chrisvoncsefalvay/vaers-outcomes huggingface dataset:
used a ProQuad diluent to reconstitute; ProQuad diluent to reconstitute Shingrix,It was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced wrong solution used in drug reconstitution (Verbatim: used a ProQuad diluent to reconstitute) and inappropriate dose of vaccine administered (Verbatim: ProQuad diluent to reconstitute Shingrix,It was administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-MAR-2023 The Healthcare professional (HCP) reported that a satellite office used the wrong diluent with Shingrix.  She reported that an HCP took the Shingrix antigen and used a ProQuad diluent to reconstitute Shingrix. It was administered to a patient over the age of 50.  No lot number or other patient information was provided.  HCP said she did not have much information and would call back later that day (reporting day).  Report was filed with limited information. HCP did not consent to follow-up. ProQuad diluent was used to reconstitute Shingrix antigen  and was administered which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Why haven't I gotten my period since I got dose 2 of covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "Why haven't I gotten my period since I got dose 2 of covid vaccine".  Additional information: Patient asked that why haven't I gotten my period since I got dose 2 of covid vaccine? Please enlighten me. Pregnancy not possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received both vaccines and upon getting up to leave he passed out and hit his head. Ambulance was called. Paramedics assessed the patient and released him
flu; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional.  This case involves male patient who experienced flu (influenza), while he received INFLUENZA VACCINE [Flu shot] . Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu every time he took flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
MILD PAIN IN THE AREA OF APPLICATION; This spontaneous report received from a consumer concerned a 29 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced mild pain in the area of application. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the area of application was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556156 and 20210556038.
Received vaccine at 0930 10/26/11. Developed pain at rest & with mvt. within 2 hrs of receiving. No redness, swelling or bruising at site but feels like joint "locked up". Spasm later in evening & felt like "rotator cuff injury".
pt recv vax & w/in 24hr post vax & exp soreness in mouth followed by skin peeling off the sides of cheeks, & appearance of white ulcerated sores on gums;also exp migraine h/a but attributes this to menstrual period during this time;
fever; headache; shaking uncontrollably; vomited; pain in my ears; This is a spontaneous report based on the information received by Pharmacy Group. A contactable 56-year-old female consumer (patient) reported that she received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Exp. Date was not reported), via an unspecified route of administration on 13Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration in May2021 at 55 years as Dose 1 single "3 weeks before" for COVID-19 immunization. It was reported that patient received dose 2 of the Pfizer COVID 19 vaccine (site of injection not reported) on Sunday (13Jun2021). The patient had received Dose 1 "3 weeks before" (date not reported). She noted that within several hours "around midnight" on 14Jun2021 she began to experience "a fever" and "a headache" and "shaking uncontrollably" and then 30 minutes later, she "vomited." She also reported "pain in my ears." By 8am on 14Jun2021 these signs/symptoms "subsided." On 15Jun2021, she "kind of felt out it." She did not seek medical attention for any of the effects that she experienced, nor did she contact her healthcare provider about it. The outcome of all events was recovered on an unspecified date in Jun2021.  No further information is expected. Information about lot/batch number has been requested.
Weds (19th) and Thurs (20th) tired no big deal arm wasn't even sore. But Friday (21st) woke up about 7am couldn't even stand up I was so dizzy.  About 10 30am I started vomiting.  I stayed in bed because of the dizziness for the next 4.5 days, until 2pm Tues (25th). During those days I vomited 2-3 times per day except Tues (25th) just 1 time of vomiting. However,  I am able to get out of bed but I am still having the dizziness.
First day, I had a real runny nose, cough, scratchy throat. I started feeling run down. My temp was 101. I notified my boss who sent me a home test, which confirmed I was positive for COVID-19. I immediately began Paxlovid because of my immune issues. I am on two and a half days today. My symptoms are improving significantly as of today.
Irregular periods and abnormally heaving bleeding intermittently. I had my first period since the inoculation 5 days before my due date and since, I have had heavy bleeding randomly about once or twice a week for the last several weeks combined with faint spotting in between.
After my 1st Moderna Vaccine,  I had symptoms consistent with "Covid Arm." The large red circle appeared, a full week after my initial injection.  It was itchy at times, sore at others, and mostly gone within 5-6 days. Immediately after my 2nd Moderna Vaccine, I had a small bump, with a bruise. By the next morning,  I had a red circle directly below the bruise (not touching at all) that was about the size of a quarter. By the end of that day, the red circle had doubled in size, become swollen, and sore. The following morning, the red circle was now doubled in size again (roughly 3 inches by 3.5 inches) and hugely swollen. It became very hot, hard, and painful.   It has remained that way, today, though redder and hotter.  I was told that Covid Arm would not happen twice, and this doesn't quite fit the same time frame- since it began immediately after the Vaccine, with no days in between.
She reports history of Moderna vaccination on Friday, March 5th.  It was her second dose.  She felt awful within an hour of vaccination and persisted with symptoms for 2.5 days.  She described it as being out of it, headache, fever, chills, profound body aches, weakness and dizziness with palpitations.  She could not get out of bed for a day.  She literally thought she was going to die given the severity of her weakness.  As quickly as the symptoms occurred, they left her on March 7th, 2021.  She went to work on March 8th and noted similar symptoms to prior ITP flares - petechiae on legs, gum bleeding, fatigue, mild headache.  She also noted dark urine but no frank blood.  Since being admitted and receiving steroids, she is feeling improved and petechiae are lessening.  She also noted mild mouth ulceration to lower lip along with oozing.
Approximately 1-2 weeks after receiving 1st dose Moderna Covid-19 vaccine patient developed productive cough - frothy sputum, dizziness, swelling to legs. Symptoms persistent x 2 months. Seen in urgent care 9/24/21 for complaint of cough x 2 months.  Chest XR shows very enlarged heart. Referred to ER for labs, further testing, and treatment for congestive heart failure. Patient denies history of heart failure - had a-fib/a-flutter that was treated with ablation in March of 2021.
slight headache; lost of weight; no appetite; vomiting; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost of weight), DECREASED APPETITE (no appetite), VOMITING (vomiting), the first episode of HEADACHE (slight headache) and the second episode of HEADACHE (slight headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced WEIGHT DECREASED (lost of weight), DECREASED APPETITE (no appetite), VOMITING (vomiting) and the first episode of HEADACHE (slight headache). On 10-May-2021, the patient experienced the second episode of HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (lost of weight), DECREASED APPETITE (no appetite), VOMITING (vomiting) and the last episode of HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Vaccine given at 0930 on 10/29.  On 10/30 noted left arm redness and edema especially on inner aspect from elbow to axilla.  MD notified, order received to elevate arm and apply heat.
positive for COVID; positive for covid; This is a spontaneous report from a contactable other healthcare professional. An adult male patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot numbers were not reported), via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunization. Medical history included leukemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who was fully vaccinated got exposed to his wife who was not vaccinated, and he came up positive for COVID which resulted in hospitalization. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Aug2021. The events resulted in emergency room/department or urgent care visit. It was unknown if treatment was received for the events. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive for COVID  based on the known safety profile.
Pt developed pink, macular rash that was patchy and blanchable on face 1-5 min after she received her vaccines.  Pt was given benadryl and monitored after.  No other reactions noted, no redness or rash at injection site, no dyspnea, no stridor, no swelling around mouth or tongue.
aBOUT 10 MIN. AFTER SHOTS, BABY BECAME LETHARGIC WHILE BEING HELD IN DAD'S ARMS, HEAD DROOPING DOWN. sHE WAS LAID ON THE EXAM TABLE AND WAS LETHARGIC, VERY PALE, WITH SOME MOVEMENT OF EXTREMITIES.PULSE -80, RR 20. SHE WAS PUT TO MOM'S BREAST, AND SHE NURSED IMMEDIATELY, WITH IMPROVEMENT IN TONE, KICKING, ETC.  02 SAT= 97%, P140.
Hospital Medicine Admission History & Physical        Chief Complaint: not eating/drinking   History Of Present Illness Patient is a 71 y.o. female with h/o dementia who presents to ED from home with c/o not eating or drinking for several days. Was seen on 2/2 and tested +COVID. Some infiltrates on Xray but has not been hypoxic. She is drowsy and unable to provide any history, has no family at bedside. Found to have UTI and being admitted. She is vaccinated for COVID but did not have booster. ASSESSMENT/PLAN:   Problems and Relevant Co-morbid conditions:: Principal Problem:   Acute cystitis without hematuria Active Problems:   COVID-19   Essential hypertension   Hyperlipidemia   Late onset Alzheimer's disease without behavioral disturbance       * Acute cystitis without hematuria Description of the Problem/Progression:New Plan: Admit. IV antibiotics pending culture. IV fluids.    Hyperlipidemia Description of the Problem/Progression: chronic Plan: Continue home meds   Essential hypertension Description of the Problem/Progression:chronic Plan: Continue home meds and monitor BP   COVID-19 Description of the Problem/Progression: New, +2/2, unable to assess for symptoms, vaccinated but not boosted Plan: Given high risk patient and infiltrates, will start IV Remdesivir. Hold steroids due to no hypoxia. Isolation.   Late onset Alzheimer's disease without behavioral disturbance Description of the Problem/Progression:chronic Plan: Continue home meds           DVT ppx - Heparin SQ
about 2 wks p/shot woke up 2AM w/severe pain lower back & rt leg to knee 16NOV91; pt went to ER & adm to hosp seen by bone & joint specialist; nerve problem, glucose of 136; meralgia paresthetica; pneumonia, Hgb 11.5, WBC 4,500;
I was diagonized with vertigo after which I lost hearing in the right ear. Since I have serious tinnitus.
Post vax, the patient developed hives and swelling of the face. The patient was treated with steroids and benadryl.
This case was reported by a pharmacist and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B for prophylaxis.  Concurrent medications included Fish oil.  On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject was tested and found to not be responding to therapy and therefore experiencing lack of effect.  At the time of reporting the outcome of the events was unspecified.
SORE ARM; FATIGUE; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fatigue was not reported. This report was non-serious.
After giving PENTACEL , pt's mother came to me to change band-aid because it had soaked through. Bleeding had stopped but I noticed localized redness & swelling about size of quarter. Dr. looked at area and said it was a localized reaction.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (side effects). At the time of the report, IMMUNISATION REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment drug was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Reporting second dose of MENACTRA, no increased reaction - 1st dose 8/15/05.
The day after the vaccine, he noticed he didn't feel well.  Tired,  headache, stomach ache, and shortness of breath.  This started out mild and as the week went on got worse.  Symptoms were leg swelling, shortness of breath, persistent stomach pain, headache, and chestpain.  On 6/24 at 3:30 am he went to the ER where they discovered a large (golf ball size) blood clot in his right lung.  He also has been diagnosed with pancreatitis.  We have talked to five different doctors and multiple other hospital staff who all say it is a direct impact of the covid vaccine.
Arm swelled up at the injection site; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Type 2 diabetes mellitus.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired). On 10-Mar-2021, VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired) had resolved.            No Concomitant medication was reported. No Treatment information was reported.
Flu vaccine 11/5/03. Reported felt normal until 11/26/03; symptoms of tingling and numbness. 2 days later, dizziness, ataxia, was seeing PCP; back x-ray done. 12/1/03, complained of feeling like band around abdomen. 12/5 PCP. 12/11/04, Neuro-conduction study. 12/16/03 fell three times and seen in ER; MRI and CT of head. Hospitalized 12/16/03 through 12/22/03. Treatment 0.4g/kg IGIV for 5 days. Improved coordination and ataxia and weakness during stay. Sent to rehab; no better or worse. Hospitalized again 1/28/04 through 2/2/04 and 03/08/04 through 03/15/04. Currently in rehab at hospital. Discharge summary disproves med error. msv
3-9 "fever" (tactile) - lasting for 2 days. 3-10 rash on back of neck. 3-11 lateral nystagmus. 3-12 office exam - lateral nystagmus seen.
third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster; third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster; got the flu shot and my third booster which was the Pfizer (COVID-19 Vaccine) booster; I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters; I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, ), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, (Booster 1)), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, (Booster 2)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "third booster which was the Pfizer (COVID-19 Vaccine) booster/ dose 5 booster"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "got the flu shot and my third booster which was the Pfizer (COVID-19 Vaccine) booster"; BURNS SECOND DEGREE (non-serious), BLISTER (non-serious), outcome "unknown" and all described as "I noticed in the same arm that in my armpit ; I have white blisters, they almost look like burn blisters".  Additional Information: It was reported that on Thursday at the pharmacy patient went in, got the flu shot and third booster which was the Pfizer (COVID-19 Vaccine) booster and patient noticed (yesterday) in the same arm that in the armpit now that patient had white blisters, they almost look like burn blisters. Patient called the pharmacist and he said, he had never heard of anything so, he gave the phone number and told me to call Pfizer if you heard of anything but he said, getting the Pfizer shot and flu shot, it would be hard to say if it was even one of them caused something, which one was that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm-6x4cm area of induration around area where shot was given an area of erythema 14x9 cm surrounding the induration.