chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was given on the top of the thigh in the vastus lateralis area instead of the side of the thigh; administered IM instead of SC; no adverse event; This spontaneous report was received from a nurse referring to a 7-year-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 19-NOV-2020, the patient was vaccinated with a dose of 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T016000, expiration date 08-MAY-2022 for prophylaxis. The vaccine was given inadvertently in the top of the thigh of the patient. It was given with a 5/8-inch needle but was given on the top of the thigh in the vastus lateralis area instead of the side of the thigh. It was given with a subcutaneous needle, but in the wrong place. No other adverse event reported.
Patient stated that he had to go to the hospital 2 days after his flu shot because he was suffering flu-like symptoms. He was feverish and dehydrated. He was sweating profusely with muscle aches and chills. He was admitted and stayed in the hospital for several days. IV's were administered combat dehydration. He was also treated for a urinary tract infection.
13 days following vaccination patient developed urticarial pruritic plaques over vaccination site, vaccination site arm, and trunk. Lesions resolved within 2 weeks without treatment.
Right shoulder started hurting, eventually went to see Dr. about pain and was diagnosed with superior labral anterior to posterior tear, delaminating full-thickness rotator cuff tear acromioclavicular joint arthrosis, subacromial impingement and ended up having operation.
Pt sent a message on 6/3 that he had developed a full-body blistering rash which was initially thought to be related to poison ivy.  He was treated with a course of prednisone, which was moderately helpful. It was treated throughout the summer with intermittent topical steroids.  However, the rash persisted in a waxing and waning fashion until after his booster on 10/28/2021.  At that point the rash became markedly worse and did not respond to another course of steroids.  On 11/23/2021 I did a punch biopsy which was consistent with a drug reaction.  We stopped all of his medications at that point, and his rash got a little better.  However, he started having runs of rapid heart beat so was started on diltiazem (assuming that the metoprolol was a cause), and then his A1c worsened and because he had been on metformin in the past, this was restarted.  Nothing changed the presentation of the rash.  He was referred for allergy testing and had that done 3/10/2022.  This was negative.  He was finally able to be seen by Dermatology on 5/12/2022 who determined his rash was secondary to the Covid vaccine.
no adverse event; Patient was administered expired PNEUMOVAX 23 via Corresponding PNEUMOVAX 23 Prefilled Syringe on 04/03/2023; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with expired vaccine of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe injection, lot #U027357, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 25-MAR-2023 (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) (Expired product administered). No Temperature Excursion reported. No additional adverse event reported (No adverse event).
my friend is vomiting her guts out and she needs to get her 2nd shot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patients friend) reported for a female patient of an unspecified age who received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated my friend was vomiting her guts out and she needs to get her 2nd shot. she reported her symptoms this morning to college location. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Chills; body aches; nausea; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for Pfizer sponsored programs. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feels "tingle" in mouth with slight swelling of the lips that is improving. No distress/trouble breathing/SOB/CP/HA/Dizziness. Patient is alert and oriented. Due to previous allergies, patient is a 30 min recommended waiter.  Paramedics consulted  Pulse ox 98 HR 83 Bp 156/100 Patient monitored 45 min total Benadryl oral tablet 50 mg administered Symptoms all showed improvement.
first dose on Feb2019, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not applicable for this report. Pharmacist reported a patient had not yet received 2nd dose till the time of reporting which led to incomplete course of vaccination. Vaccine was administered at a different facility and pharmacist does not have exact date of administration nor lot number and expiration date. The reporter consented to follow up. HCP gave permission to follow-up.
Warm to touch, itchy, redness at injection site , spreading down arm. Pt went to dr office and received Keflex 500 three times daily and Prednisone 10 mg taper.
thought he had Covid earlier; thought he had Covid earlier; lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned.; can smell some things like petroleum products; This is a spontaneous report from a contactable consumer(employee).A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, on unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient had not received any other vaccine within 4 weeks. Patient had no known diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patients medical history and concomitant medications were not reported. No history of Additional Vaccines Administered on Same Date of the Pfizer Suspect.Pfizer employee stated he was not able to report this online for some reason, but he had a friend over this weekend who shared some information about the Comirnaty vaccine and he wanted to report it.  On an unknown date the reporter stated that the patient had lost sense of smell, has regained some of it for some smells, but indicated his full sense of smell has not returned, can smell some things like petroleum products, thought he had Covid earlier. Reporter also stated that he thought he had Covid earlier but does not provide if it was before or after the vaccine administration and Pfizer employee unable to provide. No further details provided. The outcome of the event for can smell some things like petroleum products was not resolved. The outcome of the event for lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned was recovering. And the outcome for the event thought he had Covid earlier was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Pt had cold hands, pale skin, nausea, diaphoresis, dizziness, and face flush.
44 days after, April 11, 2021 broke out in whole body hives beginning on head scalp.  Over next 24 hrs, spread downward on trunk, fron and back, stopping at knees Hives were burning, itching, irregular in size and places on body.  Appeared where I had not touched also.
unable to get the 2nd dose; dizziness; Falling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FALL (Falling) and PRODUCT DOSE OMISSION ISSUE (unable to get the 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hard of hearing.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizziness) and FALL (Falling). On 12-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to get the 2nd dose). On 12-Apr-2021, PRODUCT DOSE OMISSION ISSUE (unable to get the 2nd dose) had resolved. At the time of the report, DIZZINESS (dizziness) and FALL (Falling) outcome was unknown. Not Provided          No concomitants products were reported.  No treatment information was reported.
Child had TDaP immunization on 9-3-08 at 11:30am.  In the early morning hours of 9-4-08 he began to feel unwell, vomiting and swelling of injection site.  Was seen in ER at 4:30AM with fever, significant swelling, redness of left upper arm.
Pt had TDAP on 01/14/14 at clinic. Pt states arm did not get sore until 01/17/14. C/O of numbness at site and pain 8-9/10 left upper arm shoulder. Treated on 01/20/14 by chiropractor with cortisone injection and Vicodin. Recommended to follow up with PCP.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 90-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm and on 25Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 90 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1686), in right arm, on 30Jan2021 as dose 2, single (Lot number: EL9261), in right arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK0895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering", described as "COVID 19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid with onset date 15May2023 and stop date as 19May2023, no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202471 Same patient/different product, different dose/event;US-PFIZER INC-202300202805 Same patient/different product, different dose/event;
breaks out hives on face and neck since shot. Have not seen a physician at this time as it happens in the evenings only.
Itchiness in throat, feeling of a lump in my throat, tingling in throat and tongue.  Very mild, no inability to breathe.  Mild discomfort only.  Benadryl seemed to keep reaction from getting worse.  Sensation persisted for several hours and was gone the next day other than the slight feeling of a sore throat.
The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter
Extremely severe arm pain at site of injection first and second day after second vaccine. Couldn?t lift arm more than an inch without severe pain. Three weeks later I?m still experiencing muscle soreness at site of injection. It is currently moderate pain
Cold with sore throat; Cold with sore throat; Runny nose; It "might just be allergies";  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. 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 (Dose 1), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), OROPHARYNGEAL PAIN (non-serious), outcome "unknown" and all described as "Cold with sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "It "might just be allergies"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Limited mobility in left arm with tenderness at injection site.  Numbness with tingling to finger tips.
2 days after shot injection site itched, became red and raised. Eventually the itching moved down arm and red rash went away. On 11/2007 she went to doctor for general exam and mentioned itch. Was given steroid cream which relieved itching. Itch continues now. Because of severe sinus infection after 08' flu shot she is undergoing allergy elimination testing. Arm continues to itch about 2" below vacc. Site.
I am experiencing irregular menstrual cycles since my covid 19 vaccination began in April 2021. Although, I had a pre-existing diagnosis of PCOS, my menstrual cycle was regular for almost past one year before my vaccination i.e. I had regular periods each month until April 2021 when I received covid-19 vaccine. I missed my periods from May 2021 onwards. I got the next period only after a span of 4 months in September 2021 (unusual heavy flow and pain in the lower abdomen) after which the periods have been again irregular.  I have been seeing an Endocrinologist for this issue and am on Metformin medication from July 2021 to restore normal menstruation.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-AUG-2015 the patient inadvertently received an expired dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-AUG-2-15, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on 07May2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and medications were not reported. Had the Pfizer vaccine on May 7, by next morning patient had a horrible headache, fever. Assumed it would fade, but continued, developed chills, body aches, shortness of breath, severe fatigue, rash. Went to urgent care, tested positive, ended up having the monoclonal immunotherapy on Friday, 21May2021. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
received mmr 1st shot had previous, lost records at dr office(dr parmelee/cozzone) varicella 2, dtp on 5/1 2008.  severe allergic reaction on 5/10/2008.  received epinepherine shot, benadryl and prednisilone?  mercy hosp er scranton ,pa. fever at 7 days then to dr for fever dx. at 10 days 9am smal welts.  at 2pm benadryl 630pm benadryl, at 930 pm severe hives raised on trunk ,legs, genitals  etc.  5/12/2008again hives at 1pm and 6pm both times giving benadryl 12.5cc.    5/13/08 Reviewed ER medical records of 5/11/2008. FINAL ER DX: allergic reaction. Records reveal patient experienced sudden onset of generalized macular red itchy rash.  Tx w/steroids, epi & antihistamine.  Improved & d/c to home.  5/16/08 Reviewed PCP medical records of 5/9-5/12/2008. Records reveal patient w/fever x 2 days, 4x/month.  Patient seen s/p ER visit & was on tapering steroids & antihistamine.   Had few erythematous macules over trunk. FINAL PCP DX: Fever, viral infection & speech/language deficits, urticaria.
Didn't feel good, its had like the virus all over again; Dizzy; The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen; high fever of 102.9F; All her joints hurt; Nausea; Headache; Arm was hurting; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Didn't feel good, its had like the virus all over again), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen) and PYREXIA (high fever of 102.9F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 in August 2021 & got an antibody infusion) in August 2021.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 17-Nov-2021, the patient experienced DIZZINESS (Dizzy), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt), NAUSEA (Nausea) and HEADACHE (Headache). On 18-Nov-2021, the patient experienced FEELING ABNORMAL (Didn't feel good, its had like the virus all over again). At the time of the report, FEELING ABNORMAL (Didn't feel good, its had like the virus all over again) and HEADACHE (Headache) had not resolved and DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm was hurting), LYMPHADENOPATHY (The lymph nodes in her left neck were swollen , the lymph nodes in her left arm were swollen), PYREXIA (high fever of 102.9F), ARTHRALGIA (All her joints hurt) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Body temperature: 102.9f (High) 102.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
approx 2 min post administration, pt was sitting on exam bed, fell forward, face first, healthcare staff present in room during vasovagal, called for help and EMS transported to Hospital.
10/4/2022 It started off as a cough, earache and a moderate sore throat. It went away for a bit, so I went to lunch the next day with friends. 10/5/2022 I was a little quiet, did not talk as much. That evening I started getting more of a sore throat and earache. I had a negative COVID test. 10/6/22, I was not feeling well. I took 4 COVID tests and all were positive. I isolated from my husband. I continued to work by phone at home. I had a tele health on 10/6/22. The physician was very concerned about me and told me to get treatment right away. I was not eligible for PAXLOVID because of health issues. I was called and told I had breathing issues. My blood pressure was too high to have monoclonal antibody therapy that day. I called my oncologist, and she told me to take PAXLOVID. I started the PAXLOVID on 10/7/22 and had no reaction except the metallic taste. The first 2 days I had coughing, stuffiness and had trouble sleeping. On the third day I began to feel better, but not quite right. I felt just off. I tested positive for COVID up to 2 days ago. I was told to quit testing after that. I feel fine now, I am okay.