chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported.  On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare.  In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020.  The patient reported slight improvement after stopping tofacitinib citrate.  The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up.  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.
pain, erythema, induration of skin just below injection site extending for about 14 cm.
2OCT96 temp up 100;3OCT96 coughing;4OCT96 coughing, temp, green phlegm;5OCT96 SOB seen in ER & adm to hosp w/dx pneumonia;
Fells fabulous after getting the vaccine/has more energy/has less brain fog; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, 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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Fells fabulous after getting the vaccine/has more energy/has less brain fog) outcome was unknown.            Treatment medication was not provided.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had multiple outbreak of shingles, first as a teenager in the 1950's).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had an outbreak of shingles a total of 8 times, the first as a teenager in the 1950's diagnosed by their family doctor. The patient was told that it was an impossibility to have it as a teenager. The patient had both shots and had an outbreak after each shot. At the time of reporting, the patient was 80 years old and the patient was going through an outbreak. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were provided.
Pt recv vax on 1/25/99; on 1/27/99 pt exp fussiness, fever (103)
low-grade fever started about 24 hours after vaccinne Erythematous, papular rash just below injection site on left thigh where DTaP was injected
report side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (report side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Off-label use; Booster; Extreme whole body aches; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration on 05Oct2021 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), valsartan, amlodipine besilate (AMLODIPINE/VALSARTAN) and metoprolol (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263) via an unspecified route of administration on 21Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration on 30Jan2021, as a single dose for COVID-19 immunisation.  On an unknown date in Oct2021, the patient experienced extreme whole body aches, headache and chills. Therapeutic measures were not taken as a result of the event. The adverse 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. The clinical outcome of the events extreme whole body aches, headache and chills was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
tingling; Itchy; arm was sore; Fast heart rate; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN IN EXTREMITY (arm was sore), HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (tingling) and PRURITUS (Itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizzy). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and HEART RATE INCREASED (Fast heart rate). On 06-Feb-2021, the patient experienced PARAESTHESIA (tingling) and PRURITUS (Itchy). On 02-Feb-2021, DIZZINESS (dizzy) had resolved. On 04-Feb-2021, PAIN IN EXTREMITY (arm was sore) and HEART RATE INCREASED (Fast heart rate) had resolved. At the time of the report, PARAESTHESIA (tingling) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment for the event was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client reported having a history of syncopal episodes during prescreening questionnaire. Vaccination was given in a zero gravity chair. Immediately following COVID vaccination client experienced a loss of consciousness lasting less than 10 seconds. A set of vitals were taken : BP 110/59, HR: 47, RR 30, A&Ox4, skins clammy, warm and pale. Client complained of a slight headache rated 2/10. Denied any other symptoms such as chest pain, shortness of breath, dizziness or numbness/tingling in mouth, face or throat. At 1050 a second set of vitals taken : BP 100/64, HR: 53, RR 18 skins normal for ethnicity, warm and dry, A&Ox4. At 1105 client stated her headache was resolved. She stated her vitals were normal for her due to her athleticism. A final set of vitals taken: BP 102/64, HR: 47, RR 12 skins normal for ethnicity, warm and dry. Client left observation site on her own accord with a steady gait at approximately 1105.
The evening of the shot, fatigue headache muscle and joint paint chills nausea fever (100 degrees F) all occurred. rash began next day after shot along with inject site pain and swelling, swelling at lymph nodes. initial symptoms that began evening of the shot did not resolve until 7/11 AM. arm is still swollen/painful at injection site.
Within seconds (less than a minute) after receiving the injection, the patient had a syncopal episode, was unresponsive (prior to vaccination reported feeling fine, was alert, appropriately conversant).  She was lowered to the floor, BP 190/90, pulse 60's, respirations normal, pulse ox 96%, glucose 229.  After being lowered to the supine position she fairly quickly became responsive.  After a few minutes we tried to sit her up again, and again she became non-responsive.  We laid her back down, she again became responsive within less than a minute.  After a few more minutes we tried to sit her up again, she had another syncopal episode, again non-responsive.  We called for EMT transport to the hospital.
Intermittent severe abdominal pain and burping.  No abdominal distension,   Increased bowel movements to 5-6 day x 4 days.  Intermittent burping. Same reaction as I has to arimidex .
This was a medication error.  Dr administered 2nd dose of Pfizer vaccine to patient.  She inadvertently administered Pfizer 12+ formulation to this patient who was 11 years old (she had the incorrect DOB).  Additionally the vaccine was administered on day 18 after the 1st dose rather than on day 21.  No known adverse event(s) related to this error.
dementia diagnosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 58-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEMENTIA (medically significant), outcome "unknown", described as "dementia diagnosis".  Clinical course: Caller stated her 58-year-old daughter got a dementia diagnosis and got 2 shots of the Covid-19 vaccine within a 1-month period. Caller stated the doses were administered by 2 different doctors since her daughter has dementia and she forgot she received the first dose, caller stated it was not an error on the part of the medical advisor. Caller would like to know if there was something to look out for or are there any dangers?  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I experienced extremely bad chest pain on 01/19/2021 and went to ER. The doctor did not know the cause of my chest pains and referred to a Cardiologist upon releasing me from the hospital. I went to see the Cardiologist on 02/02/2021. All the est results came back normal (Echo-cardiogram and stress test). I continue to experience chest pain for a while after leaving the hospital.
Fussiness, sleeping more than usual. Temperature of 101.1 per ear probe thermometer this morning (03/03). Has been using Tylenol as directed by RN on day of vaccines (every 4-6 hours). Motrin given for fever which was up to 104 per ear probe. Child taken to hospital. Blood work, urine, and observation conducted.
arm is red (injection site); arm is swollen (injection site); A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site swollen and redness  The patient's medical history was not provided. Concomitant medications were not provided.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event injection site redness and swollen.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection site redness and swollen were  unknown.
Inflammation in face, mostly nose and cheeks, had itchy feeling inside nose, skin peeling on nose and lips
Severe (L) arm, shoulder, neck pain 2 days following injection. No redness or swelling present. Decreased ROM (L) am rt pain. No fever, chills, malaise.
Since receiving vaccines, has had red rash near vaccine site right arm.  Received on 02/03/04 or on 02/18/04.
Very painful joint pain in shoulder/Very painful joint pain in elbow; 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 ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow). At the time of the report, ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) outcome was unknown.            No concomitant medications were mentioned.  No treatment details were reported.  Patient had joint pain in elbow and shoulder for the first dose also
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA 7/9/2022 --  RECURRENCE OF SAME SYMPTOMS
Approximately 2 hours post vax client called complaint of shortness of breath and faint feeling. Advise call 911. Called client 4 hours later states taken by friend to Hospital, given shot of Benadryl told by MD reaction to Hep A.
Arm pain after injection; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 19-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient enquired, could he/she take ibuprofen for arm pain after Shingrix injection. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Redness at site of DTAP - swollen, zero s/sxm of cellulitus LL
Onset of blurred/distorted vision (October 2021) that progressively worsened to double vision (March 2022) within days of receiving vaccine and onset of atypical headache (started October 2021) surrounding the right eye radiating to R/ Temp/parietal area ranging from a 3-10 in pain scale. Additionally experienced hypertensive crisis, onset of SOB and Extreme fatigue about 6 weeks after vaccine resulting in a significant cardiac workup. Finally cleared cardiac.Headaches continued, vision worsened. After multiple providers not believing symptoms and a misread MRI, the finding of a carotid cavernous fistula was discovered.
This spontaneous report was received from a physician refers to a 50 years old female patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
I kept getting short of breath way more than normal.  The second day it started and just got worse.  Got into my dr on March1.  She did blood work and ordered chest xray.
Over 42 days for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over 42 days for the second dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, 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 (Over 42 days for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 42 days for the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Tingling in the arm
Right after taking the vaccine she stated she got a weird sensation over her body. She stated that that her throat started to feel like someone was choking her. The symptoms continued when she got home and she called her healthcare provider who instructed her to take Benadryl. She started vomiting and heart started was racing. The next day she had diarrhea and her blood pressure was elevated. Shortness of breath. She started to have impaired speech where she couldn't speak, her words had started to slur. Went to the ER she had a low grade fever, elevated pulse rate and blood pressure was high. Was given a treatment of steroids.
Started with itching of the scalp, neck, upper back, chest, and private area, then hives developed all over my body with severe itching with any kind of pressure, worse at night time; then dermatographia; swollen joints, stiffness and severe joint pain; stomach/digestion issues, bloating; eye infections, with white discharge, puffiness and itching.
Numbing on left side of face; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in arm right on 24Mar2021 at 12:00 (Age at vaccination 56 years) as single dose for COVID-19 immunisation. Medical history included high blood pressure. There was no concomitant medications. Patient did not had allergies to medications, food, or other products. On 26Mar2021 at 14:00, the patient experienced numbing on left side of face. Patient was not received treatment for event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient did not received any other medications within 2 weeks of vaccination. The clinical outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 102; Chills; Headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 13Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient has actually got the COVID Vaccine on 13Jan2021 at 3 PM. The patient had fever of 102, chills and a headache on an unspecified date with outcome of unknown.   Information on the batch/lot number has been requested.
Information has been received from a 61 year old female patient who in approximately June 2007, was vaccinated subcutaneously in the right arm with a dose of Zostavax (Oka/Merck).  On approximately 01-JUL-2007, "within the last 3 weeks" the patient developed a VZV like rash after vaccination.  Initially she experienced an injection site reaction with swelling, erythema and pruritus at the injection site.  Later, at an unspecified time interval, she developed spots (about 10-11 spots) on multiple areas of her body."  The patient reported that one of her spots was located on her ankle.  It was described as a red bump, nickel size with scab like center as if a blister had popped.  The patient sought unspecified medical attention.  The patient started treatment with Famvir.  The patient's outcome was reported as recovering.  There was no product quality complaint involved.  Additional information has been requested.