chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered to a 51 year old patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case via health professional and physician. Agency number: 01287082.  This case involves a 51-year-old male patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PCV 20).  On 20-Sep-2022, the 51-year patient received suspect FLUZONE HIGH-DOSE QUADRIVALENT at dose 0.7ml once via intramuscular route in the left arm (lot: UJ904AB, expiry: 30-Jun-2023) for immunization with no reported adverse event (product administered to patient of inappropriate age) a same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired FLUZONE HIGH-DOSE QUADRIVALENT was administered to a patient with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 88 years old female patient who experienced expired fluzone high-dose quadrivalent was administered to a patient with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 20-Sep-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once  (lot UJ774AA; expiry date: 30-JUN-2022) via intramuscular route in the right deltoid for immunization.  On 20-SEP-2022 the patient reported a non-serious event expired fluzone high-dose quadrivalent was administered to a patient with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of DAPTACEL being administered with no adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient to whom expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 21-Sep-2022, the patient was administered an expired dose 0.5 ml (dose 4) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5765BA; Expiration: 28-AUG-2022) via intramuscular route in the right arm for immunization with no adverse event (expired product administered)(latency on same day).  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administration of FLUBLOK to patient under 18 years of age with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA393689(CLUSTER).  This case involves a 6 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] administered to patient under 18 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2022, the patient received 0.5 ml dose once of suspect influenza quadrivalent recombinant vaccine (strength and formulation not reported) (lot UJ887AA; Expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for immunization to patient under 18 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency; on same day).  Action taken :not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Parosmia
Clinical narrative: Heightened sense of smell; This spontaneous case from the was retrieved on 29-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2098470-1), reported by other healthcare professional and concerned a 53-year-old, male patient.  The patient's concurrent conditions included type two diabetes and atrial fibrillation. The patient's concomitant medications were not reported.  On 06-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose: reported as '1', and indication: not reported). The batch number reported was P100352313.   On the same date, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; route of administration: IM, anatomical location: right arm (RA), dose: reported as '3', and indication: not reported). The batch number reported was 30130BA.  On 07-Oct-2021, one day after receiving Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced heightened sense of smell that had persisted.  On unspecified date, the patient visited physician office, however no further details were provided.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 53-year-old male patient experienced heightened sense of smell one day after vaccination with the suspect Afluria Quadrivalent vaccine. Causality was confounded by concurrent vaccination with non-company co-suspect Pfizer-Biontech COVID-19 vaccine. Nevertheless, causality for the event is assessed as possibly related based on plausible temporal relationship. Sender's Comments: A 53-year-old male patient experienced heightened sense of smell one day after vaccination with the suspect Afluria Quadrivalent vaccine. Causality was confounded by concurrent vaccination with non-company co-suspect Pfizer-Biontech COVID-19 vaccine. Nevertheless, causality for the event is assessed as possibly related based on plausible temporal relationship.
Age: 30.0
Sex: M
Vaccine: FLUC3
Symptoms: Bursitis
Clinical narrative: Left arm bursitis; This spontaneous case was retrieved on 06-Sep-2022 from Reporting System (reference number 0901712-1), reported by other healthcare professional, and concerned a 30-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 05-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was 276551 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On 10-Oct-2020, five days after receiving Flucelvax Quadrivalent, the patient experienced left arm bursitis.  On an unspecified date in 2020, the patient visited physician's office, however, further details were not reported. There was no laboratory data.  At the time of initial reporting, the patient was recovering from the event, as it was reported that bursitis was mostly resolved. There was a concern about long term issues.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 30-year-old male patient experienced left arm bursitis five days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine (anatomical location - left arm). Information regarding relevant laboratory findings and diagnostic data was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.; Sender's Comments: A 30-year-old male patient experienced left arm bursitis five days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine (anatomical location - left arm). Information regarding relevant laboratory findings and diagnostic data was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: Pt has numbness on left side; This spontaneous case was retrieved on 06-Sep-2022 from Reporting System (reference number: 0900746-1), reported by other healthcare professional and concerned a 67-year-old, female patient.  The patient's concurrent condition included allergy to morphine. The patient's concomitant medications were not reported.  On 04-Dec-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine inact sag 3v; dose: reported as 'two'; route of administration: intramuscular; anatomical location and indication: not reported). The batch number reported was 279736 (reported batch number was identified by Seqirus to be linked to suspect product Fluad (TIV) instead of reported suspect product Fluad Quadrivalent).   On 05-Dec-2020, one day, after receiving Fluad (TIV), the patient experienced numbness on left side.   On an unspecified date in 2020, the patient went to the emergency room (ER), however no further information was reported.  At the time of initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 67-year-old subject was vaccinated with Fluad (TIV). Reportedly, one day after receiving Fluad (TIV), the patient experienced numbness on left side. Considering suggestive chronology and no alternative aetiology provided, causal role of the suspect vaccine is assessed as probably related.; Sender's Comments: A 67-year-old subject was vaccinated with Fluad (TIV). Reportedly, one day after receiving Fluad (TIV), the patient experienced numbness on left side. Considering suggestive chronology and no alternative aetiology provided, causal role of the suspect vaccine is assessed as probably related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shots!,then three repeats/suspected vaccination failure; have had three repeats./ on my behind/Since then then I have had had three repeats; it is very painful sitting!!; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient got shingles around waist) and pain (it was really painful).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient later got the shingles shots. Since then he/she had three repeats of shingles.  The reporter stated that, not as bad, but on his/her behind and it was very painful sitting. The reporter further stated that, hate to feel how it be if he/she had not gotten the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive SARS-CoV-2 test; Congestion; Cough; Runny nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test), COUGH (Cough) and RHINORRHOEA (Runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOPIDOGREL and EZETIMIBE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). On 16-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test). On 16-Feb-2021, SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2 test) had resolved. At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: upon internal review on 27-Sep-2022 case level seriousness was updated; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the mRNA-1273 does not contain a virus capable of causing infection, the occurrence of SARS-CoV-2 test positive  after vaccination is accessed as unlikely related to mRNA-1273.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Discomfort, Feeding disorder
Clinical narrative: Stomach Pain; Difficulty Eating; Uncomfortable; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain), FEEDING DISORDER (Difficulty Eating) and DISCOMFORT (Uncomfortable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Upon internal review on 27-Sep-2022 case level seriousness was updated. On 03-May-2021: Live follow-up added; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Runny nose/blew and blew my nose/ it kept pouring; Sneezing for 3 hours; Redness; Couldn't eat, just drank; Sore arm; Fever/fever all night; Nauseated; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No medical history reported.). Concomitant products included LANSOPRAZOLE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills). At the time of the report, RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Runny nose/blew and blew my nose/ it kept pouring; Sneezing for 3 hours; Redness; Couldn't eat, just drank; Sore arm; Fever/fever all night; Nauseated; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No medical history reported.). Concomitant products included LANSOPRAZOLE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills). At the time of the report, RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Weakness; Aches and pains; Low grade temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Reporter's Comments: This serious case concerns a 68 Y/O female with an unexpected event of asthenia along with expected events of pain, pyrexia, chills. Event onset on Day 2 after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Agitation, Chills, Feeling abnormal, Irritability, Pain
Clinical narrative: highly agitated; irritable; makes them want to kill somebody, heightens their system; aches; arm is still red; body chills; This spontaneous case was reported by a patient and describes the occurrence of AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and VACCINATION SITE ERYTHEMA (arm is still red) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches), VACCINATION SITE ERYTHEMA (arm is still red) and CHILLS (body chills). At the time of the report, AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and CHILLS (body chills) outcome was unknown and VACCINATION SITE ERYTHEMA (arm is still red) had not resolved.            No Concomitant medications were provided. On 10 Feb 2021 patient received first dose of Moderna vaccine with lot number information was not provided. On 17 Mar 2021, patient received second dose of Moderna vaccine with lot number information was not provided. On 29 Oct 2021 patient received third dose (first booster dose) of Moderna vaccine with lot number as 939905.  It was reported that patient gotten highly agitated and irritable after getting the Moderna bivalent (second) booster dose last Friday, 23 Sep 2022. Patient state that it was the same kind of reaction patient get when take Sudafed. Makes want to kill somebody and heightens system. Patient also had the aches, body chills and arm was still red.  No treatment medications were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: highly agitated; irritable; makes them want to kill somebody, heightens their system; aches; arm is still red; body chills; This spontaneous case was reported by a patient and describes the occurrence of AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and VACCINATION SITE ERYTHEMA (arm is still red) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches), VACCINATION SITE ERYTHEMA (arm is still red) and CHILLS (body chills). At the time of the report, AGITATION (highly agitated), IRRITABILITY (irritable), FEELING ABNORMAL (makes them want to kill somebody, heightens their system), PAIN (aches) and CHILLS (body chills) outcome was unknown and VACCINATION SITE ERYTHEMA (arm is still red) had not resolved.            No Concomitant medications were provided. On 10 Feb 2021 patient received first dose of Moderna vaccine with lot number information was not provided. On 17 Mar 2021, patient received second dose of Moderna vaccine with lot number information was not provided. On 29 Oct 2021 patient received third dose (first booster dose) of Moderna vaccine with lot number as 939905.  It was reported that patient gotten highly agitated and irritable after getting the Moderna bivalent (second) booster dose last Friday, 23 Sep 2022. Patient state that it was the same kind of reaction patient get when take Sudafed. Makes want to kill somebody and heightens system. Patient also had the aches, body chills and arm was still red.  No treatment medications were provided   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus
Clinical narrative: I?m having itchiness at the injection site and slightly around the injection site. I am able to  refrain from scratching the area.  It it just enough to let me know that it?s there.  I am going to take a Zyrtec/Claritin to see if it will stop.  I have no allergies.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinitus in both ears. Appeared late April - Early May, 2021.  Reported to Dr. in 2021 and again in 2022. Went to ENT in 2021. Ringing in ears.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Confusional state, Delirium, Euphoric mood, Hypoaesthesia, Language disorder
Clinical narrative: Systemic: Patient reported feeling changes in mental status, delirious, couldn't use words properly, confused, euphoric-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Altered mental status lasted about a day and a half, now that mental status changes have resolved. Patient is numb in right leg. Cannot feel skin on leg only deep pressure if poked very hard. Normal movement and use of limb.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mental status changes
Clinical narrative: Systemic: Patient reported feeling changes in mental status, delirious, couldn't use words properly, confused, euphoric-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Altered mental status lasted about a day and a half, now that mental status changes have resolved. Patient is numb in right leg. Cannot feel skin on leg only deep pressure if poked very hard. Normal movement and use of limb.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient stated that when she recieved her shingles vaccine she felt a "shock" go through her body. She stated that she can move her arm around, but that her arm hurts when she raises it over her head and when she moves it. She also states that it hurt while she was sleeping.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: No period after 2nd booster (4th dose) August 2022. Period returned 3 September for 4 days then again on 24 September with heavy bleeding 26 & 27 September; still on period.  No period after 1st booster (3rd dose) February 2022. Period returned 5 March for approximately 10 days with heavy bleeding on day 7 (11 March). Product:Pfizer COVID-19 Vaccine; Lot #:FJ1614-PFIZER-2021; Route:Intramuscular;  Site:Right Deltoid.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient came to pharmacy to show us itchy rash/bumps on deltoid area that developed after her flu shot.  I counseled her to apply hydrocortisone to relieve the itching.  I left a note, and they confirmed she used a 5/8" needle when administering the flu shot.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation
Clinical narrative: Systemic: burning sensation on both side of the jawline-Medium
Age: 51.0
Sex: U
Vaccine: COVID19-2
Symptoms: Injection site swelling, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Vaccine positive rechallenge
Clinical narrative: Muscle pain, shivering, weakness. This is the first day after the vaccination. Had the same reaction with the first dose (effects only lasted 1 day  with the first dose).
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: PATIENT DEVELOPED A RASH AFTER THAT MAY BE RELATED TO VACCINE MODERNA BIVALENT ON 9-20, ADVISED TO SEE MD AND TO TAKE BENADRYL AS NEEDED
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough   dose 1  3/3/21  011A21A dose 2 3/31/21  010M20A
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: extreme pain at fingertips, wrists, all joints
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Pain, Paraesthesia
Clinical narrative: No concerns after shot. Felt good, so decided to spray for spiders about 6:30 pm. Mixed Tempo SC Ultra Premise in pump sprayer and sprayed. Rinsed hands afterwards, no soap. No gloves or respirator used. 9PM, started having tingling of lips and stinging of eyelids and skin around eyes but not in eyes. Put cool washcloth on for relief. Went to bed, awakened about 2 am with continued stinging and tingling. No rash, trouble breathing or swelling but it was uncomfortable. 9/22/22 am patient called office, spoke with myself. Some tingling of lips and still has some stinging of skin around eye, much better. Encouraged patient to call his provider NP to advise of situation. Called patient back at 4:30 pm 9/22/22. He said he had called provider NP and advised her of situation, she didn't advise doing anything further. He said he had almost no stinging left on eyes. Says not much on lips at noon but none now at all. Phone call 9/26/22- he said by the morning of 9/23/22 had no symptoms at all. Advised patient that VAERS form would be filled out by health office.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt received the Moderna bivalent booster only one month after her previous moderna booster (L# 011B22A). No signs or symptoms. Pt was called and reported no sickness or side affects after receiving the booster.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin discolouration, Skin exfoliation, Vitiligo
Clinical narrative: Skin peeled the next day, dried out, became rough, and faded to white.  Now I have vitiligo.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Angiocardiogram, Arthralgia, Back pain, Blood test, Computerised tomogram abnormal
Clinical narrative: Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Muscle tightness, Neck pain, Nervous system disorder, Pain, Scan myocardial perfusion
Clinical narrative: Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Sensory loss, Therapeutic nerve ablation, Ultrasound scan, X-ray
Clinical narrative: Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Inflammation
Clinical narrative: Received the 2nd dose of the vaccine at approximately 10:00 am on March 15, 2021.  At approximately 02:30 am on March 16, 2021 I woke up with no feeling in my left arm except the thumb and forefinger.  Also, had severe pain in the shoulder, neck and mid-back.  Arrived at the Hospital at approximately 04:00 am and was admitted to the emergency room.  Was initially treated there for pain and over the next two days was tested for possible cardiac issues.  It was finally determined that it was a neurological problem and neurologist determined that from a CT Scan and MIR Scans that I had suffered a massive inflammatory response to the 2nd vaccine.  Spent 5 days in the hospital and was finally discharged after receiving treatment for the inflammation and with continued prescriptions for Baclofen 10 mg 3 X daily and Gabapentin 300 mg 3 X daily.  Ultimately this only somewhat calmed the problem but to this day I suffer from pain and muscle tightness throughout my body but significantly in my neck and shoulders.  Continue to receive treatments including trigger point injections, steroid injections, brachial branch blocks and laser ablation of nerves in my spine.  Continue to have significant problems throughout my body.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, Laboratory test
Clinical narrative: DIAGNOSED WITH 4 X DVT.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site pain, Muscle tightness, Neck pain
Clinical narrative: Patient reports after first shingles vaccine 7/27/22 on the way home jaw  tightened up.  Night after receiving the vaccine patient reports having Headache and neck pain.  Following day pt c/o right arm numbness and pain from site of injection through  fingertips.  Symptoms resolved 2 days after the Shingles injection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports after first shingles vaccine 7/27/22 on the way home jaw  tightened up.  Night after receiving the vaccine patient reports having Headache and neck pain.  Following day pt c/o right arm numbness and pain from site of injection through  fingertips.  Symptoms resolved 2 days after the Shingles injection.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Dysstasia, Feeling cold, Headache
Clinical narrative: Had 18 hours of torture. It started when I got cold, my hands and nose was cold, and I got really thirsty. I got colder and colder, and shuttering. I took my temp and it was 101.9,  and I would keep shuttering. My whole body would tense up every min. It acted just like the flu. I had every symptom of the flu, except I did not cough. I had a headache, a little bit of sore throat, little bit sick to my stomach, but I didnt throw up, I had chills and fever. I could hardly move or stand up. I did not have diahrea.  I took two tylenol about 8:00 at night. That lasted till about 4am this morning.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Mobility decreased, Nausea, Oropharyngeal pain, Peripheral coldness
Clinical narrative: Had 18 hours of torture. It started when I got cold, my hands and nose was cold, and I got really thirsty. I got colder and colder, and shuttering. I took my temp and it was 101.9,  and I would keep shuttering. My whole body would tense up every min. It acted just like the flu. I had every symptom of the flu, except I did not cough. I had a headache, a little bit of sore throat, little bit sick to my stomach, but I didnt throw up, I had chills and fever. I could hardly move or stand up. I did not have diahrea.  I took two tylenol about 8:00 at night. That lasted till about 4am this morning.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Tension, Thirst
Clinical narrative: Had 18 hours of torture. It started when I got cold, my hands and nose was cold, and I got really thirsty. I got colder and colder, and shuttering. I took my temp and it was 101.9,  and I would keep shuttering. My whole body would tense up every min. It acted just like the flu. I had every symptom of the flu, except I did not cough. I had a headache, a little bit of sore throat, little bit sick to my stomach, but I didnt throw up, I had chills and fever. I could hardly move or stand up. I did not have diahrea.  I took two tylenol about 8:00 at night. That lasted till about 4am this morning.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal discomfort, Asthenia, Blood pressure increased, Chills, Cough
Clinical narrative: Twelve hours after the shot, I had dramatic, onset of symptoms -  I had a cough, runny nose, chills, upset stomach, headache, elevated blood pressure. irregular heart beat and my heart rate was high - 103.   That night I couldn't sleep due to the chills and cough.  I slept most of the following day and that night.  I had no energy and couldn't eat.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Heart rate increased, Heart rate irregular, Hypophagia, Rhinorrhoea
Clinical narrative: Twelve hours after the shot, I had dramatic, onset of symptoms -  I had a cough, runny nose, chills, upset stomach, headache, elevated blood pressure. irregular heart beat and my heart rate was high - 103.   That night I couldn't sleep due to the chills and cough.  I slept most of the following day and that night.  I had no energy and couldn't eat.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Sleep disorder
Clinical narrative: Twelve hours after the shot, I had dramatic, onset of symptoms -  I had a cough, runny nose, chills, upset stomach, headache, elevated blood pressure. irregular heart beat and my heart rate was high - 103.   That night I couldn't sleep due to the chills and cough.  I slept most of the following day and that night.  I had no energy and couldn't eat.
Age: 39.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Dose leakage from syringe pt given approximately half of dose
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness, Impaired work ability, Pain, Pyrexia
Clinical narrative: This patient became quite ill with fever, fatigue and body aches for a full 5 days following her vaccination and missed two days of work. She did have some of this immune response after previous vaccinations, but nothing this significant.