chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Crying, Dyspnoea, Feeding disorder, Feeling of body temperature change, Headache
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Joint stiffness, Lymph node pain, Memory impairment, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Photophobia, Seizure, Sensory disturbance, Speech disorder, Suicidal ideation
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Temperature regulation disorder, Throat tightness
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest discomfort, Consciousness fluctuating, Cough, Dizziness
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Fatigue, Gait inability, Head discomfort
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hyperacusis, Joint stiffness, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Photophobia, Seizure, Spinal pain, Tremor
Clinical narrative: As reported, "I had no reaction within the 15 minutes observation time, then I left. I went on a short hike and felt completely normal. By 10:30 that night I started suddenly convulsing, not shivers. I couldn't walk, couldn't drink and was shaking wildly. My roommate was home but I did not signal for help. As I was convulsing, I felt chest pressure and short of breath, like I could not breathe enough, felt like I was passing out, in and out of consciousness. Obviously my joints were stiff, muscles were really stiff. My head, the only way to describe it is as if my brain matter was pressing out in all directions. I couldn't tell the difference between convulsions, muscle tightness in my neck and back. I was in and out of consciousness. I remember waking up and looking at my phone to see it was 10 am the next morning. For the next couple of days my head was the worst pain I have felt in my life. I felt like my head wanting to leave my skull. That pain stayed and the short of breath up until last night (11/10/21). I couldn't catch a full breath, it was hard to breathe, there wsa weight on my chest like what people describe when they get COVID, that's what I felt. The coughing was not severe, it was light. Lights and sounds because my head hurt so much. My working memory wasn't functioning at normal capacity, I could not recall basic things. One minute I was thinking I'm okay, the next minute thinking, what's going on, like a complete loss. I became really dizzy each time I lost my breath. Yesterday not an exception I felt memory loss, headache, dizzy, fatigue, short of breath all happening. Last night while I was trying to take a deep breath starting on right side of spine I felt sensations like firecrackers  going off up and down my spine rapidly. Then right to left that pain repeatedly went up and down my spine. Exploding pain on both sides with an up and down movement, not stationary. I have since been to the Emergency Room. I do not have a primary care physician."
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Cardiac disorder, Chest X-ray normal, Chest pain
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 61-year-old male. The patient's height, and weight were not reported. The patient's past medical history included unspecified broken bone, and concurrent conditions included: gout, acid reflux, hypertension, poison ivy allergy, alcohol user (couple of beers a night, but not since symptom onset), and cigar smoker (infrequent Cigar smoking). The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 01 total administered on 29-OCT-2021 for prophylactic vaccination into left arm. No concomitant medications were reported.  On 09-NOV-2021, the patient noticed he became short of breath while walking to his mailbox. On 10-NOV-2021, the patient experienced chest pain that felt like his chest would explode. On 11-NOV-2021, the patient contacted his general practitioner and Computerised tomogram (CT) scan (NR: not provided), Chest X-ray (NR: not provided), Electrocardiogram (EKG) (NR: not provided) were ordered and resulted in diagnosis of Pulmonary Embolism. He went to the Hospital emergency room (ER) and was subsequently admitted for pulmonary embolism/blood clots in his lungs. On 12-NOV-2021, the patient was discharged from the hospital with blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133711-Covid-19 vaccine ad26.cov2.s- pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea exertional, Echocardiogram, Electrocardiogram normal, Enzyme abnormality
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 61-year-old male. The patient's height, and weight were not reported. The patient's past medical history included unspecified broken bone, and concurrent conditions included: gout, acid reflux, hypertension, poison ivy allergy, alcohol user (couple of beers a night, but not since symptom onset), and cigar smoker (infrequent Cigar smoking). The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 01 total administered on 29-OCT-2021 for prophylactic vaccination into left arm. No concomitant medications were reported.  On 09-NOV-2021, the patient noticed he became short of breath while walking to his mailbox. On 10-NOV-2021, the patient experienced chest pain that felt like his chest would explode. On 11-NOV-2021, the patient contacted his general practitioner and Computerised tomogram (CT) scan (NR: not provided), Chest X-ray (NR: not provided), Electrocardiogram (EKG) (NR: not provided) were ordered and resulted in diagnosis of Pulmonary Embolism. He went to the Hospital emergency room (ER) and was subsequently admitted for pulmonary embolism/blood clots in his lungs. On 12-NOV-2021, the patient was discharged from the hospital with blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133711-Covid-19 vaccine ad26.cov2.s- pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Obstruction, Pulmonary embolism, Suspected COVID-19, Ultrasound Doppler
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 61-year-old male. The patient's height, and weight were not reported. The patient's past medical history included unspecified broken bone, and concurrent conditions included: gout, acid reflux, hypertension, poison ivy allergy, alcohol user (couple of beers a night, but not since symptom onset), and cigar smoker (infrequent Cigar smoking). The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 01 total administered on 29-OCT-2021 for prophylactic vaccination into left arm. No concomitant medications were reported.  On 09-NOV-2021, the patient noticed he became short of breath while walking to his mailbox. On 10-NOV-2021, the patient experienced chest pain that felt like his chest would explode. On 11-NOV-2021, the patient contacted his general practitioner and Computerised tomogram (CT) scan (NR: not provided), Chest X-ray (NR: not provided), Electrocardiogram (EKG) (NR: not provided) were ordered and resulted in diagnosis of Pulmonary Embolism. He went to the Hospital emergency room (ER) and was subsequently admitted for pulmonary embolism/blood clots in his lungs. On 12-NOV-2021, the patient was discharged from the hospital with blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133711-Covid-19 vaccine ad26.cov2.s- pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 61-year-old male. The patient's height, and weight were not reported. The patient's past medical history included unspecified broken bone, and concurrent conditions included: gout, acid reflux, hypertension, poison ivy allergy, alcohol user (couple of beers a night, but not since symptom onset), and cigar smoker (infrequent Cigar smoking). The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 01 total administered on 29-OCT-2021 for prophylactic vaccination into left arm. No concomitant medications were reported.  On 09-NOV-2021, the patient noticed he became short of breath while walking to his mailbox. On 10-NOV-2021, the patient experienced chest pain that felt like his chest would explode. On 11-NOV-2021, the patient contacted his general practitioner and Computerised tomogram (CT) scan (NR: not provided), Chest X-ray (NR: not provided), Electrocardiogram (EKG) (NR: not provided) were ordered and resulted in diagnosis of Pulmonary Embolism. He went to the Hospital emergency room (ER) and was subsequently admitted for pulmonary embolism/blood clots in his lungs. On 12-NOV-2021, the patient was discharged from the hospital with blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133711-Covid-19 vaccine ad26.cov2.s- pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Lymphadenopathy, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the left arm on 09Nov2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was allergic to sulpha meds and cephalosporins. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included VITAMIN C for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received ASPIRIN and experienced drug allergy. On 09Nov2021 at 15:00, the patient experienced discomfort in the left arm and swollen feeling in the armpit. On 09Nov2021 at 20:00, the patient experienced 101.5 fever and swollen lymph nodes underneath left arm. On 10Nov2021, the patient experienced 103.5 fever, lymph nodes very swollen, muscle ache, headache, and nausea. On 11Nov2021, the patient experienced fever 101.5, lymph nodes very swollen, headache, nausea, and body aches. On 12Nov2021, the patient did not have fever but the lymph nodes were swollen and had headache. On 13Nov2021 and 14Nov2021, the patient experienced lymph node swollen and on 15Nov2021, the lymph nodes were still swollen. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. On 09Nov2021, 10Nov2021, and 11Nov2021, the patient underwent body temperature tests and the result was 101.5 (unspecified units), 103.5 (unspecified units), and 101.5 (unspecified units) respectively. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 12Nov2021, discomfort in the left arm and swollen feeling in the armpit, swollen lymph nodes underneath left arm, swollen lymph nodes, lymph nodes were still swollen, headache, nausea, ache, and muscle ache were not resolved at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the left arm on 09Nov2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was allergic to sulpha meds and cephalosporins. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included VITAMIN C for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received ASPIRIN and experienced drug allergy. On 09Nov2021 at 15:00, the patient experienced discomfort in the left arm and swollen feeling in the armpit. On 09Nov2021 at 20:00, the patient experienced 101.5 fever and swollen lymph nodes underneath left arm. On 10Nov2021, the patient experienced 103.5 fever, lymph nodes very swollen, muscle ache, headache, and nausea. On 11Nov2021, the patient experienced fever 101.5, lymph nodes very swollen, headache, nausea, and body aches. On 12Nov2021, the patient did not have fever but the lymph nodes were swollen and had headache. On 13Nov2021 and 14Nov2021, the patient experienced lymph node swollen and on 15Nov2021, the lymph nodes were still swollen. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. On 09Nov2021, 10Nov2021, and 11Nov2021, the patient underwent body temperature tests and the result was 101.5 (unspecified units), 103.5 (unspecified units), and 101.5 (unspecified units) respectively. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 12Nov2021, discomfort in the left arm and swollen feeling in the armpit, swollen lymph nodes underneath left arm, swollen lymph nodes, lymph nodes were still swollen, headache, nausea, ache, and muscle ache were not resolved at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Limb discomfort, Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the left arm on 09Nov2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was allergic to sulpha meds and cephalosporins. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included VITAMIN C for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received ASPIRIN and experienced drug allergy. On 09Nov2021 at 15:00, the patient experienced discomfort in the left arm and swollen feeling in the armpit. On 09Nov2021 at 20:00, the patient experienced 101.5 fever and swollen lymph nodes underneath left arm. On 10Nov2021, the patient experienced 103.5 fever, lymph nodes very swollen, muscle ache, headache, and nausea. On 11Nov2021, the patient experienced fever 101.5, lymph nodes very swollen, headache, nausea, and body aches. On 12Nov2021, the patient did not have fever but the lymph nodes were swollen and had headache. On 13Nov2021 and 14Nov2021, the patient experienced lymph node swollen and on 15Nov2021, the lymph nodes were still swollen. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. On 09Nov2021, 10Nov2021, and 11Nov2021, the patient underwent body temperature tests and the result was 101.5 (unspecified units), 103.5 (unspecified units), and 101.5 (unspecified units) respectively. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 12Nov2021, discomfort in the left arm and swollen feeling in the armpit, swollen lymph nodes underneath left arm, swollen lymph nodes, lymph nodes were still swollen, headache, nausea, ache, and muscle ache were not resolved at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 33026BD) via an unspecified route of administration in the left arm on 09Nov2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient was allergic to sulpha meds and cephalosporins. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included VITAMIN C for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received ASPIRIN and experienced drug allergy. On 09Nov2021 at 15:00, the patient experienced discomfort in the left arm and swollen feeling in the armpit. On 09Nov2021 at 20:00, the patient experienced 101.5 fever and swollen lymph nodes underneath left arm. On 10Nov2021, the patient experienced 103.5 fever, lymph nodes very swollen, muscle ache, headache, and nausea. On 11Nov2021, the patient experienced fever 101.5, lymph nodes very swollen, headache, nausea, and body aches. On 12Nov2021, the patient did not have fever but the lymph nodes were swollen and had headache. On 13Nov2021 and 14Nov2021, the patient experienced lymph node swollen and on 15Nov2021, the lymph nodes were still swollen. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. On 09Nov2021, 10Nov2021, and 11Nov2021, the patient underwent body temperature tests and the result was 101.5 (unspecified units), 103.5 (unspecified units), and 101.5 (unspecified units) respectively. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 12Nov2021, discomfort in the left arm and swollen feeling in the armpit, swollen lymph nodes underneath left arm, swollen lymph nodes, lymph nodes were still swollen, headache, nausea, ache, and muscle ache were not resolved at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: I received the vaccine in the morning on Thursday about 0905. I went to bed that night and woke up with chills but no fever; Muscle aches over a good portion of my body; A sore left arm; Splitting headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 11Nov2021 at 09:05 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 21Oct2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient received the vaccine in the morning about 09:05. He went to bed that night and woke up with chills but no fever, muscle aches over a good portion of his body, a sore left arm and a splitting headache. The totality of it lasted until sometime on 13Nov2021 morning with each symptom rising and falling at varying levels throughout that time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events he received the vaccine in the morning on 11Nov2021 about 09:05, he went to bed that night and woke up with chills but no fever, muscle aches over a good portion of his body, a sore left arm and a splitting headache was resolved on 13Nov2021.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Infection, Injection site pain, Injection site swelling
Clinical narrative: Booster given in left arm  above elbow.  Next morning upon waking left lower arm swollen red and hot to touch.    Redness continued to enlarge become darker as days passed requiring doctor visit 2 days post injection
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Extra dose administered, Injection site cellulitis, Injection site infection, Peripheral swelling
Clinical narrative: Booster given in left arm  above elbow.  Next morning upon waking left lower arm swollen red and hot to touch.    Redness continued to enlarge become darker as days passed requiring doctor visit 2 days post injection
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Booster given in left arm  above elbow.  Next morning upon waking left lower arm swollen red and hot to touch.    Redness continued to enlarge become darker as days passed requiring doctor visit 2 days post injection
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pharyngeal swelling, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: Anaphylaxic shock, fever, aching joints. Haven't went to hospital yet. No appetite.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Arthralgia, Decreased appetite, Pyrexia
Clinical narrative: Anaphylaxic shock, fever, aching joints. Haven't went to hospital yet. No appetite.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient was given first dose of Janssen Covid vaccine with no issues upon administration. He was sitting during observation period and fainted after about 10 minutes. I checked on him immediately and he was alert and responsive. EMS was called and they checked and cleared him.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Patient was given first dose of Janssen Covid vaccine with no issues upon administration. He was sitting during observation period and fainted after about 10 minutes. I checked on him immediately and he was alert and responsive. EMS was called and they checked and cleared him.
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported; the 1.5 year old child wiggled and some of the dose was not administered; This spontaneous report has been received from a medical assistant, referring to an 18-month-old (reported also as "1.5 years old) patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.  On 18-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot number U002539, and expiration date for prophylaxis (dose and frequency were unknown by the reporter; strength, route of administration, anatomical site administration was not provided). During the administration, the child wiggled and some of the dose was not administered (incorrect dose administered). The medical assistant reported that the physician followed up with the child's mother and she reported no adverse events from the administration
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE details available; vaccine was admnistered after experiencing temperature excursion; This spontaneous report was received from a medical assistance and refers to a 13 month old patient of unknown gender. The patient's concurrent conditions,  pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On 14-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number T032317 with expiration date 22-SEP-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, after experiencing a temperature excursion at a temperature 6°F to 14°F (8.5F) for 0 hours, 18 minutes and 0 seconds; and a temperature 6°F to 14°F (11.9°F) for 1 hour, 0 minutes and 0 seconds; for a cumulative timeframe of 1 hour and 18 minutes (product storage error). There no previous temperature excursion. No additional adverse events (AE) details were available.
Sex: M
Vaccine: MMR
Symptoms: Atypical pneumonia, Incomplete course of vaccination, Injection site urticaria, Mobility decreased, Movement disorder
Clinical narrative: walking pneumonia; did not have immunity to Rubella; injection site hives; unable to move; broke out in massive hives on right side of body; This spontaneous report was received from a 36 year old male patient, reporting on himself.  the patients concurrent conditions and pertinent medical history were not provided. On an unspecified date the patient was vaccinated with M-M-R II vaccine but she did not complete the dose series due to religious reasons, the patient was also vaccinated with an unspecified 'nasal spray flu vaccine' and she had formaldehyde allergy.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis.  It was confirmed that the patient did not have immunity to Rubella (rubella antibody negative).  Since an unspecified date, the patient experienced walking pneumonia (atypical pneumonia). It was mentioned, that after the corresponding, unknown, flu vaccine injection, the patient was in bed for 5 Days, she was unable to move, and could not go to bathroom (movement disorder), and also had 'broke out in massive hives on right side of body (injection site urticaria).   The outcome of atypical pneumonia, urticaria, movement disorder, injection site urticaria and rubella antibody negative was unknown. The causal relationship between the events and the suspect vaccine was not reported.  Upon internal review, atypical pneumonia was considered a medically significant event.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative, Urticaria
Clinical narrative: walking pneumonia; did not have immunity to Rubella; injection site hives; unable to move; broke out in massive hives on right side of body; This spontaneous report was received from a 36 year old male patient, reporting on himself.  the patients concurrent conditions and pertinent medical history were not provided. On an unspecified date the patient was vaccinated with M-M-R II vaccine but she did not complete the dose series due to religious reasons, the patient was also vaccinated with an unspecified 'nasal spray flu vaccine' and she had formaldehyde allergy.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis.  It was confirmed that the patient did not have immunity to Rubella (rubella antibody negative).  Since an unspecified date, the patient experienced walking pneumonia (atypical pneumonia). It was mentioned, that after the corresponding, unknown, flu vaccine injection, the patient was in bed for 5 Days, she was unable to move, and could not go to bathroom (movement disorder), and also had 'broke out in massive hives on right side of body (injection site urticaria).   The outcome of atypical pneumonia, urticaria, movement disorder, injection site urticaria and rubella antibody negative was unknown. The causal relationship between the events and the suspect vaccine was not reported.  Upon internal review, atypical pneumonia was considered a medically significant event.
Age: 75.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Adverse event
Clinical narrative: similar reaction/symptoms; This spontaneous report has been received from the patient's sister via GlaxoSmithKline (GSK), regarding a 74-year-old male patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   Approximately in November 2020 (reported as "about a year ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, dose number, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported), and influenza vaccine (FLUZONE).   Consequently, when he received the vaccines similar had a reaction and symptoms (unspecified) (adverse event following immunisation). However, it was not reported if test or studies were performed regarding the event. The outcome of the events was not provided.   The causality assessment between the event and the suspect therapy was not provided.   This is an amended report. The events of Guillain-Barre syndrome, gait disturbance, Ill-defined disorder, pyrexia, nausea, chills and asthenia were deleted, and adverse event following immunization was added. The narrative was updated accordingly.  This case has been downgraded as the serious event was deleted from the case.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs; 10NOV2021 MMRII was administered that expired on 07OCT2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 10-NOV-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, lot # S031482 with expiration date on 07-OCT-2021 (strength, dose number, anatomical location and route of administration were not reported). The sterile diluent that was used to reconstitute the vaccine had lot # S031276 with an expiration date on 06-JUN-2022.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Neurotrophic keratopathy, Ophthalmic herpes zoster
Clinical narrative: herpes keratitis of the left eye; neurotrophic keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 18-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) by a healthcare provider at the hospital, for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient was treated by a healthcare provider at the hospital, and patient sought subsequent treatment from a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes keratitis of the left eye and neurotrophic keratitis of the left eye.  The outcome of the events was unknown. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the event of herpes keratitis of the left eye was considered to be medically significant.