chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: feeling pain in the arm especially when lifting the arm, the pain goes away when he takes aleeve
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness
Clinical narrative: Systemic: Chills-Severe, Systemic: flu like symptoms-Severe, Systemic: Headache-Severe, Additional Details: very little info given about ADE unknown brand given  date given / severity
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Dysgeusia, Injection site erythema, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Site: Redness at Injection Site-Severe, Systemic: Metallic Taste/ Arm soreness couldnt move/ head symptoms (tingling)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: on steroids for allergic reaction
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Staphylococcal infection
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient claims doctor says patient has staph infection and was given antibiotics, Other Vaccines:  VaccineTypeBrand: flucevax; Manufacturer: seqirus; LotNumber: 388532; Route: im; BodySite: right arm; Dose: 1; VaxDate: 10/18/2024
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Shakiness-Severe, Additional Details: pt experienced severe rigors /shaking with high fever. paramedics called to home. pt assessed and was not transported to hospital. ems did not feel pt has emergency.  pt has since recovered with any additonal issue. this was pts 3rd covid vaccine.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Pyrexia
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: 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
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Other Vaccines:  VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Additional Details: BP normal (120/80). BPM 60.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Lymphadenopathy
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: patient complaint of pain under his left armpit starting 3 days after recieving his covid-19 booster. stated he's seen a provider and done an evaluation with provider. patient is still currently in pain
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Allodynia, Arthralgia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Allodynia-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Other Vaccines:  VaccineTypeBrand: fluad trivalent; Manufacturer: seqirus; LotNumber: 388461; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Systemic: pt had redness of right arm but no at the injection site-Mild, Additional Details: patient has redness in the right arm but not at the injection site, pt has had this reaction in the past after getting a pneumonia vaccine
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: unable to move arm
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Respiratory distress
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: patient stated to agent received Covid, flu and shingles tpgether. only see tdap, shingles, flu in registry. patient informed had respiratory distress and was placed on antibiotics. patient disconnected did not speak to pharmacist, Other Vaccines:  VaccineTypeBrand: flu; Manufacturer: unknown; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Tdap; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient presented with pain and limited movement in left arm. Patient expressed concern that the vaccine was inject too high in the arm not in muscle. She is experiencing weakness and limited movement or use in the left arm. Patient is retired physician with understanding of vaccination procedures
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Joint injury, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient reports pain in left arm at site of injection and difficulty to move arm.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site abscess
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient reports pain in left arm at site of injection and difficulty to move arm.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: warm to touch-Mild
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient started to feel lightheaded and dizziness after receiving vaccine and stated that she is going to faint. Patient was given an alcohol pad to smell but ultimately still fainted. She slid off the chair where she was sitting and laid on the floor till the episode passed. Episode lasted about 30 seconds. After the episode passed, we advised patient to sit on the chair till she felt well enough to leave. She mentioned that she has fainted before and is normal for her. , Other Vaccines:  VaccineTypeBrand: Covid-19 Vaccine, mRNA; Manufacturer: Pfizer; LotNumber: LM2216; Route: Intramuscular; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Boostrix; Manufacturer: GSK; LotNumber: 333SK; Route: Intramuscular; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388521; Route: Intramuscular; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Pain, Visual impairment
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: feeling of heavy weight, Other Vaccines:  VaccineTypeBrand: fluzone hd; Manufacturer: sanofi; LotNumber: u8499aa; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after getting both vaccines (Variella and Priorix)
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after getting 2 vaccines (Varivax and Priorix)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Eye swelling, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient was given 1 dose of diphenhydramine 50mg capsule on site and her symptoms (shallow breathing/flushed/sweating/tingling sensation) improved. Patient was kept being monitored after she started feeling better. , Other Vaccines:  VaccineTypeBrand: flulaval; Manufacturer: gsk-id biomedic; LotNumber: 2724l; Route: intramuscular; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypopnoea, Mouth swelling, Nausea, Paraesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient was given 1 dose of diphenhydramine 50mg capsule on site and her symptoms (shallow breathing/flushed/sweating/tingling sensation) improved. Patient was kept being monitored after she started feeling better. , Other Vaccines:  VaccineTypeBrand: flulaval; Manufacturer: gsk-id biomedic; LotNumber: 2724l; Route: intramuscular; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient was given 1 dose of diphenhydramine 50mg capsule on site and her symptoms (shallow breathing/flushed/sweating/tingling sensation) improved. Patient was kept being monitored after she started feeling better. , Other Vaccines:  VaccineTypeBrand: flulaval; Manufacturer: gsk-id biomedic; LotNumber: 2724l; Route: intramuscular; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Medium, Systemic: Headache-Medium, Systemic: Weakness-Severe, Additional Details: PATIENT TOOK AREXVY ON 10-19-2024(SAT), SHE MENTIONED IT WAS ADMINISTERED NOT ON DELTOID MUSCLE BUT BACK OF THE ARM ON FATTY SKIN, IT HAD RED BUMPY SPOT, SHE WAS VERY WEAK,HAD HEADACHE BUT LOT BETTER ON 10-22-2024, SHE HAS SOME SYMPTOMS, I ADVISED HER TO TAKE TYLENOL & DRINK LOTS OF FLUID, SHE SAID SHE IS FEELING BETTER
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: site pain and  norm. recover in 10 minutes and left-Mild, Additional Details: complain of bubbles of air on site of administration, pain and norm at site of administration. refuse EMS help, was monitored and he left after 10 minutes when he felt okay, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 946616; Route: im; BodySite: left shoulder; Dose: ; VaxDate: UNKNOWN
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Mouth swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Mild, Additional Details: PT RECEIVED 3 VACCINES ON THE SAME DAY AND ALERTED US TO THE REACTIONS TODAY. THE REACTIONS INCLUDE: FEVER, RASH ON ARMS AND LEGS THAT IS RAISED AND NOT ITCHY AND IS NOT THAT RED, AND SWELLING OF THE LEFT EYELID. PT STILL HAS REACTIONS AND HAS NOT SEEKED MEDICAL CARE YET; HAS BEEN COUNSELED TO SEEK MEDICAL CARE. , Other Vaccines:  VaccineTypeBrand: M-M-R II; Manufacturer: ; LotNumber: X027903; Route: SUBCUTANEOUS; BodySite: RIGHT ARM; Dose: ; VaxDate: 10/14/2024, VaccineTypeBrand: HEPLISAV-B; Manufacturer: ; LotNumber: 945655; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: 10/14/2024
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Fever-Mild, Additional Details: PT RECEIVED 3 VACCINES ON THE SAME DAY AND ALERTED US TO THE REACTIONS TODAY. THE REACTIONS INCLUDE: FEVER, RASH ON ARMS AND LEGS THAT IS RAISED AND NOT ITCHY AND IS NOT THAT RED, AND SWELLING OF THE LEFT EYELID. PT STILL HAS REACTIONS AND HAS NOT SEEKED MEDICAL CARE YET; HAS BEEN COUNSELED TO SEEK MEDICAL CARE. , Other Vaccines:  VaccineTypeBrand: M-M-R II; Manufacturer: ; LotNumber: X027903; Route: SUBCUTANEOUS; BodySite: RIGHT ARM; Dose: ; VaxDate: 10/14/2024, VaccineTypeBrand: HEPLISAV-B; Manufacturer: ; LotNumber: 945655; Route: INTRAMUSCULAR; BodySite: RIGHT ARM; Dose: ; VaxDate: 10/14/2024
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Flushing, Hyperhidrosis, Loss of consciousness, Malaise, Presyncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a vasovagal episode for 3-4 minutes. After vaccines were administered, he stated that he did not feel well and then started to pass out. After 3 minutes, he became alert and oriented. Monitored patient for the next 10 minutes, VS were normal. , Other Vaccines:  VaccineTypeBrand: Hepsliav; Manufacturer: Dynavax; LotNumber: 944920; Route: Intramuscular; BodySite: Right Deltoid; Dose: 1; VaxDate: 10/23/2024, VaccineTypeBrand: MMR; Manufacturer: Priorix; LotNumber: X3M3D; Route: Subtaneous; BodySite: right posterior arm; Dose: 1; VaxDate: 10/23/2024
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a vasovagal episode for 3-4 minutes. After vaccines were administered, he stated that he did not feel well and then started to pass out. After 3 minutes, he became alert and oriented. Monitored patient for the next 10 minutes, VS were normal. , Other Vaccines:  VaccineTypeBrand: Hepsliav; Manufacturer: Dynavax; LotNumber: 944920; Route: Intramuscular; BodySite: Right Deltoid; Dose: 1; VaxDate: 10/23/2024, VaccineTypeBrand: MMR; Manufacturer: Priorix; LotNumber: X3M3D; Route: Subtaneous; BodySite: right posterior arm; Dose: 1; VaxDate: 10/23/2024
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: As per patient also had other adverse reaction like patient bleed and patient felt the shot went sideways.-Mild
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Mild, Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: GSK; LotNumber: 724l5; Route: IM; BodySite: Left arm; Dose: 1; VaxDate: 10/17/2024
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: 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, Additional Details: See telephone encounter 10/23/2024. Patient symptoms are self reported. The patient was not seen by me for his symptoms. The injections was given by me and there were no immediate adverse reactions after giving the vaccines to the patient. The patient did not report any discomfort or symptoms to me after I gave him the vaccine. , Other Vaccines:  VaccineTypeBrand: Fluzone Trivalent High Dose (65+ years); Manufacturer: Sanofi; LotNumber: UT8473CA; Route: Intramuscular; BodySite: Right Arm; Dose: 1; VaxDate: 10/16/2024
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: PT IS CONTACTING MD BUT I WANTED TO REPORT
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Shakiness-Medium
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lethargy, Pruritus, Rash, Tremor
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Shakiness-Medium
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: PATIENT STATED HE HAD SEVERE BURSITIS BEFORE RECEIVING VACCINATION. HE ASKED TO HAVE INJECTION IN TRICEP OR BICEP. ADVISED WE MUST USE DELTOID AND HE COULD WAIT FOR BURSITIS TO RESOLVE. HE INSISTED THE DR WANTED HIM TO GET IT NOW. HE STATED IT COULD BE GIVEN IN ANY MUSCLE AND ASKED IF THERE WERE CAMERAS AND IF I WOULD USE ANOTHER MUSCLE. I EXPLAINED I WAS LICENSED ONLY TO USE THE DELTOID MUSCLE. AFTER RECEIVING HE SAID HIS ARM HURT AND IT WAS THE WORSE VACCINE HE EVER RECEIVED.
Age: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injury associated with device
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Patient reports a piece of the needle still remained in his arm. He had a neighbor come remove it. Refused to come to the pharmacy and refused to go be seen by a physician or other provider. Said it was fine. removed remainder of the needle himself-Medium, Other Vaccines:  VaccineTypeBrand: Comirnaty COVID 24-25; Manufacturer: Pfizer; LotNumber: LM2215; Route: Intramuscular; BodySite: Right Deltoid; Dose: n/a; VaxDate: 09/25/2024, VaccineTypeBrand: Fluzone High Dose; Manufacturer: Sanofi; LotNumber: UT8470DA; Route: Intramuscular; BodySite: Left Deltoid; Dose: n/a; VaxDate: 09/25/2024
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Systemic: 8 episode of explosive bowel movement the next day-Medium, Additional Details: Patient stated eight episodes of explosive bowel movement on 101624, the day after the vaccine and went to ER and was hospitalized for 2 days and received iron transfusion and now on ferrett 325 mg once per day.Patients husband also got moderna vaccine on same day by same immunizer and no problem. The patient said she is not sure if it was the vaccine or something going on in her body since her husband did not have any problem.  , Other Vaccines:  VaccineTypeBrand: moderna; Manufacturer: moderna; LotNumber: 3042439; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: u8489ca; Route: i/m; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Patient said he got covid post receiving covid vaccine-Mild, Additional Details: Patient said he got covid after covid vaccine and the vaccine made the covid worst. Patient was at the ER 2 days after the covid vaccine. He did not feel sick and no symptoms the day of vaccine when asked. Patient request pharmacy to have the standard procedure to give covid test before covid vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Mild
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Other Vaccines:  VaccineTypeBrand: Flu (flucelvax); Manufacturer: serqirus, inc.; LotNumber: 946616; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 10/21/2024
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: pt reports redness at site of injection about the size of a quarter that has not faded in the last 10 days, he reports no other symptoms, no pain or limitation in use of the arm just redness
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Eye swelling, Feeling abnormal, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: 7 mins after shot patient reported at consultation window that she was experiencing throat tightness and a fuzzy feeling on her tongue, but she was talking well.  7 mins after that we decided symptoms were progressing and called EMS and administered epinephrine. Patient was conscious and coherent when ambulance picked her up.  She returned to the pharmacy 3 hours later to report she was doing well, thanked me, that hospital agreed with our assesment & action and I helped her pick out benadryl.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mouth swelling, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: 7 mins after shot patient reported at consultation window that she was experiencing throat tightness and a fuzzy feeling on her tongue, but she was talking well.  7 mins after that we decided symptoms were progressing and called EMS and administered epinephrine. Patient was conscious and coherent when ambulance picked her up.  She returned to the pharmacy 3 hours later to report she was doing well, thanked me, that hospital agreed with our assesment & action and I helped her pick out benadryl.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Joint injury, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Right arm is painful when moved in a specific way such as trying to remove clothing and sleeping on the shoulder. Patient confirms that one vaccine was given in the right arm however both vaccines were listed as administered in left arm. Pain began right after administration once at home and noticed that bandaid was placed higher than usual. , Other Vaccines:  VaccineTypeBrand: Flulaval Trivalent; Manufacturer: GalaxoSmithKline; LotNumber: 5zg92; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/08/2024
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Right arm is painful when moved in a specific way such as trying to remove clothing and sleeping on the shoulder. Patient confirms that one vaccine was given in the right arm however both vaccines were listed as administered in left arm. Pain began right after administration once at home and noticed that bandaid was placed higher than usual. , Other Vaccines:  VaccineTypeBrand: Flulaval Trivalent; Manufacturer: GalaxoSmithKline; LotNumber: 5zg92; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/08/2024
Age: 79.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient stated that she was having trouble raising her arm and it was painful.
Age: 79.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient stated that she was having trouble raising her arm and it was painful.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Experianced reaction 5 days after vaccine administration
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Concern for possible incorrect admin site of Fluzone vaccine. Pt's L arm was lifted in an odd manor after being asked to relax his arm and full amount of vaccine did not pass through needle. Needle withdrawn to replace and try again in new site for admin and a small hematoma had started to form and was evident admin was too high on pt's arm. Pt advised of possible bruising/swelling/pain at injection site and advised to follow up with us or with PCP if pain persists.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood glucose, Fatigue, Lethargy, Seizure, Syncope
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Nurse gave varicella vaccine to pt on 10/24/24 10:30am. pt said he hates needles and he has a history of faining after getting vaccine. pt fainted after getting varicella vaccine and seemed to have a seizure , called 911 and pt had a second seizure after paramedics pricked his finger to measure glucose level. then he was transferred to hospital
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Nurse gave varicella vaccine to pt on 10/24/24 10:30am. pt said he hates needles and he has a history of faining after getting vaccine. pt fainted after getting varicella vaccine and seemed to have a seizure , called 911 and pt had a second seizure after paramedics pricked his finger to measure glucose level. then he was transferred to hospital
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia
Clinical narrative: Systemic: LOSS OF VOICE ON AND OFF-Medium, Additional Details: TODAY 10/24/2024 @ 2;33PM, PT REPORTED SHE EXPERIENCED LOSS OF VOICE AFTER VACCINATIONS (COVID, FLU) ON 08/28/2024, SHE SPOKE AND EXAMINED BY NP, I SPOKE WITH  OFFICE AS WELL TODAY 3:01PM, PER PATIENT CAN CONTACT AT OFFICE FOR ANY MEDICAL CONDITIONS, I HAVE LEFT VOICE MAIL TO PATIENT TO CALL US BACK., Other Vaccines:  VaccineTypeBrand: FLUZONE HIGH DOSE; Manufacturer: SANOFI; LotNumber: U8429BA; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state, Dizziness, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: After recieving the covid and the flu shot, the patient became immediately short of breath. She could not walk, and had to sit down. Patients blood pressure was 190/108. Emergency services were called. After being evaluated, the patient refused to go to the ER despite recommendations from the paramedic team , Other Vaccines:  VaccineTypeBrand: fluad tri-valent; Manufacturer: seqirus; LotNumber: 388498; Route: im; BodySite: right arm; Dose: 1; VaxDate: 10/24/2024
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait inability, Hyperhidrosis, Immediate post-injection reaction, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: After recieving the covid and the flu shot, the patient became immediately short of breath. She could not walk, and had to sit down. Patients blood pressure was 190/108. Emergency services were called. After being evaluated, the patient refused to go to the ER despite recommendations from the paramedic team , Other Vaccines:  VaccineTypeBrand: fluad tri-valent; Manufacturer: seqirus; LotNumber: 388498; Route: im; BodySite: right arm; Dose: 1; VaxDate: 10/24/2024
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain, Tachycardia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: ADVISED PT TO CONSULT PCP
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came in just to talk about her cellulitis reaction. She is a physician. Physician did not like the way the immunizer swabbed her arm(should only swab once) so she had pharmacist administer shot. Physician(patient) had cellulitis that developed day after. Waited a few days, was not resolving. Got Keflex from physician took 10 days to resolution. Area where vaccine had been given was slightly darkened and below for for about a 3 inch circle in circumfrance. Pt did not want me to report, Other Vaccines:  VaccineTypeBrand: Fluzone HD; Manufacturer: Sanofi; LotNumber: UT8470CA; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Comirnaty 2024-2025; Manufacturer: Pfizer; LotNumber: LM2215; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Other Vaccines:  VaccineTypeBrand: Fluzone High dose; Manufacturer: sanofi; LotNumber: U8489DA; Route: im; BodySite: Right arm; Dose: 0; VaxDate: 10/22/2024
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Shakiness-Severe, Additional Details: patient said with in 5 mins of injection started  shaking. went home had fever 101 and was shaking ,chills. called provider but no response . came back to pharmacy and nurse took blood pressure . patient took tylenol with no relief. patient lefy under instructions that if more severe or not resolving to call provider, Other Vaccines:  VaccineTypeBrand: covid 2024-2025; Manufacturer: moderna; LotNumber: 8080748; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient presented with red, warm and tender surrounding area of site of injection
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Dizziness, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Additional Details: Patient received 2 vaccines and a couple minutes later he had a sudden drop in BP pt we monitored pts bp and called EMS we also followed up with patient on 10/25/2024 and spoke with him hes is doing much better he explained to us he had vasovagal syncope , Other Vaccines:  VaccineTypeBrand: FLULAVAL; Manufacturer: GSK-ID BIOMEDIC; LotNumber: Z29D3; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient recieved the covid and flu vaccine. she was fine after she recieved the injection. she waited in the waiting area. she went shopping in the store. she went to get check out out front. she fainted while waiting in line. a customer called the nurse to go up front to check on her. When she went up front, the patient was already alert and speaking. an ambulance was called just to come and check up on her condition. she went to hospital , Other Vaccines:  VaccineTypeBrand: fluzone hd; Manufacturer: sanofi; LotNumber: u8489ca; Route: im; BodySite: left arm; Dose: 1; VaxDate: 10/25/2024
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Systemic: Cellulitis below injection site-Severe, Additional Details: Patient presented to the pharmacy 2 days after vaccination with a reaction on her left arm below the injection site, above the elbow. Pharmacist advised patient to go to urgent care. Pharmacist verified vaccination was given in left deltoid muscle. Patient was seen at urgent care then with PCP the following morning. Patient was diagnosed with cellulitis and was told it was from the vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Eye pruritus, Rhinorrhoea
Clinical narrative: runny nose; itchy eyes; This spontaneous report was received from consumer and refers to a 4-year-old male. The patient's medical history included  conjunctivitis, and pneumonia. The patient's concurrent conditions included  localised erythema and eczema. Concomitant therapies were not reported.  On 15-FEB-2024, the patient started therapy with dupilumab (DUPIXENT), 200/1.14 milligram per millilitre solution for injection, 200 milligram, qow, administered for eczema (lot #, expiry date, and route of administration were not provided). On an unknown date in August 2024, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 1 dosage form, administered unknownly for immunisation (strength, lot #, and expiry date were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, administered unknownly for immunisation (strength, lot #, and expiry date were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS), 1 dosage form, administered unknownly for immunisation (strength, formulation, lot #, and expiry date were not provided).  On an unknown date in August 2024, the patient experienced runny nose (rhinorrhea), and itchy eyes (eye pruritus). At the time of reporting, the patient had not recovered from the events. The action taken regarding dupilumab (DUPIXENT) was reported as dose not changed.  The causal relationship between the events and the suspect vaccines and therapy was reported as unknown.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gardasil 9 first dose on 02Aug2019/ second dose on 30Jun2021; This spontaneous report was received from a nurse and refers to a 16-year-old male patient. The patient's medical history included cardiac murmur and eczema. His concurrent conditions included seasonal allergy, and hypersensitivity to blue dye. Historical vaccines were diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX), hepatitis a vaccine inact (HAVRIX), hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (ompc) (COMVAX), hepatitis b vaccine rhbsag (yeast) (ENGERIX B), hib vaccine conj (tet tox) (ACTHIB), meningococcal vaccine a/c/y/w conj (crm197) (MENVEO), measles vaccine live (enders-edmonston) (+) mumps vaccine live (jeryl lynn) (+) rubella vaccine live (wistar ra 27/3) (M M R II), measles vaccine live (enders-edmonston) (+) mumps vaccine live (jeryl lynn) (+) rubella vaccine live (wistar ra 27/3) (+) varicella zoster vaccine live (oka/Merck) (PROQUAD), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX), varicella zoster vaccine live (oka/Merck) (VARIVAX), pneumococcal vaccine conj 7v (crm197) (PREVNAR), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and polio vaccine inact 3v (vero) (IPOL). Concomitant therapies were not reported.  On 02-AUG-2019 at the age of 11-year-old, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection. Subsequently, on 30-JUN-2021, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection. Both doses were administered as prophylaxis (doses, strengths, routes and anatomical locations of administration, lot numbers and expiration dates were not provided) (inappropriate schedule of product administration).   Other vaccines received by the patient included Covid-19 vaccine.    This is one of the 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA004819:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received her first dose of GARDASIL 9 in 2007 and second dose in 2008 and she never received her third dose/patient was 16 or 17 years old at time of first dose; No additional AE; This spontaneous report was received from a medical assistant concerning to an adult (reported as "in her 30s") female patient.  Her medical history, concurrent conditions, concomitant therapies, and drug/reactions/allergies were not reported.  On an unknown date in 2007, at 16 or 17-year-old, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided). Then, on unspecified date in 2008, she received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiry date, anatomical location and route of administration were not provided). Both doses were administered as prophylaxis. However, she never received her 3rd dose (inappropriate schedule of product administration), and the reporter inquired about vaccination recommendations for the patient. No additional adverse events (AE) were reported (no adverse event.)  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received Heplisav-B First Dose, and Engerix-B As Second Dose; HEPLISAV-B administered to 9-month-old male; Initial report received on 27-Sep-2024.  A pharmacist in the reported that a 10-month-old male (race and ethnicity not provided) received the first dose of a hepatitis B vaccine with HEPLISAV-B (hepatitis B vaccine) and received a second dose with ENGERIX-B more than thirty-one days later.  Medical history and concomitant medications were not reported.  On 27-Aug-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, route, and site not reported; NDC # 43528-003-05)] from a pharmacist. On 27-Sep-2024, 31 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine with ENGERIX-B (no details provided).  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose, and Second Dose 65 days later; Initial report received on 10-Oct-2024.  A pharmacist reported that a 54-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given the second dose late.  No medical history or concomitant medications were reported.  On 06-Aug-2024, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot # 944941, expiration date 26-Dec-2026, and NDC # 43528-0003-05)] intramuscularly in the right deltoid from a pharmacist.   On 10-Oct-2024, 65 days after having been vaccinated with the first dose, the patient received the second dose of HEPLISAV-B (lot# 944943, expiration date 01-Aug-2026, and NDC # 43528-0003-05) intramuscularly in the right deltoid from a pharmacist.   No other information was available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Ecchymosis, Fat necrosis, Imaging procedure abnormal, Peripheral swelling
Clinical narrative: Fat necrosis; This literature report (initial receipt: 15-Oct-2024), concerns an adult female patient presented to clinic complaining of swelling and ecchymoses about the left deltoid 24 hours after receiving the quadrivalent influenza vaccination (Afluria) (lot number not reported - to be requested upon follow up).  She had no history of allergies to influenza vaccination, nor did she have any other history of panniculitis, though she did reportedly have a history of deltoid abscess that resolved many years ago, She continued to complain of a bump four months after her initial vaccination.  The imaging findings were characteristic of fat necrosis, and no further imaging or biopsy was recommended.; Reporter's Comments: Causality: Unassessable. The information provided is insufficient to perform a more in-depth analysis (onset date, outcome, dosing/therapy details, latency/temporality).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: she had rash for 4 days but it went away. She had rash before with flu shot but not this bad.
Age: 21.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Contusion, Hypoaesthesia, Peripheral swelling, Rash
Clinical narrative: Per patient, she had bruising, swelling, rash on the left arm and developed some numbness in her pinky finger at night. She's still numb on her pinky finger and also the ring finger of her left arm. I advised her to contact her dr as well.
Age: 90.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Cellulitis
Clinical narrative: Patient stated she got cellulitis
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Contusion, Joint stiffness, Mobility decreased, Pain
Clinical narrative: Description: Upper arm/shoulder pain that led to excessive bruising, and the pain increased over the course of 1 week. Shoulder joint had limited mobility due to pain. Initial bruising was from elbow to shoulder. As of 31 days later, there is still visible bruising near the upper arm/shoulder. Treatment: Pt tried ibuprofen 800 mg RX that he had previously. It brought him limited relief, but not enough to move shoulder. PT also tried Tylenol. Outcomes: Pt saw PA of PCP and they believe that it may be related to not moving shoulder due to pain and the tendons became tight, limiting mobility. They recommended physical therapy.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Patient got vaccine and then went to the Restroom with mom and mom saw reaction. Mom immediately asked for help from MA and then MA got doctor to analyze area. MA and nurse took vitals and they looked great they were kept at clinic for 5-10 minutes and vitals were checked again. They looked great and they went home
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: dermatomal rash after Shingrix vaccination
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Swelling
Clinical narrative: symptoms are swelling and itchiness
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Cardiac failure, Cardiomyopathy, Echocardiogram, Ejection fraction decreased
Clinical narrative: PFIZER #1 11/30/2021 PFIZER #2 2/28/2022 DEVELOPED VACCINE INDUCED SUBCLINICAL MYOCARDITIS MANIFESTED AS HEART FAILURE AND NONISCHEMIC CARDIOMYOPATHY LVEF 25%.  TREATED WITH CARVEDILOL, ENTRESTO, VERQUVO, FARXIGA, AMIODARONE, COLCHICINE, LIFE-VEST, AND PROTOCOL BASE SPIKE DETOXIFICATION.