxis.  On 09-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter/ once, lot #W012741, expiration date 16-OCT-2023, (strength, anatomical location, and route of administration were not provided) reconstituted with sterile diluent, administered as prophylaxis (Inappropriate schedule of product administration). The patient had no adverse effects or symptoms following the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administration.
This spontaneous report as received from a Registered Nurse refers to an over 65 years old patient. The patient was vaccinated with PNEUMOVAX 23 (lot# was unknown) on 13-AUG-2012 and reported that the injection arm, the left arm, was reddened that evening. On 16-AUG-2012 the patient consulted physician because of the left arm redness. The nurse reported that the injection site was not the primary site of the redness, the redness was more toward elbow. The physician prescribed TYLENOL and an unspecified antibiotic for the patient to treat the adverse event. Additional information has been requested.
Win 5 min, pt had nose running, tearing swelling of eyelids, SOB, chest pain, nervousness, very hot & red skin, chocking sensation, confused;
1 shot. 20 minutes after shot. Chest tightness and difficulty breathing for 30 minutes.   2nd shot 20 minutes after shot. For 1 1/2 hors chest very tight and difficulty breathing again
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: now on day 17 testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks and No known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One and one half days after vaccination reported upper arm pain and could not raise arm above shoulder. Like holding 5 pound weight with arm out. Finally after about two and 1/2 months it was better. Can Still feel the pain and can not raise arm higher than previously. Kept thinking it was going to go away.
01/06/15 mentioned at office visit that his left arm (deltoid) is still sore (point tenderness) at site of injection. FLUVIRIN given 10/14/2014.
Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red.  Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins.  Diagnosis was idiopathic subclavian deep vein thrombosis (DVT).  Started on enoxaparin and warfarin on Feb 15th.  Referred to hematology and coumadin clinic to monitor INR.
pt non-responsive for 30 seconds, eyes rolled back, lip color pallor, incontin of urine; p/30 seconds pt was responsive upon stimuli, lip color light pink; pulse & resp nl;
My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.; My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school.".  Clinical course: My thoughts were my daughter has gotten the Covid vaccine and ended up catching Covid the first day of school. So I'm kinda in the middle of the road about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extremely dizzy; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy) and HEADACHE (horrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (extremely dizzy) and HEADACHE (horrible headache). At the time of the report, DIZZINESS (extremely dizzy) and HEADACHE (horrible headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact
light headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Spice allergy.    On 23-Feb-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 HEADACHE (light headache). At the time of the report, HEADACHE (light headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Nausea, dizziness, headache and flushing of face an hour after injection.
Received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The date of administration 11-May-2022, 04-May-2022 and 08-May-2022.  Each vial (3 vails) was thawed the day before the appointment i.e. 03-May-2022, 07-May-2022 and 10-May-2022.  The vial did not undergo temperature excursion.  No treatment medications were provided.   This case was linked to MOD-2022-565558, MOD-2022-565522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Follow-up document received on 12-May-2022 contains significant information include patient details and suspect dose details added.
Exhaustion and in bed for 2 days, joint pain/arthritis, brain fog, and chest pain. (Later diagnosed with Costochondritis at the ER from the vaccine on 9/21)
PATIENT RECEIVED PFIZER BIONTECH VOVID 19 BIVALENT ORIGINAL& OMICRON FOR 12YERS AND OLDER
I got the second shot and I waited the recommended 15 minutes. I felt a sensation of what I thought may be an onset of a back spasm, but it didn't go any further so I attributed it to anxiety over the vaccine itself. When I returned home, I was doing some things around the house when the pain really started to set in, around 3-4 hours later. By the next morning, it had gotten to the point where I could hardly move without pain. I had to move around hunched over and could really only lay on the couch. I went to my doctor who refilled my prescription for 5 mg cyclobenzaprine (1 tablet twice daily.) He also advised that I could take ibuprofen for inflammation. It took the rest of the week before I was able to return to normal activity.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L013203, expiration date: 28-JAN-2017 (dose, frequency and route of administration were not reported). There was no adverse effect reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
side effects experiencing after receiving the new Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects experiencing after receiving the new Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact.
Aching, woke up in middle of night feeling like I was going to pass out. Feeling really flush feeling. Nauseated, Ill feeling passed in about 24 hours.
Papular blanching rash, fever 103.6, 102.9 within 48 h of med, arm pain, myalgias and weakness.
pt recv vax 4FEB98 & same day pt devel swelling of arm all the way down to wrist & fever of 1022;
Swelling, red, irritation at sign of injection. 3"x4" wide, itches, pain. (L) arm cellulitis. Treated with KEFLEX.