chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Adrenal mass, Anaemia macrocytic, Angiogram pulmonary normal, Arthritis
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood magnesium normal, Blood uric acid, Bradycardia, Brain natriuretic peptide increased, C-reactive protein increased
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Condition aggravated, Congenital foot malformation, Dyspnoea
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Exostosis, Fibrin D dimer, Full blood count abnormal, Gout, Pain in extremity
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Procalcitonin, Red blood cell sedimentation rate increased, SARS-CoV-2 test positive, Tachypnoea, X-ray limb abnormal
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Condition aggravated, Dyspnoea, Inflammatory marker increased
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Positive airway pressure therapy, Procalcitonin increased, Pulmonary hypertension, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with a positive COVID PCR and dyspnea.  Provider d/c note:  "Reason for Admission:  Patient is a 65-year-old female with history of chronic obstructive pulmonary disease on 5 L at home who presents to emergency department with a gradual onset dyspnea and wheezing.     Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  See below note for details re: this hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   1. Acute on chronic hypoxemic respiratory failure due to COVID infection on top of underlying ILD, pulmonary HTN  - 4L O2 is her baseline. Needed BIPAP and HFNC support initially. - Solu-medrol, Remdesivir course completed. - Empiric ceftriaxone/doxycycline received. Procal is sl elevated. - all inflammatory markers are up.  - Continued home Trelegy equivalent  - Continued home Sildenafil, furosemide  - add Vit C, Vit D. Zinc. - improved and was weaned down back to her baseline 4 L O2 nasal canula at discharge."
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient was asking could we take ibuprofen for the fever associated with the shingles shot. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: almost fainted; 102 temperature,; missed 3 days of work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, activities of daily living impaired and felt faint. On an unknown date, the outcome of the fever and activities of daily living impaired were recovered/resolved and the outcome of the felt faint was unknown.   It was unknown if the reporter considered the fever, activities of daily living impaired and felt faint to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that got first vaccine and ran 102 degree Fahrenheit temperature for 2 days. The patient missed 3 days of work and almost fainted 2 times. The patient went back to work and asked should he/she get the follow up dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 102 temperature,; This case was reported by a consumer via interactive digital media and described the occurrence of high temperature in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced high temperature. On an unknown date, the outcome of the high temperature was unknown.   It was unknown if the reporter considered the high temperature to be related to Shingles vaccine.     Additional Information: GSK receipt date :23-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of shingrix vaccine and had 102 temp. The patient asked if he/she should get the follow up booster dose.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: fever of 101.8; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Bexsero and Bexsero 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 Information: GSK Receipt Date: 24-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her son got a dose of Bexsero vaccine yesterday (the day before reporting) and the patient had a fever of 101.8 degree Fahrenheit.  Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Get shingles after first vaxx; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got shingles after first vaccination. Additional supportive information: The follow-up could not be possible as no contact detail were available.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Injection site rash, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; Heart medication/ Heart disorder; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection), CARDIAC DISORDER (Heart medication/ Heart disorder) and INJECTION SITE RASH (injection site rash) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to Severe).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection), CARDIAC DISORDER (Heart medication/ Heart disorder) and INJECTION SITE RASH (injection site rash). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) and CARDIAC DISORDER (Heart medication/ Heart disorder) was resolving and INJECTION SITE RASH (injection site rash) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event(s) of injection site rash and upper respiratory infection with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Heart medication with Adalimumab Solution for Injection was Not Provided.   No treatment medications were reported.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Severe neck and shoulder pain lasting more than 3 weeks now. Same thing happened with second shot.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Adenoidal hypertrophy, Chills, Cold sweat, Ear infection, Injection site pain
Clinical narrative: body pain, pain and swelling at injection site, fever, chills, cold sweats, enlarged tonsils and adenoids, pharyngitis, ear infections, disturbed sleeping pattern.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Injection site swelling, Lymphadenopathy, Pain, Pharyngitis, Pyrexia
Clinical narrative: body pain, pain and swelling at injection site, fever, chills, cold sweats, enlarged tonsils and adenoids, pharyngitis, ear infections, disturbed sleeping pattern.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Sleep disorder, Tonsillar hypertrophy
Clinical narrative: body pain, pain and swelling at injection site, fever, chills, cold sweats, enlarged tonsils and adenoids, pharyngitis, ear infections, disturbed sleeping pattern.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Adenoidal hypertrophy, Chills, Ear infection, Injection site pain, Pharyngitis
Clinical narrative: fever, chills, cold sweats, pharyngitis, ear infections, swollen tonsils and adenoids, pain at injection site.
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Tonsillar hypertrophy
Clinical narrative: fever, chills, cold sweats, pharyngitis, ear infections, swollen tonsils and adenoids, pain at injection site.
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease
Clinical narrative: Patient had to go for open heart surgery, because he had clogged arteries.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries.) (seriousness criterion hospitalization). The patient was treated with Surgery (open heart surgery) for Arterial occlusive disease. At the time of the report, ARTERIAL OCCLUSIVE DISEASE (Patient had to go for open heart surgery, because he had clogged arteries.) outcome was unknown.            No concomitant information provided  Reporters good friend had to go for open heart surgery, because he had clogged arteries. I just realized that he got vaxed with Moderna Covid-19 vaccine. The Dr said it wasn't from the vaccine. But reporter thought it was and his Dr was lying.  No treatment information provided  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (caused/prolonged hospitalization) event of Arterial occlusive disease which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273 bivalent BA.4/BA.5. Patient was reported to have had to undergo open heart surgery because he had clogged arteries. There is no additional information regarding clinical course, diagnostic tests/procedures, and treatment medication. There is also no available information regarding other doses of COVID-19 vaccine, if any. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (caused/prolonged hospitalization) event of Arterial occlusive disease which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273 bivalent BA.4/BA.5. Patient was reported to have had to undergo open heart surgery because he had clogged arteries. There is no additional information regarding clinical course, diagnostic tests/procedures, and treatment medication. There is also no available information regarding other doses of COVID-19 vaccine, if any. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: had a blood clot in the leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (had a blood clot in the leg) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (had a blood clot in the leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (had a blood clot in the leg) outcome was unknown.            Concomitant medication information was not provided.   Treatment information was not provided. Company Comment This spontaneous case concerns an unknown-years-old patient, with no medical history reported who experienced the expected seriousness criterion medically significant AESI of Thrombosis unknown days after  a  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2022-680935, US-MODERNATX, INC.-MOD-2022-681158 (E2B Linked Report).; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old patient, with no medical history reported who experienced the expected seriousness criterion medically significant AESI of Thrombosis unknown days after  a  dose of  mRNA-1273 vaccine.  The benefit-risk relationship of mrna-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement. US-MODERNATX, INC.-MOD-2022-680935:Stepdad's case, same reporter US-MODERNATX, INC.-MOD-2022-681158:husband's case, same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu shot, got the flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu shot, got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch number, expiry date: unknown) via unknown route in unknown administration site for Flu Vaccination. Information on batch number and expiry date was requested.  On an unknown date the patient had a non-serious event of got the flu shot, got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival discomfort, Gingival hypertrophy
Clinical narrative: Pt with Lower Gingival Hyperplasia and irritation
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: sore arm; arm still touchie; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received a dose of Shingles vaccine four days ago and reported arm was still touchy and sore and asked was that normal. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a consumer via social media (J and J Corporate) concerned a patient of unspecified age and sex. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced Bell's Palsy. As per the consumer, "Maybe you can explain why my cousin after the COVID shot got bells palsy but was deemed safe by every single commercial on TV and by fact checkers, you have to give every single possible side effects on every other medication out there but not one of you promoting the jab had to mention anything". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221201872-Bells palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Dizziness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Weakness-Mild, Additional Details: Patient had indicated no issues with previous covid vaccinations but had fainted with a seizure over 3 years ago with another vaccine. Patient was okay after covid vaccination but after recieving the flu vaccination. Patient fainted and had a seizure briefly. Patient was lain on the ground and came back to consciousness after a few minutes. Aftering laying down for at least 30 minutes with mother, patient had mother call for medical help and left.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Vaccination site haemorrhage
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Bleeding after administration of the vaccine- about 2 cc, no other events-Mild, Additional Details: Administered vaccine in left deltoid- patient had approximate 2 cc of bleeding after the fact. Another dose of vaccine was administered in the right deltoid- this was unremarkable
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: pt left after receiving flu vaccine and came back to the pharmacy after 3 mnutes claiming dizzy and actually fainted woke up sat x 15-20 min and drank water and left
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Mouth swelling, Rash, Swelling face, Swelling of eyelid
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient's mother reports the patient developed swelling and hives a few hours after administration. The mother administered an Epi-Pen when the rash spread across the patient's face, neck, trunk, and extremities. The patient was not hospitalized. Residual rash can be seen on his face. Patient received Varivax and M-M-R II vaccines on the same visit.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient's mother reports the patient developed swelling and hives a few hours after administration. The mother administered an Epi-Pen when the rash spread across the patient's face, neck, trunk, and extremities. The patient was not hospitalized. Residual rash can be seen on his face. Patient received Varivax and M-M-R II vaccines on the same visit.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Immediate post-injection reaction
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: pt went unresponsive soon after vaccine like within 30 seconds, couldnt not feel a pulse, called 911. patient came with it less than 30 sec. EMS came and eventually patient left with mom.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pulse absent, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: pt went unresponsive soon after vaccine like within 30 seconds, couldnt not feel a pulse, called 911. patient came with it less than 30 sec. EMS came and eventually patient left with mom.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Mouth swelling, Rash, Swelling face, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient's mother reports the patient developed swelling and hives a few hours after administration. The mother administered an Epi-Pen when the rash spread across the patient's face, neck, trunk, and extremities. The patient was not hospitalized. Residual rash can be seen on his face. Patient received Varivax and M-M-R II vaccines on the same visit.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Neck pain, Pain
Clinical narrative: Systemic: Pain that radiated up the neck of the patient from the injection site, followed by numbness of the arm under the injection site, both of which completely resolved within minutes of injection.-Mild
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Experienced swelling in lymph node of acute left arm pit in pervious IM injections. Bivalent injection has created swelling and throbbing pain of left armpit but has also increased and spread to lymph nodes in left arm (upper and lower) and nearby left breast tissue.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: Patient received extra dose of primary series. Parent forgot they received 3rd dose while on vacation.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Patient with COVID vaccines who admitted to hospital with dyspnea and COVID detected PCR.  Patient started on decadron and discharged home.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Illness, Pain
Clinical narrative: I experienced symptoms similar to brochities with general body aches and mucus that went from yellow to green, fever up to 100.8 degrees at the highest. I had general fatigue and body aches and a fairly bad headache two or three days after commencing my sickness.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: I experienced symptoms similar to brochities with general body aches and mucus that went from yellow to green, fever up to 100.8 degrees at the highest. I had general fatigue and body aches and a fairly bad headache two or three days after commencing my sickness.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia
Clinical narrative: I had a really high fever of 102, body ache.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented to clinic for third dose in primary series.  MA inadvertently administered bivalent booster instead of third dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/5/21, 5/8/21, 11/23/21. Positive on 12/2/22
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 1/13/21, 2/3/21. Positive on 12/2/22
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Patient presented due to leg swelling on 11/28/2022 that started on 11/24/2022.  An ultrasound was found to have a venous thrombosis in the greater saphenous vein of the left leg, extending into the thigh.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood test normal, Female sex hormone level, Menstrual disorder, Menstruation irregular
Clinical narrative: Starting sometime in the month of December of 2021, I developed amenorrhea. I usually have a menstrual cycle on the short side. After the 2nd dose, it would come every 21 days. Now, since receiving the booster, it comes every 4 months. I have been seeing a nurse/doctor and have gotten repeated blood work done with normal hormone levels and no indication of perimenopause or menopause. No other symptoms exist.
Age: 6.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cough, Medication error, Product preparation error, Sneezing, Vaccination error
Clinical narrative: Patient arrived to community vaccination clinic with Mom and annual flu shot given without incident. Pfizer Bivalent  5 -11 year old booster was administered without being diluted. Patient received 0.2 cc of undiluted Pfizer Bivalent booster @ about 3:30 pm. Vaccination error noted around 5:30 pm on 12/1/22. This RN called mom - on 12/2/22 @ 11:15 am.  Mom was informed re: medication error and aware that this RN would call and follow up with pediatrician. Mom reports that Patient has slight cough and some sneezing over night (12/1) but woke up and went to school as scheduled.  Mom instructed to encourage water for the rest of 12/2 with patient.  Nurse from Dr.'s office made return call to this RN @ 2 pm on 12/2 and instructed RN to have Mom continue to monitor patient closely today and over the weekend. No prn medications ordered, Mom to call MD if patient develops any unusual symptoms.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 6/1/21. Positive on 12/4/22
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 8/5/21, 8/25/21. Positive on 12/4/22
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 8/30/21, 9/20/21, 3/3/22. Positive on 12/3/22
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Diffuse itching (developed within an hour of getting vaccine). Diffuse hives developed within 24 hours.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 1/27/21, 2/22/21, 11/9/21, 10/12/22. Positive on 12/4/22
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 3/15/21, 12/20/21. Positive on 12/4/22
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine given after 24hr expiration, patient had no adverse reaction at that time. Nurse manager notified along with calling Pfizer for next step regarding if patient will need to be revaccinated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/20/21, 3/22/21. ? Positive on 12/2/22
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Catheterisation cardiac, Electrocardiogram
Clinical narrative: I know have CHF
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: patient is greater than 12 years old, and received ProQuad which should be used on children less than 12 years of age.  Patient did not have any adverse reaction to this vaccine error.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative, Streptococcus test positive
Clinical narrative: He got a rash in October, and they tested for Strep, and he tested positive. They said if he tested positive for Strep, they were going to go with that instead of Hand Foot Mouth. Then, this happened again in November. Then it happened again for the 3rd time. That is when the doctor said he had Hand Foot Mouth. They prescribed amoxicillin first. Then, the second time they prescribed cephalexin. He is doing better now, but still has a very faint rash.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Influenza virus test, Nasal congestion, Oropharyngeal pain
Clinical narrative: I noticed body aches, fatigue and fever of 99.2. The symptoms were generally mild. Today is the 1st day without all of the symptoms. I went to urgent care on December 1st, and was swabbed for strep; COVID-19, and flu. They advised me to do over the counter medications and did not prescribe any medication. The fever has finally gone away. I am still a little stuffy and have a sore throat with sinus drainage. I do have sinus issues developing and I am unsure whether they are related
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Paranasal sinus hypersecretion, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I noticed body aches, fatigue and fever of 99.2. The symptoms were generally mild. Today is the 1st day without all of the symptoms. I went to urgent care on December 1st, and was swabbed for strep; COVID-19, and flu. They advised me to do over the counter medications and did not prescribe any medication. The fever has finally gone away. I am still a little stuffy and have a sore throat with sinus drainage. I do have sinus issues developing and I am unsure whether they are related
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus disorder
Clinical narrative: I noticed body aches, fatigue and fever of 99.2. The symptoms were generally mild. Today is the 1st day without all of the symptoms. I went to urgent care on December 1st, and was swabbed for strep; COVID-19, and flu. They advised me to do over the counter medications and did not prescribe any medication. The fever has finally gone away. I am still a little stuffy and have a sore throat with sinus drainage. I do have sinus issues developing and I am unsure whether they are related
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Recurrent episodes/outbreaks of shingles
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to the touch
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Injection site pain, numbness in whole arm, hands. Pain in arm,
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 101.5 fever for 2 days, body chills,  body aches, shaking, headache, really swollen around injection site, red ring, hot to the touch
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: 101.5 fever for 2 days, body chills,  body aches, shaking, headache, really swollen around injection site, red ring, hot to the touch
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Impaired work ability, Influenza like illness
Clinical narrative: On the morning of 07/17/2022, I woke up feeling like I had the flu. I had the chills and achiness in all of my joints. My throat was also sore and scratchy. I did not have a fever though and I felt a bit nauseous but never threw up. Monday morning, I felt a bit better and tried to go to work, but it got worse, so I went home and took a COVID-19 test which was positive. I called my doctor who prescribed PAXLOVID, zinc, vitamin D, MUCINEX, and an acid reflux medication. I took all of those as prescribed and beginning the next day, I felt almost completely better. On 07/22/2022, I was negative for COVID-19. The Monday following that, I took an additional COVID-19 test and was positive again. I felt fine but was testing positive until 08/10/2022. The only symptom I experienced during my second round of COVID-19 was a scratchy throat, which still occasionally returns to this day.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: On the morning of 07/17/2022, I woke up feeling like I had the flu. I had the chills and achiness in all of my joints. My throat was also sore and scratchy. I did not have a fever though and I felt a bit nauseous but never threw up. Monday morning, I felt a bit better and tried to go to work, but it got worse, so I went home and took a COVID-19 test which was positive. I called my doctor who prescribed PAXLOVID, zinc, vitamin D, MUCINEX, and an acid reflux medication. I took all of those as prescribed and beginning the next day, I felt almost completely better. On 07/22/2022, I was negative for COVID-19. The Monday following that, I took an additional COVID-19 test and was positive again. I felt fine but was testing positive until 08/10/2022. The only symptom I experienced during my second round of COVID-19 was a scratchy throat, which still occasionally returns to this day.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient COVID + on 12/2/22 after completing COVID vaccine series
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted COVID-19 - tested positive around 8/30/22 almost 3 months from last booster.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Hypertension, Medical diet, Palpitations, Pyrexia
Clinical narrative: About 2 months after my COVID-19 vaccination it was brought to my attention that my blood pressure was running high. I changed my diet to low sodium and began monitoring my blood pressure. These things have slightly improved my blood pressure but haven't corrected it entirely. I have also been experiencing heart palpitations daily and low grade fever off and on. I am currently seeing multiple specialists to try and get answers.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient received flu and covid vaccines, while patient was checking out it appears that she passed out. Patient was responding by the time the nurse got to the other side of the check out desk.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered a monovalent COVID vaccine instead of the Bivalent Booster