chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. 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. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter.
Information has been received from a physician assistant concerning a female patient of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 for prophylaxis (dose, route, application site, frequency and lot # were not reported). By the following morning, the patient developed redness and swelling at the vaccination site. The patient was treated (medication not specified). The outcome of the events was unknown. The reporter considered the events to be related to PNEUMOVAX23. The reporter said that he had two patients that had a reaction to the same batch of PNEUMOVAX23 that occurred two weeks apart from each other. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005575:
Fever of 100.5 for 36 hrs, tachycardia, fatigue, injection site soreness greater than 1st vaccination in series.
Covid; Covid; back pain; flu like symptoms; Crohn's disease flare; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): .  A 42-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in 2020 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown", described as "Crohn's disease flare"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; BACK PAIN (non-serious), outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid", "crohn's disease flare", "back pain" and "flu like symptoms" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Additional information: HUMIRA 40MG/0.4ML- COVID-19, Crohns disease aggravated, Back pain, Flu like symptoms, Not Reported. Pfizer BioNTech COVID-19 vaccine- Back pain, Crohns disease aggravated, Flu like symptoms, Possible.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective, covid-19 and back pain are possibly related to the suspect BNT162b2 and events condition aggravated and flu like symptoms are not related.
Client received shot in am.  That evening, he reports that he noticed hives on his arm that continued into following day.  Not really itchy, thought it was poison ivy (client is a park ranger). Hives continued on both arms and eventually resolved by 10/30/2012.  He did not seek medical treatment for this.
Very sore arm for 2 days.  Headache started in the evening and had the next morning.  Used cold wet cloth at injection site and used the arm as suggested to relieve pain.  Headache was a dull throb.  Chose not  to use Tylenol as I wanted to do nothing that might affect the efficacy of the vaccine.  Just rested.
RLE edema in the calf with difficulty breathing x 2 weeks.  R calf 2x the size of LLE.
p/vax pt inj site began to swell immed to size of golf ball;w/in a few min ice was applied;MD checked pt c/o not feeling well, dizziness, lips tingling;BP 130/140/80-90, P72;
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions and concomitant medications were reported. The reported stated that on an unknown date the (Oka/Merck)  VARIVAX was improperly stored and was administered to unspecified number of patients were (strength, route not reported0. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Itchiness; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MECLIZINE [MECLOZINE] for Dizziness, LISINOPRIL for Hypertension.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash). The patient was treated with HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking allergy plus for dust and mites .Patient shared that had EUSTATIAN TUBE DYSFUNCTION.
Narrative: Patient reported itching at the site of the injection of their 2nd dose of pfizer covid vaccine. Patient stated they had a similiar reaction following their 1st dose of vaccine. Patient did not need any intervention and was able to be released.
Patient had his bivalent booster dosed for 5-11 year olds one week after turning 5.  He developed a fever the next day, as he did with his initial 2-dose course of the Moderna vaccine for the 6 months -5 year old dose; however, after this recent booster his fever lasted a full 7 days.  He had no other symptoms and no indication of other illness, and tested negative for covid on both an antigen and molecular test.  The pediatrician believes he just had a particularly strong immune response to the vaccine, but no indication of allergic reaction or other issues.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 15-APR-2013 (lot number, dose, frequency and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Night of vaccine developed rash with itching.  Started using topical Benadryl and stated itching was worse and was developing welts.  Pt felt did have some respiratory compromises at times.  No SOB when presented to facility 3 days after injection.  Rash was reported on patients entire body.
RED RASHES IN SEVERAL LOCATIONS OF THE BODY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced red rashes in several locations of the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rashes in several locations of the body. This report was non-serious.
During early morning hours I awoke with pain and swelling at injection site, and hand and fingers were numb util effectively exercised a few minutes. Shortly thereafter, I developed a sever headache along with fever, chills and lethargy. Sever body aches followed with joint pain throughout entire body. All symptoms lasted 24-36 hours. 48 hours later, still feeling stiff with aching back muscles and feeling tired.  Large underarm lumps have developed 72 hours after injection. All of the aforementioned occurred after the second injection.
Patient reported a severe headache along with chills and general malaise. She received the vaccine at about 10 AM and by 1 PM she was in bed with acute flu-like symptoms. Symptoms resolved by the next morning. Patient also reported significant pain at the injection site that radiated up from her left deltoid to her neck. Patient stated that the worst symptom was the severe headache. Patient took acetaminophen to mitigate the symptoms, but did not seek medical care. She reports today (10/30/2017) that she feels absolutely normal with no symptoms of the adverse event lingering.
Pt recvd 2 doses of Engerix-B; 1 of the doses given 6JUN91 & 21JUN91 pt exp numbness, problems w/"gate" (gait); in addition, pt seen by MD because was not feeling well;
patient passed away; This case was reported by a other health professional via patient support programs and described the occurrence of unknown cause of death in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 17th July 2019, less than 2 years after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 17th July 2019, the outcome of the unknown cause of death was fatal. The patient died on 17th July 2019. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient passes away on 17th July 2019 by unknown cause. The reporter did not agree to follow up.; Reported Cause(s) of Death: Death NOS
8MAY noticed redness rt deltoid area where pt recv inj;seen by MD on 9MAY 7 x 7 1/2cm redness noted;better than yesterday;no tx f/u appt 12MAy;
Very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very tired). At the time of the report, FATIGUE (Very tired) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No concomitant medicines were reported. No treatment information were reported.
Alopecia Areata; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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; unknown manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown".  Additional information: The patient stated that vaccine gave Alopecia Areata about 3-4 weeks after receiving the booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Rapid beating of the heart; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX Support.  This male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient asked if he can take the 2nd dose of the covid-19 vaccine since he experienced rapid beating of the heart after the 1st dose. The outcome was unknown.    Information on the lot/batch number has been requested.
As soon as she got home, she felt some pain to the injection site. The pain progressed to near syncope symptoms. Said, she felt like she was having a Latex allergy reaction/anaphylaxis.
Hives and swelling migrating/reoccurring at different body sites over 2 days.
No adverse event, When family came for second dose we had double checked the age and realized the child was no old enough for the first dose.
Onset of hives within a couple hours after vaccine was administered. Patient started Benadryl.
Six hours after being administered by the vaccine I started to feel soreness around the site. Within the hour it progressed to pain in my left upper arm radiating down to my lower arm. By this time, I had difficulty raising my arm and limited ROM. This continued for three days. The symptoms eased up a little bit but there was constant pain whenever I raised my affected arm. When I went to work on the night of the Jan third, I felt my arm hurting during the night. I took ADVIL for the pain and continued to do so. Jan 6 and 7 At night, I was awoken with excruciating pain on the same arm. This lasted for approximately a couple of mins. I sought a virtual consultation with my PCP who advised me to take ten days off from work. I am currently on medical leave. I haven't experienced the same excruciating pain as I had those two nights. However, my ROM is still limited because there is still moderate pain involved. I've stopped taking Advil since it has started to upset my stomach.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Patient received other vaccine and no other medication in 2weeks. There were no concomitant medications. 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 drug ineffective, covid-19 Paxlovid started on 26Nov2022 and stopped on 30Nov2022. Clinical course was reported as, Covid rebound on 04Dec2022 at 06:00. No treatment received for symptoms and patient was not recovered from symptoms. No other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of PNEUMOVAX 23 (lot# reported as N004798, expiration date 31-OCT-2019; lot# N003993, expiration date: 20-AUG-2018; lot# N004564, expiration date: 22-OCT-2018) (dose, and route were not reported) for prophylaxis. The vaccine (lot# reported as N004798, expiration date 31-OCT-2019; lot# N003993, expiration date: 20-AUG-2018) were exposed to temperature excursion of 32 Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130 minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The vaccine (lot# N004564, expiration date: 22-OCT-2018) was exposed to temperature excursion of 1 Degrees Celsius or colder for undetermined time. The data logger was involved. There was no previous temperature excursion. No adverse effect reported. This is one of three reports received from the same reporter. Reporter reported PNEUMOVAX 23 with Lot # N004798 which was not valid for PNEUMOVAX 23; Sender's Comments:  US-009507513-1708USA010275: US-009507513-1709USA000645:
Pt received J&J vaccine at 0900 on Monday. Pt had ha and bodyaches on Monday night. Tuesday went to clinic for HA and bodyaches and was given tylenol. Pt woke up on Wednesday with a nose bleed and stomach ache.  CHIEF COMPLAINT & HPI:  23 yo M here with epigastric pain, nausea, shortness of breath, fever, chills, since receiving the covid vaccine several days ago.
Within about 45 minutes of receiving the vaccine I started getting mild hives spreading around the injection site and across my belly. I had mild wheezing and feeling of loose fluid in my brachial area of my chest. Now at 24 hr out, hives are head to toe, and I took diphenhydramine at bedtime in addition to my loratadine each AM.  I've used my inhaler twice to see if that helped - it doesn't, so it's not a regular asthma attack.  Today I have intermittently dealt with mild sweats, moderate chills, mild nausea, shakes (might be the inhaler as that sometimes makes me shake), headache fluxing between mild to moderate, eyes watering and lids swollen slightly with hives, injection site soreness, swelling about the diameter of a softball (interfering with ROM on left arm - I am an interpreter, so this interfered with work a lot today!), left arm from shoulder to elbow is hot to the touch, and I have had mild disconnects with my ability to focus/breaks in completing thoughts today.    I am keeping my EpiPens close, just in case.  I live 3 miles to the nearest ER, and someone is here with me just in case I need to go.
The pt developed a 2cm tender, red and warm area around the site of the vaccinia vaccination; treated with Augmentin 875mg BID X 5 days.
Around 1 hr after vaccine, I felt soreness at the site of injection and can only  lift my arm barely due to pain.  Around 3-4hours later, I felt fatigue, general body ache; however temperature was only 99.  The next day around 3pm, I had fever, Tmax 100.7. It lasted around 8pm and stopped. Oh note, I took Tylenolaround 7. I took another one before sleep at 11pm.  I woke up afebrile with only slight pain on injection site.
felt like she had a cold or a sinus infection; slight fatigue; sore arm; shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (felt like she had a cold or a sinus infection), DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath). On an unknown date, the patient experienced SINUSITIS (felt like she had a cold or a sinus infection), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, SINUSITIS (felt like she had a cold or a sinus infection), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown and DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath) had not resolved.            No concomitant medications were reported. The patient was prescribed with Antibiotics. Patient had a cardiac MRI with the rest of the tests.
pt recvd vax for prophylaxis;eve following dose 2,exp dyspnea,coughing, & a sore throat;tx w/ proventil & solu-medrol IV;
30OCT92 pt recvd vax & 31OCT92 pt became lethargic; 1NOV92 was tired & devel a h/a, achy msucles & vomiting; vomiting was treated w/Ibuprofen & Vicodin; 2NOV92 outcome was unk;
Covid Arm - Large red raised rash for about a week but happened 8-9 days after vaccination.  Had cold at the exact same time when rash appeared. Went away after a week.
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 14th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.