chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster; Vaccine administered after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date).    No concomitant medication was provided by the reporter.  It was reported that HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years instead of the bivalent booster to 2 adult patients, also after its beyond use date. The vial was initially thawed on 10-Oct-2022. HCP was unsure about how many doses the patient received in the past.  No treatment medication was provided by the reporter.
9-1-16 - 6 days past flu vaccine c/o body aches, HA, nausea, cough, neck and back pain. No fever.
This spontaneous report as received from a nurse refers to a patent of unknown demographics. No information about medical history, concurrent conditions was reported for the patient. On 09-SEP-2015 the patient was inadvertently administered with expired dose of MMR II lot # J008534, expiration date 12-JUL-2015 (dose strength, route unspecified). No adverse effects reported. Additional information has been requested.
That same night and 48 hrs after that my whole body ached as if I had the worst flu I've ever had. The injection site was not only red, but my arm's upper half up tol the shoulder swelled considerably for several days.
a area size of a "baseball" that is red, swollen and painful/injection site swelling; a area size of a "baseball" that is red, swollen and painfull/injection site swelling; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient who experienced area size of a "baseball" that is red, swollen and painful/injection site swelling (vaccination site reaction and inflammation), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.  On 07-Feb-2020, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6220AA and expiry date: 13-May-2020] via an unknown route at an unknown administration site.  On an unknown date, the patient developed a non-serious area size of a "baseball" that is red, swollen and painful/injection site swelling (vaccination site reaction and inflammation), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of laboratory data not reported.  Final diagnoses were vaccination site reaction and inflammation.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown as it was not reported for vaccination site reaction and inflammation.
pulse was high upto 108; Raised BP (little high but not that bad); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)). On 01-Mar-2021, HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a registered nurse referring to a patient of unknown age. On an unknown date the patient was in an unspecified pharmacy at an unspecified location and was vaccinated in armpit with a dose of ZOSTAVAX (lot# and dose not reported). No adverse experience was reported. Additional information has been requested.
Expired vaccine administered to patient/Expired dose administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  Lot expired on 14 Oct 2021. Injection was given on 20 Oct 2021. It was reported that on 20-Oct-2021, the vial was initially stored in the refrigerator, and the vial did not went under any temperature excursions. It was reported that the vial did not have any expiration date labelled on it, they checked it using the tool. It was reported that Injection was given within 6 hours window from  puncture.   Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2021: Follow up information received on 23-OCT-2021 Includes non significant information added.
After my 2nd Dose in May; My Close Vision is VERY BLURRY, especially with reading letters.. I cannot see without using readers ( Reading Glasses). My eyesight was great before then.
Large red area around injection site described by patient to be the size of a "saucer." Also warm to the touch. Patient has now been prescrobed KEFLEX and BACTRIM.
NUMBNESS AROUND MOUTH AND GUMS AND HANDS SPORATICCALLY.  OCCURRING SEVERAL TIMES DAILY AFTER VACCINE GIVEN.
I had low grade fever, diarrhea, cough, congestion, headache, and wheezing. I tested positive for COVID-19. I talked to my doctor, and they prescribed me PAXLOVID. I also used my QVAR and albuterol inhaler.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)   This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;   This case involves (an adult) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
This spontaneous prospective pregnancy report as received from a healthcare professional for GARDASIL, a Pregnancy Registry product, concerning refers to a 22 year old female patient. The patient had a history of 3 previous pregnancies and 2 live birth(s) of 39 weeks both, no preterm deliveries, no spontaneous abortion, no elective terminations and no fetal deaths were reported. There were no birth defects in previous pregnancies and no complications in previous pregnancies. On 04-DEC-2013, the patient was vaccinated with the third dose of GARDASIL, lot # J006850, expiration date 31-MAR-2016 (route was not provided). The patient's last menstrual period was on 05-NOV-2013 and the estimated delivery date would be on 12-AUG-2014. The pregnancy outcome was unknown. Additional information has been requested.
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m.  Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Kph54) at the age of 68 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fk9896), in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: El3247), in right arm, on 09Feb2021 as dose 2, single (Lot number: El9269), in right arm and on 31Aug2021 as dose 3 (booster), single (Lot number: Fc3183), in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 07Dec2022 to 12Dec2022.
?COVID arm?. Swelling at injection site, a large lump under the skin about a day after injection. Sore arm all the way to base of fingers. Tight feeling like blood pressure sleeve is on it. Treating with sitz bath, ice pack, antihistamines, ibuprofen.
This spontaneous report as received from a office manager/nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-MAY-2017 the patient was vaccinated with GARDASIL 9 dose 2, (lot number, expiration date not reported) for prophylaxis. The patient was vaccinated with first dose of GARDASIL 9 on 12-MAY-2017. No adverse effects reported. No additional information provided. Additional information has been requested.
Initially reported an "unbrushed teeth" taste in mouth post-vaccination and for 5 minutes afterward.  Reported he did indeed brushed teeth this morning. Unusual taste lasted 10 minutes.  Reported no unusual foods consumed prior to vaccination.  Onsite MD assessment reported slight headache but staff had prior to vaccine injection, not worsened. However, he has had history of headaches with vaccines. Some tingling also reported in left arm (vaccinated arm). Denied other signs and symptoms. Resolved symptoms after 30 minute observation period (post-vaccination).
pain up into neck; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shoulder discomfort (shoulder issue).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient possibly had previous shoulder issue. The patient after receiving Shingrix complained of pain up into neck. The reporter agreed to follow up.
have been having vision issues; heart issues; This spontaneous case was reported by a patient and describes the occurrence of VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues). At the time of the report, VISUAL IMPAIRMENT (have been having vision issues) and CARDIAC DISORDER (heart issues) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.
Hepatitis B vaccine was given instead of Hepatitis A vaccine. No adverse symptoms reported at this time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Other medical history Diabetes; "PCN" (unspecified if ongoing), notes: Known allergies PCN. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received covid treatment. Other medication in 2weeks were Unknown. Anti-viral details, brand Pfizer with treatment start date from 28Sep2022 till 02Oct2022 for COVID-19. Known allergies included PCN and other medical history included Diabetes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives along left arm and they continued to show upon stomach, legs and arms afterwards; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 10:15 as a single dose for COVID-19 immunisation. The patient was allergic to bee sting and sting location will swell and be itchy for about a week. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (SRONYX) for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient developed hives along the left arm approximately three days after the first shot and they continued to show up on the stomach, legs and arms afterwards. The hives have not resolved and she was due for the second COVID vaccine shot on 15Apr2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives and included treatment with OTC (over the counter) antihistamines (MANUFACTURER UNKNOWN). Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the event hives along the left arm approximately three days after the first shot and they continued to show up on the stomach, legs and arms afterwards was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 030A21A;  Moderan 4/1/21 Lot# 025B21A;  Moderan 11/17/21 Lot# 939905;  Moderna 4/20/22 Lot# 002M21A
chills; fatigue; This is a spontaneous report from a contactable physician.  An elderly (reported as 65+ Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 21Dec2020 (Lot number: ej1685) via an unspecified route of administration, second dose on 11Jan2021 (Lot number: e21685) via intramuscular, both at single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and erythromycin. The patient's concomitant medications were not reported. The patient experienced chills and fatigue on an unspecified date. No treatment was received for adverse events. The patient received vaccine in hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered on an unspecified date.
Case number PHEH2013US020254, is an initial spontaneous report received from a nurse on 25 SEP 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch  number: not reported), intramuscularly without being r4econsititut4ed with Men A lyophilized conjugate component on 16 SEP 2013. No adverse event was reported following this administration error.
Information has been received from a registered nurse, through the Merck pregnancy registry, concerning a 17 year old female smoker with an allergy to codeine and had a history of positive papilloma viral infection (HPV). On 02-JAN-2007, the patient was vaccinated with Gardasil, at another facility, while she was 4 weeks pregnant. Concomitant therapy included prenatal vitamins. The patient sought unspecified medical attention. On an unspecified date, the patient underwent a pregnancy test, "OB panel", urine culture and urine drug screen (results not reported). At the time of this report, the outcome of the event was unknown. Follow up information received stated that on 15-JAN-2007 the patient had a positive urine screen for marijuana. It was also noted that on 04-APR-2007 she had a normal quad screen and on 19-APR-2007 an ultrasound which showed normal fetal anatomy. Additional information has been requested. 12/12/2010 Information recieved from the physician's office indicated that the patient never returned for follow up care, and was lost to follow up. No further information is available.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: pt released to her father. spoke with father a few hours later. pt is fine.
Information has been received from a physician concerning a 20 year old female patient who was vaccinated with GARDASIL (dose and route unknown) on an unspecified date. Subsequently the patient experienced blindness in her one eye. The patient went to the optomologist and was given unspecified treatment for blindness. The optomologist was blaming GARDASIL for blindness in her one eye. At the time of the report, the patient's outcome was unknown. Upon internal review, blindness in one eye was considered to be an other important medical event. Additional information has been requested.
Pt was given pediatric primary series Moderna (6mo-5 year) instead of Adult dose Moderna bivalent. No adverse reaction was noted by Pt after notification of med error.
I always struggle with migraines I have a venous stent in my brain. I was having worse migraines so i had a ct angiogram on it they found a clot around the stent. I'm going to a coumadin clinic 3 times a week and in a month will have new images.