chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP. A 47-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 025A21A),  at the age of 47, intramuscularly, in left arm, on Mar 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced tinnitus (since the day she got the vaccine, she has experienced ringing in left ear), onset Mar 1, 2021, with outcome of not recovered; disturbance in attention, loss of personal independence in daily activities (she is not able to concentrate, affecting her quality of life); vomiting and tremor (transported to the hospital because she was throwing up and shaking violently), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures taken as a result of tinnitus, disturbance in attention, loss of personal independence in daily activities, vomiting and tremor. Additional information: The patient experienced possible adverse events after receiving the 1st dose of the vaccine on Mar 1, 2021 in left arm. The lot number for the vaccine is 025A21A; expiration date not provided. Caller stated since the day she got the vaccine, she has experienced  ringing in the ear. She experienced ringing in both ears but more particularly in left ear. Because of this ringing, she was not able to concentrate and affecting her quality of life. She has gotten  multiple tests done (MRI, scans etc.), but all are coming back normal. She has seen multiple doctors (including ENT as well, but no one can figure out what may be going on. Patient  transported to hospital twice via EMS but was not kept overnight. She was transported to the hospital because she was throwing up and shaking violently; not convulsing though. She was released from the hospital the same day. She was prescribed medications to alleviate the symptoms. She is taking low-dose aspirin, diazepam, gingko biloba, hydroxyzine, and OTC  supplements (flavonoid). The medications are not helping. The ringing in ear still ongoing. She also missed her second dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Tingling sensation in fingers of left arm and going up on arm; Two fingers are numb; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb). The patient was treated with CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation in fingers of left arm and going up on arm) and HYPOAESTHESIA (Two fingers are numb) outcome was unknown.            Concomitant medications were not provided.  Company Comment : This case concerns a 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68-year-old female with serious unexpected events of paraesthesia, and hypoaesthesia. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Baseball sized red hot spot at injection site showing up 1 day post vaccination. Sore, hot to touch, lump, with itching and pain.
Shoulder pain starting the next morning that worsened for the next few days then difficulty raising arm and pain as well. Has not improved since then.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced pain at the injection site the day of the vaccination. The area was sore till the time of reporting. When he turns his hand one way or the other, the pain was felt up his arm in the muscle where the injection was administered.
Submitting limited AE for possible deviation to the authorized vaccine schedule; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age 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.   In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule).    No concomitant medications were reported.     A nurse who works basically with the homeless population states that they have a young lady patient who got her 3rd and 4th shot on Oct and Dec-2022. They were asking if they were able to tell them from the lot numbers if these 2 doses were the bivalent or the monovalent. When agent requested for the lot numbers, HCP realized that they did not had them on hand.  No treatment medications were reported.   Reporter did not allow further contact
A non-serious spontaneous report of ADMINISTRATION OF FLUMIST TO A 60 YEAR OLD was received from a health professional concerning a 60 year old male subsequent to administration of FLUMIST.  Relevant medical history and concomitant medications were not reported.  On 31-Oct-2009, the patient received FLUMIST.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
ONE WEEK FOLLOWING 1ST INJECTION, PT DEVELPD SEVERE JOINT DISCOMFORT. HAD TROUBLE MAIPULATING HER HANDS AND GETTING OUT OF BED. HAD VOMITING AND DIARRHEA. 4-13-90 SYMPTOMS BEGAN DECREASING AND SHE IS IMPROVING.WILL NOT RECV MORE DOSES.
Gonarthrosis; Slept all day and night; Sick as a dog; Felt very Drained; Chills; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OSTEOARTHRITIS (Gonarthrosis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Non-tobacco user. Concomitant products included METHOTREXATE for Rheumatoid arthritis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced OSTEOARTHRITIS (Gonarthrotic) (seriousness criterion hospitalization), HYPERSOMNIA (Slept all day and night), ILLNESS (Sick as a dog), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Physical therapy (4 Physical therapy visits at home) for Osteoarthritis. At the time of the report, OSTEOARTHRITIS (Gonarthrotic), HYPERSOMNIA (Slept all day and night), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and ILLNESS (Sick as a dog) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything good. 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. Patient had knee replacement on 10-Feb-2021.  She had to stopped Humira two week prior and two week after surgery then she went back to every two weeks dose. The Nurse was sent for first three days at home and they changed her bandages than was give four physical therapy visits at home. She said Humira helped her knee replacement. Her rheumatoid arthritis was also in control with Humira and she was able to move again and live normal life. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: patient demographics updated, medical history updated, concomitant  medications updated (Methotrexate), Humira therapy details updated, event term updated (total knee replacement to Gonarthrotic), seriousness criteria updated from non-serious to hospitalization for the event Gonarthrotic.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
no adverse event; 1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.).    No concomitant medications were reported. The reporter doesn't have any patient information at this time. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2023: Non-significant follow up appended
Seizure (unwitnessed) with fever < 1 minute. Dad reports unconscious when he arrived. Taken to ER by ambulance. Post ictal <10 minutes. No further treatment. +family history of seizure in paternal uncle.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. It was reported that pain returned when dose was missed. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; INTENTIONAL PRODUCT MISUSE; OFF LABEL USE; This spontaneous report was received from literature.   This report concerned a 70 year old female of unspecified ethnicity. Initial information was processed along with additional information on 21-SEP-2021. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: ANCA (anti-neutrophil cytoplasmic antibody) type MPO (myeloperoxidase) associated vasculitis, and microscopic polyangiitis. The patient had no previous COVID-19 infection. The patient was previously treated with rituximab for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Patient did not required dialysis during periods of vaccination. Concomitant medications included unspecified steroids and cyclophosphamide for induction of immunosuppression. The patient was initially received 2 doses of the Pfizer vaccine (BNT162) for prophylactic vaccination and had not mount a humoral response for prophylactic vaccination.  On an unspecified date, the patient experienced suspected immunological vaccination failure, intentional product misuse and off label use. Laboratory data (dates unspecified) included: CD19 lymphocyte count abnormal (NR: not provided) less than 20 (0) cell/mL (percent), Estimated GFR (NR: not provided) 44 mL/min/{1.73_m2}, Protein urine (NR: not provided) 219 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) less than 1. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure, intentional product misuse and off label use was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182 and 20210935336. This report was associated with a product quality complaint: 90000194198.; Sender's Comments: V0-20210935307-covid-19 vaccine ad26.cov2.s -Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Reported warmth, redness and flushing of the facial cheeks and middle forehead with small, circular papules that appeared within 2 hours after vaccine administration. Denied SOB, itchiness, pain.
This spontaneous report as received from a nurse refers to a 10 months 15 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Complained of decreased sleep first evening following immunizations.  At 6:00 am on 3-23-05 Fever of 103 degrees F.  Complained redness at left arm site with pain and swelling of the elbow.  During the day, ear, neck and left side of face swollen.  Rx: Ibuprofen and decongestant. Then to school(EMT classes).  To ER that evening with continued complaint of face and neck swelling.  Complained of blood draining from left ear.  Received antibiotic shot, ear drops, Vicatin, and Flexeril, per client. Fever on and off with swelling of arm continued for 2 weeks through 1st week of April reports client.  MD(ENT) visit later with antibiotic and ear drops.  Occasional soreness continues at site in left arm.
4 days after my first vaccine I started to have numbness, pressure and tingling in my upper lip and lower face, which varies in how uncomfortable it is.  I have had sinus issue in the past and some previous issues with facial pressure, but this seems different.  I have not previously had this kind of pressure or numbness in my upper lip, lower face, unless I was having an allergic reaction to a medication
pt recv vax;9 days later,rash devel on torso,low grade fever&irritability;pox covering entire body;200+ pox on body,intense itching;pox faded w/in 60 days;
Called and left voicemail for patient.  Awaiting call back to see if she is experiencing any signs/symptoms.
bells palsy--initial cleared up after prednisone and valtrax  2nd episode of bells palsy after Moderna booster vaccine administered on November 19, 2021--unset of symptoms started Sunday, December 5, 2021--back on same medication, not fully recovered
This case was reported by a consumer via call center representative and described the occurrence of cough in a elderly female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, 14 days after receiving dTpa vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received TDAP booster dose about 8 weeks before the date of reporting in expectation of 2 new grandsons. The patient do not know if it was given intramuscular but said it was in the upper arm. She took no other medications. Two weeks after receiving the vaccine, she developed a cough which remained. The patient stated, one baby came early and was in neonatal intensive care unit (NICU) and there was no way they would let her in with the cough. The patient stated, the vaccine was supposed to kill the virus and asked what was up with this. The reporter would see the doctor the afternoon on the date of reporting and will try and get lot number, expiration date and other information. This case has been linked with case US2018176409, reported by the same reporter.
Patient stated had arm pain (whole arm) shortly after receiving vaccination. Patient was advised to use ice, Ibuprofen to help pain, primary doctor was contacted and pt was told to call if symptoms worsen. Patient called pharmacy again on 11/15 approximately 10 AM and stated arm was still sore where injection was given. Patient states can't lift her arm because too painful.
PSORIASIS LIKE FORMATIONS ALL OVER SKIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced psoriasis like formations all over skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis like formations all over skin. This report was non-serious.