chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
I had a bad nose bleed for a few hours. I went to the ER and they put a clap on my nose and they ran some blood tests to make sure my blood pressure was fine. They diagnosed it as a nose bleed. This nose bleed would not stop.
Very red, swollen arm surrounding injection site, up to shoulder and down to elbow. ER measured at 10x10; doc office afternoon of Nov. 1 measured at 12x14.
Patient received J&J vaccine at 10:00am. At 10:05am patient complained of ringing of ears, fast heart rate, and dizziness. Pt was given water and advised to lie down for 15 minutes. Pt. felt immediate relief. However, pt still complained of a fast heart rate while other symptoms had been resolved. Pt was given a snack to assist with dizziness. Pt declined EMS services. Heart rate was taken at 10:30am and  was slightly elevated at 96bpm but still within normal range. At 10:37am patient said she felt better and a medical staff walked her to her car where her husband was waiting to take her home.
dizziness; cold sweats; stiff neck; vomiting; Sore arm first 24 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Aug2021 16:45 (Lot number: EW0186) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "kidney disease" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 20Jul2016 (ongoing); VITAMIN D NOS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "Sore arm first 24 hours"; DIZZINESS (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "dizziness"; COLD SWEAT (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "cold sweats"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "stiff neck"; VOMITING (non-serious) with onset 20Aug2021 15:00, outcome "not recovered", described as "vomiting". Therapeutic measures were not taken as a result of pain in extremity, dizziness, cold sweat, musculoskeletal stiffness, vomiting.  Additional Information: patient did not have Covid prior vaccination and did not tested post vaccination. patient did not have known allergies. AE outcome was recovered with sequelae. The event did not require the initiation of new medication/other treatment procedure.  No follow-up attempts are needed. No further information expected.
Fever, body aches, joint land bone pain, headache. Improved with antipyretics and sleep. This occurred in the evening, so I?m not sure how long symptoms would have lasted as I went to sleep. I woke up feeling just slight tired and sore.
patient received vaccine, sat on chair in front of pharmacy to begin 15min wait, about 2 or 3 min into the wait he became extremely dizzy,  he was in the middle of texting and it came on so fast he couldn't react, he passed out and fell out of his chair, hit the front top portion of his head and chipped a tooth, patient woke up within about 10 seconds, he was very sweaty, we were able to move him to the nearby clinical room to lay him on the floor, he was still very dizzy but stable and alert, an ambulance was declined by the patient and I felt it was not necessary, after about 10-20 min his color was getting better but each time he tried to sit up he remained very dizzy,  eventually family members came to take him home, he rested in our clinical room for over an hour before he felt he was able to walk to the car at which time he looked fine and his BP & glucose were within normal limits, he consulted with his physician the next day who referred him to get a scan due continued dizziness, results of scan are pending, aside from dizziness patient is feeling fine ---- of note patient has passed out when having blood drawn in the past
swollen lymph nodes; Muscle pain; chills; injection site pain; stiffness; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 10:30 (Lot number: 30145BA) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "swollen lymph nodes"; MYALGIA (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "Muscle pain"; CHILLS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "chills"; VACCINATION SITE PAIN (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "injection site pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "stiffness"; MALAISE (non-serious) with onset 11Oct2021 23:30, outcome "recovered" (Oct2021), described as "feeling unwell". Therapeutic measures were not taken as a result of lymphadenopathy, myalgia, chills, vaccination site pain, musculoskeletal stiffness, malaise.  Follow-up attempts are completed. No further information is expected.
ITCHING HEADACHE JOINT ACHES LARGE LUMP @ INJECTION SITE
got covid in Apr2022 after getting their booster shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got covid in Apr2022 after getting their booster shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 025L20A) for COVID-19 vaccination.     The patient did not had any allergies.  Concurrent medical conditions included Atrial fibrillation (several year).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (got covid in Apr2022 after getting their booster shot). At the time of the report, COVID-19 (got covid in Apr2022 after getting their booster shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication included heart medication that was not specified.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The event did not cause patient to seek medical care. The patient did not experienced a similar event in the past.  The patient received a monocluid antibody Bebteloviamab.  Company Comment: This spontaneous case concerns an 80-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 5 months after completion of mRNA-1273 as primary series vaccination and as first booster dose. Circumstances leading to the event and presenting symptoms were not provided in the case, although the patient mentioned this did not require her to be hospitalized. She was treated with Bebtelovimab and recovered from the event after an unknown duration. The patient's advanced age remains a confounder for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns an 80-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 5 months after completion of mRNA-1273 as primary series vaccination and as first booster dose. Circumstances leading to the event and presenting symptoms were not provided in the case, although the patient mentioned this did not require her to be hospitalized. She was treated with Bebtelovimab and recovered from the event after an unknown duration. The patient's advanced age remains a confounder for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report
Fever, rash on trunk, neck, face, arms, and legs. Toxic erythema. Supportive Rx.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid (Lot number: 1923798A) for COVID 19 treatment from 29Dec2022. No known allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  COVID 19, drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Patient states she was highly anxious about receiving flu vaccine. Later red, blotchy skin. Went to ED for treatment.
This spontaneous report received from a nurse regarding multiple patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD. Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 11 year old (also reported as 13 year old) female patient. On 10-JUN-2013, the patient was vaccinated with PROQUAD. This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
22JUL98 12PM fine rash started on face & has spread over body-itching started about a wk ago-spreading to eyes;also had some bumps all over body;not like the rash has now;c/o itching in roof of mouth;advised to see PMD;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient missed receiving a scheduled dose of RECOMBIVAX HB (unknown lot, unknown expiration date) "due to the product being on back order" (product quality issue). The patient was scheduled to receive the 2nd Dose of RECOMBIVAX HB on 14-AUG-2017. No adverse effects reported.
Patient admitted to the hospital 3/22-3/28 and 4/3-4/11 for severe Covid-19 pneumonia, after completing vaccine series with Moderna 1/18/2021 and 2/15/2021
Narrative:  73yo male with h/o substance abuse, mental health issues & legal problems was found deceased at his home on 8/2/21. Pt had covid vaccines on 3/15/21 and 4/13/2021. Likely covid vaccines not related to pt's death.
I'm having facial spasms under my Right eye. The muscle on the right side of  my  face is  twitching  involuntarily. It started around 7am this morning and has continued all morning. It's now after 12:30 PM cst.
Information has been received from a Licensed Practical Nurse concerning a 71 year old male with diabetes mellitus insulin-dependent, former cigarette smoker and penicillin allergy and a history of prostate cancer who on 27-OCT-2009 was vaccinated with a dose PNEUMOVAX 23 (lot # 662874/1125X) 0.5ml, intramuscularly into right arm. Concomitant therapy included LIDODERM, hydrocodone, citalopram, metformin, metoprolol, PRILOSEC, pravastatin NA, NORVASC and Diazepam. On 27-OCT-2009 the patient experienced swelling, redness, warmth, pain and tenderness of the right arm, violent chills and he was very weak. He treated himself with TYLENOL and ice. He was examined in the office on 29-OCT-2009. The affected area on his right arm by injection site was 10-12 cm in size. The patient's entire right arm was tender and he had fever 100.1 F. He was treated with cool compresses, TYLENOL, BENADRYL and prednisone. At the time on the report on 29-OCT-2009 the patient had not recovered. There were no laboratory diagnostics studies performed. Follow up information was received from the Licensed Practical Nurse who indicated that the patient was a retired male who on 27-OCT-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 662874/1125X) into his right arm at 09:07 AM. According to the practical nurse, the patient developed redness, swelling and warmth of the right upper arm post injection of PNEUMOVAX 23 without relief of symptoms with ice and TYLNEOL, prednisone to reduce inflammation. The patient sought medical attention by a doctor visit. The patient recovered on 30-OCT-2009. No further information is expected.
On right upper leg (thigh) pt's leg at site of Varicella was a vesicular rash.  Tiny area of firm tissue at site of Hib.
Feeling unwell; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 52-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 Ankylosing spondylitis.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third 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 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) outcome was unknown and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information provided. No treatment medication information provided.  Company comment: This spontaneous case concerns a 52 years old female patient, with no medical history reported, who experienced the unexpected non serious AESI event SARS Cov2 test positive. Additionally non serious event malaise is also reported. Event SARS Cov2 test positive occurred 5 months 20 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 24-May-2022.  The current pandemic situation of COVID 19 may remain as confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52 years old female patient, with no medical history reported, who experienced the unexpected non serious AESI event SARS Cov2 test positive. Additionally non serious event malaise is also reported. Event SARS Cov2 test positive occurred 5 months 20 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 24-May-2022.  The current pandemic situation of COVID 19 may remain as confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Soreness in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in the muscle) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness in the muscle). At the time of the report, MYALGIA (Soreness in the muscle) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient stated that soreness in the muscle went away in a day or two.  It was reported that the patient was not on any concomitant medication and had not taken any treatment.   This case was linked to MOD-2021-424520, MOD-2021-424521 (Patient Link).
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. No information about the patient´s medical history, concomitant medications or concurrent conditions was provided. On 07-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M033219, expiration date 18-AUG-2017), for prophylaxis (dose, frequency and route were not provided).  Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved.
Soreness in arms after each dose; This case was reported by a consumer and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR156695   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient shared that, she received her Shingrix vaccine back in the summer of 2020 and she did not remember the exact month. The patient experienced soreness in her arm after injection in 2020. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR156695; Sender's Comments:  US-GSK-US2022AMR156695:Same reporter
Patient had warm red sensation around injection site that spread to most of upper arm. Prescribed Medrol dose pack and BACTRIM DS.
Information has been received from a physician concerning a 19 year old female American Indian who was vaccinated with a 1st, 2nd and 3rd dose of MMR on 7/11/80, 8/22/91 and 6/17/97, respectively and on 7/13/99 and 7/31/99, the pt's rubeola antibody titers were negative. On 7/13/99, the pt's rubella antibody titers were positive. The reporter had a concern with the lot # of the last dose of MMR.
recently discovered she did not have antibodies to measles.; This spontaneous report was received from a 42-year-old female patient referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (when she was a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, dose of 0.5 milliliter (strength, anatomical location, route of administration, lot # and expiration date were not reported) as prophylaxis. On an unknown date (recently), the patient discovered she did not have antibodies to measles (measles antibody negative). She stated she did have antibodies to mumps and rubella. The outcome of the event was unknown. There was not any treatment given for the event and the patient did not seek medical attention.  The causality assessment was not provided.
Pt mentioned that she experienced a metallic taste within a few minutes after vaccine administration. Symptom didn't resolve until late at night, about 7 hours later.
I had chills for about two hours after the vaccine. I attended a wedding and was exposed to COVID-19. I tested positive in 01/2023. I had a stuffy head, and I had a telehealth visit with my doctor. I got a prescription for PAXLOVID. I tolerated the medication, and the only complaint is the metallic taste. As of today, I am feeling better with no lingering symptoms.