chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not a rash, did not look inflamed, and looked like red blotches with circles around them; This spontaneous report was received from a pharmacist referring to a 73 years old female patient. The patient had no drug reactions/allergies. Information about medical history, concurrent conditions and concomitant therapies were not provided.    On 22-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T016160, expiration date 13-FEB-2022; dose and route were not reported) for prophylaxis.    On 24-SEP-2020, the patient experienced red blotches with circles around them, not a rash, did not look inflamed. It was reported that the skin issue was localized to the same arm of administration. On the same day (reported as 2 days after the vaccination), the patient went to pharmacy and did not go to the emergency room (ER) or hospital. The patient received topical hydrocortisone cream for the event. The outcome of the event unknown. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016160; expirationdate: 13-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
sleepy, not operable, incontinent, nausea, vomiting, tremors in hands, numbness in legs, speech issues
Awoke at 1:15am the day after receiving the vaccine with flu symptoms and unable to fall back asleep. Symptoms continued through the day until 8:30pm.
Chills, body ache, severe arm pain, nausea, dizziness, confusion, fatigue
Patient is a 50 year old female with PMH of hypothyroid, headache, anxiety/depression, TBI s/p MVA, HTN and recently diagnosed with a cerebral venous occlusion who presents to the ED after a syncopal episode. As per patient, she had a BM, started to leave the bathroom and felt dizzy. Patient sat back down and then when attempting to return to the bedroom she had a syncopal episode without warning. As per the patient, her wife said that she had loss of consciousness for 1-2 minutes. The patient said that her wife said her eyes were open but "no one was home". Patient reports that she had c/o coughing, headache and fatigue and was diagnosed with covid 1/19/22. Patient is double vaccinated with Moderna. Patient denies chest pain, shortness of breath and is no longer coughing. as per ED record, patient was hypotensive enroute to ED and received IV fluids.  In the ED, rapid covid test is positive.
Patient reports convulsing with body shakes all over followed by fever and vomiting that started about 1 hour after immunization. Patient then began to notice extreme redness in his left arm that was also very hot and appeared to be "spreading" down the arm. Patient was recommended to be seen by his primary care immediately. Patient was instructed to place a cold pack over the arm to see if it reduced swelling, but nothing improved after 15 minutes.
patient was 17 years old at the time of administration and should have received Pfizer instead of Moderna, followed up with patient and no adverse effects were noted
He said his arm was hurting. I took off his shirt to look and it was warm to the touch. It was really red, swollen, and hard. I put come ice on it and called the doctor. He said it felt better after we applied the ice and he took a nap like normal. once we talked to the doctor, it got redder that day. It was very bright beet red. The hole where the injection was now visible. It was super red around it. Before it was flat, then it was swollen and visible. The doctor told me to outline it to track if it was infected or not. It did spread outside of that line, but the redness went down as I was icing it. She told me to give him Benadryl at night before bed to see if that helped then Zyrtec during the day. She said to call back if it did not become better. In the morning, I called again because it spread outside of the original line. The first day it was really red and bright looking. The next day it was bigger but lighter and less angry looking. The nurse told me to give him some Zyrtec and to keep icing and watching it. She saw the pictures and said it did look better. She said to call back again if it doesn't continue getting better. IT?s gotten better each day and there is a faint spot where it was. It?s faintly red and the skin is peeling a little bit around the injection site.
fluzone hd qiv was accidentally given to a 9 year old with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old and unknown gender patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was accidentally given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, strength, formulation, and lot number: unknown) via unknown route in unknown administration site for prophylactic vaccination at inappropriate age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
second dose > 35 days after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) in a 52-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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose > 35 days after first dose) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received and AE contact information updated
6/2/04 site of Dtap vaccine-left upper thigh became erythematous (4"x4") a few hours after injection medications prescribed: 6/4/04. Cephalexin 250mg/5ml, Diphenhydramine
Pt reported coldness, stiffness, chills, spasticity occurred 4 hrs after vaccine (flu). Episode lasted 5 minutes.
Morning after receiving vaccine, I feel feverish, fatigued, short of breath when I stand up, and sore in my leg and abdominal muscles. I took an Ibuprofen after symptoms began. I?m not pursuing any treatment because I?m assuming this is just an immune response.
Sick for almost 72 hours; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she recently took the first dose of the shingle ricks (Shingrix) vaccine and unfortunately, the patient was sick for almost 72 hours.  The patient asked was this normal.
Soreness, redness at injection site. Muscle pain, tiredness, headache, shivering, possible fever, and upset stomach.
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
Information has been received from an RN concerning a pt who, post vax, developed a swollen arm with red induration. Unspecified medical attention was sought. The reporter expressed a concern with the lot. Additional information has been requested.
Pt reports that her L deltoid is sore after receiving the vaccine, two days later she developed a red rash in the area that is tender. Pt presented the day the rash developed.
Fever 102degrees for two days following vaccine, general achiness, site injection soreness, flu-like feelings
Allergic reaction to seafood, certain drinks, and certain food; Sick; Tiresome/fatigue; Headache; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 1424) via an unspecified route of administration in the right arm on 05Mar2021 (at 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received morphine from an unknown date for an unknown indication and experienced allergy. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. On 24Mar2021 the patient was sick for 6 days with tiresome/fatigue and headaches. She reported developing an allergic reaction to seafood, certain drinks and certain foods. She saw an allergist and was waiting on the results from an allergy test. She reported going to the emergency room twice and was treated with intravenous diphenhydramine hydrochloride (BENADRYL) and intravenous steroids. The patient received the second dose of BNT162B2 (lot number 0943) on 26Mar2021. The clinical outcomes of the events were not recovered. Since vaccination the patient had not been tested for COVID.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 19Jun2022 to 24Jun2022. The patient did not received any other medication in two weeks. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I never had pain in my left leg. Six weeks prior I had pitting edema in my right leg. On June 10, 2022 I developed a blood clot behind my knee on my left leg. Once I received my diagnosis I was instructed to come into the emergency room hospital to be treated and released. I left with a prescription of ELIQUIS and told to continue wearing my compression hose. I have been told I have Factor V Leiden mutation that predisposes me to thrombotic abnormalities.
I did a COVID test Wednesday morning following the onset of symptoms and got a positive. I called my doctor, and it was pretty much a sinus infection that turned into a localized cough. Both were pretty persistent. Got a hold of my doctor on Wednesday and prescribed Paxlovid and started the 5-day regimen. Finished that Monday morning. Within a day or day and a half, it made a big difference. At the end of the 5 days, it got rid of most of the symptoms. Still some congestion and persistent cough but seems to be resolving itself. Didn?t get to my chest. Did my 6-day isolation period as well. It did produce some fatigue as well during this time period. In the process of recovery.
pt recvd vax 1OCT92 & 4OCT t102-103, chills & sore throat, vomited for 4 hrs; seen by MD who told family it was a reaction to the MMR;
shingles; Felt drugged and tired; I woke up with pain in my lower left back below my ribs - thought it might be kidney stones; rash "bloomed" up like poison oak, but it had three stripes to it. It felt extremely itchy; I felt nauseous; chills; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer reported that:  A 41-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. Patient had no known allergies and other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 09Apr2021 22:00, the patient experienced felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash bloomed up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. It felt extremely itchy but also like it had tentacles of shooting pain beneath it Night of 14Apr2021 into 15Apr2021 I woke up to intense pain again in same spot. She felt nauseous, and had chills. A hot shower and Tylenol made me feel better the next morning. That day she felt twinges of pain In the same spot and eating made it worse 16Apr2021 she worked out and felt a little better but the pain now wrapped around my side to the front. The patient underwent lab tests and procedures which included shingles: diagnosed it as shingle on  went to doctor for kidney stones and poison oak and she diagnosed it as Shingles. Therapeutic measures were taken as a result of felt drugged and tired, i woke up with pain in my lower left back below my ribs - thought it might be kidney stones, rash "bloomed" up like poison oak, but it had three stripes to it. it felt extremely itchy, i felt nauseous, chills, shingles. Patient received treatment with valtrex for events. The clinical outcome of events were recovering.
Itching, red rash, and slight swelling at the site of injection 9 days following the vaccine.
swelling around eyes and face. rash on both arms. Cold helps the swelling a little.
I have NO INSURANCE and NO MONEY to go a doctor.  VERY SWOLLEN LEGS FOR 14 DAYS,, low to high grade headaches AND STILL ON GOING, I HAVE TO TAKE PAID DRUGS EVERY DAY TO WORK AT ALL.  I HAVE NOT BEEN ABLE TO WORK EVEN HALF TIME IN LAST 2 WEEKS - NO UNEMPLOMENT IS ALLOWED FOR THIS SO I HAVE ALREADY LOST 2 WEEKS of INCOME!!!
Rash consistent with varicella - no fever - 20 eruptions total on upper extremities & upper torso no fever.
Per mom warmth and swelling. 2 days after MENACTRA vaccination. Denies fever. Today decreased swelling and erythema.
Headache, chills, fever, vomiting, diarrhea, weakness. From just after midnight day of injection for around 12 hours  following on and off.
Potential AE due to doses administered from vials that may have been compromised.; Administered vaccine from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised.), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. It was reported that group of 13 pharmacies had given the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They are aware in some of the freezers there was a temperature excursion that their data logs show. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. Potential AE due to doses administered from vials that may have been compromised. Vaccines were stored in an unapproved freezer and thus may have been compromised. Beyond used date (BUD) was reported as 02-Feb-2022.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypertension-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild
Night after vaccines were given patient had nausea, dizziness, headache, fever and confusion. Symptoms persisted with fatigue, nausea and fevers on Day 1 and 2. At this time also developed painful red rash and swelling to left upper arm. Day 3 fatigue and nausea improved but still had night sweats. Day 4 still lethargic but fevers are gone, large red swollen rash to left upper arm that is tender but not infected.
Cough, sore throat, fever, body aches.  Given antibiotics for 10 days to treat  Sinusitis and respiratory infection  Resolved after treatment
Flu like symptoms,  SEVERE  muscle cramps. Loss of feeling in limbs. Headache and nausea. Lightheaded. Chills and shaking.
Patient got PNEUMOVAX shot Friday 10/4. She called the pharmacy Sunday 10/6 to report that her arm was swollen, red and uncomfortable. She was advised to take ibuprofen, BENADRYL and apply a cold pack.
Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Pediarix. On 17-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-MAY-2023 The medical assistant reported another staff member administered a dose of Pediarix to a patient. The reporter stated there were no other vaccines documented for this patient aside what was administered one day before reporting, so this may had been the first dose in the series.   At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received an expired dose of Pediarix, which led to expired vaccine used.
Patient received flublok which is indicated for 18 and older and the patient was 10 years old
Patient has reddened area approximately 2" x 2 1/2".  Patient noted about 7:00 am and states that it has continued to increase in size as day has passed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve repair in 2017", start date: 2017, stop date: 2017, notes: mitral valve repair in 2017. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jan2023) negative, notes: Tested negative on day 10; (19Jan2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral product COVID 19 treatment, Paxlovid, from 08Jan2023 to 13Jan2023. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.