chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, rigors (no fever). Comorbidity: Pregnancy, HTN, DM type 2(insulin) H/O preeclampsia.
Feeling very tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On the last Thursday, the patient received Shingrix. Till the time of reporting, the patient was feeling very tired and the patient asked was this normal.
full on vertigo, I had it for two days to a week.; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (full on vertigo, I had it for two days to a week.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0032B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (full on vertigo, I had it for two days to a week.). At the time of the report, VERTIGO (full on vertigo, I had it for two days to a week.) had resolved.            No concomitant medications were reported.   The patient came down with full on vertigo, had never experienced it before. She had it for two days to a week. Took that long to get equilibrium  back.  No treatment information was provided.   This case was linked to MOD-2021-283110 (Patient Link).
Headache, Myalgia, Arthralgia,  fatigue, injection site pain  Narrative:
in 2019, the patient received the first dose / did not return within the recommended time frame to receive the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination not applicable for this report.   Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, patient received 1st dose of Shingrix on an unknown date in 2019. The healthcare professional ended up the chat before providing demographics and patient/vaccine information.
8 days after the vaccine I realized that I had been scratching my arm throughout the day and later realized it was the same location on my arm that the shot was received.  The area is swollen, very red, and has a temperature of 102.2 F (This was yesterday). I checked my forehead and do not have a fever. Today it?s the same. I also was extremely fatigued and slept for 4 hours throughout the afternoon.  Other than some tenderness the day after the shot I didn?t have side effects until yesterday. I?m only concerned because it?s been over a week and I?m just now getting these side effects.
Patient was just administered an expired vaccine and we noticed it a few minutes ago when entering the information into  our system.  Patient has not yet reported any adverse events and we will follow up with the manufacturer this week to verify the proper course of action moving forward.
2-3 minutes post vax, pt became pale and stated that she did not feel well. Pt was placed in a supine position with legs elevated. BP 104/60, pulse 82, resp 18 non-labored. Pt recovered in 15-20 minutes. Last BP taken 112/80, pulse 86, resp 18. Left health dept ambulatory.
Had interrupted sleep the entire time; Congestion; Bad cold; Sore throat; This spontaneous case was retrieved on 27-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1774802-1), reported by other non-healthcare professional and concerned an adult patient, of an unreported age and gender. The patient's medical history and concomitant medications were not reported. The patient had a flu shots for 25 years with no adverse event reported.On an unspecified date in 2021, reported as earlier this year, the patient was vaccinated with non-company co-suspect Covid 19 vaccine (brand not specified; indication, dose, route of administration, anatomical location: not reported). The batch number was not reported.On 22-Sep-2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported) for prophylactic vaccination. The batch number was not reported.On an unspecified date in 2021, reported as following friday, an unknown amount of time after receiving influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine, the patient developed sore throat, bad cold, congestion and had interrupted sleep the entire time. It was unknown if the patient experienced any additional symptoms or events.The details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of initial reporting, the patient had not recovered from all events. The reporter assessed the events as related to influenza virus vaccine polyvalent. The patient stated that got a flu shot for 25 years and never had this problem.The case was assessed as non-serious.Company comment: A patient was vaccinated with the suspect product influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine. Within one week the patient developed sore throat, nasopharyngitis, congestion and had interrupted sleep the entire time. Causality is confounded by concurrent administration of co-suspect vaccine. Causality for sleep disorder is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.; Reporter's Comments: The patient stated that got a flu shot for 25 years and never had this problem. Sender's Comments: A patient was vaccinated with the suspect product influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine. Within one week the patient developed sore throat, nasopharyngitis, congestion and had interrupted sleep the entire time. Causality is confounded by concurrent administration of co-suspect vaccine. Causality for sleep disorder is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.
Acute respiratory failure with hypoxia; COVID-19 virus infection; acute heart failure, unspecified; acute kidney injury; type 2 myocardial infarction
sinus symptoms; COVID-19; elbow problem; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus symptoms), ARTHROPATHY (elbow problem) and COVID-19 (COVID-19) in a 75-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. In August 2022, the patient experienced ARTHROPATHY (elbow problem). On an unknown date, the patient experienced SINUS DISORDER (sinus symptoms) and COVID-19 (COVID-19). At the time of the report, SINUS DISORDER (sinus symptoms) and ARTHROPATHY (elbow problem) outcome was unknown and COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events of sinus symptoms, elbow problem and COVID-19 was not provided. The reporter assessed events of sinus symptoms, elbow problem and COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  Company Comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of the mRNA-1273 vaccine and the co-suspect product Adalimumab, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was resolving. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of the mRNA-1273 vaccine and the co-suspect product Adalimumab, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was resolving. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Generalized moderate-severe pruritus - entire body.  No urticaria or clear rash.
One week following vaccination on left arm, developed left sided neck discomfort and swollen supraclavicular lymph nodes. Persistent 9 days later. no rash/bruising. no other systemic symptoms.
This case was reported by a medical assistant and described the occurrence of vasovagal response in a 10 year old female subject who was vaccinated with hepatitis A vaccine inactivated for prophylaxis. On 7/26/05, the subject received first dose of Havrix (lot number not specified). Concurrently at the same time, the subject also received an injection of polysaccharide typhoid vaccine. The medical assistant reported that after Havrix was given, the subject experienced vasovagal response and almost fainted. She was given juice and the events resolved. Shortly thereafter, on the same date, the subject felt nauseated and vomited. After leaving the physician's office, at an unspecified time later the same day, the subject experienced began experiencing abdominal pain. The subject's mother contacted the physician's office who advised her to return to the office for evaluation. This case was assessed as medically serious (OMIC). At the time of reporting the nausea, vomiting, and abdominal pain was unresolved.
This case was received from a health care professional on 30 July 2009. A 72-year-old male patient, with a history of codeine allergy, received an intramuscular left arm injection of ADACEL (lot number C3031AA) and an intramuscular right arm injection of PNEUMOVAX (Merck, lot number 1333X) on 22 April 2009. The patient was taking CRESTOR, triamterene, NIASTAN, hydrochlorothiazide, aspirin, METROGEL, ranitidine, ZETIA, colchicine, NORVASC, and metoprolol concomitantly (indications for use were not provided). In May 2009, the patient began complaining of knee pain. He subsequently developed numbness in the hands, and was seen in consultation by orthopedic and neurology specialists. On 22 June 2009 he was admitted to the hospital, and diagnosed with Guillain-Barre Syndrome. He remained hospitalized until 09 July 2009. No additional information was reported, and outcome was unknown. Of note, ADACEL is licensed for individuals up to 65 years of age, and this patient received the vaccine at the age of 71. This is also considered to be a medication error.
18 hrs p/vax pt broke out w/urticaria diffusly over body;
All of a sudden, I started to get these random pains. It would start in my right ankle, and it would be very painful for a couple of days then fade away. Then it would show up in my left knee and it was painful for a couple days then go to my right shoulder. Then it was in my right knee, left shoulder. Then right hip. It was moving around all over the place. My muscles were atrophying (muscle atrophy) primarily my legs and my arms starting with my left arm. General muscle weakness and my legs are now all skinny. So that was pretty much it. It would stop for a week then pick up somewhere else. Very painful for a few days then stop, then pick up some place again. That went on for several months until I started to seek medical help. I consulted with my PCP who suggested that I see a rheumatologist and a neurologist. Dr. is the rheumatologist, and she has been the most responsive. She started to treat me for rheumatoid arthritis and that was methotrexate. 2.5mg 6 tablets once a week. She also prescribed folic acid 1g daily to help with the biproduct of the methotrexate. Around the same time, the neurologist started me on baclofen 10mg twice daily. That seemed to stop the cycle of the pains of muscle atrophy. Dr. was concerned having me on the heavy-duty RA medication. She took me off of that and put me on prednisone 5mg once daily. She wants to get me off the prednisone but because of my history of lung problems, it was something that showed up in a CAT scan in my lungs. She had two medications that she was choosing between and now wanted input from my pulmonologist. They kept missing each other so now I'm pursuing that with my pulmonologist and getting another Cat scan there. Once I get that done, I will see him next month and we'll decide for what medication to put me on. The rheumatologist said they are confused as to what specifically I have. There is a general inflammation in my body that they have not pinpointed yet. They're looking for something that will calm down the inflammation. The medications have helped with the inflammation, but I still have the muscle weakness. During vacation recently, my left leg gave out on me 3 times and I fell during vacation. The medications have reduced the inflammation but they're not where they want me to be. I'm no longer on the methotrexate but I am still currently on prednisone.
After the pt's 1st dose of Lymerix, the pt had no untoward effects. 2 months post 2nd dose of vax, the pt experienced joint pain in his shoulders, knees, and fingers. No lab studies were performed. The symptoms are ongoing.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses ROTATEQ (lot #K010222 with expiration 12-JUN-2018;lot#/batch# was reported as K022986 with expiration date 22-JUL-2016;  dose, frequency and frequency were not reported) which has been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Blood pressure was low (74/33); This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was low (74/33)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOTENSION (Blood pressure was low (74/33)). On 14-Jan-2021, HYPOTENSION (Blood pressure was low (74/33)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 74/33 (Low) Low blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include Something for the thyroid and something for bone density.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up received on 08-Apr-2021 included no new information; Reporter's Comments: Based on the 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.
Mild headache and temp of 106.6 and went down to 99.5. muscle aches and fatigue.
After giving injection of Prevnar. Immun baby had an apnea episode lasting approximately 5 seconds. Color pale in appearance. Baby was stimulated after stimulation baby was alert and responding well. Reaction was immediately most likely secondary to pain of injection.
On 3/12/97, pt was vaccinated with MMR, DTP and HIB. On June 6, 1999 the pt experienced and itchy red rash over the entire body with fever of 104F and lesions all over body. The pt was dx'd with a full blown case of chickenpox in the ER. Lesions continued to break out over the next several days. She was exposed to varicella 18 days before the outbreak. On June 16, 1999 the pt experienced problems with her asthma. The pt was treated for otitis media. MD informed mother the rash was probably due to weed killer the family used. Recovered from sx on June 16, 1999 with the exception of the skin problem. She was seen by a physician for skin problem on 8/30/99.
Initial report received from a health care professional (nurse) on 21 May 2010: This patient was vaccinated with expired S-OIV FLUVIRIN, (batch no: 102142P1), (dose: 0.5 ml) intramuscularly on an unspecified date. No adverse reaction had occurred.
liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included one dose of acetaminophen 500mg and heating pad.  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; 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
This case was reported by a doctor of philosophy an described a patient who had a decreased antibody response to immunization with hepatitis b recombinant (Engerix B). The report has not been verified by a physician or other health care professional. On unspecified dates, the patient received an unspecified number of doses of Engerix B. Subsequently, on an unspecified date, a hepatitis B surface antibody titer was low titer.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.   A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2021 as dose 3 (booster), single (Lot number: FL 3197) at the age of 49 years, in left arm for covid-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 07Jan2021 as dose 1, single (Lot number: 025L20a) and on 01Feb2021 as dose 2, single (Lot number: 043L20a) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Dec2021, outcome "unknown", described as "vaccine brand other Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (06Sep2022) Negative; (09Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient did not received any other medication in 2 weeks. I completed 5-day course of Paxlovid, tested negative on 06Sep2022. Symptoms recur 08Sep2022 and tested positive again 09Sep2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded. Given the nature of the event of interchange of vaccine products, role of suspect product BNT162b2 cannot be assessed for it.