chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Myalgia
Clinical narrative: PAIN IN JOINTS OF BOTH ARMS, BOTH KNEES, BOTH SHOULDERS; PAIN IN THE MUSCLES OF BOTH ARMS, BOTH SHOULDERS,  BOTH LEGS; This spontaneous report received from a parent concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced pain in joints of both arms, both knees, both shoulders. On MAY-2021, the patient experienced pain in the muscles of both arms, both shoulders, both legs. Laboratory data (dates unspecified) included: MRI (NR: not provided) INCONCLUSIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in joints of both arms, both knees, both shoulders, and pain in the muscles of both arms, both shoulders, both legs. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Blood glucose increased, COVID-19
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Malaise, Nausea, Pneumonia, Pyrexia
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood glucose increased, COVID-19, Chills, Cough
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Fatigue, Intensive care, Nausea
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation abnormal, Positive airway pressure therapy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: pt presented to ED with c/o fever, cough, nausea, SOB, chills, fatigue, weakness; blood glucose elevated; pt on antibiotics and steroids x 5 days after being seen @ urgent care; sx have worsened since then; PMH:  OSA, HIV; started on decadron, antibiotics, remdesivir; positive for COVID; O2 requirements worsened; tranferred to ICU; DNI; BiPAP use, eventually wanted to dc BiPAP and had CPAP brought from home to use; decided on hospice and pt was dc'd to home with hospice; pt died at home
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Patient reports experiencing "big, red welts or hives" on extremities and trunk the day after receiving shingles vaccine. Patient states she took "a dose of Benadryl and the hives went away". Patient also reports experiencing "positional dizziness", and is still experiencing some dizziness as on 12/22/2021.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dizziness postural, Erythema, Urticaria
Clinical narrative: Patient reports experiencing "big, red welts or hives" on extremities and trunk the day after receiving shingles vaccine. Patient states she took "a dose of Benadryl and the hives went away". Patient also reports experiencing "positional dizziness", and is still experiencing some dizziness as on 12/22/2021.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test negative
Clinical narrative: I experienced a normal reaction to my second dose of the vaccine on September 20'th, 2021. I had a sore arm for approximately one day. On Thursday, September 23'rd, 2021, after dinner I began having shortness of breath. I've never had shortness of breath before. Over the weekend (September 24 - September 26), my shortness of breath became worse over time. I began experiencing tightness and pain in my chest. On Monday, September 27'th, I contacted my general practitioner and was told to go to the emergency room with shortness of breath and pain in my chest. I went to an Urgent Care facility and they performed a rapid Covid test. I was negative for Covid 19.  The emergency room admitted me and recorded a blood pressure of 170 / 110. I have never had a history of high blood pressure. The emergency room did an EKG, blood work, and a chest X-Ray. They were all normal. They sent me home with a useless diagnosis of "nonspecific chest pain". I have never had chest pain in my life.   The next day my chest pain and shortness of breath continued to get worse. I called my doctor again and they were unable to schedule me for a visit. On Wednesday, September 29'th, I was told by my doctor to return to the emergency room as he was worried about my chest pain and shortness of breath.   On September 29'th, 2021, I went to the Emergency Room. My blood pressure was 180 / 100. They did an EKG, more blood work, and a chest CT. They found nothing. They asked if I had a history of anxiety. I do not. They suggested I visit a cardialogist.  On November 4'th, 2021, I had an echocardiogram performed by clinic. My echo showed a perfectly healthy heart, so I was diagnosed with pericarditis. I began taking NSAIDs and Colchicine. Over the next 6 weeks, I experienced the worst pain I've ever felt in my life. I was unable to care for my children, prepare food for myself, or do basic household tasks. I was unable to work. I was unable to drive.  I experienced adrenal surges, face numbness, painful moments of high blood pressure, disassociation, brain fog, and brainfog. But the worst was the unrelenting pain in my chest and the constant shortness of breath. I was unable to lean backwards or lie on my back without feeling dizzy and passing out.   Gradually, my pain began subsiding by around December 8'th. Over the next two weeks, my condition improved where I was able to work and drive again, though I still felt lightheaded (almost drunk), so I was apprehensive.  This week, I must have overexerted myself physically because my chest pain has returned for the past three days. It's as intense as it's ever been.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adrenal disorder, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: I experienced a normal reaction to my second dose of the vaccine on September 20'th, 2021. I had a sore arm for approximately one day. On Thursday, September 23'rd, 2021, after dinner I began having shortness of breath. I've never had shortness of breath before. Over the weekend (September 24 - September 26), my shortness of breath became worse over time. I began experiencing tightness and pain in my chest. On Monday, September 27'th, I contacted my general practitioner and was told to go to the emergency room with shortness of breath and pain in my chest. I went to an Urgent Care facility and they performed a rapid Covid test. I was negative for Covid 19.  The emergency room admitted me and recorded a blood pressure of 170 / 110. I have never had a history of high blood pressure. The emergency room did an EKG, blood work, and a chest X-Ray. They were all normal. They sent me home with a useless diagnosis of "nonspecific chest pain". I have never had chest pain in my life.   The next day my chest pain and shortness of breath continued to get worse. I called my doctor again and they were unable to schedule me for a visit. On Wednesday, September 29'th, I was told by my doctor to return to the emergency room as he was worried about my chest pain and shortness of breath.   On September 29'th, 2021, I went to the Emergency Room. My blood pressure was 180 / 100. They did an EKG, more blood work, and a chest CT. They found nothing. They asked if I had a history of anxiety. I do not. They suggested I visit a cardialogist.  On November 4'th, 2021, I had an echocardiogram performed by clinic. My echo showed a perfectly healthy heart, so I was diagnosed with pericarditis. I began taking NSAIDs and Colchicine. Over the next 6 weeks, I experienced the worst pain I've ever felt in my life. I was unable to care for my children, prepare food for myself, or do basic household tasks. I was unable to work. I was unable to drive.  I experienced adrenal surges, face numbness, painful moments of high blood pressure, disassociation, brain fog, and brainfog. But the worst was the unrelenting pain in my chest and the constant shortness of breath. I was unable to lean backwards or lie on my back without feeling dizzy and passing out.   Gradually, my pain began subsiding by around December 8'th. Over the next two weeks, my condition improved where I was able to work and drive again, though I still felt lightheaded (almost drunk), so I was apprehensive.  This week, I must have overexerted myself physically because my chest pain has returned for the past three days. It's as intense as it's ever been.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dissociation, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: I experienced a normal reaction to my second dose of the vaccine on September 20'th, 2021. I had a sore arm for approximately one day. On Thursday, September 23'rd, 2021, after dinner I began having shortness of breath. I've never had shortness of breath before. Over the weekend (September 24 - September 26), my shortness of breath became worse over time. I began experiencing tightness and pain in my chest. On Monday, September 27'th, I contacted my general practitioner and was told to go to the emergency room with shortness of breath and pain in my chest. I went to an Urgent Care facility and they performed a rapid Covid test. I was negative for Covid 19.  The emergency room admitted me and recorded a blood pressure of 170 / 110. I have never had a history of high blood pressure. The emergency room did an EKG, blood work, and a chest X-Ray. They were all normal. They sent me home with a useless diagnosis of "nonspecific chest pain". I have never had chest pain in my life.   The next day my chest pain and shortness of breath continued to get worse. I called my doctor again and they were unable to schedule me for a visit. On Wednesday, September 29'th, I was told by my doctor to return to the emergency room as he was worried about my chest pain and shortness of breath.   On September 29'th, 2021, I went to the Emergency Room. My blood pressure was 180 / 100. They did an EKG, more blood work, and a chest CT. They found nothing. They asked if I had a history of anxiety. I do not. They suggested I visit a cardialogist.  On November 4'th, 2021, I had an echocardiogram performed by clinic. My echo showed a perfectly healthy heart, so I was diagnosed with pericarditis. I began taking NSAIDs and Colchicine. Over the next 6 weeks, I experienced the worst pain I've ever felt in my life. I was unable to care for my children, prepare food for myself, or do basic household tasks. I was unable to work. I was unable to drive.  I experienced adrenal surges, face numbness, painful moments of high blood pressure, disassociation, brain fog, and brainfog. But the worst was the unrelenting pain in my chest and the constant shortness of breath. I was unable to lean backwards or lie on my back without feeling dizzy and passing out.   Gradually, my pain began subsiding by around December 8'th. Over the next two weeks, my condition improved where I was able to work and drive again, though I still felt lightheaded (almost drunk), so I was apprehensive.  This week, I must have overexerted myself physically because my chest pain has returned for the past three days. It's as intense as it's ever been.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypertension, Hypoaesthesia, Loss of personal independence in daily activities, Pain
Clinical narrative: I experienced a normal reaction to my second dose of the vaccine on September 20'th, 2021. I had a sore arm for approximately one day. On Thursday, September 23'rd, 2021, after dinner I began having shortness of breath. I've never had shortness of breath before. Over the weekend (September 24 - September 26), my shortness of breath became worse over time. I began experiencing tightness and pain in my chest. On Monday, September 27'th, I contacted my general practitioner and was told to go to the emergency room with shortness of breath and pain in my chest. I went to an Urgent Care facility and they performed a rapid Covid test. I was negative for Covid 19.  The emergency room admitted me and recorded a blood pressure of 170 / 110. I have never had a history of high blood pressure. The emergency room did an EKG, blood work, and a chest X-Ray. They were all normal. They sent me home with a useless diagnosis of "nonspecific chest pain". I have never had chest pain in my life.   The next day my chest pain and shortness of breath continued to get worse. I called my doctor again and they were unable to schedule me for a visit. On Wednesday, September 29'th, I was told by my doctor to return to the emergency room as he was worried about my chest pain and shortness of breath.   On September 29'th, 2021, I went to the Emergency Room. My blood pressure was 180 / 100. They did an EKG, more blood work, and a chest CT. They found nothing. They asked if I had a history of anxiety. I do not. They suggested I visit a cardialogist.  On November 4'th, 2021, I had an echocardiogram performed by clinic. My echo showed a perfectly healthy heart, so I was diagnosed with pericarditis. I began taking NSAIDs and Colchicine. Over the next 6 weeks, I experienced the worst pain I've ever felt in my life. I was unable to care for my children, prepare food for myself, or do basic household tasks. I was unable to work. I was unable to drive.  I experienced adrenal surges, face numbness, painful moments of high blood pressure, disassociation, brain fog, and brainfog. But the worst was the unrelenting pain in my chest and the constant shortness of breath. I was unable to lean backwards or lie on my back without feeling dizzy and passing out.   Gradually, my pain began subsiding by around December 8'th. Over the next two weeks, my condition improved where I was able to work and drive again, though I still felt lightheaded (almost drunk), so I was apprehensive.  This week, I must have overexerted myself physically because my chest pain has returned for the past three days. It's as intense as it's ever been.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pericarditis
Clinical narrative: I experienced a normal reaction to my second dose of the vaccine on September 20'th, 2021. I had a sore arm for approximately one day. On Thursday, September 23'rd, 2021, after dinner I began having shortness of breath. I've never had shortness of breath before. Over the weekend (September 24 - September 26), my shortness of breath became worse over time. I began experiencing tightness and pain in my chest. On Monday, September 27'th, I contacted my general practitioner and was told to go to the emergency room with shortness of breath and pain in my chest. I went to an Urgent Care facility and they performed a rapid Covid test. I was negative for Covid 19.  The emergency room admitted me and recorded a blood pressure of 170 / 110. I have never had a history of high blood pressure. The emergency room did an EKG, blood work, and a chest X-Ray. They were all normal. They sent me home with a useless diagnosis of "nonspecific chest pain". I have never had chest pain in my life.   The next day my chest pain and shortness of breath continued to get worse. I called my doctor again and they were unable to schedule me for a visit. On Wednesday, September 29'th, I was told by my doctor to return to the emergency room as he was worried about my chest pain and shortness of breath.   On September 29'th, 2021, I went to the Emergency Room. My blood pressure was 180 / 100. They did an EKG, more blood work, and a chest CT. They found nothing. They asked if I had a history of anxiety. I do not. They suggested I visit a cardialogist.  On November 4'th, 2021, I had an echocardiogram performed by clinic. My echo showed a perfectly healthy heart, so I was diagnosed with pericarditis. I began taking NSAIDs and Colchicine. Over the next 6 weeks, I experienced the worst pain I've ever felt in my life. I was unable to care for my children, prepare food for myself, or do basic household tasks. I was unable to work. I was unable to drive.  I experienced adrenal surges, face numbness, painful moments of high blood pressure, disassociation, brain fog, and brainfog. But the worst was the unrelenting pain in my chest and the constant shortness of breath. I was unable to lean backwards or lie on my back without feeling dizzy and passing out.   Gradually, my pain began subsiding by around December 8'th. Over the next two weeks, my condition improved where I was able to work and drive again, though I still felt lightheaded (almost drunk), so I was apprehensive.  This week, I must have overexerted myself physically because my chest pain has returned for the past three days. It's as intense as it's ever been.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: pains/Ache; slight fever; Booster; temperature excursion; temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 16Sep2021 19:00 (Lot number: 301308A) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis; "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Date: 17Feb2021, Lot Number: EL9266, Expiry Date: 31May2021, Route of Administration: Intramuscular , Anatomical Location: 0.3mL, Left arm), administration date: 17Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "pains", "aches", "slight fever"; Bnt162b2 (Dose: 2, Date: 10Mar2021, Lot Number / Expiry Date: EN6205/ 30Jun2021, Route of Administration: Intramuscular , Anatomical Location: 0.3mL, Left arm), administration date: 10Mar2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "pains", "aches", "slight fever". The following information was reported: IMMUNISATION (non-serious) with onset 16Sep2021 19:00, outcome "unknown", described as "Booster"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 16Sep2021, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Sep2021 19:00, outcome "unknown" and all described as "temperature excursion"; PAIN (non-serious), outcome "recovered", described as "pains/Ache"; PYREXIA (non-serious), outcome "recovered", described as "slight fever".  Additional information: The caller tried to do this online but was told it was too early and was concerned because they received a slight temperature, aches and pains with the vaccine and was concerned about having another vaccine. The caller confirms his wife also had pains, aches, and a slight fever, which she also had with the first two shots. When probed for outcome of the pains, aches, and slight fever, he confirms his wife's symptoms were gone in two days just like it was previously. He verifies the booster dose was given on 16Sep2021. He verifies his wife's Lot number was the same as his. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None; other than she takes injections with Enbrel every couple of weeks for her Rheumatoid Arthritis Complete only if a 3rd dose was administered, check one option: Other, please specify: Type II Diabetes. CVS called several days after vaccine and advised vaccine was exposed to colder than required temperature, please get booster revaccinated.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101588073 same reporter/drug/event, different pt
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt recently diagnosed with pna and leukocytosis in the nursing home; on levaquin and 2 L O2; family at first did not want any other intervention, then 2 days later decided to seek treatment; was brought to ED; PMH:  DM, metastatic lung CA; hypoxic (80% on 2 L of O2), EMS started pt on NRB @ 15 L; pt required intubation; began to worsen shortly after being intubated; O2 sats in 60s; heart rate began to drop; family decided on comfort care; pt died in the ED
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Endotracheal intubation, Heart rate decreased, Hypoxia, Leukocytosis
Clinical narrative: pt recently diagnosed with pna and leukocytosis in the nursing home; on levaquin and 2 L O2; family at first did not want any other intervention, then 2 days later decided to seek treatment; was brought to ED; PMH:  DM, metastatic lung CA; hypoxic (80% on 2 L of O2), EMS started pt on NRB @ 15 L; pt required intubation; began to worsen shortly after being intubated; O2 sats in 60s; heart rate began to drop; family decided on comfort care; pt died in the ED
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: pt recently diagnosed with pna and leukocytosis in the nursing home; on levaquin and 2 L O2; family at first did not want any other intervention, then 2 days later decided to seek treatment; was brought to ED; PMH:  DM, metastatic lung CA; hypoxic (80% on 2 L of O2), EMS started pt on NRB @ 15 L; pt required intubation; began to worsen shortly after being intubated; O2 sats in 60s; heart rate began to drop; family decided on comfort care; pt died in the ED
Age: 66.0
Sex: F
Vaccine: FLUX, FLUA4
Symptoms: Fatigue, Feeling abnormal, Parosmia, Rhinorrhoea, Swelling
Clinical narrative: This spontaneous case was retrieved on 06-Dec-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1819181-1), reported by other healthcare professional and concerned a 66-year-old, female patient. The patient's relevant medical history included thyroidectomy in 2020 due to follicular cancer. The patient's concurrent conditions included acid reflux, latex allergy and iodine allergy. The patient's concomitant medications included Synthyroid (Levothyroxine sodium), reported as thyroid medications due to thyroidectomy, and unspecified medications for acid reflux. The patient's historical vaccine included Moderna Covid 19 vaccine, it was not reported if the patient experienced any adverse reaction. On 25-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312842. On the same date, an unknown amount of time after receiving Fluad Quadrivalent, the patient had extreme exhaustion, brain fog, runny nose, smell burning odor, and feeling body was swollen. The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A 66-year-old female patient experienced foggy feeling in head, feeling of swollen body, fatigue, rhinorrhea and parosmia on the same day after vaccination with Fluad Quadrivalent. Causality for parosmia is assessed as not related due to biological implausibility. Causality for all other events is assessed as possibly related due to plausible temporal relationship.; Sender's Comments: A 66-year-old female patient experienced foggy feeling in head, feeling of swollen body, fatigue, rhinorrhea and parosmia on the same day after vaccination with Fluad Quadrivalent. Causality for parosmia is assessed as not related due to biological implausibility. Causality for all other events is assessed as possibly related due to plausible temporal relationship.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Colonoscopy, Culture, Discomfort, Endoscopy upper gastrointestinal tract
Clinical narrative: After 24 hours, I had numerous COVID-19 symptoms such as body aches, high fever, chills, headache and fatigue.  The COVID like symptoms lasted for 72 hours.  In 48 hours, I developed a small rash under my eye.  Then I developed mirrored vaginal ulcers.  It was extremely painful to urinate.  More ulcers developed on the labia and on the outside of my vagina.  The pain was unbearable when trying to urinate.  The ulcers began to fill with puss 72 hours later.  I called the doctor's office on Monday, August 23rd, and was seen and tested for all STI's and tested negative for all.  I was prescribed Valtrex (pending the results of the culture) and was also applying lidocaine to  my vaginal area so I could urinate. These vaginal ulcers lasted for one week and cleared up.   The mental anguish this caused was awful.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes virus test, Malaise, Pain, Pyrexia
Clinical narrative: After 24 hours, I had numerous COVID-19 symptoms such as body aches, high fever, chills, headache and fatigue.  The COVID like symptoms lasted for 72 hours.  In 48 hours, I developed a small rash under my eye.  Then I developed mirrored vaginal ulcers.  It was extremely painful to urinate.  More ulcers developed on the labia and on the outside of my vagina.  The pain was unbearable when trying to urinate.  The ulcers began to fill with puss 72 hours later.  I called the doctor's office on Monday, August 23rd, and was seen and tested for all STI's and tested negative for all.  I was prescribed Valtrex (pending the results of the culture) and was also applying lidocaine to  my vaginal area so I could urinate. These vaginal ulcers lasted for one week and cleared up.   The mental anguish this caused was awful.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Sexually transmitted disease test, Vaginal ulceration
Clinical narrative: After 24 hours, I had numerous COVID-19 symptoms such as body aches, high fever, chills, headache and fatigue.  The COVID like symptoms lasted for 72 hours.  In 48 hours, I developed a small rash under my eye.  Then I developed mirrored vaginal ulcers.  It was extremely painful to urinate.  More ulcers developed on the labia and on the outside of my vagina.  The pain was unbearable when trying to urinate.  The ulcers began to fill with puss 72 hours later.  I called the doctor's office on Monday, August 23rd, and was seen and tested for all STI's and tested negative for all.  I was prescribed Valtrex (pending the results of the culture) and was also applying lidocaine to  my vaginal area so I could urinate. These vaginal ulcers lasted for one week and cleared up.   The mental anguish this caused was awful.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eyelid rash, Fatigue, Headache, Pain
Clinical narrative: After 24 hours, I had numerous COVID-19 symptoms such as body aches, high fever, chills, headache and fatigue.  The COVID like symptoms lasted for 72 hours.  In 48 hours, I developed a small rash under my eye.  Then I developed mirrored vaginal ulcers.  It was extremely painful to urinate.  More ulcers developed on the labia and on the outside of my vagina.  The pain was unbearable when trying to urinate.  The ulcers began to fill with puss 72 hours later.  I called the doctor's office on Monday, August 23rd, and was seen and tested for all STI's and tested negative for all.  I was prescribed Valtrex (pending the results of the culture) and was also applying lidocaine to  my vaginal area so I could urinate. These vaginal ulcers lasted for one week and cleared up.   The mental anguish this caused was awful.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sexually transmitted disease test, Vaginal ulceration
Clinical narrative: After 24 hours, I had numerous COVID-19 symptoms such as body aches, high fever, chills, headache and fatigue.  The COVID like symptoms lasted for 72 hours.  In 48 hours, I developed a small rash under my eye.  Then I developed mirrored vaginal ulcers.  It was extremely painful to urinate.  More ulcers developed on the labia and on the outside of my vagina.  The pain was unbearable when trying to urinate.  The ulcers began to fill with puss 72 hours later.  I called the doctor's office on Monday, August 23rd, and was seen and tested for all STI's and tested negative for all.  I was prescribed Valtrex (pending the results of the culture) and was also applying lidocaine to  my vaginal area so I could urinate. These vaginal ulcers lasted for one week and cleared up.   The mental anguish this caused was awful.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Chest pain, Dizziness, Electrocardiogram normal, Facial pain
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fibrin D dimer normal, Full blood count normal, Headache, Heart rate increased
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Metabolic function test, Myocardial necrosis marker normal, Neck pain, Painful respiration
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test negative, Tenderness
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood glucose increased, Blood pressure increased, Blood test, Cardiac stress test
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Decreased appetite, Dyspnoea, Electrocardiogram
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Laboratory test
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Sensation of foreign body, Swelling, Tinnitus
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Chest pains, shortness of breath, joint pain, Ringing of the ears, Headaches some are intense, vision issues,  raised blood pressure, raised sugar, Fatigue ,loss of sleep, brain fog  arm swelling , throat swelling , lumps throat and under arms ,  no go or will to do much, loss of Appetit foods taste different . Best of my knowledge
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site rash, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I took the first dose of Moderna vaccine for COVID-19 at the Pharmacy. I did not have any of the usual symptoms associated with taking the vaccine, such as fever, body discomforts, etc. I have the usual pain associated with the shot at the injection site, according to what the person who gave me the shot said. I was also told that the pain would go away after several days.  However, the pain did not gat times it was so severe that it felt as if the needle was still in my arm. The pain is only at the injection site and hurts all of the time. If I hold a book, carry grocery bag of even hold on to the handles of the elliptical machine or trend mill for more than 5 minutes or more my hurts with stinging sharp pain, but only at the site of the injection, I have seen my PCP twice about this, he recommended warm compress to the area, I also it to reported it to the Pharmacy in November if I remember correctly.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: I took the first dose of Moderna vaccine for COVID-19 at the Pharmacy. I did not have any of the usual symptoms associated with taking the vaccine, such as fever, body discomforts, etc. I have the usual pain associated with the shot at the injection site, according to what the person who gave me the shot said. I was also told that the pain would go away after several days.  However, the pain did not gat times it was so severe that it felt as if the needle was still in my arm. The pain is only at the injection site and hurts all of the time. If I hold a book, carry grocery bag of even hold on to the handles of the elliptical machine or trend mill for more than 5 minutes or more my hurts with stinging sharp pain, but only at the site of the injection, I have seen my PCP twice about this, he recommended warm compress to the area, I also it to reported it to the Pharmacy in November if I remember correctly.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone decreased, Immunisation, Off label use, Vitamin D increased
Clinical narrative: my TSH blood test result in a low reading/her TSH was just a tad higher but much lower than usual; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid/cholesterol" (unspecified if ongoing); "thyroid/cholesterol" (unspecified if ongoing); "Known allergies: iodine contrast" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. do not know, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. do not know, Location of injection: Arm Left), administration date: Jan2021, when the patient was 72 years old, for Covid-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "Booster"; BLOOD THYROID STIMULATING HORMONE ABNORMAL (non-serious) with onset 08Nov2021, outcome "unknown", described as "my TSH blood test result in a low reading/her TSH was just a tad higher but much lower than usual". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood thyroid stimulating hormone abnormal.  Additional information: Patient did not have any bad reaction to your vaccines, she just wanted to ask a question. Here was what was going on. She had her first covid vaccine Jan2021 and the second 23Feb2021. She had the Booster (3rd) on 02Nov2021. She had the test done again on Monday, 25Nov2021. her TSH was just a tad higher but much lower than usual. Patient visit with her Endocrinologist was Friday, 19Nov2021 and she lowered my intake of meds by a very small margin and we will see if that was the culprit. She took 75 mcg a day and an extra 1/2 once a week. We just stopped the extra 1/2. All the other thyroid results were perfect- just the TSH was off. So, next blood draw (6 months) will be the "tell" Patient just wanted to know IF Pfizer had any ingredients in the vaccine that could possibly have been the reason-for my results to be different than for the past few years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone abnormal, Immunisation
Clinical narrative: my TSH blood test result in a low reading/her TSH was just a tad higher but much lower than usual; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid/cholesterol" (unspecified if ongoing); "thyroid/cholesterol" (unspecified if ongoing); "Known allergies: iodine contrast" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. do not know, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. do not know, Location of injection: Arm Left), administration date: Jan2021, when the patient was 72 years old, for Covid-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "Booster"; BLOOD THYROID STIMULATING HORMONE ABNORMAL (non-serious) with onset 08Nov2021, outcome "unknown", described as "my TSH blood test result in a low reading/her TSH was just a tad higher but much lower than usual". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood thyroid stimulating hormone abnormal.  Additional information: Patient did not have any bad reaction to your vaccines, she just wanted to ask a question. Here was what was going on. She had her first covid vaccine Jan2021 and the second 23Feb2021. She had the Booster (3rd) on 02Nov2021. She had the test done again on Monday, 25Nov2021. her TSH was just a tad higher but much lower than usual. Patient visit with her Endocrinologist was Friday, 19Nov2021 and she lowered my intake of meds by a very small margin and we will see if that was the culprit. She took 75 mcg a day and an extra 1/2 once a week. We just stopped the extra 1/2. All the other thyroid results were perfect- just the TSH was off. So, next blood draw (6 months) will be the "tell" Patient just wanted to know IF Pfizer had any ingredients in the vaccine that could possibly have been the reason-for my results to be different than for the past few years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: No additional AE or PQC reported; a patient received two doses of PNEUMOVAX 23; This spontaneous report was received from a pharmacy doctor and refers to a male patient of unknown age. There was no information regarding his medical history, concurrent conditions or concomitant therapies provided.  On 27-SEP-2021, the patient was vaccinated at a pharmacy with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 03-DEC-2021, at another pharmacy, he received the second dose of the vaccine (0.5 ml, lot # U018632, expiration date 11-JAN-2023; route of administration and anatomical location were not provided) (extra dose administered). No adverse event (AE) was reported.
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE or PQC reported; a patient received two doses of PNEUMOVAX 23; This spontaneous report was received from a pharmacy doctor and refers to a male patient of unknown age. There was no information regarding his medical history, concurrent conditions or concomitant therapies provided.  On 27-SEP-2021, the patient was vaccinated at a pharmacy with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 03-DEC-2021, at another pharmacy, he received the second dose of the vaccine (0.5 ml, lot # U018632, expiration date 11-JAN-2023; route of administration and anatomical location were not provided) (extra dose administered). No adverse event (AE) was reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 59-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm left, administration date Feb2021 (also reported as 02Feb2021) 13:00 (Lot number: EN5318) at the age of 59 years as dose 2, single for COVID-19 immunization at the nursing Home/Senior Living Facility. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication included: LOSARTAN. Vaccination history included: Bnt162b2 (dose 1 (lot number=EN5318) at 01:15PM administered on the right arm), administration date: Feb2021 (also reported as 23Feb2021-pending clarification), when the patient was 59 years old for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 10Mar2021 12:00, outcome "not recovered", described as "Skin rash on arms legs and buttocks. Buttocks has faded a bit". The event "skin rash on arms legs and buttocks. buttocks has faded a bit" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The patient had no other vaccine received in four weeks and no known allergies.   No follow-up attempts are possible. No further information is expected.