chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Several days after patients were vaccinated, it was discover that the refrigerator that housed the vaccine had temperatures varying from 32.8 - 33 degrees F for 3-4 days. No adverse events noted. No abnormality noted after vaccine itself, but manufacturer instructed facility to fill out VAERS form.
Rash on abdomen; This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: The patient developed rash on abdomen after taking Shingrix vaccine. The reporter did not agree to follow up from GlaxoSmithKline.
had Covid-19 & COVID pneumonia in Jan2021; had Covid-19 & COVID pneumonia in Jan2021; had Covid-19 & COVID pneumonia in Jan2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Crohn's disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), COVID-19 PNEUMONIA (medically significant) all with onset Jan2021, outcome "unknown" and all described as "had Covid-19 & COVID pneumonia in Jan2021". Therapeutic measures were taken as a result of drug ineffective, covid-19, covid-19 pneumonia.  Clinical course: It was reported that the patient had Covid-19 and COVID pneumonia in Jan2021. Reportedly the patient has taken the Pfizer vaccine and boosters, also had the antiviral treatment in Feb2021. Any way the patient can help advance would be wonderful.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt feeling very warm and lightheaded with subsequent loss of consciousness with seizure like activity. After regaining consciousness patient agitated and diaphoretic, vomited.
Sense of unbalance, light headedness, dizziness -brain feels like its being jostled in head, can't focus
fever, chills, headache, stomach pain, fatigue, negligible soreness of injection site  Symptoms persisting 26 hours after onset (still ongoing at time of this report)  Have taken 1500mg Tylenol, 75mg Zantac, Pepto-bismo
Pt vaccinated with DTP after arriving home took a nap, mother heard him scream shortly after fell asleep & sent in & found entire bed was shaking w/thrashing of his arms & legs lasted 30 seconds to 2 minutes & subsided spontaneously.
adult patient received unspecified dose of VARIVAX that was improperly stored; No adverse effects reported; This spontaneous report has been received from an office manager concerning an adult patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions were not reported. Concomitant therapies included sterile diluent (DILUENT MRK).  On 21-AUG-2019 (also reported as "in the last few days"), the patient was administered  a dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # R035222 and expiration date on 04-DEC-2020 (strength, dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 46 Fahrenheit degrees for 6 months. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported.
FEVER, UNCONTROLLABLE SHAKING, MUSCLE ACHES, JOINT PAIN, HEAD ACHE, ECCESSIVE SWEATING, LETHARGIC, SORE THROAT, RASH, BURNING SENSATION ON SKIN, TOOTH ACHE, SLIGHT NAUSSEA, MIND FOG,
pt recv vax 11FEB97 & exp a rash on the face, armpits, hands & lower extremities w/swelling of the eyes, face & hands, & had diff breathing;sx abated;no ER or MD visit was required to treat sx;
Sore Arm; Lethargy; Headache; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (DAILY VITAMINS), METOPROLOL, SIMVASTATIN, OLMESARTAN and WARFARIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased). At the time of the report, PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: unknown (High) Patient experienced elevated temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Patient gave consent to safety for Follow-up.   This case was linked to MOD-2021-061119, MOD-2021-061119 (Patient Link).
pt devel hardness & redness @ inj site & fever;pt had seen MD; Dx w/cellulitis & prescribed oral ATB & doxycycline;
pt recv hib vax instead of hep b;MD assured pt that HIB vax would not have any adverse affects;pt concerned about arm being sore state would be back in a couple of weeks;
PATIENT CLAIMS THIS IS HER FIRST VACCINE.  HOWEVER, OTHER POSSIBLE VACCINE DOSES ADMINISTERED PER IMMTRAC RECORD. POSSIBLE ADMINISTRATION OF 2  MODERNA VACCINES ADMINISTERED BY EMS AND ONE  PREVIOUS PFIZER VACCINE ADMINISTERED BY HEALTH DISTRICT.
I woke up with a headache and sore throat, that progressed to full body pain. I was coughing and low oxygen saturation, extremely tired, could barely stand up, feverish, no appetite, nausea, diarrhea, GI issue, no taste or smell. I was prescribed PAXLOVID, but I now have neurologic issues, I wake up headaches.
Hives started on 3/1/22  behind ears then spread all over body. Unbearably itchy and red. On 3/3/22 hives led to swollen eyelids and earlobes and face. Still dealing with this.
It was discovered after the patient left that the patient received a full vial of undiluted vaccine (6 doses). Our organization contacted Pfizer, CDC, Poison Control and the Hospital Infectious Disease for recommendations on next steps. The patient was notified of the dosage error the same day and had not had any unusual side effects at that time.
Redness and pain at injection site, persistent itching developed impetigo at injection site. Pt being treated with Mupirocin.
pt recv vax 5MAY97 & 20MAY97 pt devel a rash that consisted of 10 lesions, fatigue, & h/a;
Nausea, vomiting, multiple falls, and ongoing multiple seizures.  Patient required intubation and sedation. After admission, the patient experienced cardiac arrest.
nausea; severe vertigo lasted 4-5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old non-pregnant female patient received first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EL9267) via an unspecified route of administration in the left arm on 24Feb2021 at 16:30 (at the age of 73-years-old) and the second dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EN6208) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema and osteopenia. The patient had known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, the patient experienced nausea and severe vertigo that lasted for 4-5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The clinical outcome of the events nausea and severe vertigo was recovered on an unknown date, at the time of this report.    No follow up attempts are needed. No further information is expected.
Client states she developed flu-like sx with body aches, fever and soreness of injection site the evening after vaccination. She woke up at 3:00 AM with her right arm throbbing with pain and she has had severe pain ever since. 800 mg of ibuprofen taken every 5-6 hours has slightly alleviated the severity. No swelling, redness to the site or warm to touch has occurred. Client states she was moving arm, massaging it and icing alternating with heat as well with no relief.
Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023; No adverse event; use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     Patient had no known condition.     On 24-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (use by 03/23/2023 -Moderna Bivalent were administered on 24MAR2023) and PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023).    Concomitant medications were not reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered on 24-Mar-2023 BUD. Vials were moved from freezer to refrigerator fridge since 22-Feb-2023 with a use by 23-Mar-2023. No AEs were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live Follow up included narrative updated, reporter information updated,; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717199:Master case
A combination of cold sores, canker sores, and painful bumps occurring inside the mouth all at once. Cold sores on sides of tongue and inside of upper lip. Canker sores on the inside of left mouth cheek. Painful bumps on tip and top of tongue.
I had a fever for 3 days loss smell and taste for 3 months, contracted Covid.
Pt states she experienced chills,  fatigue, and body aches "on and off" for several days. She did not take any medications. She presented to clinic today (3/29/21) feeling better
Approximately 4 months after the 2nd COVID vaccine I noticed after my normal menstrual cycle I experience several days of breakthrough bleeding. I received the booster (third shot) about 3 months ago and this remains an ongoing problem.
Tingling in left arm and left leg, continuous for 4 months. He developed a neuropathy within 1 week following his last vaccination. Evaluation ot this neuropathy fails to reveal another causative etiology for it. I cannot firmly ascribe his neuropathy to the vaccincation, however, I have no other reason for it to date. With this in mind and factoring in his CONUS limitations due to a chronic medical condition, he might be considered for no further Anthrax vaccinations.
Breast tenderness with swelling and not under the armpits.; Breast tenderness with swelling and not under the armpits.; This is a spontaneous report from a contactable other hcp (patient). A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Right on 05Feb2021 09:00 (age at vaccination 52-Years-old) (Lot Number: EL9265) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension and allergy to sulphur drugs. The patient's concomitant medications were not reported. The patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 05:00 (age at vaccination 52-Years-old) (Lot Number: EK4176) as DOSE 1, SINGLE for covid-19 immunization. Patient was not tested for COVID prior or post vaccination. Patient did not receive any other vaccine in four weeks. Patient was not pregnant during vaccination. On 12Feb2021 07:00, the patient experienced breast tenderness with swelling and not under the armpits. No therapeutic measures were taken with respect to events. At the time of this report, the outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
passed out/unconscious; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 06:00 (Lot Number: ER8732) as SINGLE DOSE and dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 06:00 (Lot Number: ER8736) as SINGLE DOSE for COVID-19 immunization. Medical history included penicillin, amoxicillin and sulfa drugs allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after both doses of the vaccine, the patient had a regular evening and a full night's sleep. On 31Mar2021 07:00, the patient stated, "When I woke up and walked to the bathroom, I passed out both times. I was unconscious for a minute and was helped up, but passed out again and woke up a minute later. Emergency medical services were contacted both times". The events resulted in visit in emergency room/department or urgent care. The outcome of the event was recovered on unspecified date.  No follow-up attempts are needed. No further information is expected.
Developed fever, cough, (L) arm redness. Dx cellulitis & pneumonia, hosp x 2 days for IV antibiotics disch on oral antibiotics x 7 days.
Itchy rash beginning on 10/28/08 progressively getting worse + face, upper ext. trunk and small amount right thigh 11/3/08 in clinic.  Rash red, slightly raised.  Reports itches.  Plans to see private MD today.
drug allergy; This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the physician who prescribed the suspect product.  The age at vaccination was not reported. The patient had a drug allergy to Adhesive contact dermatitis, Codeine,  Fish derived products, Peanut containing drug products, Ppd tuberculin purified protein derivative, Shellfish derived products, Gabapentin, Influenza Vaccine Split Quad, Latex, Methadone, Other, Ace Inhibitors and Bactrim.
Pt experienced immediate severe pain of the entire arm after receiving injection. Limited movement and significant pain without improvement to present. Ice/heat provide no relief. A few doses of Ibuprofen were helpful but pt instructed not to take Ibuprofen due to hx of gastric bypass. Pt saw walk in clinic provider 10/31/11 & was told "issues with her rotator cuff" and given a cortisone injection.
Extreme hypersensitivity to cold and hot temperatures. Difficulty breathing, shakiness, migraine headaches. Nausea, more frequent urination, extreme joint pain and back pain, chills and fever, and vasovagal syncope=extreme fainting.
pain near kidneys.; showing 1.06 high creatinine levels.; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Mar2021 (at the age of 53-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hashimoto disease. Concomitant medications included thyroid (ARMOUR THYROID); and hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). On 12Mar2021, the patient experienced pain near kidneys, showing 1.06 high creatinine levels. The patient did not receive treatment for the events. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood creatinine: 1.06 on 12Mar2021 High  bloodwork was done on 12Mar2021  showing 1.06 high creatinine levels , blood creatinine: 1.06 on 28Apr2021 High , blood creatinine: 1.03 on 06May2021 High , blood creatinine: 1.16 on 19May2021 High , blood creatinine: 1.10 on 05Aug2021 High, blood creatinine: 1.13 on 16Aug2021 High , blood creatinine: 1.29 on 08Sep2021 High. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
At 2pm patient experienced watery itchy eyes, runny nose and chop cough.  Resolved with over the counter antihistamine and symptoms were gone next morning.
Woke with Headache. 100.3 fever. By 6:30 pm Felt Dizzy and Nausea. Had to sit down. Hives.
pt recv vax 24APR96 & 30APR96 pt exp a rash which was described as about six pinpoint little red spots;1MAY96 pt devel 80 pox which inc to 150;pt was exposed to varicella (date not reported);
Same day of vaccination Headache, stomach cramps, nausea, fatique, and body aches
Rash over belly, back, legs, extending just a bit onto arms and neck. Dots are red, almost like tiny bug bites. Not a dark red though.
Red rash on the abdomen, spread to the back, arms, and legs.; The spots are red and slightly raised.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration on 09Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, seven days after receiving the first dose, the patient experienced a red rash on the abdomen. It gradually spread to her back, arms, and legs over the course of the next two weeks. The rash was not itchy, but the spots were red and slightly raised (no blisters). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of red and slightly raised rash and included treatment with steroid cream. The clinical outcome of the events red and slightly raised rash on the abdomen, back, arms, and legs was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.