chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Redness around the injection site; Swelling around the injection site; warm to the touch around the injection site; arm was sore; difficulty lifting arm; injection site is still tender; rash around the injection site, like a shingles rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 3rd December 2021, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In December 2021, the patient experienced pain in arm, injected limb mobility decreased, injection site pain and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, pain in arm and injected limb mobility decreased were recovered/resolved and the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, pain in arm, injected limb mobility decreased, injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of Shingrix vaccine in an unknown arm and immediately experienced redness, swelling and warm to the touch around the injection site. Less than 2 weeks after vaccination, the patient's arm was sore and had difficulty lifting arm but both had now subsided (date unknown). The patient reported that the redness subsided within 24 hours, swelling subsided this weekend (unknown date) and injection site was still tender. The patient reported that 10 days after receiving the vaccine, she noticed a rash around the injection site that looks like a shingles rash (date unknown) and that on 13th December 2021, the rash spread down to her elbow and on 14th December 2021, the rash travelled up to her shoulder. The patient enquired about the efficacy of the vaccine and side effects of the vaccine.  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness around the injection site; Swelling around the injection site; warm to the touch around the injection site; arm was sore; difficulty lifting arm; injection site is still tender; rash around the injection site, like a shingles rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 3rd December 2021, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In December 2021, the patient experienced pain in arm, injected limb mobility decreased, injection site pain and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, pain in arm and injected limb mobility decreased were recovered/resolved and the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, pain in arm, injected limb mobility decreased, injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of Shingrix vaccine in an unknown arm and immediately experienced redness, swelling and warm to the touch around the injection site. Less than 2 weeks after vaccination, the patient's arm was sore and had difficulty lifting arm but both had now subsided (date unknown). The patient reported that the redness subsided within 24 hours, swelling subsided this weekend (unknown date) and injection site was still tender. The patient reported that 10 days after receiving the vaccine, she noticed a rash around the injection site that looks like a shingles rash (date unknown) and that on 13th December 2021, the rash spread down to her elbow and on 14th December 2021, the rash travelled up to her shoulder. The patient enquired about the efficacy of the vaccine and side effects of the vaccine.  The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Rash
Clinical narrative: Redness around the injection site; Swelling around the injection site; warm to the touch around the injection site; arm was sore; difficulty lifting arm; injection site is still tender; rash around the injection site, like a shingles rash; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 3rd December 2021, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In December 2021, the patient experienced pain in arm, injected limb mobility decreased, injection site pain and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, pain in arm and injected limb mobility decreased were recovered/resolved and the outcome of the injection site pain and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, pain in arm, injected limb mobility decreased, injection site pain and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of Shingrix vaccine in an unknown arm and immediately experienced redness, swelling and warm to the touch around the injection site. Less than 2 weeks after vaccination, the patient's arm was sore and had difficulty lifting arm but both had now subsided (date unknown). The patient reported that the redness subsided within 24 hours, swelling subsided this weekend (unknown date) and injection site was still tender. The patient reported that 10 days after receiving the vaccine, she noticed a rash around the injection site that looks like a shingles rash (date unknown) and that on 13th December 2021, the rash spread down to her elbow and on 14th December 2021, the rash travelled up to her shoulder. The patient enquired about the efficacy of the vaccine and side effects of the vaccine.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Feeling hot, Headache, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) for a Regulatory Authority sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Covid", start date: Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Vomiting/she threw up"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore on the injection site"; SLUGGISHNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sluggish"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Felt tired at 6am"; INFLUENZA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Acid reflux"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Woke up dizzy". Additional information: she wanted to confirm if it's okay not to have the 2nd dose, and what would be the implication if she would not receive it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Gastrooesophageal reflux disease, Headache, Influenza
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) for a Regulatory Authority sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Covid", start date: Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Vomiting/she threw up"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore on the injection site"; SLUGGISHNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sluggish"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Felt tired at 6am"; INFLUENZA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Acid reflux"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Woke up dizzy". Additional information: she wanted to confirm if it's okay not to have the 2nd dose, and what would be the implication if she would not receive it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Vaccination site pain, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP) for a Regulatory Authority sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Covid", start date: Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Vomiting/she threw up"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore on the injection site"; SLUGGISHNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sluggish"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Felt tired at 6am"; INFLUENZA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Acid reflux"; DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Woke up dizzy". Additional information: she wanted to confirm if it's okay not to have the 2nd dose, and what would be the implication if she would not receive it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: -Left jaw pain/swelling -> acute parotitis -Left neck lymph node swelling -> acute cervical lymphadenopathy Onset of symptoms occurred within 24 hours of Moderna Booster Vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in jaw, Parotitis, Swelling face
Clinical narrative: -Left jaw pain/swelling -> acute parotitis -Left neck lymph node swelling -> acute cervical lymphadenopathy Onset of symptoms occurred within 24 hours of Moderna Booster Vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: 16 year old previously healthy male who presented on 12/18/21 with acute chest pain and nausea starting approximately 2 days prior to admission when he received the Pfizer COVID-19 vaccine. States that he felt his heart racing with initially minimal chest pain almost immediately after the vaccine was administer that began to progressively worsen over the next 24 hours. Although he had this chest pain, he denied history of recent fever, cough, congestion, runny nose, sick contact exposures, vomiting, diarrhea, altered mental status or sensorium, and he has been able to walk up and down stairs without any difficulties. He was brought to the Hospital ED where it was noted that he had a dramatically elevated troponin level to 13.7 ng/mL (13750 pg/mL) but otherwise normal and reassuring labs. He was transferred to the pediatric ICU at medical center where his troponin levels were trended and were found to be decreasing (see below for details of troponin and BNP levels). He was monitored for 3 days with consultation by Cardiology and despite an elevated troponin level of 1.81 ng/mL (similar to prior levels), he was tolerating his diet, comfortable on room air, with good markers of cardiac output with serial echocardiograms showing no evidence of depressed function or dysfunction. He was discharged on 12/21/21 with close follow up with both his pediatrician as well as pediatric cardiology and with careful return precautions.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, Chest pain, Intensive care, Nausea, Palpitations
Clinical narrative: 16 year old previously healthy male who presented on 12/18/21 with acute chest pain and nausea starting approximately 2 days prior to admission when he received the Pfizer COVID-19 vaccine. States that he felt his heart racing with initially minimal chest pain almost immediately after the vaccine was administer that began to progressively worsen over the next 24 hours. Although he had this chest pain, he denied history of recent fever, cough, congestion, runny nose, sick contact exposures, vomiting, diarrhea, altered mental status or sensorium, and he has been able to walk up and down stairs without any difficulties. He was brought to the Hospital ED where it was noted that he had a dramatically elevated troponin level to 13.7 ng/mL (13750 pg/mL) but otherwise normal and reassuring labs. He was transferred to the pediatric ICU at medical center where his troponin levels were trended and were found to be decreasing (see below for details of troponin and BNP levels). He was monitored for 3 days with consultation by Cardiology and despite an elevated troponin level of 1.81 ng/mL (similar to prior levels), he was tolerating his diet, comfortable on room air, with good markers of cardiac output with serial echocardiograms showing no evidence of depressed function or dysfunction. He was discharged on 12/21/21 with close follow up with both his pediatrician as well as pediatric cardiology and with careful return precautions.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 16 year old previously healthy male who presented on 12/18/21 with acute chest pain and nausea starting approximately 2 days prior to admission when he received the Pfizer COVID-19 vaccine. States that he felt his heart racing with initially minimal chest pain almost immediately after the vaccine was administer that began to progressively worsen over the next 24 hours. Although he had this chest pain, he denied history of recent fever, cough, congestion, runny nose, sick contact exposures, vomiting, diarrhea, altered mental status or sensorium, and he has been able to walk up and down stairs without any difficulties. He was brought to the Hospital ED where it was noted that he had a dramatically elevated troponin level to 13.7 ng/mL (13750 pg/mL) but otherwise normal and reassuring labs. He was transferred to the pediatric ICU at medical center where his troponin levels were trended and were found to be decreasing (see below for details of troponin and BNP levels). He was monitored for 3 days with consultation by Cardiology and despite an elevated troponin level of 1.81 ng/mL (similar to prior levels), he was tolerating his diet, comfortable on room air, with good markers of cardiac output with serial echocardiograms showing no evidence of depressed function or dysfunction. He was discharged on 12/21/21 with close follow up with both his pediatrician as well as pediatric cardiology and with careful return precautions.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Palpitations, Pleuritic pain, Troponin increased
Clinical narrative: 16 year old previously healthy male who presented on 12/18/21 with acute chest pain and nausea starting approximately 2 days prior to admission when he received the Pfizer COVID-19 vaccine. States that he felt his heart racing with initially minimal chest pain almost immediately after the vaccine was administer that began to progressively worsen over the next 24 hours. Although he had this chest pain, he denied history of recent fever, cough, congestion, runny nose, sick contact exposures, vomiting, diarrhea, altered mental status or sensorium, and he has been able to walk up and down stairs without any difficulties. He was brought to the Hospital ED where it was noted that he had a dramatically elevated troponin level to 13.7 ng/mL (13750 pg/mL) but otherwise normal and reassuring labs. He was transferred to the pediatric ICU at medical center where his troponin levels were trended and were found to be decreasing (see below for details of troponin and BNP levels). He was monitored for 3 days with consultation by Cardiology and despite an elevated troponin level of 1.81 ng/mL (similar to prior levels), he was tolerating his diet, comfortable on room air, with good markers of cardiac output with serial echocardiograms showing no evidence of depressed function or dysfunction. He was discharged on 12/21/21 with close follow up with both his pediatrician as well as pediatric cardiology and with careful return precautions.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Pt-went for second covid vaccination. Appointment time was 9:30am, but we had to wait for vaccine to thaw.  Vaccine was given at 10:05am into Right arm by pharmacy tech. I was notified sixteen minutes later by pharmacist, that wrong dose was given and instructed to watch for fevers and treat symptomatically. I was told that the vaccine was not diluted as recommended. I called back 35 minutes later to inquire regarding more details and spoke with pharmacist. At that time, I was told that the adult and pediatric vials were mixed together and my son was given a combination of both. When speaking with him, he said that he was unsure if the vials had dilutant in them or the amount of each vial that was combined.  He said that he would call me back after he figured out more numbers.  At approx 1300, he called back and instructed me to take my son to the ED if he develops any symptoms. He stated that he could not give me any more information. If I wanted further information, I needed to contact facility liability insurance company.   I spoke with pharmacy manager at approx 10am on 12/20/2021. At that time, he explained that he had not spoken with either staff member, but he did review report submitted by pharmacist. He stated that the adult and pediatric vials of pfizer covid vaccine were combined. He is unsure if full vials were combined or how much from each vial was added to the other vial.  He stated that the vaccines were not diluted as recommended. 0.2ml of concentrated combined Adult/Pediatric vaccine was drawn up and given to my 6 year old son.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue, Product use issue
Clinical narrative: Pt-went for second covid vaccination. Appointment time was 9:30am, but we had to wait for vaccine to thaw.  Vaccine was given at 10:05am into Right arm by pharmacy tech. I was notified sixteen minutes later by pharmacist, that wrong dose was given and instructed to watch for fevers and treat symptomatically. I was told that the vaccine was not diluted as recommended. I called back 35 minutes later to inquire regarding more details and spoke with pharmacist. At that time, I was told that the adult and pediatric vials were mixed together and my son was given a combination of both. When speaking with him, he said that he was unsure if the vials had dilutant in them or the amount of each vial that was combined.  He said that he would call me back after he figured out more numbers.  At approx 1300, he called back and instructed me to take my son to the ED if he develops any symptoms. He stated that he could not give me any more information. If I wanted further information, I needed to contact facility liability insurance company.   I spoke with pharmacy manager at approx 10am on 12/20/2021. At that time, he explained that he had not spoken with either staff member, but he did review report submitted by pharmacist. He stated that the adult and pediatric vials of pfizer covid vaccine were combined. He is unsure if full vials were combined or how much from each vial was added to the other vial.  He stated that the vaccines were not diluted as recommended. 0.2ml of concentrated combined Adult/Pediatric vaccine was drawn up and given to my 6 year old son.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The vaccine was administered below the deltoid muscle, into the subcutaneous fatty tissue. The patient is able to palpate the 0.25ml bolus of vaccine under her skin. No fever or headache nor any swelling nor other signs of infection.  I informed her that though it was not administered into the muscle, the vaccine will be absorbed by the body, albeit much more slowly due to the poor blood perfusion in fatty tissues. She did state that it felt smaller on the 20th, than it did on the 16th.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccine was administered below the deltoid muscle, into the subcutaneous fatty tissue. The patient is able to palpate the 0.25ml bolus of vaccine under her skin. No fever or headache nor any swelling nor other signs of infection.  I informed her that though it was not administered into the muscle, the vaccine will be absorbed by the body, albeit much more slowly due to the poor blood perfusion in fatty tissues. She did state that it felt smaller on the 20th, than it did on the 16th.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Blepharospasm, Condition aggravated, Headache, Hypoaesthesia
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia eye, Hypoaesthesia oral, Lumbar puncture, Magnetic resonance imaging head abnormal, Magnetic resonance imaging thoracic
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Paraesthesia oral, Pharyngeal hypoaesthesia, Pruritus
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Tinnitus, Transient ischaemic attack, Ultrasound Doppler, Urticaria
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blepharospasm, Headache, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lumbar puncture normal, Magnetic resonance imaging head normal, Pharyngeal hypoaesthesia, Tinnitus
Clinical narrative: Patient reported 3 hours after receiving vaccine to have ringing in her ears. Symptoms then progressed to headache and eye twitching that have all lasted since her shot (reported to hospital on 11/30/21). Approximately one week prior to coming to the hospital patient reported having numbness in her lips. The numbness then started spreading around the left side of her face up to her eye. Then progressed back toward her ear then down to her throat.  During hospitalization patient was worked up for possible stroke. At discharge patient still reported symptoms but not continuing to worsen. Discharge on aspirin and statin.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccine side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccine side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccine side effects). At the time of the report, VACCINATION COMPLICATION (vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment information was reported. Patient had asked whether the patient could take painkillers or not to manage the side effects of the vaccine.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: sid effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sid effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sid effects). At the time of the report, VACCINATION COMPLICATION (sid effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Second shot appeared to have cleared their sinus; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Second shot appeared to have cleared their sinus) had resolved.            No concomitant information was reported. No treatment information was reported. Reporter stated that second shot appears to have cleared sinus problem somewhat.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 008C21A and 039A21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE (PIRMELLA) for Birth control.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm). At the time of the report, INTERMENSTRUAL BLEEDING (Breakthrough bleeding after booster started with spotting at about 4pm and then by 7pm) outcome was unknown.            Patient received the booster at 2pm today and was given a slip of paper with Spikevax information on it and She had not experience break through bleeding for her first two doses of the Moderna vaccine and she was expecting her period to only begin this Sat or Sunday also she have been on the pill on a long time and no missed doses recently. She is not taking any other medications, although she also mentioned that she stopped her supplements one week prior to the Moderna vaccine. No Treatment information was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients recieved the Moderna COVID-19 vaccination after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021 at 3:49 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date). On 17-Dec-2021 at 3:49 PM, EXPIRED PRODUCT ADMINISTERED (Patients recieved the Moderna COVID-19 vaccination after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine expired on 24 October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up was received and included no significant information.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient is covid positive, mild infection despite vaccination
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Blood pressure increased, Cluster headache, Dizziness, Dry eye
Clinical narrative: From 04/22/2021 to 11/10/2021 the person reporting the adverse reactions experienced the following: Constant migraines, nightly cluster headaches (sometimes up to 4 times a night) for months,  a rise in blood pressure that caused stress and the cycle of headaches to continue, eye pain and dry eyes that ended up constantly causing blurred vision. Experienced syncope, light headedness along the way. Missed several days of work due to work, and ended up in the emergency room on 08/11/2021 as a result of extreme spike in blood pressure.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Impaired work ability, Migraine, Stress, Syncope
Clinical narrative: From 04/22/2021 to 11/10/2021 the person reporting the adverse reactions experienced the following: Constant migraines, nightly cluster headaches (sometimes up to 4 times a night) for months,  a rise in blood pressure that caused stress and the cycle of headaches to continue, eye pain and dry eyes that ended up constantly causing blurred vision. Experienced syncope, light headedness along the way. Missed several days of work due to work, and ended up in the emergency room on 08/11/2021 as a result of extreme spike in blood pressure.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: From 04/22/2021 to 11/10/2021 the person reporting the adverse reactions experienced the following: Constant migraines, nightly cluster headaches (sometimes up to 4 times a night) for months,  a rise in blood pressure that caused stress and the cycle of headaches to continue, eye pain and dry eyes that ended up constantly causing blurred vision. Experienced syncope, light headedness along the way. Missed several days of work due to work, and ended up in the emergency room on 08/11/2021 as a result of extreme spike in blood pressure.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection, mild despite vaccination
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Haematoma, Head injury, Nervousness, Syncope
Clinical narrative: After patient was given the Pfizer booster in the morning, patient was told to stay for 15 minutes for observation in the post vaccination area.  Per Rph, patient left after 5 minutes from the  area, and the accompanying mother screamed that her son  had collapsed.  Police Department and Ambulance arrived 5-7 minutes after being called immediately.  Firefighters say he had a hematoma around the  head area. RPH called the father and CT scans came out normal.  After everything  had happened, mother of the patient said he was nervous and had not eaten anything night prior. RPH confirmed that patient had mild symptoms with the first two covid shots.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Influenza
Clinical narrative: I received the shot on my right arm. Three hours after the shot I experienced swollen lymph nodes on my right side, jaw also felt mildly sore (not sure if related), and my right arm started to feel mildly sore. 13 hours after the shot I experienced the chills pretty bad. Next day my body felt tired and worn out, like I had the flu. This lasted most of the day. Two days after shot I felt a mild case of pericarditis for a couple of hours, after that I felt fine. That night, at midnight, I woke up with chest pains, checked into hospital, diagnosed with myocarditis. Four days after shot I had mild case diarrhea. After that, I felt fine.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myocarditis, Pain in extremity, Pain in jaw, Pericarditis
Clinical narrative: I received the shot on my right arm. Three hours after the shot I experienced swollen lymph nodes on my right side, jaw also felt mildly sore (not sure if related), and my right arm started to feel mildly sore. 13 hours after the shot I experienced the chills pretty bad. Next day my body felt tired and worn out, like I had the flu. This lasted most of the day. Two days after shot I felt a mild case of pericarditis for a couple of hours, after that I felt fine. That night, at midnight, I woke up with chest pains, checked into hospital, diagnosed with myocarditis. Four days after shot I had mild case diarrhea. After that, I felt fine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Thrombosis
Clinical narrative: Redness, soreness, stiffness, kinda felt like blood was clotting in shot area. Left bruise days later
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear, Nausea, Palpitations, Pruritus
Clinical narrative: 10-20-2021: Event 1 was an extreme reaction to kinesio tape on my belly; wherever the adhesive was became very itchy, red, raised and swollen. The rash became worse and worse until I removed the tape and washed off the adhesive. 10-28-2021: Event 2 was a red, raised, itchy, swollen rash on my face and neck. It became worse and worse throughout that day. I apply cortisone cream from the drug store throughout the evening, but it doesn't seem to help and feels like its making me feel worse. 10-29-2021: Early AM, I awoke feeling dizzy, nauseated, very itchy (face and neck were worse, more swollen and red and raised) and my heart was racing. I was scared I was having a very bad reaction to something but I didn't know what to do. I called a friend that was a nurse and my boss as I was traveling. 10-30-2021: Rash continues, but other symptoms start to improve 10-31-2021: Rash continues 11-01-2021: Rash continues 11-02-2021: Rash continues, I see my primary care provider. She prescribes an antihistamine (2nd gen, breastfeeding safe) and a stronger topical cortisone cream. 11-03-2021: Rash begins to resolve 11-06-2021: Rash returns, worse than before 11-13-2021: Rash returns, worse than before 11-23-2021: Appointment to test for food allergies as food diary shows rash is linked to possible allergy of apples and/or tomatoes. Testing shows no allergies to food but allergy to latex. 12-04-2021: Rash returns, worse than before within 30 minutes of having eaten take out.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Swelling
Clinical narrative: 10-20-2021: Event 1 was an extreme reaction to kinesio tape on my belly; wherever the adhesive was became very itchy, red, raised and swollen. The rash became worse and worse until I removed the tape and washed off the adhesive. 10-28-2021: Event 2 was a red, raised, itchy, swollen rash on my face and neck. It became worse and worse throughout that day. I apply cortisone cream from the drug store throughout the evening, but it doesn't seem to help and feels like its making me feel worse. 10-29-2021: Early AM, I awoke feeling dizzy, nauseated, very itchy (face and neck were worse, more swollen and red and raised) and my heart was racing. I was scared I was having a very bad reaction to something but I didn't know what to do. I called a friend that was a nurse and my boss as I was traveling. 10-30-2021: Rash continues, but other symptoms start to improve 10-31-2021: Rash continues 11-01-2021: Rash continues 11-02-2021: Rash continues, I see my primary care provider. She prescribes an antihistamine (2nd gen, breastfeeding safe) and a stronger topical cortisone cream. 11-03-2021: Rash begins to resolve 11-06-2021: Rash returns, worse than before 11-13-2021: Rash returns, worse than before 11-23-2021: Appointment to test for food allergies as food diary shows rash is linked to possible allergy of apples and/or tomatoes. Testing shows no allergies to food but allergy to latex. 12-04-2021: Rash returns, worse than before within 30 minutes of having eaten take out.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension, Palpitations
Clinical narrative: I got hypertension several hours after the dose, i felt very uneasy and my heart was beating  really hard.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Oral herpes, Pyrexia
Clinical narrative: Fever 104+ for 3 days Cold sorted covering both lips starting within 12 hours of shot Extreme fatigue * 4 days Extreme pain?? continues in ALL MY bones and joints
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Myocarditis, Painful respiration
Clinical narrative: Severe discomfort and pain in middle of chest. I couldn't breath without pain. Started around midday and by 7 pm decided to go to hospital. Chest X-ray and bloodwork done. They eliminated the worry of heart attack or clotting issues. Cause believed to be pericarditis or myocarditis. Advised to follow-up with primary care physician. Take Advil or Motrin for a few days until discomfort resolved.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Severe discomfort and pain in middle of chest. I couldn't breath without pain. Started around midday and by 7 pm decided to go to hospital. Chest X-ray and bloodwork done. They eliminated the worry of heart attack or clotting issues. Cause believed to be pericarditis or myocarditis. Advised to follow-up with primary care physician. Take Advil or Motrin for a few days until discomfort resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Palpitations
Clinical narrative: Being out of breath, heart palpitations, heart pain.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax
Clinical narrative: Initially felt sore/muscle aches and feverish which I felt with the first two doses. The second day getting the shot I did not eat a lot nor drink a lot of water as I was in bed all day with aches and a fever. I decided to go to a restaurant to get some food to go and a drink. I was standing waiting for my food when I fainted for about 40 seconds bystanders said. Bystanders stated that I also appeared to be seizing for a bit of time. With no prior history of seizing or fainting I looked up vaccine fainting and saw that muscle compulsions were common within that.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Heart rate increased, Myalgia, Pyrexia, Seizure
Clinical narrative: Initially felt sore/muscle aches and feverish which I felt with the first two doses. The second day getting the shot I did not eat a lot nor drink a lot of water as I was in bed all day with aches and a fever. I decided to go to a restaurant to get some food to go and a drink. I was standing waiting for my food when I fainted for about 40 seconds bystanders said. Bystanders stated that I also appeared to be seizing for a bit of time. With no prior history of seizing or fainting I looked up vaccine fainting and saw that muscle compulsions were common within that.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Initially felt sore/muscle aches and feverish which I felt with the first two doses. The second day getting the shot I did not eat a lot nor drink a lot of water as I was in bed all day with aches and a fever. I decided to go to a restaurant to get some food to go and a drink. I was standing waiting for my food when I fainted for about 40 seconds bystanders said. Bystanders stated that I also appeared to be seizing for a bit of time. With no prior history of seizing or fainting I looked up vaccine fainting and saw that muscle compulsions were common within that.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea, Pyrexia, Retching
Clinical narrative: My son was sick 3 full days after his second vaccination. He was nauseated and dry heaving for days, fever and fatigue. I had no idea that a vaccine could cause a child to be so sick. I had one sick little boy.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Reoccurring migraines - between 5-11 a month. From may to September 2021. Had to get onto medication for them. I believe this was caused by the modern vaccine. I did not have them like that before.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Magnetic resonance cholangiopancreatography, Magnetic resonance imaging abdominal, Pancreatitis acute, Scan with contrast
Clinical narrative: Idiopathic acute pancreatitis
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Idiopathic acute pancreatitis
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Decreased appetite, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: Approximately 12 hours after the shot at around 8pm, the injection site started to hurt. At around 1am on Tuesday, December 7th, I woke up and couldn't get warm or stop shaking. About an hour later, I woke up again in a sweat and fainted on my way to the bathroom. After coming to, I threw up. I was nauseous and exhausted for the next five days. At 2am on December 13th, I woke up again and felt extremely nauseous. I had diarrhea during the night and again during the day of December 13th. For the next five days, I remained nauseous, had no appetite, and was exhausted and constipated.