chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GOT COVID; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000255287.
suspected vaccination failure; I got it twice; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
New "Booster Only" vaccine is a different strength and dose is 0.5 mL not 0.25 mL with the regular Moderna. Pt came in to get the second "half" of vaccine. No adverse reactions.
Patient was given vaccine at 2 weeks instead of 3 weeks.  Patient reported no signs or symptoms
Pt. became pale after the vaccination, lost consciousness for 3 minutes - appeared to have a seizure vital signs stable. Paramedics came and pt. refused transport to ER - (Pt. alert and oriented after the 3 minutes.).
VACCINE ADMINISTERED ONE DAY AFTER THE BEYOND EXPIRATION DATE OF 12/13/2023.
Since having the Anthrax series, pt has experienced fatigue, lethargy, little physical and mental endurance, reduced concentration, short term memory loss, difficulty sleeping, cough,headaches, sore eyes, SOB and itchy rashes.
Jun 4'21  Had MRI;  Report :  Need Ultra Sound to investigate further  //  Jun 11'21  Had Ultra Sound - Report:  Two prominent lymph nodes under L arm;  further testing required  //  Jun 16'21 had 2nd Ultra Sound;  Report:  Nodule behind L nipple;  return in 6 mo. for MRI & Ultra Sound  //  Jun 21'21  Saw doctor;  she wanted opinion of 2nd radiologist  //  Jul 14'21  Report from 2nd radiologist:  return for a left clinical correlation immediately & a bilateral breast MRI in 6 months  //
product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event; product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional (hcp).   This case involves a 43 years old and unknown gender patient to whom INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength: unknown) (lot UJ899AA, 23-Jun-2023) via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event (product storage error)(poor quality product administered)  following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.
Chest congestion; Contracted Covid 3 weeks after second dose/Exposed to someone with COVID; Hard time breathing; Fever; A spontaneous report was received from a consumer (patient's mother), regarding a 21 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chest congestion (pulmonary congestion), contracted COVID three weeks after second dose/exposed to someone with COVID (COVID-19), hard time breathing (dyspnea), and fever (pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On the same day, 11 Feb 2021, the patient developed fever with a body temperature of 102 (unknown units). On 02 Mar 2021, three weeks after his second dose, the consumer stated that her son was exposed to his girlfriend who had COVID. The consumer stated that his girlfriend, her roommates and four male friends that were visiting also contracted the COVID virus. The consumer reported that eight of ten people that were at girlfriend's house, contracted the COVID virus. The consumer stated that the patient had fever, a hard time breathing, and chest congestion. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of events, chest congestion, Contracted COVID three weeks after second dose/exposed to someone with COVID, hard time breathing, and fever were not reported.; Reporter's Comments: Based on temporal association and the known safety profile of the vaccine, a causal association between the event of fever and mRNA-1273 cannot be excluded.  The event of COVID s not consistent with the vaccine profile and is of an infective etiology, hence assessed as unlikely related to mRNA-1273. Pulmonary congestion and dyspnea are assessed as symptoms of COVID-19 also assessed as unlikely related.
mom states pt had to be held constantly w/o movement for >24hr, would scream if any part of body was touched;temp only 99;returned to nl p/36hr;sl redness lt leg;
Pt reports she received PREVNAR 13 vaccine on 11/8/18. The following evening (11/9/18), pt states she had redness, swelling, itching and warmth around the injection site (left upper arm).  She also had an elevated temperature for which she took Aleve. Pt states that arm has continued to be red, hot swollen, and painful. Pt prescribed Deltasone 20mg and Keflex 500mg. Advised to use cool compresses and NSAIDs PRN.
High fever (103.3 F), high fever persisted for next 3 days. Acetaminophen and ibuprofen were lowering it to about 101.7 F. Fever was jumping back up to 104.4 F by the time drug action wears out (4 - 5 hours following administration). Fever subsided on day 3. In the morning of day 4 normal temperature of 98.2 F was observed. We are still monitoring the child.
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-DEC-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot number U024221, expiration date 04-OCT-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported. The vaccine underwent a temperature excursion of 39.55 degrees Fahrenheit for 10 hours with no previous excursions reported.
the arm had turned red/covid arm; that below the injection site a red dot appeared which ressembled that of a bullseye; her arm had turned red below the injection site/ The redness and issue is occurring in her left arm as well; She was in front of the mirror, and saw it. It was hot and a little itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 at 14:15 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tick bite" (unspecified if ongoing); "Rash" (unspecified if ongoing), notes: rash reaction not penicillin 1967, amoxicillin, and shell fish (iodine reaction) none of them anaphylactic all a rash.; "anaphylactic" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (First Vaccine, Lot number:EL9262), administration date: 26Jan2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (Second vaccine , lot number: EL9266), administration date: 16Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (First booster , lot number: FF2590), administration date: 18Oct2021, when the patient was 67-year-old, for COVID-19 Immunization; Shingles vaccine (She did get her Shingles vaccine in Dec2021 or Jan2022); Tick antivenom (Her last tick bite was in Jan2022), administration date: Jan2022. The following information was reported: PRURITUS (non-serious) with onset 13Apr2022, outcome "recovering", described as "She was in front of the mirror, and saw it. It was hot and a little itchy"; ERYTHEMA (non-serious) with onset 13Apr2022, outcome "recovering", described as "her arm had turned red below the injection site/ The redness and issue is occurring in her left arm as well"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 13Apr2022, outcome "unknown", described as "that below the injection site a red dot appeared which ressembled that of a bullseye"; LIMB DISCOMFORT (non-serious) with onset 13Apr2022, outcome "recovering", described as "the arm had turned red/covid arm".  Additional information: Prior Vaccinations (within 4 weeks) patients Medical History (including any illness at time of vaccination) other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: never had anaphylactic shock, rash reaction not penicillin 1967, amoxicillin, and shell fish (iodine reaction) none of them anaphylactic all a rash. NDC/lot/expiration-no. over a decade ago. Some multiple but decade ago.  No follow-up attempts are possible. No further information is expected.
Instant onset pneumonia like cough, breathing labored, heavy chest, rapid heart rate, itching. Developed severe strep throat by 1/12/2000 and continual headaches.
3APR92 to clinic w/large red, splotches on face exp rt cheek, fingers appear red & swollen both hands, has scattered splotches on trunk but not as prominent as face; mom denies fever or redness @ inject site;
I developed flu like symptoms the morning after receiving the first round of the moderna vaccine. I had chills, was weak, but did not show an elevated temperature. I felt like I had the flu until I took some I ibuprofen.
complete bad reaction; rash itches and burns; rash all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
This is a spontaneous report from a contactable consumer (patient) from program.   A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, solution for injection, lot number: EL3246), via an unspecified route of administration on 25Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL0140), via an unspecified route of administration on 04Jan2021 as dose 1, single for covid-19 immunisation. The patient stated that had no know contacts and developed covid symptoms, tested positive on 06Aug2021. The patient lab test included SARS-CoV-2 molecular test was positive on 08Aug2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Large bruise (~2in diameter) formed at the injection site several days after injection.; The injection site hurt and was tender to touch; The center of the bruise, where the injection was a hard small lump; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 01Jul2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021, the patient experienced large bruise (~2in diameter) formed at the injection site several days after injection. The injection site hurt and was tender to the touch. The center of the bruise, where the injection was a hard small lump. The bruise was largely yellow/green indicating in came deep within the arm and not at the surface. At 3 weeks after the first vaccine, the bruise was diminishing. Only the bottom half of the bruise remained (dark green) and the bump of the injection site remained. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large bruise (~2in diameter) formed at the injection site several days after injection, the injection site hurt and was tender to touch and the center of the bruise, where the injection was a hard small lump was resolving at the time of this report.
Tingling from my neck to left side of my mouth; Tongue was swollen; Face swelled; Sensation of feverish feeling in mouth; Headache; Tired; Had chills; Felt drained; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt drained), PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled) and FEELING HOT (Sensation of feverish feeling in mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ASTHENIA (Felt drained). On 18-Apr-2021, the patient experienced PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), SWELLING FACE (Face swelled), FEELING HOT (Sensation of feverish feeling in mouth), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Had chills). At the time of the report, ASTHENIA (Felt drained), SWELLING FACE (Face swelled), HEADACHE (Headache) and CHILLS (Had chills) had resolved and PARAESTHESIA (Tingling from my neck to left side of my mouth), SWOLLEN TONGUE (Tongue was swollen), FEELING HOT (Sensation of feverish feeling in mouth) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information was provided.   This case was linked to MOD-2021-137894 (Patient Link).
Severe migraine-type headache began about 10 hours after receiving vaccine. Unable to leave bed due to severe headache pain and light/sound sensitivity, also unable to sleep, from 4:00 AM to about 6:00 PM-- approximately 24 hours post-vaccine symptoms began to subside.
Patient inadvertently received the 5-11 year old Pfizer vaccine instead of the 6m - 4yr Pfizer vaccine for her 3rd dose. This vaccine will count as the third dose of the series. Patient counceled on possible adverse events. Per mother on 9/12/22, patient experienced no adverse events/side effects
Injection received at 1330 on 12/24/20. Localized reaction about 2 hours after.  By 2000 hours same day, severe muscle aches and joint pain. Nausea and vomiting at 2330 same day. Fever of 101.6, controlled with Tylenol but requires regular redosing.   Chills and headache.
At 1 yr 3 mos. patient received (2/28/02) DTP, Hib, pneumococcal on the same day. He soon developed shaking in his hands. He still has shaking hands at 9 yrs.
Few hours after flu shot developed hives, scratchy throat. Given BENADRYL, PEPCID, SOLU-MEDROL - sx resolved.
Received ADACEL 8/27/09 - 8/28/09, seen at ED for site of vaccine, (L) arm swelling with pain, 3/10, pain level (x'd I.V. Vancomycin, stopped due to itching, then given BENADRYL 50mg IV became tachycardic with chills. She was sent home and given BACTRIM to take, which she did returned to ED, with facial swelling. All medications stopped. 8/31/09: seen at clinic, (L) Deltoid: non swollen, non erythematous, full ROM. skin warm /dry.
Fist sized Rash, warm to the touch, but no itching, no other adverse effects.  feel fine otherwise.  According to this should go away in 5 days.
Symptoms include redness, swelling and pain at injection site, and mild shortness of breath. Home treatment included ibuprofen only. Pharmacist recommended BENADRYL, however patient was on the way to Dr's office and wanted to wait.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-NOV-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Migraine; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced MIGRAINE (Migraine) and NAUSEA (Nausea). At the time of the report, MIGRAINE (Migraine) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
migraine; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2022, the patient received Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced migraine. The patient was treated with zolmitriptan. On an unknown date, the outcome of the migraine was not recovered/not resolved.   The reporter considered the migraine to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient reported that last night got my first Shingrix vaccine. Patient received vaccine at 7 pm last night and at the time of reporting it was 11:30 am. Patient had migraine which he/she believed was related to a weather front rather than the shot. Patient was able to take a Zolmitriptan pill for his/her migraine.
Burning sensation raised rash all over back appeared 1/31/2021 around 8:30pm.  I took one 200mg ibuprofen tablet.  The rash was gone the next day but the sensation of pins and needles was still present on 2/1/2021.  I then took benedryl and the sensation went away.
Felt strange 5 days after getting shot, weakness in  legs, fatigued.  Next day started having slurred speech, weakness in bil lower ext.