chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of effect; Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days). At the time of the report, VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) for 17 days.         No concomitant product was reported. No treatment information was reported.  Company comment: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected non serious event of COVID-19, unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine (reported as second booster shot). Additionally, Vaccination failure (lack of effect) was reported. SARS-CoV-2 test was positive. No information on primary vaccination schedule, time to onset from the last dose of vaccine, signs and symptoms of COVID 19, other relevant investigations, treatment was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Patient received her flu shot on 9/26/17. It was placed by Medical Assistant. On 9/26/17 at 8:28 pm patient sent me a video of her swollen arm where she received her flu shot. She decided to go to the doctor to figure out what was going on. She took off of work on 9/27/17 to visit her doctor.
4/1/2021 1135 - Administered Menactra and Tdap in client's right deltoid in that order.  About 10 seconds after receiving Tdap, client's eyes rolled back in head, skin paled, and client lost consciousness. RN and mother supported client upright in chair. Client had 5 involuntary muscle spasms of upper torso. 30 seconds after losing consciousness, client regained consciousness without intervention. Nurse and mother assisted client into recovery position on the floor. Another nurse retrieved cold washrag, cold water, and graham crackers. Cold washrag applied to back of the neck. After 2 minutes on the floor, client's color returned and client stated feeling better. Nurse administered HPV into left deltoid with client in side-lying position on floor, no reaction. Mother stated client had never had a syncopal episode with vaccinations before, but has another child prone to syncopal episodes. When asked if client had breakfast, both client and mother said no. About 5 minutes after receiving HPV vaccine, client felt well enough to move into a sitting position, tolerated graham crackers and water. After 5 minutes in sitting position, client felt able to stand. Client stood for 2 minutes and stated feeling fine. Client escorted by mother out of clinic.
Itching all night long; it's red; It has Lumps; It's Itchy and i was not able to sleep because of itching; not able to sleep because of itching; It's red; Hard Lumps; Sometimes hurts; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's red), INFLAMMATION (Hard Lumps), PAIN (Sometimes hurts), PRURITUS (Itching all night long) and ERYTHEMA (it's red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts). On 20-Jan-2021, the patient experienced PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching). At the time of the report, ERYTHEMA (It's red), INFLAMMATION (Hard Lumps) and PAIN (Sometimes hurts) had resolved with sequelae and PRURITUS (Itching all night long), ERYTHEMA (it's red), INJECTION SITE INFLAMMATION (It has Lumps), PRURITUS (It's Itchy and i was not able to sleep because of itching) and SLEEP DISORDER (not able to sleep because of itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported. Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 16 years old, female patient with no pertinent medical history reported. On 21-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the arm, dose not reported). Concomitant therapies included MENACTRA (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported) and Hepatitis A vaccine (manufacturer unknown) (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source.
Over course of next 24 hours, increased pain and LAD; No constitutional symptoms except for non-specific fatigue; Seems most consistent with VZV infection; erythematous lesions without obvious blisters on my left chin; erythematous lesions without obvious blisters on my left chin which were painful; erythematous lesions without obvious blisters on my left chin which were painful with unusual numbness and dysesthesia in surrounding area; erythematous lesions without obvious blisters on my left chin which were painful with unusual numbness and dysesthesia in surrounding area; This was followed by lymphadenopathy in my submandibular and high cervical glands; This is a spontaneous report from a contactable physician (patient).  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular at left arm on 21Dec2020 15:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypothyroidism, and zoster outbreak previously about one year ago (2019). No prior medical history (hx) of allergies or adverse reactions to vaccination in childhood or as adult. No allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). No other vaccines within 4 weeks prior to the COVID vaccine. For historical vaccine, the patient had taken usual Influenza vaccinations yearly and dTap. The patient was not diagnosed with COVID-19 prior to this vaccination, and since this vaccination, the patient been had not tested for COVID-19. It was reported that three days post-vaccine (24Dec2020 08:00), the patient developed erythematous lesions without obvious blisters on left chin which were painful with unusual numbness and dysesthesia in surrounding area. This was followed by lymphadenopathy in her submandibular and high cervical glands. Over course of next 24 hours, increased pain and "LAD". No auricular, nasal or ocular involvement. No facial palsy. No constitutional symptoms except for non-specific fatigue. Seems most consistent with VZV infection or possibly adverse drug reaction. The patient had zoster outbreak previously about one year ago but not in this dermatome. Given progression of symptoms, the patient discussed with her physician virtually and had started Valcyclovir and used Ibuprofen and Gabapentin for pain control. She had been taking these medications for 36 hours at time of this report without much change. The outcome of the events was not recovered.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002913. 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "experienced cardiac event". Additional information: On 08Aug2022 it was reported that a patient started treatment on an unspecified date with PFIZER BIONTECH COVID-19 VACCINE. It was reported the patient experienced cardiac event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Joint pain, lethargy, muscle ache, injection site redness, swelling, tenderness, - that enlarged - Rx KEFLEX 500 tid x 7d, OTC ZYTREC.
Patient in at 1046. patient has hx of same s/sx with blood draws and giving blood. patient VS 98%, 60 HR, BP 128/81. Sx pale, vertigo, light headed, dry throat. VS at 1122 117/79, HR 82 while sitting. patient had 0 SOB and 0 palpitations. Patient supine and provided water and a snack. left at 1155 normal.
Administration error. Nurse failed to mix the two vials for Menveo, pt received only the liquid vial of Menveo. Spoke with nurse manager who advised dose needed to be re-administered in correct manner. Parent and patient notified.
MOUTH SALIVATION, LIGHT HEADEDNESS, TINGLING FINGERS AND MILD STOMACK QUEASY. FEELING WARM FLUSHED.  given diphenhydramine and improved.  Next day went to emergency department due to moderate severity headache which was constant, worsening , frontal and parietal.  Also with fatigue, nasal congestion and mylagia.   Headache resolved after IVF 1L and magnesium sulfate 2g. . Pt's symptoms most likely secondary to reaction to Moderna vaccine. Odd symptoms so severe after first dose, but it is possible that patient may have pre-existing antibodies to actual Covid 19 infection and was asymptomatic. Therefore, the first dose was more severe.
Bleeding from injection site,  finger tingling (3-5) , shoulder and upper back pain, faint feeling... Day 2 has been fever, body aches, chills. No relief from ibuprofen
Information has been received from a physician concerning a 19 year old female patient who was vaccinated in the arm with a first dose of Gardasil. Subsequently the day after, the injection complained of significant pain in the arm at the injection site and in her upper arm toward her shoulder. The soreness in her arm lasted for one week and then dissipated. However, subsequently the soreness returned and as 30-MAY-2007 the patient was still experiencing pain and soreness. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a 21 year old female with a history of penicillin allergy who on 26-MAR-2007 was vaccinated IM with her second dose of Gardasil vaccine (yeast). Concomitant therapy included NUVARING. On 26-MAR-2007 the patient experienced "a dilated right pupil" after receiving her second dosage. The patient used Visine to treat her eye. The patient's dilated right pupil persisted. The patient did not seek medical attention. Additional information has been requested.
TOOK ONE PILL EACH DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case (PVX2019-1361) was received from a physician on 28-May-2019. It describes a female consumer who "took one pill each day instead of every other day". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses every day instead of every other day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one pill each day instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one pill each day instead of every other day" was considered as not applicable.
pt recvd vax;became flushed & short of breath;to er;hx of apnea episodes;rx inhaler to use but pt refuses per daughter;sent home;8dec TC at home; doing fine;
covid vaccine breakthrough case  dose 1 Moderna 2/2/21  012L20A dose 2 Pfizer 7/28/21  EW0173
Experienced achy muscles, low grade fever, hot and cold flashes, and head ache. Very sore at the site of the injection.
LOST APPETITE; FEVER; STRONG BODY ACHES; This spontaneous report received from a patient 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 not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced strong body aches. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from strong body aches, and fever, and the outcome of lost appetite was not reported. This report was non-serious.
A 20 year old patient received PROQUAD.; no additional advers event; This spontaneous report was received from a medical assistant and refers to a 20-year-old patient.  The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No adverse event was reported.
Full blown flu complete with sore throat, respiratory congestion (nasal and bronchial) three-plus degree fever, aches, chills, vomiting.
When she get out the banded she notes a red spot and it where hurt for 2 days; When she get out the banded she notes a red spot and it where hurt for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (When she get out the banded she notes a red spot and it where hurt for 2 days) and VACCINATION SITE PAIN (When she get out the banded she notes a red spot and it where hurt for 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (When she get out the banded she notes a red spot and it where hurt for 2 days) and VACCINATION SITE PAIN (When she get out the banded she notes a red spot and it where hurt for 2 days). At the time of the report, VACCINATION SITE ERYTHEMA (When she get out the banded she notes a red spot and it where hurt for 2 days) and VACCINATION SITE PAIN (When she get out the banded she notes a red spot and it where hurt for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Employee reports fever on 10/4/11, and swelling/pain of (L) deltoid area, (L) trapezius area, and swollen glands (L) axilla.  States no history of similar reaction to Tetanus vaccination in past.  States range of motion is intact but very painful.
A little "COVID arm" after vaccine; Arm itchy after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after vaccine). At the time of the report, VACCINATION SITE REACTION (A little "COVID arm" after vaccine) and VACCINATION SITE PRURITUS (Arm itchy after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Treatment includes Benadryl. no concomitant information was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-026604 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026604:Husband Case
Started with pain in left arm and then the pain increased  around 5pm on saturday. At midnight the pain increased and went down the left arm and across the shoulder and neck , down the right arm, down the back and ribs and into the legs. His hands and knuckles swelled up. From 1am to 5am he couldn't hardly walk, he felt almost paralyed. Around 6am(Sunday) he was starting to move more but the swelling in his hands lasted into Tuesday.
Rheumatoid arthritis flareup after 2nd and 3rd doses; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 23:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 70 years, in left arm for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "linear IGA dermatosis" (unspecified if ongoing). Concomitant medications included: DAPSONE; HYDROXYCHLOROQUINE. Past drug history included: Enbrel, reaction: "Known allergies: Enbrel". Vaccination history included: BNT162b2 (Dose: 1, Administration time: 09:15 AM, Lot number: EL3247, Vaccine location: Left arm), administration date: 19Jan2021, when the patient was 69-year-old, for Covid-19 immunization, reaction: "COVID 19 Treatment"; BNT162b2 (Dose: 2, Administration time: 08:15 AM, Lot number: EL8982, Vaccine location: Left arm), administration date: 09Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reactions: "Rheumatoid arthritis flareup", "COVID 19 Treatment". It was reported that rheumatoid arthritis flared up after 2nd and 3rd doses. Flareups keep getting worse causing patient to start abatacept (ORENCIA) from an unspecified date to 02Jul2022. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966407 same patient and event, different dose;US-PFIZER INC-202200960651 same patient, different AEs, different dose;
Swollen lymph node over collar bone; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 17Mar2021 at 14:15 hours (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included chronic inflammation and COVID-19 from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included low dose naltrexone (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM) received medications in two weeks. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccination. On 20Mar2021 at 08:00 hours, the patient experienced swollen lymph node over the collar bone. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event swollen lymph nodes was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient had common side effects starting the day after administration. After approximately 36 hours, the side effects subsided. 5 days later, the side effects started again this time including dizziness which is not listed as a normal side effect of the vaccine.
Tested positive to COVID-19; Tested positive to COVID-19; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the parent.  A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), administered in the left arm, administration date 02Dec2021 20:00 or 21:00 (Lot number: FJ8762) at the age of 13 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID-19 vaccine. The following information was reported: The patient's mother reported that she and her son have got their first shot of Pfizer-BioNTech COVID-19 vaccine. On 23Dec2021, they had the appointment for the second dose, however, both have tested positive to COVID-19. The pharmacist told the mother to wait one month but she read on the Internet that she could get it after 10 days. The mother asked when can they get the second dose of the vaccine. The patient has not received the second dose yet. The patient underwent the following laboratory tests and procedures: COVID-19 test: (23Dec2021) positive. Therapeutic measures were taken as result of the event which included taking over the counter pills. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101850682 same reporter, drug, and event; different patient