chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Lethargy, Pain, Pyrexia, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Pt received 4 vaccines on same day. Pharmacist informed pt 4 is a lot given her age however pt stated she wanted all 4 and that she was aware of the risks given she used to be a registered nurse. pt experienced fever, chills, red spots on her face, left arm injection site pain, body acches/lerthargic for 3 days. pt took ibuprofen q6 hours for symtoms, Other Vaccines:  VaccineTypeBrand: Prevnar 20; Manufacturer: pfizer; LotNumber: la6406; Route: intramuscular; BodySite: right; Dose: 1; VaxDate: 09/20/2024, VaccineTypeBrand: Fluzone high dose; Manufacturer: sanofi pasteur; LotNumber: u8499ca; Route: intramuscular; BodySite: left; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Pfizer 2024-2025 12+; Manufacturer: pfizer; LotNumber: lm2211; Route: intramuscular; BodySite: right; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Other Vaccines:  VaccineTypeBrand: fluzone high dose tri-val; Manufacturer: sanofi; LotNumber: U8527AA; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 09/16/2024, VaccineTypeBrand: shingrix; Manufacturer: GSK; LotNumber: 24M7E; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 09/16/2024
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Other Vaccines:  VaccineTypeBrand: covid 19; Manufacturer: pfizer; LotNumber: lm2211; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Pain
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Other Vaccines:  VaccineTypeBrand: covid 19; Manufacturer: pfizer; LotNumber: lm2211; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Cough, Dyspnoea, Nausea
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: coughing-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Pt received the flu and Pfizer shot and within few minutes she started coughing and complains of stomach pain. Have difficult breathing. Call 911 and the EMT came and assess the pt. Mom drove pt to the emergency room to get checked out., Other Vaccines:  VaccineTypeBrand: Flulaval Trivalent; Manufacturer: GSK; LotNumber: E75AC; Route: Intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: coughing-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Pt received the flu and Pfizer shot and within few minutes she started coughing and complains of stomach pain. Have difficult breathing. Call 911 and the EMT came and assess the pt. Mom drove pt to the emergency room to get checked out., Other Vaccines:  VaccineTypeBrand: Flulaval Trivalent; Manufacturer: GSK; LotNumber: E75AC; Route: Intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt reports boil developed and skin peeled off.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin exfoliation
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt reports boil developed and skin peeled off.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: Fluzone high dose; Manufacturer: sanofi; LotNumber: ut847da; Route: intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: pt has a circular rash that is about 6 inches in diameter with a white area the size of a quarter in the center. it is really red and warm to the touch. the pt is also experiencing numbness and tingling down that arm. benadryl has been ineffective so far
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia, Rash, Skin warm
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: pt has a circular rash that is about 6 inches in diameter with a white area the size of a quarter in the center. it is really red and warm to the touch. the pt is also experiencing numbness and tingling down that arm. benadryl has been ineffective so far
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported arm red and hot. Injection site feels hard.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported arm red and hot. Injection site feels hard.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient called next day to vaccine and mentioned she has been having dizziness and is limiting her daily activity. Mentioned from when she originally called she seems to be improving and the dizziness has gotten slightly better. Counseled her to monitor symptoms if it worsens to reach out to provider and in the meantime can also take meclizine OTC to help with dizziness. Will follow up with her again at end of day.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Incoherent
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: patient received 4 vaccines and then very soon after, the patient was very faint and light headed,sweating profusely, incoherent for a few minutes. we sat him back down, turned fan on and gave him gatorade to drink. After a few minutes, he was able to tell us his name and dob and where he was. there was a woman with him and they left together afterwards., Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: glaxo smith; LotNumber: 4799G; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: priorix; Manufacturer: glaxo smith; LotNumber: x3m3d; Route: subcutaneous; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: recombivax hb; Manufacturer: merck; LotNumber: y009436; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: patient received 4 vaccines and then very soon after, the patient was very faint and light headed,sweating profusely, incoherent for a few minutes. we sat him back down, turned fan on and gave him gatorade to drink. After a few minutes, he was able to tell us his name and dob and where he was. there was a woman with him and they left together afterwards., Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: glaxo smith; LotNumber: 4799G; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: priorix; Manufacturer: glaxo smith; LotNumber: x3m3d; Route: subcutaneous; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: recombivax hb; Manufacturer: merck; LotNumber: y009436; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 09/24/2024
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainted-Mild, Additional Details: Patient fainted after vaccination., Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: GlaxoSmithKline; LotNumber: a555j; Route: im; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Systemic: cellulitis of upper right thigh-Medium, Additional Details: Patient said a few days after her upper thigh became red, hot, swollen, and very itchy, even though vaccine was given subcutaneously in the upper left arm the doctor diagnosed her with cellulitis and said its probably from the mmr vaccine. She was prescribed a steroid and antibiotic, and has seen improvements, Other Vaccines:  VaccineTypeBrand: pfizer 2024-2025; Manufacturer: pfizer; LotNumber: lm2216; Route: IM; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: flucelvax; Manufacturer: seqirus inc; LotNumber: 388521; Route: IM; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Other Vaccines:  VaccineTypeBrand: fluzone trivalent; Manufacturer: sanofi; LotNumber: u8500aa; Route: im; BodySite: left deltoid; Dose: ; VaxDate: 09/20/2024, VaccineTypeBrand: Gardasil9; Manufacturer: Merk; LotNumber: x022737; Route: im; BodySite: right deltoid; Dose: 3; VaxDate: 09/24/2024
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Other Vaccines:  VaccineTypeBrand: fluzone trivalent; Manufacturer: sanofi; LotNumber: u8500aa; Route: im; BodySite: left deltoid; Dose: ; VaxDate: 09/20/2024, VaccineTypeBrand: Gardasil9; Manufacturer: Merk; LotNumber: x022737; Route: im; BodySite: right deltoid; Dose: 3; VaxDate: 09/24/2024
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fall, Hypotonia, Skin abrasion
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient made us aware that they feint after getting vaccinations. Vaccine was administered and pt was wold to wait in waiting are for monitoring. Pt became dizzy and slumped out of chair and unto the ground. Pt recieved a small abrasion on forehead from rugburn.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: pfizer 2024-2025; Manufacturer: pfizer; LotNumber: lm2219; Route: im; BodySite: right arm; Dose: 1; VaxDate: 09/12/2024
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Fatigue, Head injury, Laboratory test
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient reported that she fainted next day while she was outside and was takent to a hospital.  She reported being dehydrated.  Hospital ran several tests since patient hit her head on the pavement but no conclusion., Other Vaccines:  VaccineTypeBrand: fluzone; Manufacturer: sanofi-pasteur; LotNumber: u8499aa; Route: intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient reported that she fainted next day while she was outside and was takent to a hospital.  She reported being dehydrated.  Hospital ran several tests since patient hit her head on the pavement but no conclusion., Other Vaccines:  VaccineTypeBrand: fluzone; Manufacturer: sanofi-pasteur; LotNumber: u8499aa; Route: intramuscular; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Other Vaccines:  VaccineTypeBrand: Covid 24-25 12yr+; Manufacturer: Pfizer; LotNumber: LM2211; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: After the patient received her Covid and Flu shot she became lighheaded and felt like she was about to faint., Other Vaccines:  VaccineTypeBrand: Fluzone trivalent; Manufacturer: sanofi; LotNumber: ut8488ka; Route: IM; BodySite: right arm; Dose: ; VaxDate: 09/24/2024
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt got light headed. unclear if patient actually fainted or started to fall.  911 was called. , Other Vaccines:  VaccineTypeBrand: fluzone trivalent; Manufacturer: sanofi; LotNumber: u8500aa; Route: IM; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Hypertension
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash, Tachycardia, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: she called saying her lips were swollen i suggested to take benadryl she didnt have any other reaction so far also told her to call 911 need be so not sure if she really took benadryl, Other Vaccines:  VaccineTypeBrand: fluad trivalent; Manufacturer: sequiris; LotNumber: 388461; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: pt had to visit a doctor and doctor had to prescribe a course of abx to the pt.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Other Vaccines:  VaccineTypeBrand: fluzone trivalent; Manufacturer: ; LotNumber: ut8408ka; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: 09/26/2024
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: lm2210; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Rash/Redness/Itching of entire right hand; numbness of right arm. Recommended seeking medical attention at urgent care., Other Vaccines:  VaccineTypeBrand: RSV (Abrysvo); Manufacturer: Pfizer; LotNumber: HY1812; Route: Intramuscular; BodySite: Left Arm; Dose: N/A; VaxDate: 09/25/2024, VaccineTypeBrand: Influenza (Seasonal) (Fluzone High-Dose Trivalent 2024-2025); Manufacturer: Sanofi-Pasteur; LotNumber: UT8470DA; Route: Intramuscular; BodySite: Left Arm; Dose: N/A; VaxDate: 09/25/2024
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient also had severe muscle pain but is recovering from it., Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 Covid 12 YR+; Manufacturer: Pfizer; LotNumber: LM2221; Route: IM; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lethargy, Myalgia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient also had severe muscle pain but is recovering from it., Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 Covid 12 YR+; Manufacturer: Pfizer; LotNumber: LM2221; Route: IM; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Patient also had severe muscle pain but is recovering from it., Other Vaccines:  VaccineTypeBrand: Pfizer 2024-2025 Covid 12 YR+; Manufacturer: Pfizer; LotNumber: LM2221; Route: IM; BodySite: Left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Injection site pain, Pollakiuria, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: frequent urination (woke up for urination 9 times the night receiving the shot, dark and yellow urine for a few days-Severe
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fatigue, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Mild
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: Patient was very sick for 2-3 days, still feeling unwell. Right arm has swelling and pain- lymphadenopathy returned as per patient - pain medicine for nerve pain not working anymore, Other Vaccines:  VaccineTypeBrand: RSV (Abrysvo); Manufacturer: Pfizer; LotNumber: HN8090; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Tdap (Boostrix); Manufacturer: ; LotNumber: 3RE73; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Fluad Trivalent; Manufacturer: ; LotNumber: 388461; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Lymphadenopathy, Malaise, Pain, Pain in extremity
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: Patient was very sick for 2-3 days, still feeling unwell. Right arm has swelling and pain- lymphadenopathy returned as per patient - pain medicine for nerve pain not working anymore, Other Vaccines:  VaccineTypeBrand: RSV (Abrysvo); Manufacturer: Pfizer; LotNumber: HN8090; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Tdap (Boostrix); Manufacturer: ; LotNumber: 3RE73; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Fluad Trivalent; Manufacturer: ; LotNumber: 388461; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: Patient was very sick for 2-3 days, still feeling unwell. Right arm has swelling and pain- lymphadenopathy returned as per patient - pain medicine for nerve pain not working anymore, Other Vaccines:  VaccineTypeBrand: RSV (Abrysvo); Manufacturer: Pfizer; LotNumber: HN8090; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Tdap (Boostrix); Manufacturer: ; LotNumber: 3RE73; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024, VaccineTypeBrand: Fluad Trivalent; Manufacturer: ; LotNumber: 388461; Route: Intramuscular; BodySite: Arm, side unknown; Dose: 1; VaxDate: 09/24/2024
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient states shoulder hurts and cannot lift arm
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After about 2 minutes of administering vaccine, the patient said she felt dizzy and hot. Her started turning red. She then said her back was tightening up and spasming. She was able to walk over to the blood pressure machine to check BP. She was given water. It was elevated (155/80). Staff RPh called EMS and the asked several questions and told us to give her 325mg of Aspirin which we did. The redness in her face slowly started to get better. EMS came and checked her out, she was good to go home
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Feeling hot, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After about 2 minutes of administering vaccine, the patient said she felt dizzy and hot. Her started turning red. She then said her back was tightening up and spasming. She was able to walk over to the blood pressure machine to check BP. She was given water. It was elevated (155/80). Staff RPh called EMS and the asked several questions and told us to give her 325mg of Aspirin which we did. The redness in her face slowly started to get better. EMS came and checked her out, she was good to go home
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypertension, Muscle spasms, Muscle tightness, Visual impairment
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After about 2 minutes of administering vaccine, the patient said she felt dizzy and hot. Her started turning red. She then said her back was tightening up and spasming. She was able to walk over to the blood pressure machine to check BP. She was given water. It was elevated (155/80). Staff RPh called EMS and the asked several questions and told us to give her 325mg of Aspirin which we did. The redness in her face slowly started to get better. EMS came and checked her out, she was good to go home
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Headache-Severe, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus,inc; LotNumber: 388523; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Muscle spasms, Muscle twitching
Clinical narrative: Patient immediately reported dizziness after vaccination. She became hot to the touch and sweaty. She fainted. She opened her eyes but was unaware of her surroundings. She had extremity muscle spasm/twitching. The patient's body was stiff.  She was unaware for around 5 minutes. She she did "wake up" we applied cold compresses to the back of her neck and chest. I took her blood pressure several times. It was low but increased over several minutes. EMS was called immediately at first complaint of dizziness. They arrived and assessed the patient in the ambulance. She was released and did return to the pharmacy to let us know she was okay and following up with her primary care provider.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Musculoskeletal stiffness, Skin warm, Syncope, Unresponsive to stimuli
Clinical narrative: Patient immediately reported dizziness after vaccination. She became hot to the touch and sweaty. She fainted. She opened her eyes but was unaware of her surroundings. She had extremity muscle spasm/twitching. The patient's body was stiff.  She was unaware for around 5 minutes. She she did "wake up" we applied cold compresses to the back of her neck and chest. I took her blood pressure several times. It was low but increased over several minutes. EMS was called immediately at first complaint of dizziness. They arrived and assessed the patient in the ambulance. She was released and did return to the pharmacy to let us know she was okay and following up with her primary care provider.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received 2 flu vaccines more than 1 month apart. 8/12 /24 and 9/29/24.  pt made aware what happened. She feels fine and no side effects to report
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse symptoms reported. 1.1 mL of the diluted Covid vaccine was administered to patient instead of the ordered 0.3 mL.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: patient had mild pain, itchiness, and bump (2 inches across). called her to check up on her and she said she felt well and the bump is gone.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Patient received covid and flu shot on right arm on 09/28/24. Patient reports that she experienced a swollen lymph node on the arm of the vaccinations. MD office notified. Patient was advised of various self treatments and will seek medical care if condition worsens. We will follow up with patient on 10/01/24.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt reported hives with previous flu vaccine. Consulted with onsite MD who instructed OK to administer but monitor pt post-injection for 30 minutes. After 30 minutes, pt denied systemic symptoms (shortness of breath, chest tightness, swelling). No visible hives, but pt reported generalized mild itching. Provider ordered OTC claritin, administered on site.
Age: 97.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Swelling
Clinical narrative: Daughter called in on Friday reporting that her mom, was complaining of pain in her right arm.  No signs of swelling, or redness at the site.  Advised to ice the area, administer ibuprofen and seek medical attention if symptoms worsen or fever develops.   Daughter was asked to follow-up with us early next week.  As of Monday, 9/30/24, patient taken to receive medical care since her shoulder is extremely swollen and she has little to no mobility in her right arm.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia, Cardiac arrest, Clostridium difficile colitis, Coronary artery disease
Clinical narrative: Hospitalization for cardiac arrest, acute respiratory failure, shock, sepsis, anemia, clostridium difficile colitis, CAD, ESRD, hypotherami, encephalopathy on dates 8/23/24- 8/26/24. Treated with no COVID-related medications.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Encephalopathy, End stage renal disease, Hypothermia, Sepsis, Shock
Clinical narrative: Hospitalization for cardiac arrest, acute respiratory failure, shock, sepsis, anemia, clostridium difficile colitis, CAD, ESRD, hypotherami, encephalopathy on dates 8/23/24- 8/26/24. Treated with no COVID-related medications.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Erythema and swelling
Age: 32.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site tenderness/localized swelling day 0-2 of injection. Day 6 woke with itching of upper right arm around injection, with a red patch surrounding (10x7 cm rhomboid)
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu shots within 45 days of one another. No signs or symptoms noted
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count normal, Eye swelling, Full blood count normal, Lymphocyte count normal, Petechiae
Clinical narrative: within minutes of receiving vaccine broke out in petechiae on face, back and arms. ater about 10 minutes developed eye and cheek swelling.  Given benadryl and decadron. taken to ER via ambulance for observation
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: within minutes of receiving vaccine broke out in petechiae on face, back and arms. ater about 10 minutes developed eye and cheek swelling.  Given benadryl and decadron. taken to ER via ambulance for observation
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: Patient received Flu mist at the school located immunization program (SLIP). Nursing  noted a drug interaction pop-up in Epic between Flu mist and salicylates. Pt is taking Pepto Bismol q 6hr PRN.  Discussed with, immunization program medical director. Although this is noted to be a theoretical interaction will ask patient to not administer Pepto x 2 weeks.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: MA had grabbed the covid vaccine out the refrigerator but stated the pediatric dosing was placed into the adult basket instead of in the pediatric basket. She proceeded to give the vaccine and did not realize the vaccine was incorrect dosage until she went to document the vaccine. She ended up giving the patient Moderna 0.25 mg 6 months to 11 years old instead of SpikeVax. Provider and patient both informed of error. Patient came back today and was given an additional dose of Moderna 0.25 mg to the patient to be equivalent to the adult dosing. Safety event was also created as well. Staff member was educated on error.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient was accidently given double the recommended dose of IPV by a medical assistant. Provider, PA review side effects to Guardian and is monitoring patient.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional adverse event; inappropriate schedule of vaccine administered; Inbound call from FBE calling to report an adverse event for GARDASIL-9.  FBE reports that the nurse who he spoke to had a patient 35 years old who was given GARDASIL-9 schedule outside the prescribing information.  FBE did not have full patient demo; This spontaneous report was received from nurse and refers to a 35-year-old.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in Febraury 2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date in March 2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). On an unknown date in April 2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: he had syncope; This spontaneous report was received from Other Health Professional and refers to a male patient of unknown age.  The patient's pertinent medical history, concurrent conditions, concomitant therapy, drug Reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced syncope. At the time of reporting, the outcome of the event syncope was not known. No additional information available.  The causal relationship between he had syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event he had syncope was determined to be medically significant. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2409USA008821:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; HCP calling to report expired MMRII was inadvertently administered after its labeled expiry date. No side effects reported. No previous temperature excursions reported. No additional information/clarification provided. Additional AEs reported, see ca; This spontaneous report was received from a pharmacist, referring to a 5-year-old patient of unknown gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 27-AUG-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 25-MAY-2024, administered for prophylaxis (strength, dose, lot #, and route of administration were not provided). The expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was inadvertently administered after its labeled expiry date (expired product administered). No side effects reported (no adverse event). No previous temperature excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA009168:
Sex: F
Vaccine: VARZOS
Symptoms: Thrombosis
Clinical narrative: blood clot in leg; This serious case was reported by a consumer via interactive digital media and described the occurrence of thrombosis leg in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced thrombosis leg (Verbatim: blood clot in leg) (serious criteria GSK medically significant). The outcome of the thrombosis leg was not resolved.   It was unknown if the reporter considered the thrombosis leg to be related to Shingrix.     The company considered the thrombosis leg to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 This case was reported by a patient via interactive digital media. The patient stated that she took the shot and then developed a blood clot in leg.; Sender's Comments: Thrombosis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: flu/ flu-like symptoms; Fever; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu/ flu-like symptoms), fever (Verbatim: Fever) and sickness (Verbatim: sick). The outcome of the influenza-like symptoms, fever and sickness were resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and sickness to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, fever and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 The patient was sick from the second shot with flu like symptoms and fever but within 24 hours was fine. This case was linked with case US2024AMR119594 reported by the same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024AMR115979:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: patient developed a fever blister on her lip; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever blister (Verbatim: patient developed a fever blister on her lip). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the fever blister was unknown.   The reporter considered the fever blister to be unrelated to Shingrix.   The company considered the fever blister to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2024 The patient received a Shingrix series schedule. Two days after a second dose of Shingrix, the patient developed a fever blister on her lip. The patient received a Valtrex medication. The reporter asked was there any interaction between Valtrex and the Shingrix vaccine, was the potency of the vaccine was somehow reduced. The pharmacist did not think this was an issue related to vaccination, this patient had a history of fever blister in the past.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: hard boiled egg inflammation at the site of the 1st vaccine; hard boiled egg inflammation at the site of the 1st vaccine/swelling at injection site; hard boiled egg inflammation at the site of the 1st vaccine; flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site inflammation (Verbatim: hard boiled egg inflammation at the site of the 1st vaccine), injection site swelling (Verbatim: hard boiled egg inflammation at the site of the 1st vaccine/swelling at injection site), injection site induration (Verbatim: hard boiled egg inflammation at the site of the 1st vaccine) and influenza-like symptoms (Verbatim: flu like symptoms). The outcome of the injection site inflammation, injection site swelling, injection site induration and influenza-like symptoms were resolved (duration 2 days).   It was unknown if the reporter considered the injection site inflammation, injection site swelling, injection site induration and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the injection site inflammation, injection site swelling, injection site induration and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2024 The patient self reported this case. The patient had the first shingles vaccine and had some strange side effects. The patient had a hard boiled egg inflammation at the site of the 1st vaccine and flu like symptoms that lasted two days. The patient told her pharmacist about it, and how concerned she was about getting the second dose. The pharmacist was surprised to saw patient today (on the day of reporting) asking for the second one. She recommended patient to ask GSK all first to see if this was a normal reaction from the first one, and if she should get the second one knowing the effects could be worse.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: then recently received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 2nd January 2024).   On 03-SEP-2024, the patient received the 2nd dose of Arexvy. On 03-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: then recently received another dose). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 19-SEP-2024 Pharmacist called to ask about what happened if a patient received a dose, and then recently received another dose, which led to extra dose administration. The reporter asked if there an advise for this two dose schedule,  Pharmacist did not consent follow-up from Safety Department.