chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023; his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): US-MODERNATX-MOC20230208000141 (Moderna).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Feb2022, outcome "unknown", described as "his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovered", DISEASE RECURRENCE (medically significant) with onset Jan2023, outcome "unknown" and all described as "his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023".  Clinical course: Caller states that they all had COVID in May2022 as well. Him and his wife have received the Pfizer COVID-19 vaccine so far but his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022. Caller states that this was his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Insomnia for 12 days....anxious.....face bright red on 5 th day.....hot and cold feeling.....metallic taste in mouth on 7 th day........dry mouth.  10 th day was better but 2 more days of sleeplessness.
Severe chills and rapid breathing with elevated heart rate.   It lasted for about one hour.  I took two Ibuprofen.  No more problems since then.
My left arm began to swell around the site where I got the vaccine. It became very warm, bright red, and felt hard to the touch. It was also incredibly painful,  such as when my shirt was just resting on it, as shirts do. This lasted for 2 days and it still has some redness and sensitivity. The joints on my hands and wrist also became swollen and incredibly sore, and this has still not gone away.
Patient falsified DOB when registering for vaccination, stating the minor was (unlisted). Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is (unlisted) which made the vaccine a contraindication.  No known adverse reactions noted.
Apx. 5 hrs after receiving the H1N1 vaccine, patient reports she was sitting at home, suddenly felt hot, itchy all over, started to feel her throat closing. Went to ER @ MC was treated and relaxed.
throat was swollen, difficult to swallow, no compromised airway, uvula swollen, TX: Patient given decadron IM and oral prednisone taper, patient responded to treatment and doing better
This spontaneous report  as received from a pharmacist refers to a 61 year old female patient. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot number were not provided) subcutaneous in the left arm. On 08-APR-2014 some of the vaccine came out and ran down the patient's left arm. The full dose of vaccine was not given. Staff error only. No adverse effects reported. Additional information is not expected.
COVID-19; COVID-19; Pfizer / BioNTech/ moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 19:30 as dose 4 (booster), single (Lot number: GM9703) at the age of 34 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 16:30 as dose 1, single (Lot number: ER8735), in right arm and on 20Apr2021 at 16:30 as dose 2, single (Lot number: EW0161), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 at 14:00 as dose 3 (booster), single (Lot number: O12H21B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: apple family" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; LEXAPRO; MELATONIN; ALEVE; D3; VICKS NYQUIL taken for covid-19 immunisation; FISH OIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021 at 14:00, outcome "unknown", described as "Pfizer / BioNTech/ moderna"; 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (Anti-viral) for COVID-19 treatment from 13Dec2022 to 17Dec2022. Other medication in 2 weeks received Men's multi-vitamin.
Systemic: Patien did not have any reaction but did not seems to understand the difference of boostrix and MMR-Mild, Additional Details: The patient tech she wanted boostrix. Before boostrix was given the rph explained to patient about the vaccine that it is given approximately every 10 years and patientt said she never had it before. patient had a 3 months old girl baby with her and was told by rph that anyone visiting the home needed to be updated with a boostrix vaccine. Patient did not have any reaction(other) but after boostrix said she wanted mmr. This patient appears to understand but not full
Regards to Janssen COVID-19 Vaccine EUA Injection? The adverse events ( e. g., Fainted vertigo/ Local bruise/Gum bleeding was hard to stop ) are began approximately two weeks after the vaccination. Due to lack of understanding of the side effect, he went back home on 07/23/2021, and then the blood routine test shows the blood clots with low platelets(25) at 08/01/2021. So far there are no further medical treatment are taken.
PT STARTED FEELING LIGHTHEADED.  AFTER EATING AND HAVING SOME COFFEE SHE STATED SHE STARTED TO FEEL BETTER. PT LEFT THE CLINIC WITH HER SISTER.
Pt recvd vax 18NOV93 & had temp 103.2, vomitting 3.5 hrs; 19NOV93 AM tremors;
Retrobulbar optic neuritis diagnosis 7/5, 6/28 Onset of symptoms, 7/3 MRI, 7/5 Diagnosis, 10/7 Still not 100% recovery.
On 2/22/01, red and swollen at injection site and fussy. Treated with Benadryl and warm compresses.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic bronchitis in the past" (unspecified if ongoing), notes: Chronic bronchitis in the past. Concomitant medication(s) included: TYLENOL; ZINC; AIRBORNE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Reporter assessed events as non serious. The patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received COVID -19 vaccine Johnson & Johnson on 7/1/21.  On 7/2/21 from an outside facility, patient presented to urgent care with chest pain/tightness, SOB, lightheadedness and fatigue with headache.  She was referred to the Hospital ED department for further evaluation.  Per ED visit, patient reassessed and feeling better.  She felt comfortable discharged home. File this incident for record keeping.
NECK AND SHOULDER STIFFNESS; RASH AT SITE OF INJECTION; PAIN AT SITE OF INJECTION; HEADACHE; REDNESS AT SITE OF INJECTION; MILD FEVER; TINNITUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tinnitus. On an unspecified date, the subject experienced neck and shoulder stiffness, rash at site of injection, pain at site of injection, headache, redness at site of injection, and mild fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tinnitus, and the outcome of pain at site of injection, neck and shoulder stiffness, headache, redness at site of injection, mild fever and rash at site of injection was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse refers to a 4 years old female patient with allergy to amoxicillin, with pertinent medical history, who  on 17-MAR-2009, was vaccinated subcutaneously with dose 1, 0.5 live (Merck) VARIVAX (Lot 662448/1785x EXP. 11-DEC-2010). No concomitant medications were reported. On 23-JAN-2013, the primary reporter, stated that a patient at the age of 12 months received live (Merck) VARIVAX and that on 23-JAN-2013, at the age of 4 years old was seen in the office and was diagnosed with widespread chickenpox. The patient subsequently recovered without requiring treatment in Jan. 2013. Additional information is not expected.
Immediate dizziness and heart race. Constant chest pain and occasional dizzy spells to this day.
infection; sniffles; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFECTION (non-serious), outcome "recovered", described as "infection"; RHINORRHOEA (non-serious), outcome "unknown", described as "sniffles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right arm increased edematous, moving around arm, right arm reddened and painful, c/o limited motion. Referred to PMD.
On 10/25/2021- when I had some vaginal dripping/ bleeding. I saw Dr. he scheduled a sonogram for 11/12/2021. On 11/12/2021 they found that I had a  tiny fibroid in the uterus. I had a pap smear, blood test for cancer markers and the results were fine. The bleeding lasted for a week. The doctor wanted me to do another ultrasound in another 3 months. The sonogram was canceled 3 times. The doctor called me and told me that the results were normal. I had bleed for a 2nd time in December 2021 or January, 2022- it lasted for 2 days and it was only a couple of drops. I had no problems after the shots. I had no tenderness after the 1st shot I was just tired.
01/20/22 presents to EC for "weakness, lightheadedness and decreased appetite". PMHx of "aflutter (s/p ablation, off  Eliquis due to GI bleed ) , polymyalgia rheumatica on prednisone , HTN , recently diagnosed colon adenocarcinoma"
neck was itching and it was little bumps and a little swollen.; neck was itching and it was little bumps and a little swollen.; neck was itching and it was little bumps and a little swollen; rash on her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose number unknown (booster), 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 (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), SWELLING (non-serious), MASS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "neck was itching and it was little bumps and a little swollen."; RASH (non-serious) with onset Dec2021, outcome "unknown", described as "rash on her neck".  Additional information: The reporter thinks she may have had the same thing after the covid vaccine and booster but hers was less. They looked the same it was on her neck and arms and was trying to figure that out but it was in Dec. She got her booster dose on 02Nov2021. The caller started to get the rash on her neck sometime in Dec. The patient neck was itching and it was little bumps and a little swollen. The caller has never had skin issues before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was in terrible, excruciating pain the evening of 3/14/2013. I couldn't even move my arm. The pain has continued, despite cortisone injection and physical therapy.
She started noticing about an hour and a half after she got her vaccination that the injection site started turning red and her arm started swelling from her shoulder down to her hand.  She has started taking Advil and icing her arm.  It has improved since the evening after she received her vaccination.
Days 1-3 I had my typical vaccine reaction - small welt, sore arm - then those symptoms went away. Day 8, I noticed some swelling of my arm at the injection site.  The next day, it was a large red blotch (about the size of my hand), hot and painful, and this lasted 2-3 days.  As those symptoms dissipated, the site became quite itchy.  Pretty much gone now (April 10), although some itchiness remains.
Plunger on predosed flu shot would not compress when in patient arm. Took out of patient arm. Liquid still inside syringe. Redosed with new syringe and needle. The patient shortly after dose given experienced paleness, did not feel well, sat down with head between legs, given something  to eat then recovered enough to go home.
Coughing, lost consciousness for less than a minute, went to local ER. Recovered.
Warm to touch; 2 inch redness around the area of the injection; Chills really bad; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), CHILLS (Chills really bad), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced CHILLS (Chills really bad) and PYREXIA (pyrexia). On 29-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection). On 28-Jul-2021, PYREXIA (pyrexia) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), CHILLS (Chills really bad) and VACCINATION SITE ERYTHEMA (2 inch redness around the area of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Body temperature: high (High) Temperature: 100.5F.     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 medication was mentioned. No treatment medication was mentioned.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
At 1:58pm Pt complaint of injection. Reaction consistency of red tips slightly raised bumps and reduced chest area not raised . No complaint of SOB. 25MG Benedryl administered and observed, Pt c/o increased redness on chest raised bumps
FLUZONE HIGH-DOSE QUADRIVALENT at a high of 49.6F for 5 hours and 10 minutes with no reported adverse event; Initial information regarding this valid unsolicited non-serious case via Medical Information (Reference number- 00858018) was received from other health care professional and transmitted to Sanofi on 15-Nov-2021.  This case involved an unknown age and unknown gender patient who experienced fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (Product storage error) when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AC and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) the patient experienced and reported non-serious fluzone high-dose quadrivalent at a high of 49.6f for 5 hours and 10 minutes with no reported adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "HCP reporting a temperature excursion due to a delay in transport between facilities."  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the event outcome reported as unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; received the Pfizer Covid vaccine on30March2021 and tested positive for covid 16Apr2021; This is an initial spontaneous report from a contactable Consumer (patient). A 54-year-old female received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 16Apr2021 patient under went lab tests and procedures which included COVID-19 test, tested positive for covid. patient wants to know should she stick to getting her next dose of the vaccine 1, 2 days or wait after she tests negative for Covid 19. Patient callback At 4:12pm submitted to healthcare facility for Positive Covid 19 between doses. Caller dropped call so warm transfer not offered. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Knot, redness, warmth at injection site. Duracif given two times a day for 7 days for cellulitis.
Initial report received on 09 February 2007 from a consumer, who is the patient. A 55 year old male received on 25 September 2004 Fluzone (lot number not reported) (side, site and side of administration were not reported) and within 15 minutes developed nausea and weakness that progressed to the right side of the face, right side of the neck and right upper extremity with numbness tingling and pain, which continue to present. Patient was able to retain mobility but was loosing strength. It was unknown if the patient was hospitalized. The patient was diagnosed with MS (multiple sclerosis) by a neurologist and did not recover. The patient was allergic to penicillin. CT scans and Spinal Tap were done. Results were not provided. The patient refused to provided all requested information.
Patient had a hive below injection site, swollen and red per patient 2-4-21, patient is still having a persistent rash and is having a almost zoster like rash around injection site on 2-6-21. Patient said the rash has gotten better but still has a bruise near the injection site. She had been treating herself with benadryl to help with the rash.
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 11-year-old child patient who received MENACTRA (expiry date 18 April 2015, batch number, route and site of administration were not reported) on 19 April 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used as patient received expired MENACTRA in 2015. The incident took place on April 19th of 2018. The medication expired on April 18th. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.