chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate decreased, Heart rate increased, Lip swelling, Pruritus, Throat irritation
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Intensive care, Lip swelling, Nausea
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral mucosal eruption, Pharyngeal swelling, Pruritus, Rales, Rash
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory distress, Rhonchi, Stridor, Swelling face, Swollen tongue
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat irritation, Throat tightness, Urticaria, Wheezing
Clinical narrative: Facial swelling, chest tightness, and diffuse hives all over body within minutes of 1st dose on 5/11/2021. Patient received Covid vaccine at immunization site.  During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness  Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over Has a history of Behcet's Disease, Ehlers-Danlos Syndrome, and self-reported history of intubations due to anaphylactic reactions from numerous medications/vaccines.  Patient presented to the ED via EMS on 5/11/21 after receiving her first Moderna COVID-19 vaccine. Shortly after receiving the dose, the patient developed chest tightness, lip swelling, and diffuse hives. She immediately received 0.3mg EPI (@9:50am) and 50mg Benadryl PO with no symptom relief. Paramedics were called, and upon arrival to the field, administered 0.5mg EPI (@10:10am), 50mg Benadryl IV, and 10mg Decadron. The patient presented to the ED at 10:25am, and at that time, the patient reported that her symptoms mostly resolved, however with lingering abnormal sensations in her chest and lips. She notes that in her past allergic reactions, she had required two EPI doses, Decadron, Benadryl, and a prednisone taper.  Of note, the patient was given Zofran by EMS for nausea en route to BWMC. The patient states to being allergic to the medication, but believes it to be from the aspartame found in Zofran's ODT formulation.  The patient was noted to have urticarial-like rashes (mouth and chin area) without uvulitis, tongue swelling, lip swellling, strides, wheezes/rales/rhonci, or respiratory distress. The patient was tachycardic, talking in full sentences, and is A/O x4. Roughly 10 to 15 minutes later, the patient started to experience refractory allergy symptoms - throat tightness or return of facial hives. Her airways were noted to be patent and her lungs were noted to be clear. She was given Ativan 1mg and placed on EPI gtt (rate: 0.05mcg/min). Thereafter, the patient states to improving symptoms. Transferred to the ICU for further management respiratory distress in the setting of anaphylactic reaction.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Memory impairment
Clinical narrative: can barely think; stated that she is a mess; can barely walk; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 82 years) for covid-19 immunization.  The patient's medical history included allergic to sulfa and brain damage (she was hit by a drunk 30 years ago). The patient's concomitant medications were not reported. The patient experienced can barely think, stated that she is a mess, can barely walk on an unspecified date. It was further stated that she had a shot a week ago. Stated she made an error. When they acknowledged if she was allergic to drugs or medication she did not acknowledge that she was allergic to sulfa. Stated that she had brain damage because she was hit by a drunk 30 years ago. Stated there was sulfa in the medication and the brain damage was hitting her hard. Stated that she's  a mess. Wanted suggestions as to what to do since she was in this state. She has it set up for the second shot and wanted to know if she should have a second shot with the same ingredients for Pfizer Cod 19 virus vaccine. Stated that she went online to see if it had sulfa in it. Stated that she had an initial reaction to sulfa before an it was extreme. Stated she should have looked it up beforehand. It has been a whole week and she can barely walk. Stated that she can barely think.  The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance, Mental impairment
Clinical narrative: can barely think; stated that she is a mess; can barely walk; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 82 years) for covid-19 immunization.  The patient's medical history included allergic to sulfa and brain damage (she was hit by a drunk 30 years ago). The patient's concomitant medications were not reported. The patient experienced can barely think, stated that she is a mess, can barely walk on an unspecified date. It was further stated that she had a shot a week ago. Stated she made an error. When they acknowledged if she was allergic to drugs or medication she did not acknowledge that she was allergic to sulfa. Stated that she had brain damage because she was hit by a drunk 30 years ago. Stated there was sulfa in the medication and the brain damage was hitting her hard. Stated that she's  a mess. Wanted suggestions as to what to do since she was in this state. She has it set up for the second shot and wanted to know if she should have a second shot with the same ingredients for Pfizer Cod 19 virus vaccine. Stated that she went online to see if it had sulfa in it. Stated that she had an initial reaction to sulfa before an it was extreme. Stated she should have looked it up beforehand. It has been a whole week and she can barely walk. Stated that she can barely think.  The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Death, Dyspnoea, Hallucination
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Death, Diet refusal, Dyspnoea, Fatigue
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hallucination, Insomnia
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Aphonia, Asthenia, Biopsy bone marrow, Blood pressure measurement
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Feeling abnormal, Feeling cold, General physical health deterioration, Hallucination, visual
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Hypophagia, Insomnia, Respiratory failure, SARS-CoV-2 test
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Pt appeared fine after vaccination on 5/5/2021, until 5/10/2121 when his wife noticed he had trouble sleeping.  The following day 5/11/2021, by late afternoon, Pt began to have hallucinations, lost his voice, refused to eat, had trouble breathing, indicated he was very tired, laid down, and expired several hours later by 8 PM.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Gait inability
Clinical narrative: After vaccine I went home and layed down, I felt like I couldn't catch my balance and I still feel it. I couldn't walk for a while and called the ambulance. I couldn't walk, only crawl and still having problems.  I have feelings like I'm falling when my sister said I wasn't falling over.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood immunoglobulin A, Blood test, Gait disturbance
Clinical narrative: After vaccine I went home and layed down, I felt like I couldn't catch my balance and I still feel it. I couldn't walk for a while and called the ambulance. I couldn't walk, only crawl and still having problems.  I have feelings like I'm falling when my sister said I wasn't falling over.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: PHARMACIST UNSURE HOW MUCH OF A DOSE PATIENT RECEIVED DUE TO "SYRINGE EXPLODED"; SYRINGE EXPLODED; UNDERDOSE; This spontaneous report received from a pharmacist concerned a 42 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced pharmacist unsure how much of a dose subject received due to "syringe exploded". On 14-MAY-2021, the subject experienced syringe exploded. On 14-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pharmacist unsure how much of a dose patient received due to "syringe exploded", syringe exploded and underdose was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: PHARMACIST UNSURE HOW MUCH OF A DOSE PATIENT RECEIVED DUE TO "SYRINGE EXPLODED"; SYRINGE EXPLODED; UNDERDOSE; This spontaneous report received from a pharmacist concerned a 42 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced pharmacist unsure how much of a dose subject received due to "syringe exploded". On 14-MAY-2021, the subject experienced syringe exploded. On 14-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pharmacist unsure how much of a dose patient received due to "syringe exploded", syringe exploded and underdose was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus, Skin irritation, Specialist consultation, Sunburn
Clinical narrative: Rash with plaques that began on arms less than one week post first Covid-19 vaccination, that continued to spread to legs shortly after. Patient had Lachydren lotion at home, which she began applying before her appointment with her dermatologist, Dr. . At the time of the patient's Dermatology appointment, she was prescribed Betamethasone, Augmented cream to apply BID & refilled Lachydren, and also given an IM injection of Kenelog 40mg.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Eczema, Rash
Clinical narrative: Rash with plaques that began on arms less than one week post first Covid-19 vaccination, that continued to spread to legs shortly after. Patient had Lachydren lotion at home, which she began applying before her appointment with her dermatologist, Dr. . At the time of the patient's Dermatology appointment, she was prescribed Betamethasone, Augmented cream to apply BID & refilled Lachydren, and also given an IM injection of Kenelog 40mg.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I had an expected but intense flu like illness start 10 hours after my shot. I also had 1 gentian herpes lesion on my upper buttocks. I started feeling better by the end of the following day. Around 2 1/2 days after my shot I started to develop hives on my torso and crawling up my back. Within 4 hours they were everywhere starting on my left side of and spreading out across my body. Torso, back, face, legs, groin, buttocks... EVERYWHERE!   I?ve never had full body hives before. The next morning I went straight to Urgent Care, they prescribed my Hydoxyzine and Pepcid, but my symptoms got worse and facial swelling started. My lip was going numb and blowing up on the left side and by the 3rd day my entire face was so swollen I was unrecognizable, my lips were massive and my eyes were starting to close from the swelling. I received a steroid shot and a Benadryl shot and the swelling went down and hives disappeared within a few hours. When I woke up this morning (4th day) however, my hives were back and just as itchy/intense. I?m now on 120mg of Allegra every 8 hours to combat the hives.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes virus infection, Hypoaesthesia oral, Swelling face, Urticaria
Clinical narrative: I had an expected but intense flu like illness start 10 hours after my shot. I also had 1 gentian herpes lesion on my upper buttocks. I started feeling better by the end of the following day. Around 2 1/2 days after my shot I started to develop hives on my torso and crawling up my back. Within 4 hours they were everywhere starting on my left side of and spreading out across my body. Torso, back, face, legs, groin, buttocks... EVERYWHERE!   I?ve never had full body hives before. The next morning I went straight to Urgent Care, they prescribed my Hydoxyzine and Pepcid, but my symptoms got worse and facial swelling started. My lip was going numb and blowing up on the left side and by the 3rd day my entire face was so swollen I was unrecognizable, my lips were massive and my eyes were starting to close from the swelling. I received a steroid shot and a Benadryl shot and the swelling went down and hives disappeared within a few hours. When I woke up this morning (4th day) however, my hives were back and just as itchy/intense. I?m now on 120mg of Allegra every 8 hours to combat the hives.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: STOMACH WAS BOTHERING -  THINKING GETTING PERIOD; HEADACHE; SORE ARM AT INJECTION SITE; ADOLESCENT RECEIVED THE JANSSEN COVID 19 VACCINE; OFF LABEL USE; This spontaneous report received from a parent concerned a 14 year old female. The patient's weight was 150 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced adolescent received the janssen covid 19 vaccine. On 16-MAY-2021, the subject experienced off label use. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced sore arm at injection site. On 17-MAY-2021, the subject experienced stomach was bothering - thinking getting period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of adolescent received the janssen covid 19 vaccine, off label use, stomach was bothering - thinking getting period and sore arm at injection site was not reported. This report was non-serious.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Headache, Injection site pain, Off label use, Product administered to patient of inappropriate age
Clinical narrative: STOMACH WAS BOTHERING -  THINKING GETTING PERIOD; HEADACHE; SORE ARM AT INJECTION SITE; ADOLESCENT RECEIVED THE JANSSEN COVID 19 VACCINE; OFF LABEL USE; This spontaneous report received from a parent concerned a 14 year old female. The patient's weight was 150 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced adolescent received the janssen covid 19 vaccine. On 16-MAY-2021, the subject experienced off label use. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced sore arm at injection site. On 17-MAY-2021, the subject experienced stomach was bothering - thinking getting period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of adolescent received the janssen covid 19 vaccine, off label use, stomach was bothering - thinking getting period and sore arm at injection site was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial pain, Hypoaesthesia
Clinical narrative: Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Eye disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test normal
Clinical narrative: Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell'sPalsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness
Clinical narrative: Syncope 5 minutes post vaccine. Increased headache and fever up to 102.4 degrees for 15 hours
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Syncope 5 minutes post vaccine. Increased headache and fever up to 102.4 degrees for 15 hours
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient came into pharmacy Friday May 14th around 3PM to receive her second dose of the Pfizer COVID 19 vaccine and unexpectedly passed away Sunday morning May 16th. An autopsy will be completed to determine cause of death. Patient said she did have other health conditions, but this information is not entirely known by pharmacy staff.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Sudden death
Clinical narrative: Patient came into pharmacy Friday May 14th around 3PM to receive her second dose of the Pfizer COVID 19 vaccine and unexpectedly passed away Sunday morning May 16th. An autopsy will be completed to determine cause of death. Patient said she did have other health conditions, but this information is not entirely known by pharmacy staff.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Palpitations, Paraesthesia
Clinical narrative: rash, palpitatins, throat tightness, SOB -> treated with iv steroids and Pepcid/Benadryl. she was given epipen in the field. evaluated in the ER and admitted for monitoring
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Dyspnoea, Palpitations, Rash, Throat tightness
Clinical narrative: rash, palpitatins, throat tightness, SOB -> treated with iv steroids and Pepcid/Benadryl. she was given epipen in the field. evaluated in the ER and admitted for monitoring
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: rash, palpitatins, throat tightness, SOB -> treated with iv steroids and Pepcid/Benadryl. she was given epipen in the field. evaluated in the ER and admitted for monitoring
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide normal, Troponin increased
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, C-reactive protein increased, Chest pain, Chills, Echocardiogram abnormal
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myalgia
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: patient had myalgias and chills on days 1 and 2.   Day 3 awoke at 4am with CP.  Seen in the ED at that morning.  Admitted to cardiology for ongoing care.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Muscle spasm in neck,; Numbness and tingling at the left side of the face; Numbness and tingling at the left side of the face; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 50-years-old non pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via, administered in Arm Left on 12Mar2021 (at the age of 50-years-old) (Batch/Lot Number: EL 9266) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included asthma, ulcerative colitis, rheumatoid arthritis, diabetes, hypertension, apnea, and allergy to sulfa. drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid 19 and has not been tested for COVID-19 Since the vaccination. Patient reported that she has allergies to medications, food, or other products: Sulfa. Concomitant medication(s) included prednisone, insulin lispro (HUMALOG), losartan potassium (COZAAR) montelukast sodium (SINGULAIR) and vedolizumab (ENTYVIO) taken for an unspecified indication, start and stop date were not reported. On 12Mar2021 08:15 the patient experienced muscle spasm in neck, numbness and tingling at the left side of the face. Therapeutic measures were taken as a result of muscle spasm in neck, numbness and tingling at the left side of the face and treatment included BENADRYL and DECADRON. The events were resulted in emergency room visit. The outcome of events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on the bottom of both of her legs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Dyspnoea, Haemoglobin normal, Palpitations
Clinical narrative: Patient reports feeling dizzy, heart racing, slight shortness of breath. had an egg for breakfast today.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, headache, chills, nausea, vomiting
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Covid arm, red circular shape 4-5 inches in diameter around injection site of arm.  Looks to be a rash.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Anti-VGCC antibody negative, Anti-muscle specific kinase antibody, Antibody test normal, Anxiety
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Bell's palsy, Blood catecholamines, Blood catecholamines normal, Blood thyroid stimulating hormone normal
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram abdomen normal, Computerised tomogram head normal, Computerised tomogram pelvis
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Echocardiogram normal, Electrocardiogram normal, Electromyogram normal
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fibrin D dimer normal, Full blood count normal, Glycosylated haemoglobin, Human chorionic gonadotropin normal
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Lipids normal, Lymphadenopathy, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Muscle spasms, Nausea, Neck pain, Speech disorder
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Stool analysis normal, Syncope, Tachycardia, Thyroxine normal, Tri-iodothyronine normal
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal, Urine analysis normal
Clinical narrative: Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting  after eating, trouble speaking,  swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking