chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs or PQC reported; VARlVAX given IM instead of SQ; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.      On 27-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (mL), lot# reported as 1017685 is not valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 21-MAY-2022) via intramuscular (IM) instead of subcutaneous (SQ) route for prophylaxis (incorrect route of product administration). No other information provided. No additional adverse event (AEs) or product quality complaint (PQC) reported.
Sore throat; Dizzy; Weak; "Feels like everything rushed to my head"; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy), ASTHENIA (Weak) and FEELING ABNORMAL ("Feels like everything rushed to my head") in a 62-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy), ASTHENIA (Weak) and FEELING ABNORMAL ("Feels like everything rushed to my head"). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy), ASTHENIA (Weak) and FEELING ABNORMAL ("Feels like everything rushed to my head") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
pT HAS A HISTORY OF 20YEARS AGO ANAPHALACTIC EPISODEWHEN TAKING PO CECLOR. PATIENT WAS OBSERVED FOR   30MINUTES. AFTER 5 MINUTES SHE BECAME FLUSHED AND STATED SHE COULD TASTE THE MEDCIATION   INITIAL BP WAS 196/68 HR64 AND O2SAT 100%100%. WATER WAS GIVEN AND SECOND BP WAS 162/86, HR 65   O2SAT100%. PT STATED SHE WAS FEELING BETTER AFTER 20MINON DEPARTURE BO WAS158/72, HR 64 O2SAT 100%. PT STATED   SHE FELT GOOD. SHE WAS ADVISED IF ANY CHANGES AND SHESTARTS TO NOT FEEL GOOD TO GO TO THE ED.
Systemic rash, diarrhea, headache, stomach upset, chest pain, photophobia. Continues to have symptoms to date.
This patient received her prevnar 20 on 10/23/2023 due to her doctor recommending her to make an appointment here to receive the vaccine.    It was discovered today that she already received the prevnar 20 at this pharmacy on 07/20/2022.  Patient's daughter called and raised concerns of her mother receiving too many doses and stated that a week after getting the vaccine her mother started "not feeling well".. She stated that her blood pressure went up, her blood sugars were not in control, and that her mother had the chills.  These symptoms caused the patient to have to visit the doctor.   It is unknown if these symptoms are related to the vaccine since they did not start until a whole week after receiving the vaccine.
Patient developed large area of erythema and induration at 48 hrs, s/p booster dose of varivax (given on 1-19-09). Area measured 7 cm x 4 cm and patient c/o itchiness at site. Area was marked with pen and mother of patient was advised to apply cool compresses on/off, apply hydrocortisone cream and give benedryl q6h prn and to call back in 1 day to give nurse update or sooner if new symptoms such as fever or vomiting or increased swelling.
Dizzy after shot, was shaking in the middle of the night 24hrs after about an hour had no temp, fever hours later, arm where shot burned for a week, few days in pain in left leg up into thigh for days, headache few days in and off and on throughout and still having, chest pain a few days in for atleast a week and a half, feel like chest is heavy, walking a short distance and I can?t breathe , use to hike 6-8 miles can?t do much exercise anymore , very tired, head was foggy for over a week, seem very confused , forgetful , not energy, definitely wasn?t a good choice for me to get the shot, over 3 weeks and some days I feel awful. Headaches scare me and don?t seem to go away, got bloodwork after a week was alittle elevated , definitely changed me , and I work in a hospital frontline the whole time and never got it, or got it and didn?t know, I get the shot and feel awful since
Arm felt warm touch; Soreness at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received Moderna's COVID-19 Vaccine and experienced soreness at the site of injection, redness at the site of injection and arm felt warm touch.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately 10 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, patient experienced soreness at the site of injection, redness at the site of injection and arm felt warm touch.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events soreness at the site of injection, redness at the site of injection and arm felt warm touch was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever, body aches, fatigue, headache, nausea, upset stomach lasting more than 24 hours
Following morning of vaccination, rash appeared at injection site about 3 inches in diameter.  Red line moved down arm in spider like appearance.  1st rash faded on Tuesday, second rash appeared in bicep area later that day.  Arm was hot to the touch and sore.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with ROTATEQ, lot # K016263, expiration date 26-JUN-2016, administered orally (dose and indication were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case PHEH2016US023986 is a spontaneous report initially received from a pharmacist on 16 Sep 2016. This case is also associated with quality complaint number (1016921). This case refers to a 90 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with a single dose of FLUAD (batch number: 165803) expiry date: not reported) at a dose of 0.5 ml intramuscularly on 15 Sep 2016. It was reported that the pharmacist inserted the needle into the patient arm and noticed that the plunger was not in the barrel. He picked up the plunger and attached it to the barrel while needle in arm and administered the vaccine. No adverse event was reported following this medication error. Combined report of internal review done on 10 Nov 2016 for the information received on 16 Sep 2016, the significant case correction was done and non significant follow up report received from a pharmacist on 16 Sep 2016: Added event wrong doing technique in product usage process, previously coded event vaccine underdose was recoded to syringe issue. Updated reporter information.
was in bed for a day; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (was in bed for a day) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (was in bed for a day). At the time of the report, BEDRIDDEN (was in bed for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant medication information provided
This spontaneous report was received from a female patient of unknown age regarding herself. The patient was vaccinated with ZOSTAVAX, (lot number 0073AE) on 12-SEP-2012. No concomitant medications were reported. The patient reported that after receiving ZOSTAVAX vaccine on 12-SEP-2012, a red rash appeared. On 13-SEP-2012 (reported as next day), the rash generated a red blotchy area that was itchy. The patient sought medical attention. BENADRYL and Z-pack antibiotics were given as a treatment. The outcome of the events were unknown at the time of this report. Additional information is not expected.
numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext; numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext; had some diziness; first dose on 29Jul2021, 2nd dose on 01Mar2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2022 as dose 2, single (Lot number: FM0698) at the age of 42 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=PZIFER, prev dose brand unknown=False, prev dose lot number=EW0185, prev dose lot unknown=False, prev dose administration date=29Jul2021 , prev dose number=1), administration date: 29Jul2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "LIGHT HEADED", "PALPITATIONS", "Tingling/numbing in both legs and arms", "Syncope Episodes". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Mar2022, outcome "unknown", described as "first dose on 29Jul2021, 2nd dose on 01Mar2022"; DIZZINESS (non-serious) with onset 03Mar2022 at 08:00, outcome "not recovered", described as "had some diziness"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 03Mar2022 at 08:00, outcome "not recovered" and all described as "numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext". The events "numbness/tingling burning sensation that started on my feet that gradually spread to my upper ext" and "had some diziness" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks: No. If covid prior vaccine: No. If covid tested post vaccination: no. First vaccine patient experienced light headed, palpitations, tingling/numbing in both legs and arms and a near syncope episodes, second vax developed numbness/tingling burning sensation that started on feet that gradually spread to upper ext/ had some dizziness. Patient was put on steroids and nerve meds.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age, and her spouse. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On or about 18-AUG-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported.) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination (dates unspecified), the patient was treated by a health care provider for shingles. As a direct and proximate result of the patient use of zoster vaccine live (ZOSTAVAX), she had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and cost include care for hospitalization, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation or preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown, single (Lot number: GH9697) at the age of 36 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 "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Jun-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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 28-Jun-2023, 5 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 38th patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:master case
Severe headaches, coughing, fever chills, arm pain , hip pain, abdominal pains, muscle pain, numbness on right side of face.
STOMACH PAIN; FELT VERY LETHARGIC; JOINT PAIN; FELT VERY FATIGUED; HEADACHE; DIFFICULTY SLEEPING; LIGHT HEADED; BODY ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced light headed. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced difficulty sleeping. On 12-MAR-2021, the subject experienced stomach pain. On 12-MAR-2021, the subject experienced felt very lethargic. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced felt very fatigued. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, body ache, headache, joint pain, stomach pain, felt very fatigued, difficulty sleeping, and felt very lethargic. This report was non-serious.
Woke up before 6am on 4/1 to severe itching from what felt like a hundred bug bites, it was a systemic allergic reaction beginning from my scalp to my feet. These continued to grow into massive, red, itchy welts that covered most of my body all over. Throat became restricted, felt harder to swallow but not impossible. Chest pains started evening of 4/1 with every swallow. Took two Benadryl and slept on 4/1. Woke up on 4/2 with left eye swollen shut, lip swollen, and hives had settled into large, flat welts all over but less itchy. Went to Emergency Dept around 7:50am on 4/2 where I was given prednisone (60mg?) and Zyrtec. Observed for about 1 hr, 45 mins, and released feeling okay but still swollen with a few welts left. Have taken Benadryl every evening through tonight, 4/5. Welts disappeared on 4/4 and itchiness stopped then, too.
Severe muscle pain in neck, nausea, headache, fatigue, weakness, nerve pain which developed into shingles outbreak 5 days later, with continued malaise.
Fever (with chills) up to 101.3 `F on 1st and 2nd days after vaccine (05/21 ~22/2022).  Also had soreness/minor swelling at injection site during this time, and some fatigue.  Cough also started at this time and became severe on 2nd day (05/22/2022).  Feeling of chills and fatigue persisted on and off after end of fever (temperature normal on 3rd day after vaccine, 05/23/2022).  Extreme internal itching of nose and sneezing started on 5th day after vaccine (05/25/2022), and low fever returned (up to 98.2 `F) on 6th day (05/26/2022).  Seem to have had the bad luck to have come down with a severe heavy cold at the same time as getting vaccine booster 2 (total dose 4).
Tennis ball sized welt at injection site within 3 hrs, aching joints, headache within 2 hrs, fever 101-102°  F within 8 hrs persisting overnight, sleeplessness overnight. acetaminophen, 500 mg twice. Fever reduced, aching persists 24 hrs later
Presented to office for evaluation on 10/3/12.  MD documented a 23cm x 17cm horizontal erythematous, indurated, warm, painful area extending from his lateral bicep and going down just below his olecranon.  He diagnosed the pt. with presumed cellulitis and administered Rocephin 1gm IM.  He returned to the office on 10/4/12 for follow up with another Dr.  His symptoms had worsened and he was sent to Hospital where he was admitted.  He was seen by infectious disease and determined not to have cellulitis, but was instead diagnosed with an "Arthus-type reaction" to a Tdap vaccine.
1st 3 mths. swelled and red with fever touch..now servere pain in muscle rotary cup joints bone and arm wakes me from solid sleep at night..fells like it's coming out of socket..weak and no strength as far as using it.
Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022 and administered on 20-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The patient received second booster on 20 Jul 2022. The vaccine was put in the refrigerator on 15 Jun 2022. Treatment information was not provided.
Unknown exact date of immunization, unknown lot number.  Patient was not vaccinated in clinic and he forgot his COVID vaccination card at work.  Patient reports having completed second COVID shot (Pfizer) around mid-March.  He was diagnosed with COVID today (6/21/2021) after experiencing nasal congestion and loss of taste/smell.
Became unconscious directly after adult TD. Full body shake noted, remained in & out x 3mins & became incontinent of urine. Assisted to supine position, O2 & vital signs monitored, became fully responsive. Mom refused EMS transport to hosp.
On 4/9/2021 I started having chills and not feeling well. On 4/11/2021 I got a migraine and have had it on 12, 13, 14,15, called dr he has called in some meds.
Fever, Chills, Nausea, Skin Swelling, Skin burning, Head Ache, Fever lasted 36 hours and then returned the next evening
headache; This is a spontaneous report received from non-contactable reporter (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible. No further information is expected.
pt recv vax 10FEB97 & on 8FEB98 the pt presented w/approx 40-50 varicella-like lesions that were various stages of development;
This spontaneous report as received from a physician assistant refers to a 8 year old female patient with no pertinent medical history and no drug reactions/allergies. On 19-MAY-2005 and 28-AUG-2008 the patient was vaccinated with two doses of VARIVAX (Merck) (dose not provided) with the respective lot numbers, lot # 0070R/expiration 07-JAN-2007 and lot # 0955X/expiration unknown. ON 23-APR-2013, the patient was found to have negative titers for varicella. The patient had sought medical attention via office visit. There were no treatment given for the adverse event. The varicella IgG blood test was performed. The outcome of the patient was found to have negative titers for varicella was reported as not recovered/ not resolved. Additional information has been requested.