chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: is now experiencing problems with her leg. States that it goes numb; stiffens up / whole body will stiffen up; she can not walk; This is a spontaneous report from a contactable consumer or other non hcp (patient) via regulatory authority.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she took 1st dose of Covid vaccine on Saturday and on an unknown date in 2021, experienced problems with her leg. Stated that it goes numb, stiffens up and she could not walk. Also stated that her whole body would stiffen up at night. She wanted to speak to someone as she was trying to decide if she could take the 2nd dose. Also stated that if she had a reaction to the 2nd dose and if this did not clear up with her legs she would get legal involved. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: is now experiencing problems with her leg. States that it goes numb; stiffens up / whole body will stiffen up; she can not walk; This is a spontaneous report from a contactable consumer or other non hcp (patient) via regulatory authority.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she took 1st dose of Covid vaccine on Saturday and on an unknown date in 2021, experienced problems with her leg. Stated that it goes numb, stiffens up and she could not walk. Also stated that her whole body would stiffen up at night. She wanted to speak to someone as she was trying to decide if she could take the 2nd dose. Also stated that if she had a reaction to the 2nd dose and if this did not clear up with her legs she would get legal involved. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; Booster; This is a spontaneous report received from a contactable consumer (Patient). A 77-years-old male patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: FE3592), via an unspecified route of administration, administered in Arm Right on 29Sep2021 12:15 as dose 3 (booster), single (at the age of 77-years-old) for covid-19 immunisation. Medical history included high blood pressure. There were no known allergies were present. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration, administered in Arm Left on 12Jan2021 09:00 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9264), via an unspecified route of administration, administered in Arm Right on 04Feb2021 10:00 as dose 2, single (Both doses at the age of 76-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. On an unknown date in Oct2021, the patient experienced myocarditis. The event assessed as serious (medically significant). The patient visited the emergency room/department or urgent care for the event. The patient took colchicine 0.6 mg as a treatment for the event. The outcome of the event myocarditis was recovered on an unknown date in 2021.  No follow-up attempts were needed. No further information was expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Myocarditis
Clinical narrative: Myocarditis; Booster; This is a spontaneous report received from a contactable consumer (Patient). A 77-years-old male patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: FE3592), via an unspecified route of administration, administered in Arm Right on 29Sep2021 12:15 as dose 3 (booster), single (at the age of 77-years-old) for covid-19 immunisation. Medical history included high blood pressure. There were no known allergies were present. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3249), via an unspecified route of administration, administered in Arm Left on 12Jan2021 09:00 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9264), via an unspecified route of administration, administered in Arm Right on 04Feb2021 10:00 as dose 2, single (Both doses at the age of 76-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. On an unknown date in Oct2021, the patient experienced myocarditis. The event assessed as serious (medically significant). The patient visited the emergency room/department or urgent care for the event. The patient took colchicine 0.6 mg as a treatment for the event. The outcome of the event myocarditis was recovered on an unknown date in 2021.  No follow-up attempts were needed. No further information was expected.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: JANSSEN COVID-19 VACCINE WAS ADMINSTERED TO 13 YEAR OLD MALE. MOTHER WAS CONTACTED, ONCE SHE KNEW  THE INCIDENCE HAS OCCURED SHE DISCONNECT THE PHONE, CALLED BACK, SHE DIDN'T ANSWER SO I LEFT A VM.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dysphagia, Fatigue, Injection site pain
Clinical narrative: Patient received Janssen vaccine 11/2/21. Patient experienced diarrhea all day, a minor headache, "weird tingling feeling all over my whole body," "weird sensations into my lower legs and feet" -- > occurred all day . Then 11/4 started to experience palpitations in the evening and tachycardia.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient received Janssen vaccine 11/2/21. Patient experienced diarrhea all day, a minor headache, "weird tingling feeling all over my whole body," "weird sensations into my lower legs and feet" -- > occurred all day . Then 11/4 started to experience palpitations in the evening and tachycardia.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Diarrhoea, Feeling abnormal, Headache, Palpitations
Clinical narrative: Patient received Janssen vaccine 11/2/21. Patient experienced diarrhea all day, a minor headache, "weird tingling feeling all over my whole body," "weird sensations into my lower legs and feet" -- > occurred all day . Then 11/4 started to experience palpitations in the evening and tachycardia.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tachycardia
Clinical narrative: Patient received Janssen vaccine 11/2/21. Patient experienced diarrhea all day, a minor headache, "weird tingling feeling all over my whole body," "weird sensations into my lower legs and feet" -- > occurred all day . Then 11/4 started to experience palpitations in the evening and tachycardia.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Airway peak pressure increased, Bacterial infection, Bronchoscopy, COVID-19, Candida infection
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheter removal, Central venous catheter removal, Chest tube insertion, Condition aggravated, Dialysis
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Haemofiltration, Mental status changes, Oxygen saturation decreased
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumomediastinum, Pneumonia, Pneumothorax, Renal failure, SARS-CoV-2 test positive
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Septic shock, Superinfection, Weaning failure
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Dyspnoea, Encephalopathy
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, General physical health deterioration, Haemodialysis, Mental status changes, Renal failure
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt had a short stay in the hosp from 9/27 - 9/28/21 with positive test for COVID; dc'd to home; presents to ED with increasing SOB and altered mental status; O2 sats @ 72% on RA; encephalopathic; positive for COVID pneumonia; intubation required; renal failure on CRRT and transitioned to hemodialysis, didn't tolerate well and required pressors; condition declined and worsened; comfort care measures instituted and pt died in the hosp
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a Moderna booster ( 0.25 mL ). He was expecting to get a flu shot, but received the booster instead, however was planning to get the booster eventually. He ended up getting both vaccines the same day. Following day he had "cognitive dysfunction" and backed into his wife's car.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Cognitive disorder
Clinical narrative: Patient received a Moderna booster ( 0.25 mL ). He was expecting to get a flu shot, but received the booster instead, however was planning to get the booster eventually. He ended up getting both vaccines the same day. Following day he had "cognitive dysfunction" and backed into his wife's car.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Cardiac stress test abnormal, Chest discomfort, Chest pain
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Echocardiogram normal, Electrocardiogram, Lipids, Nausea
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal swelling, Paraesthesia oral, Periorbital swelling, Positron emission tomogram, Swelling face
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Troponin
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lip dry, Nausea, Paraesthesia, Stomatitis
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: Pfizer booster administered at Covid vaccine clinic 5 minutes after administration, patient c/o dry lips, headache, and feet/hands tingling Placed in reclining chair by RR nurses for observation RR nurses asked patient several times how she was feeling and patient reported that she was experiencing mild nausea and felt like "my tongue is thick".  Denied: SOB, abd pain, throat swelling, lips swelling. Alert and oriented x 3 throughout Skin warm and dry. No cyanosis No resp distress No vomiting. O2 Sat 100% Temp 97.3 Pulse 87 and regular Patient made several phone calls while resting.  Contacted AC clinician to discuss  Clinician advised admin EpiPen due to 2 body systems involved Patient initially refused Discussed with patient 911 transport to ED for continued evaluation, even if she continued to refused EpiPen. Patient refused EpiPen several times. Patient then began complaining of "cheeks feel like they are getting closer to my teeth." Patient then agreed to EpiPen.  Administered into left outer thigh 911 called Patient reported condition was not worsening after EpiPen administered. At no point did patient present as unstable or in distress. Patient was walked to the ambulance by EMS Transferred to ED via Ambulance.  Accompanied by spouse.  Additional Documentation
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Ocular vascular disorder, Oedema, Photopsia, Visual impairment
Clinical narrative: I had a stroke in my eye; After the first dose was given I was having eye flashes; I also had edema for months after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that after received Pfizer shots in Mar2021, patient had a stroke in eye. After the first dose was given was had eye flashes, also had edema for months after received the vaccine. Patient thinks it reacted with BP meds. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ocular vascular disorder, Oedema, Photopsia
Clinical narrative: I had a stroke in my eye; After the first dose was given I was having eye flashes; I also had edema for months after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that after received Pfizer shots in Mar2021, patient had a stroke in eye. After the first dose was given was had eye flashes, also had edema for months after received the vaccine. Patient thinks it reacted with BP meds. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed generalized pruritis shortly after getting Pfizer COVID booster. Patient was evaluated by me.  VS stable.  She denies shortness of breath, lip / tongue swelling, wheezing, coughing, GI symptom.  Erythema patch noted at injection site.  Few erythematous patches on bilateral arms and upper thighs. Two round erythematous patches with central clearance, raised border noted at right upper thigh, likely chronic.  A&P: Patient developed allergic reaction to Pfizer COVID booster, but no evidence of anaphylaxis.  Discussed diphenhydramine.  Patient has no available rides.  She opted with oral diphenhydramine at this time as IM diphenhydramine might be too sedating.   - Diphydramine 25 mg PO given - Discussed ED precautions. - Reported to VAERS.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Erythema, Hypersensitivity, Injection site erythema, Pruritus
Clinical narrative: Patient developed generalized pruritis shortly after getting Pfizer COVID booster. Patient was evaluated by me.  VS stable.  She denies shortness of breath, lip / tongue swelling, wheezing, coughing, GI symptom.  Erythema patch noted at injection site.  Few erythematous patches on bilateral arms and upper thighs. Two round erythematous patches with central clearance, raised border noted at right upper thigh, likely chronic.  A&P: Patient developed allergic reaction to Pfizer COVID booster, but no evidence of anaphylaxis.  Discussed diphenhydramine.  Patient has no available rides.  She opted with oral diphenhydramine at this time as IM diphenhydramine might be too sedating.   - Diphydramine 25 mg PO given - Discussed ED precautions. - Reported to VAERS.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Patient developed generalized pruritis shortly after getting Pfizer COVID booster. Patient was evaluated by me.  VS stable.  She denies shortness of breath, lip / tongue swelling, wheezing, coughing, GI symptom.  Erythema patch noted at injection site.  Few erythematous patches on bilateral arms and upper thighs. Two round erythematous patches with central clearance, raised border noted at right upper thigh, likely chronic.  A&P: Patient developed allergic reaction to Pfizer COVID booster, but no evidence of anaphylaxis.  Discussed diphenhydramine.  Patient has no available rides.  She opted with oral diphenhydramine at this time as IM diphenhydramine might be too sedating.   - Diphydramine 25 mg PO given - Discussed ED precautions. - Reported to VAERS.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired product administered; This spontaneous report as received from a nurse refers to a 34 year old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 01-NOV-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025610 with expiration date of 18-AUG-2021; dosage regimen details were not provided)  for prophylaxis. No adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Cough, Eye movement disorder, Pallor
Clinical narrative: The patient had an anaphylactic reaction to the MMR vaccine. He felt that his tongue felt funny. He started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back.; The reaction that he had on 31 Oct 2014 was due to the gelatin in the MMR vaccine; This spontaneous report was received from a nurse practitioner who was also the patient's mother, concerning a 4-year-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 31-OCT-2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prophylaxis. Afterwards, he felt that his tongue felt funny, and the doctor noticed he started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back (anaphylactic reaction). He was not admitted to the hospital, he was driven to the emergency room (ER) and was covered in hives and treated with steroids and antihistamines. When he woke up, he asked his mom if he could be superman and she let him go trick or treating. He would have the same kind of reaction when he chewed gummy vitamins to where his tongue felt funny. He did a food challenge and it turned out he was not allergic to any of it. The reaction that he had was due to the gelatin in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (allergic reaction to excipient).  At the time of the report, the patient had not recovered from allergic reaction to excipient. The outcome of anaphylactic reaction was unknown.  The causal relationship between the events and the suspect vaccine was related.  Upon internal review, the event of anaphylactic reaction was determined to be medically significant.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Paraesthesia oral, Salivary hypersecretion, Urticaria, Wheezing
Clinical narrative: The patient had an anaphylactic reaction to the MMR vaccine. He felt that his tongue felt funny. He started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back.; The reaction that he had on 31 Oct 2014 was due to the gelatin in the MMR vaccine; This spontaneous report was received from a nurse practitioner who was also the patient's mother, concerning a 4-year-old male patient. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies.  On 31-OCT-2014, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported), as prophylaxis. Afterwards, he felt that his tongue felt funny, and the doctor noticed he started to hypersalivate and began to wheeze and cough, he lost all his color, his freckles, and his eyes started to roll back (anaphylactic reaction). He was not admitted to the hospital, he was driven to the emergency room (ER) and was covered in hives and treated with steroids and antihistamines. When he woke up, he asked his mom if he could be superman and she let him go trick or treating. He would have the same kind of reaction when he chewed gummy vitamins to where his tongue felt funny. He did a food challenge and it turned out he was not allergic to any of it. The reaction that he had was due to the gelatin in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (allergic reaction to excipient).  At the time of the report, the patient had not recovered from allergic reaction to excipient. The outcome of anaphylactic reaction was unknown.  The causal relationship between the events and the suspect vaccine was related.  Upon internal review, the event of anaphylactic reaction was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Visual impairment
Clinical narrative: suffered herpes zoster and vision problems.; suffered herpes zoster and vision problems.; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster).After receiving Defendants' zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered herpes zoster and vision problems. As a result of these symptoms, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiffs sustained severe and permanent personal injuries. Further, as a tragic consequence of  wrongful conduct, Plaintiffs suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiffs have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The lawyer considered herpes zoster and vision problems to be related to zoster vaccine live(ZOSTAVAX).   The lawyer considered the reported events to be disabling.
Age: 89.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: has a cold; This case was reported by a consumer via patient support programs and described the occurrence of cold in a 89-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included renal stone (had kidney stones from an unknown date in August 2021 till September 2021) and hospitalization (was in hospital for Kidney stones from an unknown date in August 2021 to September 2021). Previously administered products included CEFUROXIME AXETIL (received Cefuroxime Axetil 500 mg (Antibiotic) from an unknown date in August 2021 to September 2021). Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy Ellipta) and proair (nos) (Pro-Air).   In October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2021-2022 season and an unknown time after starting Trelegy Ellipta, the patient experienced cold. The patient was treated with cefuroxime axetil. On an unknown date, the outcome of the cold was not recovered/not resolved.   It was unknown if the reporter considered the cold to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient was receiving Pro-Air 90 mcg, 1 puff or takes when needed from January 2017 and Trelegy Ellipta inhalation powder 100 to 62.5 mcg use 1 inhalation by mouth daily from November 2019 for chronic obstructive pulmonary disease. The patient had an outpatient procedure to remove kidney stones in either August or September of 2021. He stated that he went in at 5 am and discharged later that evening, he had fully recovered.   The patient recently received his Flu vaccination, a week has passed and had a cold.  The physician prescribed him Cefuroxime Axetil. The healthcare professional consented to follow up. The reporter consented to follow up. This case has been linked with US2020AMR006146 for same patient, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR006146:same patient, same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Pain all over body; Headaches; Fever; Sweats; Chills; Broke out rash; This case was reported by a consumer via patient support programs and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2021, the patient received Shingrix. On 31st October 2021, less than a day after receiving Shingrix, the patient experienced general body pain, headache, fever, sweating, chills and rash. On an unknown date, the outcome of the general body pain, headache, fever, sweating, chills and rash were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache, fever, sweating, chills and rash to be related to Shingrix.  Additional details were reported as follows: This report was submitted via the online direct entry reporting system. The patient reported that, she received the Shingrix vaccine on Sunday evening and for the last four days she was experiencing pain all over body, headaches, fever, sweats & chills, and broke out rash. The patient other history was unknown The patient consented to follow up
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pain all over body; Headaches; Fever; Sweats; Chills; Broke out rash; This case was reported by a consumer via patient support programs and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2021, the patient received Shingrix. On 31st October 2021, less than a day after receiving Shingrix, the patient experienced general body pain, headache, fever, sweating, chills and rash. On an unknown date, the outcome of the general body pain, headache, fever, sweating, chills and rash were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, headache, fever, sweating, chills and rash to be related to Shingrix.  Additional details were reported as follows: This report was submitted via the online direct entry reporting system. The patient reported that, she received the Shingrix vaccine on Sunday evening and for the last four days she was experiencing pain all over body, headaches, fever, sweats & chills, and broke out rash. The patient other history was unknown The patient consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab
Clinical narrative: shingles; scabs; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In October 2021, 5 months after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles was unknown and the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the shingles and scab to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient The age at vaccination was not reported. The patient had 1st shot 6 months ago from the date of reporting. The patient acquired shingles one month ago from the date of reporting, scabs were currently fading. She would not disclose any other information such as DOB or address. Permission denied for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: had the single shingle shot in 2018; had shingles/ last time in august 2021; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient experienced 1st shingles outbreak on an unknown date, refer case US2021AMR227108).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2021, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the single shingle shot in 2018 and experienced shingles 2 times. The last time in August 2021.  The patient asked if when patient can get the shingles shot?; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227108:same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the single shingle shot in 2018 and experienced had shingles. The patient asked if he/she could get the shingles shot For 2nd occurrence refer case US2021AMR227089.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227089:same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What if longer than 6 months for 2nd dose?; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient asked what if longer than 6 months for 2nd dose, also asked would be the series repeated. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose past 6 mos.?; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable. The patient asked 2nd dose past 6 months. Till the time of reporting, the patient did not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never followed up for 2nd dose; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received of shingrix vaccine in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient enquired about what was the recommended course of action for a patient who received first dose of Shingrix in 2019 and never followed up for 2nd dose. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The follow up would not possible as contact information was not available.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: hard bump at the injection site; redness at injection site; rash at injection site, 2"x1.5" in size, hard bump; This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 59N97, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 10 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site rash and injection site lump. On an unknown date, the outcome of the injection site erythema and injection site rash were recovered/resolved and the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash and injection site lump to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient reported redness and rash at injection site that developed 10 days after vaccination. Rash described as 2x1.5 inch in size with a hard bump at the injection site.  The patient stated the rash was similar to rash that developed following receipt of Moderna COIVD-19 vaccine, but not as itchy. When checked with pharmacy, pharmacist confirmed the patient received Fluarix and provided the lot number. The rash and redness had nearly resolved after 3 days.  The patient stated she did not seek additional care, nor was any OTC (over the counter) or nonmedical treatment used. The reporter did not consent to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: fever of 102.6, referral to ER; diarrhea, referral to ER; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N2AB, expiry date 10th February 2023) for prophylaxis.   On 28th October 2021 10:45, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and diarrhea. On an unknown date, the outcome of the fever and diarrhea were unknown.   It was unknown if the reporter considered the fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever of 102.6 and diarrhea that required treatment and referral to emergency room. The reporter consented to follow up.