chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Shot 4 years ago and just got Shingles now; Just horrible pain; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the shot 4 years before the date of reporting and just got Shingles now. There were no rash or blisters but just horrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
I had a spontaneous hyphema in my left eye; I also had an arthritis flare up in my left hand; This spontaneous case was reported by a patient and describes the occurrence of SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 05-Nov-2023, the patient experienced SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) (seriousness criterion medically significant) and ARTHRITIS (I also had an arthritis flare up in my left hand). On 13-Nov-2023, SPONTANEOUS HYPHAEMA (I had a spontaneous hyphema in my left eye) and ARTHRITIS (I also had an arthritis flare up in my left hand) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  The vaccine was administered in patient left deltoid. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported. Company comment: This spontaneous case concerns a 57-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of SPONTANEOUS HYPHAEMA, and the unexpected and non-serious AESI of ARTHRITIS, 3 days after an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. No details of previous doses were provided. No treatment information was reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Headache, Fever, flushed, body aches (unspecified), fatigue Narrative:
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # reported as M029233, expiration date 09-AUG-2018; lot # M007763, expiration date 15-SEP-2017, dose and route not reported). The doses of vaccine were improperly stored at 48.9 degree Fahrenheit for 8 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist via a company representative concerning a female young teenager (age not specified). Information regarding concurrent condition, medical history and concomitant therapy was not reported. The reporter stated she heard from an unspecified healthcare provider that the patient received the first dose of an unspecified HPV vaccine (manufacturer unknown, dose and route not reported) on an unknown date. Then on an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS). The pharmacist was not sure but she thought the HPV vaccine that the patient had received was GARDASIL 9. It was also unknown if the patient had received any further doses of the HPV vaccine. The outcome of postural orthostatic tachycardia syndrome was unknown. Additional information has been requested.
Flu; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case received via social media from a consumer (patient).  This case involves a patient of unknown demographic who had flu (Influenza), while the patient received INFLUENZA VACCINE.  Medical history, concomitant medications, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non serious flu (Influenza) (unknown latency) following administration of INFLUENZA VACCINE.  It was reported that the patient never had the flu except that time. Patient believes it should be a choice so if anyone feels then should take it, please do. Patient would not take it to protect others. Others should make the decision to protect themselves and their families if they so choose. Patient believes in boosting immune system, taking vitamins, being clean, and alternative therapies and was thankful to live in a country with freedom of choice.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
FLU SYMPTOMS; CHIPPED TOOTH FROM SHIVERING; GRIMACING OF FACE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced flu symptoms, chipped tooth from shivering, and grimacing of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and the outcome of chipped tooth from shivering and grimacing of face was not reported. This report was non-serious.
Pt became flush over her chest , neck and face. Denied any shortness of breath . Had no angioedema  Flush fade with in a half hour.
pt recvd vax 7MAR94 & on 26MAR93 awakened w/severe swelling of both hands, arms & face w/numbness; 28MAR94 pt was seen by MD who dx w/arthritic type synd;
Dizzy & Light-headed immediately following immunization.  Continued to feel light-headed and right arm 'tingled' several hours in to evening.  Parents called this RN.  Instructed to take to ER if symptoms persist or worsen.
Patient received dose 24 hours after puncture; Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 017C21A and 003C21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Chronic kidney disease, Chronic obstructive pulmonary disease and Drug allergy (Antidepressant). Concomitant products included TRAZODONE for Insomnia, BUPRENORPHINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), LISINOPRIL, GABAPENTIN and METHOCARBAMOL for an unknown indication.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Jun-2022 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In June 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022). On 23-Jun-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator 21-Jun-2022, and the vail was first punctured on 22-jun-2022 at 09:00 am and the vaccine was administered 23-jun-2022 at 09:00 am 24 hours after first Puncture. Post puncture the vail was stored in fridge.  The vial had not undergone any temperature excursion and the vial was never placed at room temperature   No treatment medications were reported   This case was linked to MOD-2022-600919 (Patient Link).
On the day of vaccination very irritable, knot in leg. No fever. 3.5-4cm red area with blotchy red rash distal to injection site. No sign of infection at site.
Mild reactions after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild reactions after 2nd primary dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Deep vein thrombosis (10 years ago which resolved).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild reactions after 2nd primary dose). At the time of the report, IMMUNISATION REACTION (Mild reactions after 2nd primary dose) outcome was unknown.            It was reported that the patient's age was over 65. Patient did not take Blood thinners anymore. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-588869, MOD-2022-588877 (Patient Link).   Reporter did not allow further contact
Patient was given 0.5ml of Moderna COVID-19 dose as a booster after the initial J&J first dose in March 2021 instead of 0.25ml
Called 6/19 and states woke up Saturday 6/17 AM w/discomfort (R) side neck, headaches, muscle ache in bicep. On 6/18 couple episodes of sharp stabbing chest pain lasted 10 seconds.
Tiredness; Headache; 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 (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medial history reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received  on 25-May-2021,contain non significant information
75-year-old female presented with nausea, chest tightness, and shortness of breath.  Patient did have some mild fatigue and a mild cough 2 weeks prior.  After getting her flu shot, about 4 hours later, she developed nausea, vomiting, and chest tightness.  This was then followed by progressive shortness of breath with orthopnea.  Upon presentation to the emergency department, patient was found to be in atrial fibrillation with RVR which is new for her.  She was also hypoxic at 87% on room air.  CT angiogram thorax showed no PE but there was bilateral infiltrates, pulmonary edema versus infectious.  Her COVID test came back positive.  She also had significantly elevated troponin at 683 with an elevated BNP at 4000. Patient has been vaccinated for COVID.  Upon discussion with Cardiology, patient was started on a heparin drip and daily aspirin.  Patient was started on Decadron and remdesivir for COVID pneumonia.  Her presentation was thought to be multifactorial cause by pulmonary edema, AFib with RVR, and COVID pneumonia.  Patient was placed on Cardizem drip.  Her symptoms and hypoxia quickly resolved after her rate was controlled.  An echocardiogram showed a decreased ejection fraction of 40% with hypokinetic distal and apical segments.  A cardiac MRI was then done which showed findings consistent with stress-induced cardiomyopathy (apical type).  There was no MRI evidence of myocardial infarction or myocarditis.  Left ventricular ejection fraction was 48%.  Patient was given a dose of Lasix with very good response and urine output.  Follow-up chest x-ray the next day showed improvement of her bilateral infiltrates which points more towards resolving pulmonary edema.  With improvement of her symptoms, patient was discharged home with plans to have a follow-up echocardiogram in 4 weeks.  Patient's metoprolol dose was increased to 75 mg daily.  She was discharged on atorvastatin 40 mg daily, Lasix 20 mg daily, and transition to Eliquis 5 mg twice a day for atrial fibrillation.  She will follow-up with cardiology as an outpatient.
6AUG broke out in rash started fever 103, diarrhea, all cont for 5 days; all went away x/@ noc has low grade fevers since vax given;
This spontaneous report has been received from a nurse practitioner referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions, drug allergies and concomitant therapies was not reported. On 07-NOV-2016, the patient was vaccinated with a second dose of GARDASIL, intramuscularly, (strength, lot# and expiration date  were not provided) for prophylaxis, and then on 04-JAN-2017 the patient was vaccinated with a third dose of GARDASIL, intramuscularly, (strength, lot# and expiration date were not provided) for prophylaxis. No adverse events were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected because the reporter details were not provided. Sender's Comments:  US-009507513-1701USA006657.
Information has been received from a physician concerning a 3 year old male who in  approximately  2003 at one year old was vaccinated with a dose of varicella virus vaccine live. On approximately 02/02/05 the pt developed chickenpox with about 20 or so bumps. It was reported that there was no fever or sickness present. Unspecified medical attention was sought. There was no product quality complaint involved. No furhter infomation is available.
Information has been received from a registered nurse concerning a 6 year old male student with no medical history and no allergies who on 05-Sep-2000 was vaccinated subcutaneously in the left arm with a 0.5 ml first dose of varicella virus vaccine live (lot #632726/0088K). There was no illness at the time of vaccination. On 17-Oct-2003 the patient developed new red, itchy, spots appearing on his trunk, legs, and buttocks. On 24-Oct-2003 the patient was seen in a clinic where it was noted that the red spots had reddened areas surrounding them with the beginnings of scabs. There were 1-2 vesicles with clear fluid in the center that appeared inflammed. Most appeared "scratched". There was no fever. The nurse reported that the patient developed a possible breakthrough disease of chickenpox. There were no diagnostic tests performed. The diagnosis was based on a visual exam and history. No prescription drug or treatment was required. It was also reported that the patient's pediatrician did not give the vaccine and had not yet seen the patient regarding this AE. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
got only half the vial of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 49NM5, expiry date 6th April 2023) for prophylaxis.   On 7th November 2021, the patient received the 1st dose of Shingrix. On 7th November 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient moved the arm while being vaccinated with first dose of Shingrix.. The reporter thought, the patient got only half the vial of the vaccine, which led to accidental underdose. The reporter did not feel comfortable providing patients initials.  The reporter consented to follow up.
Client here for Kds PE and immunizations.  Immunization record received from WMC, given IPV and MMR at 11:00AM.  Client began with Erythema, itching and hives on trunk and face at 11:10AM.  Benadryl 25MG by mouth administered.  Approximately at 11:20AM client wheezing and lethargy, given EPI 0.2ML S/A stat at 11:25AM.  EMT (911) called.  Oxygen applied via face mask.  EMT arrived 11:35AM, BP 110/60.  Client was better and decreased wheezing, decreased hives, increased responsiveness at time of transfer.  Tranfered to WMC - Pediatric ER at 11:45AM, stable for transport.
16 hours post vaccine: High temp; fatigue; chills and body aches lasted at least 3 days.
2 weeks after second injection I developed a severe case of hives.  Never had hives before and they lasted 6 days.
Patient passed out for a few seconds. When she woke up she broke out in a cold sweat and threw up. She said her arms tingled.
A medical assistant was administered a flu shot in the posterolateral aspect of her right upper arm.  It was apparently given in the subcutaneous tissue as opposed to intramuscularly. The following day she noted a 6 cm area of erythema, warmth and tenderness of the arm. She has pain when moving the arm and when sleeping on her right side. She tried ibuprofen and ice with minimal improvement in her discomfort. She continues to work without restrictions.
Felt like the gush of the medicine "went into her arm, then it went around her arm"; Mobility is difficult; Arm was swollen to size of golf ball/Swelling seems to be expanding; Arm started to bother her; Warm to touch/It was hot; It is hard; Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger; Fever; Chills; Redness; Injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her) and VACCINATION SITE WARMTH (Warm to touch/It was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender). At the time of the report, VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
expired  5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.  It was reported that Moderna vaccine was pulled from freezer on 16-Dec-2021 and beyond use date was 15-Jan-2022. On 26-Jan-2022, staff brought it to attention that it was still in fridge and expired and 5 doses had been given. Patient denied any adverse effects. On 31-Jan-2022 Moderna responded that revaccination was not required.
As per patient, right after the vaccine she experienced pain on the left side of the whole body from toes and up. She has to go through physical therapy and is still in pain to some extent.