chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored dose of GARDASIL 9; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number N022952 with expiration date on 14-JUN-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) (32.1 F)  for 8 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Menstruation delayed by two weeks and lighter than normal; Menstruation lighter than normal; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 16:45 (Lot number: 330268d) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included: CITRAZINE, multivitamin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8727, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 21Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6198, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 27Feb2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 16:45, outcome "unknown", described as "booster"; MENSTRUATION DELAYED (non-serious) with onset 03Jan2022 11:00, outcome "unknown", described as "Menstruation delayed by two weeks and lighter than normal"; OLIGOMENORRHOEA (non-serious) with onset 03Jan2022 11:00, outcome "unknown", described as "Menstruation lighter than normal". Therapeutic measures were not taken as a result of menstruation delayed, oligomenorrhoea.  No follow-up attempts are possible. No further information is expected.
After approximately 18 hrs after receiving the flu vaccine (Saturday morning), I developed a small bump on left calf muscle.  After approximately 42 hrs (Sunday morning) developed several larger bumps on left calf and several small bumps on right calf.  These bumps were red and circular approximately 1/2 to 1 cm in diameter.  They itched.  By Monday morning both were more rash like and grown in size to an area about 3 x 8 cm.  By about 9pm on Monday (10/10/2022), another bump appeared on the right hamstring - about 14 cm from the inside of the knee joint. By Tuesday morning at 6:30 am, the bump on the hamstring had grown into a rash similar in size and appearance and size as the others.  They all itch and are quite annoying though not debilitating.
Vertigo and vomiting for six hours. Fluids, bedrest at home. Less dizzy the following day.
THEY GAVE US THE NOSE ONE IN SCHOOL ITS A LIVE VACCINE AND MAKES YOU FEEL LIKE CRAP; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: NASK    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced they gave us the nose one in school its a live vaccine and makes you feel like crap (preferred term: Feeling abnormal).     The outcome of the event was unknown.    The event was considered non-serious.
1) Fever began 5:30pm 01/13/04. Swelling occurred during night on right thigh (injection site).  2) 3 whelps appeared on 01/14/04-01/15/04, just large red area.  3) Began Benadryl 1/2 tsp every 4-6 hours 01/13/04 and gave Tylenol 1/8 tsp, Motrin 1/8 tsp together every 4 hours for fever of 102.8.  4) MD instructed continue with Benadryl and Tylenol/Motrin. 01/15/004: Talked with mother, she states area is red, swelling has decreased, fever has decreased, continues to give Benadryl and Tylenol and will throughout the day. Child crawling around and in good mood.  Mother feels reaction is getting better and will resolve soon.
Received Pfizer vaccines on 2/23/21 and 3/16/21 Tested positive for COVID 19 by PCR on 4/16/21 Asymptomatic, was tested due to upcoming procedures at our facility.
Pain; Flu like symptoms; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ulcerative colitis.    Concurrent medical conditions included Psoriatic arthritis and Ulcerative colitis (moderate to severe).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication were reported.  It was not known weather the patient was enrolled in covid-19 vaccine trail.  The Daily dose of Humira was reported as Citrate Free.   No treatment medication were reported.
Patient complained of pruritis and rash post vaccine on arms legs and surface of tongue. Given diphenhydramine 50 mg po x 1 dose and symptoms resolved
It was reported that a 70 year old female received Fluzone 98-99 on 10/2/98. Reportedly pt jaundiced within 24 hours post vax. Pt is not undergoing tests.
4/07/21 12:40 PM B/P 140/78 Pulse 71, 12:56 PM B/P 144/72 Pulse 69.  Chief Complaint loss of consciousness.  No history of diabetes mellitus or seizure disorder, loss of consciousness with seizure like activity, not post ictal, recovered in less than 5 minute, then alert and oriented per EMT notes.  EMS called and transferred to Hospital.
Signs & Symptoms started 12/16/2021.  Hospitalized 12/25-27/2021 and 1/1-1/26/2022.  Treatment included Baricitnib, steroids, diuretics and antibiotic; support with  O2 via Airvo and BiPap.  Pt did have an episode of C diff colitis.
Mild spotting post menopause; This is a spontaneous report from a contactable other hcp (patient).   A 58-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE3590) via an unspecified route of administration, administered in left arm on 29Oct2021 (at the age of 58-year-old) at 15:30 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at doctor office/urgent care. Medical history included stress urinary incontinence and allergies to sulfa drugs from an unknown date and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), colecalciferol (VIT D [COLECALCIFEROL]), fish oil, paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and melatonin all medication taken for an unspecified indication with start and stop dates were unknown (in two weeks). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318) on 30Jan2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198) as dose 2, single on 23Feb2021 both at the age of 57-year-old via unspecified route, administered in left arm for COVID-19 Immunization. On 31Oct2021 at 18:00 patient had mild spotting post menopause. It was reported that patient had received booster on Friday afternoon, and on Sunday afternoon she had one incident of mild menstrual spotting despite being in menopause. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. On an unspecified date, patient underwent lab tests and procedures which included gynaecological examination (pelvic exam), ultrasound scan and urine analysis, all the results were unknown. The patient had not received any other vaccine within four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event postmenopausal haemorrhage  and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Tingling in right arm; Blurred vision in right eye; weakness in the legs after 15 minutes ofmonitoring; Body aches; Fatigue; soreness on injection site; Right thumb twitched entire day; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. Concomitant medication included phentermine (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unknown date. The patient previously took dextromethorphan (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 11:00, immediately after receiving the second dose, the patient experienced tingling in right arm and a few moments later, the patient experienced blurred vision in right eye and after 15 minutes of monitoring she had weakness in the legs and also had body aches, fatigue, soreness on injection site and the right thumb twitched the entire day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as result of the events. The clinical outcome of the events tingling in right arm, blurred vision in right eye, weakness in the legs, body aches, fatigue, soreness on injection site and right thumb twitched were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt called pharmacy 3 days after receiving the vaccine complaining about a fever, headache and nausea also said his arm was swollen from the site to his elbow. Called pt next day to follow up, said he was doing better.
Cellulitis right arm 2 hours varicella.  In hospital for 1 day, discharged with clindimycin.  9/11/2008 MR received for DOS 7/18-19/2008 with D/C DX:  Local vaccine reaction to chicken pox vaccine.  R/O arm cellulitis.   Pt presented from PCP office with 1 day hx of R arm swelling and pain.  The pm of the injection pt developed swelling and blisters forming at the injection site. Blisters draining clear fluid. (+) itching. Started on IV abx with improvement in erythema, induration and pain. D/C on po abx.
This case was reported by a nurse via interactive digital media and described the occurrence of paralysis in a 60-year-old female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant), disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder nos. On an unknown date, the outcome of the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome and pain were not recovered/not resolved and the outcome of the general physical health deterioration, immune system disorder and brain disorder Nos were unknown. It was unknown if the reporter considered the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder Nos to be related to dTpa vaccine. Additional details were receive as follows: In 2007, the patient received Tdap vaccine, which as per the reporter was the beginning of the end of the her life. The patient suffered and remained suffering and was struggling from having a severe adverse side effects from the Tdap vaccine that left her disfigured, permanently and totally disabled, paralyzed on her left upper extremity with the paralysis spreading to the right side, which was progressive and no cure, severe brachial plexus injury, myofascial pain, constant and continuous right trapezius muscle spasm. At times, the patient could not turn her head side to side or look up or down and complex regional pain syndrome. The patient was in pain every single second of the day. CRPS, made the patient feel as if being burned alive. The patient was on medications, but it just took the edge off for a very short time. The pain never went. The patient was devastated that she lost her dream job as a critical care NICU RN. The patient loved the job, preemies and peers. At the time of reporting, she required help even to be able to take care of herself, all because of the mandated vaccine. The patient's right thumb and the body was slowly deteriorating and became completely paralyzed. The patient stated that those who fear a side effect had never seen this illness in action. As per her, the vaccine destroyed her immune system, as well as, part of the brain and body.
SHINGLES; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (SHINGLES) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (SHINGLES). At the time of the report, HERPES ZOSTER (SHINGLES) outcome was unknown. Reporter did not allow further contact
Swollen lymph nodeunder left arm,; Painful arm; Feeling weak; Hot and cold flashes; Strong body ache; Bound to bed; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25May2021 at 16:30 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. The patient previously the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 16:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021 at 02:00, the patient experienced strong body ache. On 26Apr2021, the patient experienced bound to bed. On 27Apr2021, the patient experienced swollen lymph node under left arm, painful arm, feeling weak and hot/cold flashes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events strong body ache was recovered on 26Apr2021. The clinical outcome of the event bound to bed, swollen lymph node under left arm, painful arm, feeling weak and hot/cold flashes was recovering at the time of report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Nausea; Fatigue; Arm pain; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 20:15 as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis, history of lung cancer, gastro-oesophageal reflux disease (GERD) and high cholesterol. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient is allergic to latex. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 20Mar2021 at 05:00, the patient experienced nausea, fatigue, arm pain and confusion. No treatment was received for the events. Event had not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for nausea, fatigue, arm pain, confusion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Body Aches Chest Pains Felt like I was having a heart attack Ended up seeing a cardiologist - was put on 3 different meds, Ibuprofen for inflammation, Colchicine and Pantoprazole
Evening after shot arm felt sore but within normal expectation.Right arm(the one she had received the vaccine in at 1PM the day before) became tingly around 9AM and her right hand began to go numb and increasingly weak. It became hard to type (she was working). Her  right hand was also colder than her left. Around 10 AM she was becoming increasing dizzy and nauseous, around 10:30 she vomited. Her face was red prior to vomitting and she appeared to be running a fever (of unknown degree) She had at this time very little feeling in all five fingers and slightly more in the center of her hand. Arm was not numb just tingly. Around 11:30 AM called doctor office to see if they thought it could be a reaction to vaccine. Was no longer very nauseous and face was only mildly flush.Family doctor was also consulted still somewhat dizzy. Was told to go to the emgergency room to be checked. After checking her out and speaking to the doctor office where she received the vaccine,  they gave her a steriod shot in the left arm (aroud 1PM). After about an half hour there began to be some improvement in the numbness of her fingers,(arm still "pin and needly feeling). By 3:30 things had improved but could still feel some weakness and numbness.
Symptoms include airway itching and warmth, subjective eyelid closing, eye itching, and localized hives on left thumb within 30 minutes of dose.
Patient was given IPV instead of Dtap. IPV was given to early. Patient didn't have adverse reactions while in clinic. And Dtap was administered.
pt c/o twitching in lt eye since the 1st noc p/receiving vax; pt was twitching off & on every day;
Patient received undiluted Pfizer Pediatric vaccine 0.2ml  (Father was told to ice arm, give Tylenol, watch for adverse event - expect to only see injection site redness and extremely sore arm.  Hydration and electrolyte drinks for comfort)
Patient presented to emergency department with complaints of worsened shortness of breath and lower extremity edema on 6/22/2021. He was admitted for further management of CHF exacerbation.  During screening for placement to post acute rehab facility, patient was found to be COVID-19 positive on 6/29/2021. He was treated for COVID-19 infection in April of 2021. He is still admitted at time of writing.
Noticed I couldn't move my right arm when making the bed in the morning at 0700.  Looked in mirror and noticed left side facial drooping.  I went to tell me wife and could not talk.  She called 911.  I was taken to a local emergency department and eventually got an MRI that showed a frontal lobe focal diffusion.  My speech symptoms continued until around 1400 the same day and they slowly subsided.  I was discharged to cardiac and neurology care going forward.
fever, vomiting, severe h/a, irritability, drowsiness, no appetite, crying, redness more than 2 inches around;lymph glands enlarged lt groin;
first dose > 35 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment information not reported.
administered Engerix-B inadvertently; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old male patient who received HBV (Engerix B) (batch number 90746, expiry date 7th September 2023) for prophylaxis.   On 1st September 2021, the patient received Engerix B. On 1st September 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The patient was administered Engerix-B inadvertently, which led to wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021222750, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222750:Same reporter