chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning her 15 year old daughter who was vaccinated with a third dose of Gardasil. Subsequently the patient developed extreme fatigue after receiving the third dose of Gardasil. The event resolved after three days without any treatment. Additional information has been requested.
First dose: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EP7534) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Mar2021, outcome "recovered" (20Mar2021), described as "First dose: Sore arm".   Additional Information: Other Products: No.Patient History: No.Investigation Assessment: No. Following the first dose of the Covid-19 vaccine, the patient had no side effect or reaction other than a sore arm.Caller reported that medicine does not work with the patient.Additional Administered Vaccines: No.Did any AE(s) require a visit to: Emergency Room: No.Physician Office: No.Prior Vaccinations (within 4 weeks): No.AE(s) following prior vaccinations: No.Family Medical History Relevant to AE(s): No.Caller reported that the patient doesn't normally even get flu shots.  Caller reported that he and the patient are healthy people.  No follow-up attempts are possible. No further information is expected.
heat throughout entire face; redness throughout entire face; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EJ1686), dose 1 via an unspecified route of administration, administered in left arm on 08Feb2021 16:15 (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. Medical history included IV contrast allergy. Concomitant medication included ergocalciferol (VITAMIN D). No other vaccine in four weeks. On 08Feb2021 16:45, the patient experienced heat and redness throughout entire face. No Covid prior vaccination nor tested for Covid post vaccination. Therapeutic measures were taken as a result of the events which included Benadryl. The patient recovered from the events on unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Clinician inadvertently gave the Pfizer Monovalent vaccine when patient was due and expected to receive the Bivalent vaccine
not hard and swollen anymore; not hard and swollen anymore; sore; itchy; rash; COVID arm". Developed rash/sore red/ hard and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy) and RASH (rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen). At the time of the report, INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medication includes: Cortisone Cream & Ice pack to do warm packs.  No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 27-May-2021, contains non-significant information.
brought to medical area to calm down, states :this has happened before" knows its anxiety. resolved after a few minutes of sitting
No adverse event; expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered to patients).    The NDC ID was reported as 80777027398.  Person number was reported as Unknown.  No concomitant medications were reported.  Order date and completion date was reported as 26-May-2022.  The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022.  It was reported that also another past lot of vaccines with lot number 065F21A was also previously expired and administered to patients.  No treatment medications were reported.
Chest pain. Went to ER. Diagnosed with a heart attack.  10/13/09 ICD-Codes received: 788.50 Unspecified chest pain, 107.1 Subendocardial infarction, 414.01 Cornary atherosclerosis, 275.2 Disorder of magnesium metabolism, 276.8 Hypopotassemia, 281.9 Unspecified deficiency anemia, 272.4 Unspecified hyperlipemia, 564.1 Irritable bowel syndrome, 356.9 Peripheral neuropathy, 715.90 Osteoarthrosis, 305.1 Tobacco use disorder, V58.65 Long term use of steroids, V58.66 Long term use of aspirin, V45.82 Percutaneous transluminal coronary angioplasty status, V43.64 Hip joint replacement status.11/30/2009 MR and DC summary for 10/4-10/6/2009,  DC Dx Chest pain    patient admitted with chest pain, patient had cardaic cath after abnormal nuclear stress test.
Became short of breath and B/P and Pulse ox were taken.  Pulse Ox was 96%.  Benadryl 25mg was given at this time.  Continued to monitor when harsh cough developed.  EMS was contacted.  Client expressed not going in ambulance.  EMS arrived and evaled.  They encourage client to be transported to local ER.  Client declined and driver of car transported to ER where she was evaled and monitored Client was given another dose of Benadryl and a dose of Pepcid.  She was d/c to home with instructions
This spontaneous case reported by a physician (subsequently medically confirmed), describes the occurrence of influenza, diarrhea), hypersensitivity (mild reactions) and vaccination site pain (arm pain) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; unspecified dose. On an unknown date, patient experienced influenza, diarrhea, hypersensitivity (mild reactions) and vaccination site pain (arm pain). At the time of the report, influenza, diarrhea, hypersensitivity (mild reactions) and vaccination site pain (arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced severe joint pain of the hands, feet, shins, knees, shoulders, elbows, wrists, and palms, eye redness, blisters in the corner of the eye, cough, pin in the foot, pain with walking, tinnitus, stiffness, fatigue, reflux symptoms (nos), chest pain, eye twitching, cold intolerance, and activities of daily living impaired. The statement further alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive sequella of an autoimmune, immune-mediated, or other biological mechanism, all caused by vaccination with LYMERIX, including but not limited to those symptoms set forth above". At the time of reporting the outcome of the events was unspecified. Follow up information was received on 05 January 2009 via medical records. The subject received her first LYMERIX vaccine on 26 April 1999. She received her second LYMERIX vaccine in approximately September 1999 or October 1999, along with an influenza vaccine (unknown manufacturer). In March 2000, she developed episcerlitis with eye redness. On 05 May 2000, she complained of arthralgias and ongoing episcleritis. On 23 May 2000, she was evaluated for complaints of hand pain. A progress note dated 25 May 2000 indicated that the subject was diagnosed with sarcoidosis secondary to Lyme vaccine. Treatment included VIOXX. On 02 October 2000, she was evaluated for a five-day history of dry cough, aches, and fatigue, in addition to the sarcoid affecting her eye. Impression included upper respiratory infection, most likely viral. On 31 January 2002, she was seen by an allergy specialist who diagnosed cough and allergic rhinitis. According to a physician's note dated 18 March 2002, the subject had a history of questionable sarcoid secondary to Lyme vaccine, but was seen subsequently by a pulmonary consultant who did not feel that she had a sarcoid. Treatment included steroids and antibiotics. On 02 July 2003 she complained of chest pain, with a chest x-ray showing no acute pathology. On 11 July 2003, the subject was seen after presenting to the emergency room due to sudden onset of substernal chest pain that worsened with deep breathing. Treatment included Toradol, and she was diagnosed with costochondritis and was discharged. At the time of examination on 11 July 2003, the subject noted fatigue associated with Lupron injections to regulate her menstrual period. Impressions included 1) costochondritis, resolved, 2) probable viral illness, and 3) fatigue possibly secondary to Lupron. On 12 March 2007, she was evaluated for "incapacitating" tinnitus treated with steroids including prednisone. Other conditions included chronic episcleritis, synovitis, and leukocytosis. Methotrexate was prescribed at that time for treatment of autoimmune disease. She also continued to experience arthralgias.
A "weirdly annoying cloudy feeling"; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid. At the time of the report, FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medication, cholesterol medication and prostate medication.
Gave Hep-B pediatrics dose instead of Hep-B adult. 1/6/2023 at 11:35am Called patient back to let him know and never received a call back regarding the immunization.  No reaction from the patient.
BODY ACHES; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 PAIN (BODY ACHES) and FATIGUE (tired). At the time of the report, PAIN (BODY ACHES) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Patient received High dose vaccine and developed a rash on her left arm. Redness and itching.
Hives on legs 7 days, fever 102-103F 3 days, lack of appetite 4 days, lethargic 3 days, irritability for 5 days.
Initial unsolicited report received from nurse on 06-Nov-2017. This case involves four patients (age and gender not reported) who were vaccinated with a dose of QUADRACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patients experienced cellulitis. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Four patients experienced Cellulitis following vaccination with QUADRACEL VACCINE. Time to onset compatibility is unknown. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
booster; Swollen eyes; This is a spontaneous report from a contactable pharmacist.   A patient of an unspecified age and gender received BNT162B2 (Pfizer COVID-19 Vaccine Formulation: Solution For injection Batch/Lot Number: FH8020 Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. Patient previously received BNT162B2 (Pfizer COVID-19 Vaccine) on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Swollen eyes and she has given the vaccine for booster. The clinical outcome of the event was unknown.  Pharmacist was unwilling to complete the report. Further probing could not be done. Hence, limited information was available over the call.
Infant began flailing/self-stimming on 12-25-04. Infant stopped babbling, eating, was irritable, not cuddly, had disturbed sleep problems, and was diagnosed with autism spectrum on 8-10-05. Medical record states congenital muscle anomally. msv  Per annual follow-up: Encepholathy, speech and language regression, cognitive impairment, autism, global developmental delay, severe egg and peanut allergy, severe gastric intestinal issues.  Additional comments: Children should not be made to receive these shots. Parents should have informed consent .  Our twins received this vaccine at 6 months and just shy of 7 months. Follow-up: Patient still has dx of regressive encephalopathy w/ features of autism.
Patient received a 4th dose of Pfizer when requesting a flu shot. Patient does not complain of any adverse effects.
Dry barking cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry barking cough) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced COUGH (Dry barking cough). At the time of the report, COUGH (Dry barking cough) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.
a fever blister bigger than thumbnail; This is a spontaneous report from a contactable consumer (patients daughter) or other non hcp. An 85-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left (Guessing left upper arm near shoulder for both doses) on 13Jan2021 17:30 (at the age of 85-year-old) as 1st dose, 0.3 ml single and second dose via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL9263) as 2nd dose, 0.3 ml single for COVID -19 immunization. The patient medical history and concomitant medications were not reported. No medical history of previous immunizations was reported. It was reported that patient was on other medications (unspecified), but not related to the fever blister. It was reported that patient did great after first COVID shot. Patient did not receive any other vaccine within 4 weeks. Patient did not require to visit to emergency room or physician office for AES nor been prior vaccinated for AES. Patient did not have any family medical history. On 14Jan2021, the patient woke up with a fever blister bigger than thumbnail or cold sore on her lip after her first dose of vaccination. Patient had not a cold sore or fever blister in years. Reporter stated that this was something unusual; hoping she would not have it again tomorrow. She received her second dose almost an hour ago after physicians advised. Patient received Abreva (had no ndc/lot/exp to provide) as treatment for the event and fever blister was almost gone. She applied Abreva two to four times a day. Abreva controlled the fever blister. The skin was still a little irritated but takes time for it to smooth back over. Fever blister was no longer active. The scab part was gone. At the time of report, event outcome was resolving.    Follow-up attempts are completed. No further information is expected.
Bell's Palsy, L. side (peripheral)-face began to feel different; facial paralysis; ttp of L. face; L. side tongue taste is overall poor; endorses dry mouth; L face soreness; inability to fully close L. eye; This is a spontaneous report from a contactable physician and consumer. A 25-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included vitamin d deficiency and Pet dander allergy (possible pet dander allergy. no official allergies on record). The patient concomitant medications were not reported. Prior to vaccination, the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 reported as unknown. The patient experienced bell's palsy, l. side (peripheral)-face began to feel different, facial paralysis, l. side tongue taste is overall poor, endorses dry mouth, ttp of L. face, l face soreness and inability to fully close L. eye on May2021. The patient visits the emergency room and physician office for the adverse events. The ED gave patient prednisone 60mg QD 7 days of steroids and valacyclovir to which she was completed both medications and has experienced little to no improvement denies improvement with facial paralysis, just a slight improvement with taste and ability to drink and denies recent sick contacts and reports that she almost entirely works from home. The patient underwent lab tests and procedures which included physical examination: mouth droop is present along L. side, inability to smile along L. side, inability to furrow brow along L. side, slight drop of L. eyelid, diminished sensation of L. side of face on an unspecified date in 2021. The outcome of the event facial paralysis was not recovered, taste abnormality was recovering while unknown for another events.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events, Bell's palsy, Facial Paralysis, and Thrombotic Thrombocytopenic Purpura and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
nosebleed an low platelets- started one week after vaccine, came to ER on day 7 when bleeding wouldn't stop.
Extreme fatigue, extreme body and joint pain, joint swelling in shoulders, neck, knees, elbows, hair and weight loss, headache, vision. Patient also reports: difficulty concentrating. Swollen lymph nodes (removed: benign and a current working diagnosis of rheumatoid arthritis with neg. RA factor. Dose 2 given 2/26/01 (same lot number). Dose 3 given 5/2/03 (same lot number). 60 Day Follow Up: I have never recovered. I am not able to work and still under doctors care. Constant pain and fatigue in all joints, no sense of smell or taste, swelling of shoulders and knees. My life is far from what I used to be. Per annual follow up: I am very ill with so many symptoms and msucle and health problems that this event has pretty much taken my life and my families lives also. i dont know if any of us remember how to smile, I am now a chronic pain sufferer with other problems with vision, smell, nervous system, depression, extreme pain and fatigue. This has taken my life from me. Somedays I feel like I am just going to die. Because of being so sick and weak. The pain I have is unbearable.
Patient called complaining of swelling, pain and heat in an area below the injection site.  Patient said the area was in the middle of her upper arm and below where the vaccine was administered.  I advised patient to contact her primary care doctor, she was not comfortable going to the urgent care.  Patient was going to contact provider.
Pt noticed an itching sensation within a few minutes. Pt began noticing her tongue and throat feeling "funny - as if they were swelling" she took BENADRYL and it helped. After that she developed a large welt at where injection was given. Welt went away yet reappeared 72 hours later and was sore. Advised to inform her PCP.
Fever of over 101, chills, body aches.  Treated with OTC ibuprofen.  Symptoms resolved over the course of 48 hours
At the point of injection, I have a large (approx 2 inch) raised bumpy and kind of hard lump on my arm.  Sometimes it itches and it's warm.
Fever, sweating, blackouts 2times. Very weak and queasy for  a good 20 hours.  Stayed in bed with body aches and headaches .  Had small meal on Wednesday evening and slept better that night. Thursday and Friday still feeling weak, but much better.  Also a lump has appeared at the base of my neck  (left side).