chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Hiberix was reconstituted with NON-GSK diluent; Hiberix was reconstituted with NON-GSK diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 1-year-old male patient who received Hib (Hiberix) (batch number hk42t, expiry date 15-MAY-2024) for prophylaxis.   On 03-NOV-2023, the patient received Hiberix. On 03-NOV-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix was reconstituted with NON-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Hiberix was reconstituted with NON-GSK diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023. Clinical supervisor reported that Hiberix was reconstituted with non-GSK diluent which was diluent for MMR and Varicella Merck and administered to a patient on 3rd November 2023, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received a first dose of Shingrix in 2021 and hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of shingrix received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received a first dose of Shingrix in 2021 and hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-DEC-2023 No exact vaccination date or lot number reported. The reporter denied the consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: she had itching (the size of her hand) at the injection site; she had warmth (the size of her hand) at the injection site; she had redness (the size of her hand) at the injection site; she had shivering; Inappropriate Schedule of Vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix in year 2020).   On 06-DEC-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 06-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). On 07-DEC-2023, the patient experienced shivering (Verbatim: she had shivering). On 08-DEC-2023, the patient experienced injection site itching (Verbatim: she had itching (the size of her hand) at the injection site), injection site warmth (Verbatim: she had warmth (the size of her hand) at the injection site) and injection site erythema (Verbatim: she had redness (the size of her hand) at the injection site). The patient was treated with acrivastine (Benadryl). In DEC-2023, the outcome of the shivering was resolved. The outcome of the injection site itching, injection site warmth and injection site erythema were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site itching, injection site warmth, injection site erythema and shivering to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site warmth, injection site erythema and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2023. The reporter(nurse) was the patient.  About 3 years later, on 6-DEC-2023, patient received her second Shingrix dose which led to lengthening of vaccination schedule. The next day on 7-DEC-2023 patient had shivering. Two days after vaccination on 8-DEC-2023, she had itching, warmth, and redness (the size of her hand) at the injection site.  The patient had been treating the injection site reaction with oral Benadryl, without relief. Nothing else was reported. The reporter consented to follow up.
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix instead of Dtap and IPV vaccines; 2 year-old patient receive Pediarix; Pediarix instead of Dtap and IPV vaccines; 2 year-old patient receive Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 08-DEC-2023, the patient received the 2nd dose of Pediarix. On 11-JUN-2023, the patient received the 1st dose of Pediarix. On 11-JUN-2023, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Dtap and IPV vaccines) and inappropriate age at vaccine administration (Verbatim: 2 year-old patient receive Pediarix). On 08-DEC-2023, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Dtap and IPV vaccines) and inappropriate age at vaccine administration (Verbatim: 2 year-old patient receive Pediarix). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   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: 11-DEC-2023 A nurse mentioned that a 2-year-old patient received Pediarix instead of Dtap and IPV vaccines, therefore, the patient in catch-up series received an extra dose of Hepatitis B.  The patient had 2 previous doses of Hepatitis B (birth dose and first dose of Pediarix given on June 11th 2023).  The patient received the second dose on December 8th 2023.  Lot number and expiration date were the same for both doses of Pediarix. The healthcare professional (HCP) asked how to proceed with Hepatitis B vaccination. The reporter consented to follow up. The patient received Pediarix doses instead of Dtap-IPV at 2 years age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 52.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reporting a patient under the age of 60 years old was administered AREXVY on 12/9/2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 52-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number N57EC, expiry date 27-MAR-2025) for prophylaxis.   On 09-DEC-2023, the patient received Arexvy. On 09-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Pharmacist reporting a patient under the age of 60 years old was administered AREXVY on 12/9/2023.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023. Pharmacist reported that a patient under the age of 60 years old was administered Arexvy on 9-dec-2023 which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has not yet received the 3rd dose of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on an unknown date, the patient received the 2nd dose of Engerix B).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Patient has not yet received the 3rd dose of the vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 The pharmacist reported that a patient receiving the Engerix-B on 0,1, 8 months. Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: had difficulty walking/unsteady gait; experienced muscle weakness and had difficulty walking; This non-serious case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip replacement.   In AUG-2023, the patient received the 1st dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced walking difficulty (Verbatim: had difficulty walking/unsteady gait) and muscle weakness (Verbatim: experienced muscle weakness and had difficulty walking). The outcome of the walking difficulty and muscle weakness were resolved (duration 4 days).   It was unknown if the reporter considered the walking difficulty and muscle weakness to be related to Shingrix.     It was unknown if the company considered the walking difficulty and muscle weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2023. Reporter was a consumer who had a Shingrix vaccine in August of 2023.   Reporter did not have an exact date of vaccination or lot number.   The reporter stated that approximately 12 hours after receiving the Shingrix vaccine patient experienced muscle weakness and had difficulty walking.   The reporter reported that muscle weakness and difficulty walking resolved approximately 4 days post vaccine administration.  The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills
Clinical narrative: had chills; he felt weak; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. On 14-JUL-2023, several hours after receiving Shingrix, the patient experienced chills (Verbatim: had chills) and feelings of weakness (Verbatim: he felt weak). The outcome of the chills and feelings of weakness were resolved (duration 1 day).   It was unknown if the reporter considered the chills and feelings of weakness to be related to Shingrix.     It was unknown if the company considered the chills and feelings of weakness to be related to Shingrix.   Additional Information: GSK receipt date: 12-DEC-2023 The reporter was the patient. The reporter stated that he received Shingrix and hours later he felt weak and had chills for 1 day. The reporter did not want to provide address or any additional information, call disconnected abruptly. No health care professional (HCP) consent. The reporter did not consent to follow up.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: patient intravenously received a dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 39-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 12-DEC-2023, the patient received Boostrix. On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient intravenously received a dose of Boostrix). The outcome of the intramuscular formulation administered by other route was unknown.   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: 12-DEC-2023 The pharmacist called to inform that earlier on day of reporting, a patient intravenously received a dose of Boostrix which led to intramuscular formulation administered by other route. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: administered a dose of Boostrix via intravenous route instead of intramuscular; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 12-DEC-2023, the patient received Boostrix (intravenous). On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of Boostrix via intravenous route instead of intramuscular). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 12-DEC-2023 The reporter reported that she was informed that a patient was administered a dose of Boostrix via intravenous route instead of intramuscular, which led to intramuscular formulation administered by other route. The reporter did not have any patient information at the time of reporting and did not know administration site.  The reporter did not have product lot number / expiration date information available at time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 12-DEC-2023, the patient received Boostrix. On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was unknown.   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: 12-DEC-2023 The pharmacy supervisor called to inform about the inadvertent administration of an expired dose of Boostrix to a patient which was expired on 9th December 2023, which led to  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Injection site pain, Injection site rash
Clinical narrative: numbness to the left side of her face that; vaccine was given in her left deltoid that was sore this morning; rash to the left arm at the injection site that; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7357L, expiry date 26-MAR-2025) for prophylaxis.   On 12-DEC-2023, the patient received the 1st dose of Arexvy (intramuscular, left deltoid). On 12-DEC-2023, 12 hrs after receiving Arexvy, the patient experienced injection site rash (Verbatim: rash to the left arm at the injection site that) and muscle soreness (Verbatim: vaccine was given in her left deltoid that was sore this morning). On 13-DEC-2023, the patient experienced numbness facial (Verbatim: numbness to the left side of her face that). On 13-DEC-2023, the outcome of the injection site rash was resolved (duration 1 day). The outcome of the numbness facial and muscle soreness were not resolved.   It was unknown if the reporter considered the injection site rash, numbness facial and muscle soreness to be related to Arexvy.     It was unknown if the company considered the injection site rash, numbness facial and muscle soreness to be related to Arexvy.   Additional Information: GSK Receipt date: 13-DEC-2023 A pharmacist reported that a patient was administered the Arexvy Vaccine one day prior to the vaccination day and  called the pharmacy on the day of reporting with the following complaints.  12 hours after vaccination, the patient had numbness to the left side of her face.  The patient also mentioned had a rash to the left arm at the injection site. The vaccine was given in her left deltoid that was sore this morning.  The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 88-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   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: 13-DEC-2023 The healthcare professional reported that patient received the Boostrix vaccine on 11th December 2023 after it expired on 12 September 2023 which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: She states she then went back to her pharmacy October 2023 to get this year's shots and received a third shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2022) and Shingrix (received 2nd dose in November 2022).   In OCT-2023, the patient received the 3rd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: She states she then went back to her pharmacy October 2023 to get this year's shots and received a third shingles shot,). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 The reporter stated that she then went back to her pharmacy to get this year's shots and received a third shingles shot, as she thought this was something she was supposed to receive every year, which led to extra dose administered. Her pharmacy then closed down so she went to a different pharmacy requesting this year's second Shingrix dose but they would not give it to her and instructed her to call in to ask if the extra dose she received would be harmful to her. The call disconnected before any further details could be obtained. The reporter disconnected before any further information, including consumer's contact information and follow-up permission could be collected.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dyspnoea, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: Anxiety; Shortness of breath; Throat tingling; Narrowed airway; This non-serious case was reported by a nurse via call center representative and described the occurrence of anxiety in a 33-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2FS5G, expiry date 30-JUN-2021) for prophylaxis.   On 02-OCT-2020, the patient received FluLaval Tetra 2020-2021 season. On 02-OCT-2020, 20 min after receiving FluLaval Tetra 2020-2021 season, the patient experienced anxiety (Verbatim: Anxiety), shortness of breath (Verbatim: Shortness of breath), pharyngeal paresthesia (Verbatim: Throat tingling) and airway compression (Verbatim: Narrowed airway). The patient was treated with acrivastine (Benadryl). On 02-OCT-2020, the outcome of the anxiety, shortness of breath and airway compression were resolved.  On 03-OCT-2020, the outcome of the pharyngeal paresthesia was resolved.   It was unknown if the reporter considered the anxiety, shortness of breath, pharyngeal paresthesia and airway compression to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the anxiety, shortness of breath, pharyngeal paresthesia and airway compression to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-Dec-2023 The reporter asked about flulaval vaccine ingredients as she wishes to avoid the substance which caused a reaction in 2020. The patient received Flulaval vaccine and about 20 minutes after she experienced tingling in her throat, shortness of breath and anxiety.  The patient drove herself to an urgent care facility where, upon examination she exhibited a narrowed airway. The patient was treated with Benadryl and steroids and released. The shortness of breath, anxiety and narrowed airway were resolved before she left the urgent care facility.   The throat tingling was lasted until the next day.   The reporter stated that she reported this adverse event to VAERS in 2020. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Menopause
Clinical narrative: Patient went into menopause after receiving dose; This spontaneous case was reported by a non-health professional and describes the occurrence of MENOPAUSE (Patient went into menopause after receiving dose) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 19-Aug-2021,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced MENOPAUSE (Patient went into menopause after receiving dose). At the time of the report, MENOPAUSE (Patient went into menopause after receiving dose) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was diagnosed with COVID-19 prior to vaccination.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: It was reported the patient recently had COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (It was reported the patient recently had COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (It was reported the patient recently had COVID-19). At the time of the report, COVID-19 (It was reported the patient recently had COVID-19) outcome was unknown.            No concomitant and treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Tremor
Clinical narrative: Temp 100.5, headache, chills, shakes, stomach  nausea, weakness Took asprin every 5 hours, slept all day Cleared in 24 hours
Age: 55.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Immunization was given out of scope of FDA approval. The patient was 55yo and the age limit is 45yo for this vaccine.  The patient is fine, but needed to be reported.
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: Vaccine was administered at 0841, 12/21/2023, left thigh intramuscular. Patient remained in Clinic for about 15 to 30 minutes to monitor for any allergic or adverse reaction. Patient was reassessed at 0913, he was sleeping. No signs of allergic or adverse reaction symptoms. Patient was stable, and discharged from clinic accompanied mom and family member.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt asymptomatic but was given the adult formulation of vaccine
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Bell's palsy, Blindness unilateral, Diplopia, Dizziness, Retinal artery occlusion
Clinical narrative: PATIENT SAID FOLLOWING NEXT DAY OF VACCINATIONS COMPLIANED DIZZINESS AND SAW LIKE DOUBLE IMAGES WITH HIS EYES. HE IMMEDIATELY WENT TO HIS EYE DOCTOR FOR CHECK UP. THE DOCTOR EXAMINED AND TOLD PATIENT THAT HE HAD STROKE IN THE EYE AND REFERRED HIM TO EMERGENCY, THERE HE WAS HOSPITALIZED FOR 3 DAYS AND SAW LIKE THREE NEUROLOGIST AT THE HOSPITAL. AS PER THE PATIENT HE CAN ONLY SEE WITH ONE EYE, COMPLIANED HE IS DIAGNOSED WITH BELL'S PALSY, HE CAN'T SEE ANYTHING AFTER 4PM IN THE EVENING. HE IS STILL SUFFERING WITH BLURRED VISION AND USING ARTIFICIAL TEARS. PATIENT IS STILL TAKING ANTIBIOTICS FOR HIS ADVERSE EFFECTS. WE SPOKE TO HIS PCP AND WE WANT TO MAKE SURE PATIENT SAW THE DOCTOR FORHIS SYMPTOMS.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Vision blurred
Clinical narrative: PATIENT SAID FOLLOWING NEXT DAY OF VACCINATIONS COMPLIANED DIZZINESS AND SAW LIKE DOUBLE IMAGES WITH HIS EYES. HE IMMEDIATELY WENT TO HIS EYE DOCTOR FOR CHECK UP. THE DOCTOR EXAMINED AND TOLD PATIENT THAT HE HAD STROKE IN THE EYE AND REFERRED HIM TO EMERGENCY, THERE HE WAS HOSPITALIZED FOR 3 DAYS AND SAW LIKE THREE NEUROLOGIST AT THE HOSPITAL. AS PER THE PATIENT HE CAN ONLY SEE WITH ONE EYE, COMPLIANED HE IS DIAGNOSED WITH BELL'S PALSY, HE CAN'T SEE ANYTHING AFTER 4PM IN THE EVENING. HE IS STILL SUFFERING WITH BLURRED VISION AND USING ARTIFICIAL TEARS. PATIENT IS STILL TAKING ANTIBIOTICS FOR HIS ADVERSE EFFECTS. WE SPOKE TO HIS PCP AND WE WANT TO MAKE SURE PATIENT SAW THE DOCTOR FORHIS SYMPTOMS.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Mobility decreased, Peripheral swelling
Clinical narrative: Comirnaty: L 1st digit hand MCT joint arthritis, sudden onset. Grossly reduced ROM + severe pain + mild/moderate swelling
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong dosage formulation
Clinical narrative: None- wrong formulation given
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood test, Chest X-ray, Computerised tomogram head, Electromyogram abnormal
Clinical narrative: Pain right side of head, muscle weakness, tremors, leg pain, numbness feet, lack of temperature control, stabbing pain in legs,  blood pressure swings,
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endoscopy, Headache, Hypoaesthesia, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: Pain right side of head, muscle weakness, tremors, leg pain, numbness feet, lack of temperature control, stabbing pain in legs,  blood pressure swings,
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nerve injury, Pain in extremity, Temperature regulation disorder, Tremor, Urine analysis
Clinical narrative: Pain right side of head, muscle weakness, tremors, leg pain, numbness feet, lack of temperature control, stabbing pain in legs,  blood pressure swings,
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Chills, Cold sweat
Clinical narrative: - Excruciating abdominal pain - nausea - Incessant diarrhea & vomitting - Lightheadedness, dizzines, about to faint - Body aches and weakness - Chills, cold clammy sweats; on the verge of fainting; almost called EMS - Headache - Itchiness localized on the scalp and neck mostly - Diarrhea and vomitting stopped at 9pm - Stomach pain, headache and weakness persisted until 2nd- 3rd day
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Cough, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: - Excruciating abdominal pain - nausea - Incessant diarrhea & vomitting - Lightheadedness, dizzines, about to faint - Body aches and weakness - Chills, cold clammy sweats; on the verge of fainting; almost called EMS - Headache - Itchiness localized on the scalp and neck mostly - Diarrhea and vomitting stopped at 9pm - Stomach pain, headache and weakness persisted until 2nd- 3rd day
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Pruritus
Clinical narrative: - Excruciating abdominal pain - nausea - Incessant diarrhea & vomitting - Lightheadedness, dizzines, about to faint - Body aches and weakness - Chills, cold clammy sweats; on the verge of fainting; almost called EMS - Headache - Itchiness localized on the scalp and neck mostly - Diarrhea and vomitting stopped at 9pm - Stomach pain, headache and weakness persisted until 2nd- 3rd day
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Arexvy at the age of 59. No adverse reaction from patient.
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Arexvy at the age of 58. No adverse reaction from patient.
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received Arexvy at the age of 56. No adverse reaction from patient.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood glucose normal, Decreased appetite, Fatigue, Urine analysis normal, Vomiting
Clinical narrative: 48 hrs after receiving both flu and COVID19 booster, patient developed vomiting.  She vomited several times per day and did not have other viral symptoms such as diarrhea.  Also low appetite and fatigue.  Nobody else in the family had similar symptoms.  today is the 6th day of vomiting.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: fatigue, dizziness, loss of balance, headache
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, Pain, Pyrexia
Clinical narrative: The patient received two doses of the influenza vaccine in the same season, and suffered from body aches, fever
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine expiration date sticker 12/11/2023, given 12/11/2023
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; expiration date sticker 12/11/2023, given 12/12/2023
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms:  10003239:ARTHRALGIA;  10028411:MYALGIA;  Narrative:    Other Relevant HX:   Other:
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal loss of weight, Apnoea, Asthenia, Breath sounds absent, COVID-19
Clinical narrative: Reported Symptoms: 10011986:DEATH; 10012727:DIARRHEA; 10021097:HYPOTENSION; 10047700:VOMITING; Narrative: Comments:Notified by nursing at 16:56 that pt had lost pulse. Went bedsite and examined pt. Did not respond to verbal stimuli or follow commands. Pupils fixed and dilated. Pt was apneic and pulseless, no radial or carotid pulse, no breath or heart sounds on auscultation. Time of death declared at 17:03 Other Relevant Hx: 71 YOM with history of PUD, HTN, and recently diagnosed with Lymphoma following months of weakness and unintentional 40 lbs weight loss comes to facility ED with new onset diarrhea for the past 4-5 days and associated with Nausea and occasional vomiting but no cough. Evaluation positive for COVID-19 with hypotension on arrival that is improving and progression of Lymphoma on imaging. Other:
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Diarrhoea, Heart sounds abnormal, Hypotension, Imaging procedure abnormal
Clinical narrative: Reported Symptoms: 10011986:DEATH; 10012727:DIARRHEA; 10021097:HYPOTENSION; 10047700:VOMITING; Narrative: Comments:Notified by nursing at 16:56 that pt had lost pulse. Went bedsite and examined pt. Did not respond to verbal stimuli or follow commands. Pupils fixed and dilated. Pt was apneic and pulseless, no radial or carotid pulse, no breath or heart sounds on auscultation. Time of death declared at 17:03 Other Relevant Hx: 71 YOM with history of PUD, HTN, and recently diagnosed with Lymphoma following months of weakness and unintentional 40 lbs weight loss comes to facility ED with new onset diarrhea for the past 4-5 days and associated with Nausea and occasional vomiting but no cough. Evaluation positive for COVID-19 with hypotension on arrival that is improving and progression of Lymphoma on imaging. Other:
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymphoma, Nausea, Pulse absent, Pupil fixed, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011986:DEATH; 10012727:DIARRHEA; 10021097:HYPOTENSION; 10047700:VOMITING; Narrative: Comments:Notified by nursing at 16:56 that pt had lost pulse. Went bedsite and examined pt. Did not respond to verbal stimuli or follow commands. Pupils fixed and dilated. Pt was apneic and pulseless, no radial or carotid pulse, no breath or heart sounds on auscultation. Time of death declared at 17:03 Other Relevant Hx: 71 YOM with history of PUD, HTN, and recently diagnosed with Lymphoma following months of weakness and unintentional 40 lbs weight loss comes to facility ED with new onset diarrhea for the past 4-5 days and associated with Nausea and occasional vomiting but no cough. Evaluation positive for COVID-19 with hypotension on arrival that is improving and progression of Lymphoma on imaging. Other:
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Reported Symptoms: 10011986:DEATH; 10012727:DIARRHEA; 10021097:HYPOTENSION; 10047700:VOMITING; Narrative: Comments:Notified by nursing at 16:56 that pt had lost pulse. Went bedsite and examined pt. Did not respond to verbal stimuli or follow commands. Pupils fixed and dilated. Pt was apneic and pulseless, no radial or carotid pulse, no breath or heart sounds on auscultation. Time of death declared at 17:03 Other Relevant Hx: 71 YOM with history of PUD, HTN, and recently diagnosed with Lymphoma following months of weakness and unintentional 40 lbs weight loss comes to facility ED with new onset diarrhea for the past 4-5 days and associated with Nausea and occasional vomiting but no cough. Evaluation positive for COVID-19 with hypotension on arrival that is improving and progression of Lymphoma on imaging. Other:
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Bronchiectasis, COVID-19 pneumonia, Deep vein thrombosis, Oedema peripheral
Clinical narrative: Reported Symptoms:  10034879:PHLEBITIS;  10043642:THROMBOSIS VENOUS DEEP;  Narrative:  Other Relevant HX:  Other:  dvt
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Phlebitis, Pulmonary fibrosis, Ultrasound Doppler abnormal
Clinical narrative: Reported Symptoms:  10034879:PHLEBITIS;  10043642:THROMBOSIS VENOUS DEEP;  Narrative:  Other Relevant HX:  Other:  dvt
Age: 64.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Anxiety, Chest discomfort, Dizziness, Dysphonia, Hypersensitivity
Clinical narrative: Reported Symptoms:  10008493:CHEST TIGHTNESS OF; 10020200:HOARSE VOICE; 10042241:STRIDOR; 10047924:WHEEZING;   Narrative: Unclear if allergic reaction vs. other.  Taken to ED and treated as if allergic reaction. Yellow Fever vaccine was administered IM unintentionally rather than Subq; however, unclear if/ how this contributed.  Other Relevant HX: Patient received vaccines before international travel. Received hepatitis A and typhoid vaccine then Yellow Fever vaccine 30-60 minutes later. Yellow Fever vaccine was unintentionally administered intramuscularly with a subcutaneous needle. Patient reported feeling whoozy and chest tightness -15 minutes after the vaccine and attributed it to anxiety. Patient then reported some hoarseness in throat so taken to ED. Emergency Department provider noted possible stridor vs. wheezing on physical exam. Diagnosis = allergic reaction phenomenon. Chest tightness resolved before intervention. Epinephrine, methylprednisolone, diphenhydramine, and famotidine administered. Patient discharged at baseline condition with 5 days of prednisone. Reported no issues one day after. Other: chest tightness, voice hoarsness, ?stridor vs. wheezing
Age: 64.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Incorrect route of product administration, Stridor, Wheezing
Clinical narrative: Reported Symptoms:  10008493:CHEST TIGHTNESS OF; 10020200:HOARSE VOICE; 10042241:STRIDOR; 10047924:WHEEZING;   Narrative: Unclear if allergic reaction vs. other.  Taken to ED and treated as if allergic reaction. Yellow Fever vaccine was administered IM unintentionally rather than Subq; however, unclear if/ how this contributed.  Other Relevant HX: Patient received vaccines before international travel. Received hepatitis A and typhoid vaccine then Yellow Fever vaccine 30-60 minutes later. Yellow Fever vaccine was unintentionally administered intramuscularly with a subcutaneous needle. Patient reported feeling whoozy and chest tightness -15 minutes after the vaccine and attributed it to anxiety. Patient then reported some hoarseness in throat so taken to ED. Emergency Department provider noted possible stridor vs. wheezing on physical exam. Diagnosis = allergic reaction phenomenon. Chest tightness resolved before intervention. Epinephrine, methylprednisolone, diphenhydramine, and famotidine administered. Patient discharged at baseline condition with 5 days of prednisone. Reported no issues one day after. Other: chest tightness, voice hoarsness, ?stridor vs. wheezing
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Narrative: Reporter Symptoms: 10037087: Pruritus; 10037844: Rash; Relevant Hx: Other:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Respiratory failure
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10084401:COVID-19 RESPIRATORY INFECTION; Narrative: Hospitalization with COVID-19 infection requiring remdesivir and supportive care Other Relevant HX: Other: Hospitalization with COVID-19 infection
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: Reported Symptoms: 10020772:HYPERTENSION; Narrative
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844: Rash; Narrative: Other
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Atelectasis, COVID-19, Chest X-ray abnormal, Chronic obstructive pulmonary disease
Clinical narrative: Reported Symptoms:  10010300:CONFUSION; 10084401:COVID-19 RESPIRATORY INFECTION;    Narrative:  COVID-19 infection requiring hospitalization.  Patient was given remdesivir for 5x days and discharged.   Other Relevant HX: 82  year old MALE of PMHx of COPD/asthma, HTN, HLD, GERD, IBS, bladder cancer,  Osteoporosis w/ history of fracture, and psoriatic arthritis who presented to   the ED due to altered mental status and cough/SOB along with history of  difficulty doing activities of daily living.   Patient lives alone at an RV. Other:  Covid-19 infection
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Cough, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: Reported Symptoms:  10010300:CONFUSION; 10084401:COVID-19 RESPIRATORY INFECTION;    Narrative:  COVID-19 infection requiring hospitalization.  Patient was given remdesivir for 5x days and discharged.   Other Relevant HX: 82  year old MALE of PMHx of COPD/asthma, HTN, HLD, GERD, IBS, bladder cancer,  Osteoporosis w/ history of fracture, and psoriatic arthritis who presented to   the ED due to altered mental status and cough/SOB along with history of  difficulty doing activities of daily living.   Patient lives alone at an RV. Other:  Covid-19 infection
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Mental status changes, Pulmonary fibrosis, Wheezing
Clinical narrative: Reported Symptoms:  10010300:CONFUSION; 10084401:COVID-19 RESPIRATORY INFECTION;    Narrative:  COVID-19 infection requiring hospitalization.  Patient was given remdesivir for 5x days and discharged.   Other Relevant HX: 82  year old MALE of PMHx of COPD/asthma, HTN, HLD, GERD, IBS, bladder cancer,  Osteoporosis w/ history of fracture, and psoriatic arthritis who presented to   the ED due to altered mental status and cough/SOB along with history of  difficulty doing activities of daily living.   Patient lives alone at an RV. Other:  Covid-19 infection
Age: 49.0
Sex: F
Vaccine: JEV1, PNC20
Symptoms: Abdominal pain, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine, Haematocrit
Clinical narrative: Reported Symptoms: 10000081:ABDOMINAL PAIN; 10047700:VOMITING; Narrative: Other Relevant HX: Other: RUQ abdominal pain
Age: 49.0
Sex: F
Vaccine: JEV1, PNC20
Symptoms: Haemoglobin, Lipase, Platelet count, Platelet count normal, Ultrasound abdomen normal
Clinical narrative: Reported Symptoms: 10000081:ABDOMINAL PAIN; 10047700:VOMITING; Narrative: Other Relevant HX: Other: RUQ abdominal pain
Age: 49.0
Sex: F
Vaccine: JEV1, PNC20
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: Reported Symptoms: 10000081:ABDOMINAL PAIN; 10047700:VOMITING; Narrative: Other Relevant HX: Other: RUQ abdominal pain
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Reported Symptoms: 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
Age: 44.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Chest discomfort, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10002391:ANGINAL PAIN; 10011232:COUGHING; 10019211:HEADACHE; 10040604:SHORTNESS OF BREATH; 1004700:VOMITING; Narrative: 44 YO M w/ PMHx of nephrolithiasis, alcohol use disorder, chronic neuropathic pain, PTSD, and depression presented to primary care clinic for a routine follow-up and received influenza (Fluzone) and 20-valent pneumococcal conjugate (Prevnar 20) vaccines at approximately 9:15 AM on 9/19/23. Patient called the nurse triage line at approximately 9:00 PM to report a burning sensation in his chest, headache, and cough that had started gradually after receiving the immunizations and was directed to go to the emergency room. He presented to the emergency room reporting the previous symptoms as well as shortness of breath. Symptoms progressed to also include hoarse voice, nausea, vomiting, and feeling of "tickling in throat" similar to anaphylactic reactions to shellfish in the past. Of note, patient has received the influenza vaccine previously without adverse reactions noted. He received 4 puffs of inhaled albuterol, epinephrine 0.3mg IM, methylprednisolone 125mg IV, diphenhydramine 50mg IV, ondansetron 4mg IV, famotidine 20mg IV, and 1 L of Lactated Ringer's with improvement in symptoms. He received an additional epinephrine 0.3mg IM and acetaminophen 650mg by mouth for remaining tightness in throat/chest and headache. Following further improvement and stability, patient was discharged from the emergency room with Epi-Pens, famotidine 20mg BID as needed for allergic reaction, and methylprednisolone dose pack. On 9/21/23, he reported to primary care nurse that symptoms were continuing to improve though still noted some remaining shortness of breath on exertion. Other Relevant HX: Patient has previously received flu shot (2022, 2021, 2019, 2015, 2010) without adverse reactions. Other: shortness of breath
Age: 44.0
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Dyspnoea exertional, Headache, Nausea, Throat irritation, Throat tightness
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; 10002391:ANGINAL PAIN; 10011232:COUGHING; 10019211:HEADACHE; 10040604:SHORTNESS OF BREATH; 1004700:VOMITING; Narrative: 44 YO M w/ PMHx of nephrolithiasis, alcohol use disorder, chronic neuropathic pain, PTSD, and depression presented to primary care clinic for a routine follow-up and received influenza (Fluzone) and 20-valent pneumococcal conjugate (Prevnar 20) vaccines at approximately 9:15 AM on 9/19/23. Patient called the nurse triage line at approximately 9:00 PM to report a burning sensation in his chest, headache, and cough that had started gradually after receiving the immunizations and was directed to go to the emergency room. He presented to the emergency room reporting the previous symptoms as well as shortness of breath. Symptoms progressed to also include hoarse voice, nausea, vomiting, and feeling of "tickling in throat" similar to anaphylactic reactions to shellfish in the past. Of note, patient has received the influenza vaccine previously without adverse reactions noted. He received 4 puffs of inhaled albuterol, epinephrine 0.3mg IM, methylprednisolone 125mg IV, diphenhydramine 50mg IV, ondansetron 4mg IV, famotidine 20mg IV, and 1 L of Lactated Ringer's with improvement in symptoms. He received an additional epinephrine 0.3mg IM and acetaminophen 650mg by mouth for remaining tightness in throat/chest and headache. Following further improvement and stability, patient was discharged from the emergency room with Epi-Pens, famotidine 20mg BID as needed for allergic reaction, and methylprednisolone dose pack. On 9/21/23, he reported to primary care nurse that symptoms were continuing to improve though still noted some remaining shortness of breath on exertion. Other Relevant HX: Patient has previously received flu shot (2022, 2021, 2019, 2015, 2010) without adverse reactions. Other: shortness of breath