chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple patients received Moderna vaccination at a vaccine clinic on 1/11/22. It was later discovered on 1/11/22 that the vials used to draw up doses were assigned a 30-day expiration out of freezer stored in fridge BUD 1/8/22. Remaining un-used doses were discarded. Per CDC/FDA, Moderna vaccine must be stored frozen. Expiration date printed on the vial label applies to frozen vials. Once vaccine is removed from the freezer, unpunctured vials may be stored in the refrigerator for 30 days. This requires manual labelling of a beyond use date (BUD) when vaccine is removed from the freezer. Unpunctured vials may be stored at room temperature for up to 24 hours. Punctured vials should be discarded after 12 hours. Pre-drawn syringes may be stored at room temperature or in the refrigerator for 6 hours from the first time the source vial is punctured. Typically, the commodity manager reaches out to the clinic to obtain volume of vaccine needed for the clinic (which does not have a freezer) and sends over vaccine from the central campus on a courier. The 30-day expiration date is written somewhere on the box by whomever on central campus is sending the vaccine. Per outpatient RPh, sometimes the expiration date is on the box, sometimes it is on plastic wrapping outside of the box and can be consequently lost. Unclear if this occurred during the event. Manufacturer was contacted for further information and direction. Manufacturer completed analysis of vials associated with storage excursion and confirmed no additional action was required and that the lot number given maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Vaginal infection/Yeast Infection; This spontaneous case was reported by a health care professional and describes the occurrence of VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection). The patient was treated with FLUCONAZOLE ongoing since an unknown date for Vaginal yeast infection, at an unspecified dose and frequency. At the time of the report, VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VULVOVAGINAL MYCOTIC INFECTION (Vaginal infection/Yeast Infection) to be possibly related.    Concomitant product use was not provided by the reporter. This spontaneous case concerns a female patient, of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious event of vulvovaginal mycotic infection. The event occurred on an unspecified date in Nov2021 after administration of the second dose of the Moderna mRNA-1273. The patient is being treated with Fluconazole. The event outcome was unknown at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no relevant medical history reported, who experienced the unexpected, non-serious event of vulvovaginal mycotic infection. The event occurred on an unspecified date in Nov2021 after administration of the second dose of the Moderna mRNA-1273. The patient is being treated with Fluconazole. The event outcome was unknown at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
VERY SICK; CHILLS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick, chills, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, chills and very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211125279.
Dizziness, Headache, Fever, high fever, muscle soreness, fatigue, headache,  dizziness Narrative:  Other Relevant History:
Fever (100.0 2AM, 103.6 5AM, 104.2 8AM) Chills Body aches Headache  Cough Wheezing  Asthma exacerbation
Pt. reported l upper arm increasing swelling, redness, annd pain.  Exam revealed erythema, warmth and tenderness of skin surrounding distal insertion of the left deltoid.  No lymphangitis.  Dx. cellulitis, treated with antibiotics.
Patient received Moderna vaccine, Moderna, first dose 2/17/21 and second dose 3/17/21 She developed a skin reaction with purulence and concern for abscess at the site of the injection. Wound  Culture completed and reports that staph presence which is sensitive to Augmentin. She was treated with Augmentin 875mg BID with resolution of  symptoms.
Local erythematous swelling, warm to the touch, T 99.4. Warm soaks to area/Cefdinir 250m/5ml. 6.25mg PO Daily x 10D.
3-4cm area of erythema, blanching. No induration, no drainage, no nodules, no warmth on left thigh. Started 24 hours ago, warm compresses and return if worsens.
significant lip swelling and facial swelling; significant lip swelling and facial swelling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (significant lip swelling and facial swelling) and LIP SWELLING (significant lip swelling and facial swelling) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SWELLING FACE (significant lip swelling and facial swelling) and LIP SWELLING (significant lip swelling and facial swelling). On 06-Feb-2021, SWELLING FACE (significant lip swelling and facial swelling) and LIP SWELLING (significant lip swelling and facial swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included IV steroids and IV fluids.
This spontaneous report was received from a female patient of unknown age reporting on herself. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On 30-NOV-2016, the patient was vaccinated with GARDASIL 9 injection (route, anatomical location, lot# and expiration date were not reported). It was her first dose in planned three dose regiment. On 30-NOV-2016 (reported as immediately after getting the first injection of GARDASIL 9, the patient fainted (reported also as "they fainted"). The patient's physician told her to wait in the office for about half an hour and then let her to go home. The outcome of the event was reported as recovered (on 30-NOV-2016). The causality between the event and vaccination with GARDASIL 9 was not reported.
Received DTaP on 06/04/02, mother noticed right deltoid red, hot, swollen. Pt complained of pain, slight fever, no diarrhea, vomiting or irritability.
Mom reports child with "severe" hip and joint pain. Complains of severe pain in legs, feels like she has the flu, mom feels this is more than an average reaction, achy all over 12/31/08 feeling a little better, mom did not want daughter to receive anymore HPV vaccines.
Patient complained of blurry vision, left felt heavy, right eye was throbbing , numbness in the mouth, face felt swollen. Even though NP checked and face was not swollen.
This case was reported by a nurse and described the occurrence of extra dose administered in a 5-year-old male patient who received FLUARIX QUADRIVALENT (batch number 2Y747, expiry date 30th June 2015). Concomitant products included FLUARIX QUADRIVALENT. On an unknown date, the patient received the 2nd dose of FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reports the inadvertent administration of 2 doses of FLUARIX QIV to a 5 years old patient on the same day.
Since receiving the vaccine I had extreme fatigue that I only had once in my life before. I also had numbness on the left side of my face. That's the same symptom I felt when I had the Guillain-Barre syndrome 17 years ago. The numbness on the left side of my face only happened that one time since getting the vaccine. I also don't think that I have been experiencing anymore fatigue either.
Horrendous hives that spread all over body; she was having difficulty walking or turning around; Flu like symptoms; Diarrhea; Severe pelvic pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (Diarrhea), PELVIC PAIN (Severe pelvic pain), URTICARIA (Horrendous hives that spread all over body) and GAIT DISTURBANCE (she was having difficulty walking or turning around) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Insomnia. Concomitant products included LORAZEPAM (ATIVAN) for Insomnia, IBUPROFEN (ADVIL [IBUPROFEN]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). 18-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PELVIC PAIN (Severe pelvic pain). On an unknown date, the patient experienced URTICARIA (Horrendous hives that spread all over body) and GAIT DISTURBANCE (she was having difficulty walking or turning around). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (Diarrhea), PELVIC PAIN (Severe pelvic pain), URTICARIA (Horrendous hives that spread all over body) and GAIT DISTURBANCE (she was having difficulty walking or turning around) outcome was unknown.            Treatment  also included: steroidal cream.
p/vax pt broke out in a rash all over stomach, back, ears, & forehead;
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # M031802, expiration date 09-NOV-2017, and/or lot # M041181 exp. date 31-MAY-2018 (strength and dose number were not provided) for prophylaxis. On 04-JUN-2017, the vaccines were exposed to a temperature of 47° Fahrenheit (F) during a time frame of 43 hours (hrs); on 06-JUN-2017, to 47°F for 18 hrs; 07-JUN-2017, to 47°F for 18 hrs; on 09-JUN-2017, to 47°F for 16 hrs; on 10-JUN-2017, to 47°F for 40 hrs; on 17-JUN-2017, to 47°F for 8 hrs 30 minutes (min); on 20-JUN-2017 and 22-JUN-2017, to 47°F for 18 hrs; on 23-JUN-2017, to 47°F for 19 hrs; on 26-JUN-2017, 29-JUN-2017 and 24-JUL-2017, to 47°F for 18 hrs. Total cumulative hours: 252 hrs 30 minutes. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA008835: US-009507513-1709USA008834: US-009507513-1709USA004111: US-009507513-1709USA008833.
After 2nd HPV vaccine 5 days later pt experienced swelling (lump) and hotness at injection site.  Recc cold compresses
Itching/redness generalized.  Severe at the time, but has since much improved.  Still c/o itching but much improved.
SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.
Seizures, decrease in response times, decrease in response to name, heart murmur and arrhythmia.
No initial adverse effects from vaccination.  On or about May 12th I started to get severe pain in the tips of my fingers.  Within a week my finger tips started to swell and turn purple.  Then a few of my finger tips started to peel , rip open and ooze clear liquid.  On May 17th I tested positive for Covid 19 after being exposed to my positive son on or about May 10th.  I have taken many many medications over the last 4 months and while the swelling, peeling, open wounds have resolved I still have severe pain in a few of my finger tips and lack of sensitivity to the corners of all my finger tips.  I just finished my last medicinal treatment and my doctor (now seeing a dermatologist) no longer has an idea.
Pt received Pfizer vaccines on 03/03/2021 and 03/24/2021. Pt was diagnosed with COVID outpatient. Pt presented to the ED on 11/13/21 with complaints of worsening cough and SOB. Pt's oxygen saturation was 80% on room air. Pt placed on high flow.
Varivax vaccine given to (L) arm SQ rash (L) arm confluent, red, tender to touch 8 cm diameter. No drainage noted
4 red bumps noted to torso 5 days prior to visit (around 7/28/2018) which was 3 days after initial vaccine administration. Bumps slightly itchy at onset but no longer. Then spread with 1-2 lesions on both arms and legs. Denied any pain or itching of rash. No new foods, medications or products reported. Given onset of rash several days after injection, reaction not presumed to definitely be from vaccine, but per request of patients acting allergist, report to be filed.
She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 10:15 as (At the age of 41-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have patient history and investigation assessment. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162) on 17Apr2021 at 10:28AM into left arm for COVID-19 immunization. The patient experienced she is experiencing mild pain on the upper arm where she got the vaccine. it is not even that painful, it comes and goes on 11Jul2021. It was reported that Caller is a consumer who received her Pfizer-Biontech Covid19 vaccine series approximately 2 months ago. She is now reporting she is experiencing mild pain on the upper arm where she got the vaccine. She states it's not even that painful, just a sensation that she was noticing, and that the sensation comes and goes. Reporter was asking Has this been reported before. Response: Spoke from Fact Sheet Sect 6.1: Solicited Local and Systemic Adverse Reactions Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Later patient was reported that She now has a very mild pain on her upper arm where she received the covid vaccine. It is not even that painful, it comes and goes: It just began yesterday. She cannot even call it a pain because it is very mild. She is just concerned because she is not sure what it is. It is bothering her, but it is very mild. It happens maybe one or two times an hour. It is so mild that she did not take Ibuprofen. Reporter seriousness for events: Unspecified. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced injection site lump and injection site rash. On an unknown date, the outcome of the injection site lump and injection site rash were unknown. It was unknown if the reporter considered the injection site lump and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 60 or 61 years. The patient developed a knot and slight rash at the injection site area one week after receipt of her SHINGRIX.
Onset of noticeable symptoms: 4.5 hours after vaccine. Fever (100.2) from 4.5 hours after shot to 9 hours after shot. Did not take acetaminophen or ibuprofen. Moderate dizziness and blurred vision from 5.5 hours after vaccination til morning after. Mild chills  and body aches for first 24 hours. Moderate to severe fatigue roughly 10 hours following dose, reduced to mild fatigue the next day
I woke up the next day feeling dizzy, exhausted and not well. My BP was 90/50. I did a nebulizer treatment at home and it popped back up to normal (110/70).
Temperature excursion, temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour; Temperature excursion, temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour; This case has been made invalid as there is no indication that the patient experienced and adverse event under BNT162B2.  This is a spontaneous report from a contactable pharmacist received via Pfizer sponsored program. This is 1 of 7 reports.  A 46-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8735; Expiration Date: Jul2021; NDC number: 58267100-1) via intramuscular on 26Apr2021 (at the age of 46-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, investigation assessment and concomitant medications were reported as unknown. The report was not related to a study or programme. The reporter came to work on 26Apr2021 at around 12:30 in afternoon and checked if the Pfizer covid vaccine he had was good or not. He found temperature excursion, the temperature reached 50.1 degrees Fahrenheit, out of range about 46 degrees for about an hour. On 26Apr2021, the consumer reported temperature excursion of a vaccine that was administered to a patient. The vaccine was administered to 6-7 patients. He does not had all the details about each patient, but does had some information. He believed that the event was medically significant but that would depend on the stability of the product. The outcome of the events was unknown.  Follow-up (26Apr2021): This is a spontaneous report from a contactable pharmacist who reported same event under the same suspect product for 7 patients, vaccine start date and other information related to events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488392 same reporter/drug/event, different patients.;US-PFIZER INC-2021488410 same reporter/drug/event, different patients.;US-PFIZER INC-2021488361 same reporter/drug/event, different patients.
When Patient presented for his 2nd dose of vaccine he stated about 2 hours after receiving the 1st injection he noted he had slurred speech, was incoherent and was not able to move.  Symptoms lasted about 24 hr. and resolved completely in 24-48 hr. Patient denied any history of hypertension or heart disease.  He did not report this to his PCP.  4/13/2021--2nd dose of Covid vaccine NOT given per recommendation of Chief Medical Officer--Patient and spouse instructed to contact PCP for additional evaluation and to reschedule appointment for 2nd dose.
Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.
Patient received 4 vaccines in total: 2 on LA and 2 on RA. Hep B on upper LA and PNEUMOVAX on lower LA. Patient developed swelling at the injection sites and left shoulder. Patient also had red rash on her upper body. Patient went to urgent care where MD diagnosed her with allergic reaction to vaccines.