chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of energy; Altered smell sensation; Sleep disturbance; gas; Naseau/Ongoing Naseau throughout the day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation), INSOMNIA (Sleep disturbance), FLATULENCE (gas) and NAUSEA (Naseau/Ongoing Naseau throughout the day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergy to penicillin), Drug allergy (Allergy to Aspirin), Allergy to antibiotic (Allergy to Erythromycin), Acid reflux (oesophageal) (acid reflux) and Drug allergy. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), LEVOCETIRIZINE for Blood pressure, PANTOPRAZOLE for an unknown indication.   On 15-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (Naseau/Ongoing Naseau throughout the day). On an unknown date, the patient experienced ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation) and INSOMNIA (Sleep disturbance). an unknown date, the patient experienced FLATULENCE (gas). At the time of the report, ASTHENIA (Loss of energy), PAROSMIA (Altered smell sensation) and INSOMNIA (Sleep disturbance) outcome was unknown and FLATULENCE (gas) and NAUSEA (Naseau/Ongoing Naseau throughout the day) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient ate smaller meals snack on pretzels, yogurt helps relieve the nausea along with gas. No Treatment medications were provided by the reporter.   This case was linked to MOD-2021-081368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow-up Appended.
shingles; Information has been received regarding a case in litigation involving a patient (pt) of unknown age and gender. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On an unknown date in 2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).  Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) use the pt suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not reported.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Still have a lump at the injection site and is becoming sore and hurts to touch again.
pt was seated when given vaccine. 15 sec after shot pt stated she could feel the pain from shot. within 5 sec pt past out. Pt was placed on exam table and placed in the supine position and feet were elevated. Pt was passed out for about 8-10 sec. Pt came back to and vitals were taken  BP 118/65  HR 76 was first set
Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy", notes: Allergy to: Morphine. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jul2022) Unknown results, notes: Rebound symptoms of COVID - return of dry cough, congestion, fatigue and headache 5 days after resolution. Had not completed antigen retest. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if patient received any other medication in 2 weeks. Known allergies to morphine. Other medical history reported as none. The patient received Paxlovid (route of administration: oral) as a treatment of COVID-19 from 18Jul2022 to 22Jul2022. After taking Paxlovid, Rebound symptoms of COVID - return of dry cough, congestion, fatigue and headache, 5 days after resolution. Had not completed antigen retest.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure and covid 19 cannot be ruled out.
SUSPECTED COVID-19 INFECTION; SWELLING OF FACE, EYES AND HANDS; AUDITORY AND VISUAL HALLUCINATIONS; This spontaneous report received from a health care professional via another pharmaceutical company (Pfizer) concerned a 47 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 in total was administered on JUL-2021 for covid-19 prophylaxis. Age at time of vaccination 46 years old. The batch number was not reported and has been requested. Concomitant medications included calcium and Omega 3 (fish oil) for an unknown indication. On an unspecified date, the patient experienced suspected covid-19 infection. The patient was treated with non-company, unspecified suspect drug from Pfizer (form of admin was not reported, route of admin: Oral, batch number: 094351012005 and expiry: Unknown) dose was not reported, administered with two doses 3 pills each from 18-JAN-2023 to 19-JAN-2023 for treatment of covid-19. On 18-JAN-2023:22:00 the patient experienced auditory and visual hallucinations, headaches, throat hurting, trouble breathing, SOB (Shortness of breath), chest hurting and swelling of face, eyes and hands. The patient denies any rash or perioral swelling. Swelling of face, eyes and hands were still present a little at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with unspecified non-company suspect drug was not reported. The patient was recovering from auditory and visual hallucinations, and swelling of face, eyes and hands, and the outcome of suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230162279- auditory and visual hallucinations. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
constant nausea; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 25Apr2021 at 15:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing thyroid disorder (states she has half a thyroid and was diagnosed with thyroid problems at age 11), diverticulum (2018 and ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced constant nausea on 25Apr2021. No treatment was received by the patient for the event. Caller states she was just curious about getting her 2nd shot of the Pfizer COVID vaccine and heard people say not to get the 2nd dose because it was dangerous and if she had the 1st one and she was freaking out because she is not feeling well. Outcome of the event was not recovered.  Follow-up (14May2021): This is a follow up spontaneous report from a contactable consumer.  No follow up attempt are needed: No further information is expected.
Pt was given IPV 0.5cc Right SQ and DTaP 0.5cc Left IM on 04/03/2003. Within 10 min, pt had hives and erythema at IPV injection site. Pt was given 25mg Benadryl. Redness and hives went down in 20 mins.
so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 28Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient had her first Pfizer COVID 19 vaccine on 28Mar2021 and her coworker tested positive so the patient went to get tested and was positive for COVID. The reporter stated that the patient was feeling much better now but she had the vaccine on 28Mar2021 and probably contracted COVID before the vaccine but tested positive after receiving the vaccine. The reporter stated the patient was scheduled for her second dose on 18Apr2021 and wondering if she can get the vaccine since she has had COVID in between the vaccines. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.
Suspected vaccination failure; shingles. Started in his/her month; Shingles pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: shingles. Started in his/her month) and pain (Verbatim: Shingles pain). The outcome of the vaccination failure was unknown and the outcome of the oral herpes zoster was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, oral herpes zoster and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, oral herpes zoster and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 This case was reported by consumer via interactive digital media. The patient had the vaccine, and still got shingles. Started in his/her month. Went down throat and on face. Terrible as patient was still in pain 2 months later. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a health professional concerning a 14 year old female who was vaccinated with Gardasil. On 29-NOV-2007 the patient experienced lymphadenopathy. The patient's outcome was not reported. Follow-up information has been received from a physician concerning a 13 year old (also reported as 14 year old) female with a penicillin allergy and allergic reaction to antibiotics with SEPTRA and CEFZIL who on 13-NOV-2006 was vaccinated with a first dose of Gardasil (lot# 653978/0955F) IM in the left arm. Concomitant therapy included Varivax. Other concomitant therapy included Hepatitis A virus vaccine (unspecified). On 05-DEC-2006, the patient came to the office. On 03-DEC-2006 the patient experienced swollen tender lymph nodes behind the left ear. The outcome was not reported. On 05-DEC-2006 Concomitant therapy included an infuenza virus vaccine (unspecified). On 15-JAN-2007 the patient was vaccinated with a second dose of Gardasil (lot# 654389/0961F) IM in the left arm. On 02-MAY-2007 the patient experienced swollen lymph nodes. On 02-MAY-2007 an ultrasound was performed to assess the mastoid area which showed redness and inflammation. The impression was there was a 1.6 x 0.8 x 1.0 cm lymph over the right mastoid. Otherwise normal soft tissue view over the mastoid area. The outcome was not reported. On 13-JUN-2007 the patient was vaccinated with a third dose of Gardasil (lot# 657868/0523U) IM in the left arm. On 13-JUN-2007 the patient was presented with lymph nodes in the cervical region. The patient had been treated for a cat scratch with improvement. The outcome was not reported. On 24-JUL-2007, the patient had a biopsy of the right mastoid lymph node and revealed lymph node with sclerosis and reactive features, no tumor was identified. A left check lymph node revealed reactive hyperplasia and no tumor was identified. Flow cytometry lymph node biopsy left cheek revealed no diagnostic lymphoid abnormality identified. No abnormalities of the B-lymphocytes are noted. No light chain restriction is noted on the CD+19 B-lymphocytes. On 04-SEP-2007 the patient experienced lymph nodes under the chin. On 14-SEP-2007 an ultrasound was performed to assess a palable lump. The impression was two sonolucent solid areas under the mandible presumed to be lymph nodes. On 03-DEC-2007, the patient was vaccinated with an influenza virus vaccine (unspecified) and hepatitis A vaccine (unspecified). On 03-DEC-2007, the patient complained of lymphadenopathy. On 10-DEC-2007 a complete blood cell count was performed and the results were normal. Cat scratch AB panel showed positive for bartonella henselae. Additional information is not expected.
On 11/13/12 patient reports hives around 8pm on buttocks, widespread large cluster then took 50 mg of BENADRYL and hives resolved. On 11/14/12 around 6 am hives erupted again in same location and same treatment repeated; hives resolved. She called MD, denied SOB, HA, respiratory distress, decreased HR. On 11/15/12 same episode (fewer hives) and treatment hives resolved.
Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination.     Medical history was not provided.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No Treatment medications were reported. No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non significant follow up appended
Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Caller received the COVID vaccine on the 18Dec and on the 20th she found out she was pregnant; Mild arm pain on left side; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female pregnant patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 16:24 at single dose, injected in left arm for covid-19 immunization. Additional vaccines administered on same date of the Pfizer suspect reported as none. Her dad had high blood pressure. Number of previous pregnancies was 1. Previous pregnancy was a chemical pregnancy that she found out on 29Jun2020. She had a miscarriage on 01Jul2020. At that time, her doctor told her it was a chemical pregnancy. The patient's other medical history reported as none. Concomitant medications included prenatals(unspecified). The patient received the covid vaccine on the 18Dec2020, and on the 20Dec2020 she found out she was pregnant. She first got pregnancy test on 20Dec2020, and retested at home on 21Dec2020. The second dose was due to be given on 08Jan2021, but received paperwork to register with Vsafe. She registered but was not pregnant at the time she registered. She had been giving text messages that she had been doing well. It did not talk about if you were pregnant or not after the first time. She had been taking prenatals for a year. Pregnant time reported as 20Dec2020 at 9:30-10 pm. First day of last menstrual period was 19Nov2020. Estimated date of Conception: Seemed like she ovulated on 15th and 16th of the month, so it would be after that. She was in her first trimester. The patient had arm pain an hour or two after injection. It was mild, then went a little higher and then she woke up with no pain. No emergency room or physician's office required. She had pain at the injection site for a few hours, like 6-7 hours, which was mild. She had had worse injection pain besides that such as the Flu Vaccine. They gave a pain that would stay for a day or 2. She would have to take ibuprofen or acetaminophen, but she did not require that with this one. It did not hamper her daily work. She did not have a lot or expiration for the previous flu vaccines that caused arm pain. Prior vaccinations (within 4 weeks) reported as none. Flu vaccine was before November. AE following prior vaccinations(Flu vaccine) was arm pain. The outcome of the event "Mild arm pain on left side" was recovering.   Information on the Lot/Batch number has been requested.   Follow-up (23Dec2020): New information received from a contactable consumer included patient's details(age, height, weight, last menstrual period), medical history, lab data, dosage regimen details of suspect vaccine, concomitant drug details, new event(Mild arm pain on left side).
Extreme fatigue, muscle/ joint pain. Unable to get out of bed for most of the day. I am still fatigued, it feels like having COVID again.
Narrative:  Patient received 1st covid vaccine Pfizer 8/27/21. He had no reported adverse effect after the 1st dose. He received the 2nd dose on 9/17/21 also Pfizer. He reported dyspnea that began 1-2 days after the 2nd dose of the vaccine. Per providers note: He completed his second round of Covid vaccine 2 weeks ago but prior to this after the vaccine within a day or 2 he began to experience mild dyspnea on exertion. He is a runner and works out regularly and notes this symptom on the higher end of exertion/exercise. This symptom amplified after the second dose. He is not dyspneic at rest. He has not noted any wheezing or cough or chest congestion per se no upper respiratory symptoms. No personal or family history of asthma, no fevers or chills or flulike constitutional symptoms. Presentation of hypersensitivity reaction to the vaccine. We discussed treatment course of upfront PFTs and chest x-ray versus as needed albuterol and revisit the issue of persisting at 6 to 8 weeks. If at any point there is any worsening or particular any acute worsening he should follow-up expeditiously with acute worsening in the ER with moderate worsening here in the office. He presented for follow up with provider on 12/29/21 at which time symptoms persist. Per providers 12/29/21 note: He does have some dyspnea at rest though fairly minor, it is more noticeable at exertion and to the point where he will typically take the elevator at work rather than going up the stairs. He does not have any chest pressure or chest sensation, there is no cough, wheezing audible, no sputum production. No palpitations. He has found initially the albuterol quite helpful in mitigating his dyspnea but less so recently. No leg swelling or calf swelling or pain. Onset of the symptoms is directly after second Covid vaccination suggesting hypersensitivity asthma reaction. Pulmonary embolus needs to be considered with persistence of symptoms will order additional studies to include chest x-ray, D-dimer, and pulmonary function testing. He will continue with the albuterol. At the point of this entry, the follow up testing has not occured. Patient has also NOT previously tested positive for COVID-19.
A report has been received from a Physician concerning a 9 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 23-Feb-2015. The patient experienced SORE THROAT and FEVER OF 102.F DEGREES which started on 25-Feb-2015. At the time of reporting, the event of SORE THROAT and FEVER OF 102 F DEGREES was ongoing. The report was considered to be non-serious.
COVID-19 vaccine (Janssen) administered during routine primary care provider outpatient visit. This vaccine product is only approved for use in patients over the age of 18 years old (patient is 13 years old). No adverse events noted in patient chart.