chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: got heart conditions, after one shot; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got heart conditions, after one shot".  Additional information: The reporter stated that the quality was trash and there was no basic manufacturing protocols. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303130 Same reporter/drug, different patient/event;
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Headache, Musculoskeletal chest pain, Myalgia, Painful respiration
Clinical narrative: pain in lower lung cavity with deep breathe; muscle pain extends to chest wall; muscle pain extends to chest wall; does not hurt with motion but hurts with deep breath/hurts with deep breathe regardless of motion; headache; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15Nov2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: NEXLIZET, on 15Aug2024. The following information was reported: DIARRHOEA (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "diarrhea"; PAINFUL RESPIRATION (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "does not hurt with motion but hurts with deep breath/hurts with deep breathe regardless of motion"; HEADACHE (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering"; MYALGIA (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 16Nov2024 at 04:00, outcome "recovering" and all described as "muscle pain extends to chest wall"; PULMONARY PAIN (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "pain in lower lung cavity with deep breathe". Therapeutic measures were not taken as a result of pulmonary pain, myalgia, musculoskeletal chest pain, painful respiration, headache, diarrhoea.  Additional information: It was reported that the patient experienced pain in lower lung cavity with deep breathe, muscle pain extends to chest wall, does not hurt with motion but hurts with deep breath, hurts with deep breathe regardless of motion, headache and diarrhea.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Pulmonary pain
Clinical narrative: pain in lower lung cavity with deep breathe; muscle pain extends to chest wall; muscle pain extends to chest wall; does not hurt with motion but hurts with deep breath/hurts with deep breathe regardless of motion; headache; diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15Nov2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for immunisation. The patient's relevant medical history included: "pacemaker" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: NEXLIZET, on 15Aug2024. The following information was reported: DIARRHOEA (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "diarrhea"; PAINFUL RESPIRATION (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "does not hurt with motion but hurts with deep breath/hurts with deep breathe regardless of motion"; HEADACHE (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering"; MYALGIA (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 16Nov2024 at 04:00, outcome "recovering" and all described as "muscle pain extends to chest wall"; PULMONARY PAIN (non-serious) with onset 16Nov2024 at 04:00, outcome "recovering", described as "pain in lower lung cavity with deep breathe". Therapeutic measures were not taken as a result of pulmonary pain, myalgia, musculoskeletal chest pain, painful respiration, headache, diarrhoea.  Additional information: It was reported that the patient experienced pain in lower lung cavity with deep breathe, muscle pain extends to chest wall, does not hurt with motion but hurts with deep breath, hurts with deep breathe regardless of motion, headache and diarrhea.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: micturition syncope; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "micturition syncope" (ongoing); "fall" (unspecified if ongoing); "hit her head" (unspecified if ongoing); "don't remember what happened" (unspecified if ongoing); "low blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset Nov2024, outcome "unknown", described as "micturition syncope". The clinical course was reported as follows: The patient stated that through the years, she had problems when she gets up at night to urinate, when she stands up, she blacks out, on that night, she hit her head and don't even remember what happened and woke up on the floor. She did not know if that was a coincidence. She also stated that she had a low blood pressure. The patient experienced episodes of fainting a few during her life, and she did not disclose this information prior to being administered the vaccine and syncope happened after the vaccine, 10 -12 hours later. On 15Nov2024, the patient got the COVID shot and that night she had one of her episodes of micturition syncope, she has had these episodes prior to receiving the COVID shot.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ephelides, Pustule
Clinical narrative: red freckles/unsightly/new ones continue to erupt every day; pustules/unsightly/new ones continue to erupt every day; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PUSTULE (non-serious) with onset 2024, outcome "unknown", described as "pustules/unsightly/new ones continue to erupt every day"; EPHELIDES (non-serious) with onset 2024, outcome "unknown", described as "red freckles/unsightly/new ones continue to erupt every day".  Additional information: The reporter was calling about the Covid 19 vaccine taken 05Sep2024. Experiencing red freckles, pustules, experiencing since then. The reporter states, they are unsightly and make patient feel uncomfortable. New ones continue to erupt every day.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took the booster two weeks ago and now have covid symptoms; took the booster two weeks ago and now have covid symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2024, latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "took the booster two weeks ago and now have covid symptoms". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: she broke out with the body rash, it wasn't red. It was kind of like the color of freckles and then it started itching and she can't get rid of it; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious), outcome "recovering", described as "she broke out with the body rash, it wasn't red. It was kind of like the color of freckles and then it started itching and she can't get rid of it". The events "she broke out with the body rash, it wasn't red. it was kind of like the color of freckles and then it started itching and she can't get rid of it" required emergency room visit. Therapeutic measures were taken as a result of rash pruritic.  Additional information: Reporter stated, "I had a question for you. My daughter got your Pfizer COVID-19 vaccine shot and the next day she broke out with the body rash, it wasn't red. It was kind of like the color of freckles and then it started itching and she can't get rid of it. So, she went to emergency and when she went to her doctor and her doctor had no idea what it could be, and it didn't go away. So, she went to ER, and they give her a pill and they said it should go away with in 5 days, and it was going away, but what I want to ask you is would this be a reaction to COVID-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: Came down with vestibular; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776692 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 25Jan2022 as dose number unknown (booster), single (Lot number: FJ6369) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Feb2021 as dose 1, single (Lot number: 006M20A) and on 18Mar2021 as dose 2, single (Lot number: 040A21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VESTIBULAR DISORDER (medically significant), outcome "unknown", described as "Came down with vestibular". The event "came down with vestibular" required physician office visit. Clinical course: In Apr2021, the patient experienced Vestibular Disorder (Came down with vestibular). It was reported that 14 to 15 days after patient second Moderna shot, patient came down with vestibular. It was taking 10 months and Patient had visited to doctor and hospital several time to detect. Patient was firmly believed it was these shot that caused this condition. It made patient life a living hell. No treatment information was reported.  No follow-up attempts are possible.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Circumoral swelling, Computerised tomogram head, Cough, Full blood count, Metabolic function test
Clinical narrative: hives, dry cough, swelling around mouth .  Treated with steroids iv then po , benadryl, pepcid
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: hives, dry cough, swelling around mouth .  Treated with steroids iv then po , benadryl, pepcid
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Induration, Pain in extremity, Respiratory tract infection viral, SARS-CoV-2 test negative
Clinical narrative: my left arm that I got the Covid vaccine and was extremely sore with a hard lump for 2 to 3 days. Six days after getting both vaccines, I came down with a respiratory virus that was not Covid based on home testing with upper and lower respiratory symptoms. But no fever or bodyaches.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain starting 1 hour after injection,  Extreme arm pain for 2 days.  Patient had to take NSAIDS but arm pain is resolved as of 11/21/2024.  Patient was not sure if due to vaccine injection technique if possibly too high on the arm since they never had so much pain from a covid vaccine previously
Age: 10.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient with 10cm x 10cm Injection site reaction, very itchy, warm, raised above skin
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC21, RV1
Symptoms: Bladder catheter temporary, Botulism, Central nervous system lesion, Clonus, Lumbar puncture abnormal
Clinical narrative: Experienced very high fever and was directed to administer Tylenol if needed. 60 days later, spinal lesions had progressed and 6 month old was paralyzed from C2-T6  due to spinal cord edema consistent with transverse myelitis. Treatment began with local hospital trying to send us home diagnosing as a virus. Mother pushed back. Local hospital admitted overnight for observation and stated no one was comfortable doing a spinal tap on infant so flight to another hospital with diagnosis of Botulism. Next steps steps were spinal tap and MRI which diagnosed TM. 3 days of steroids, PT and OT. Discharged on 6/7/16 with unknown further consequences. Discovered neurogenic bladder and bowel requires daily bowel routine and catheters every 4 hours , clonus and wears leg braces.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC21, RV1
Symptoms: Magnetic resonance imaging spinal abnormal, Myelitis transverse, Nerve injury, Neurogenic bladder, Neurogenic bowel
Clinical narrative: Experienced very high fever and was directed to administer Tylenol if needed. 60 days later, spinal lesions had progressed and 6 month old was paralyzed from C2-T6  due to spinal cord edema consistent with transverse myelitis. Treatment began with local hospital trying to send us home diagnosing as a virus. Mother pushed back. Local hospital admitted overnight for observation and stated no one was comfortable doing a spinal tap on infant so flight to another hospital with diagnosis of Botulism. Next steps steps were spinal tap and MRI which diagnosed TM. 3 days of steroids, PT and OT. Discharged on 6/7/16 with unknown further consequences. Discovered neurogenic bladder and bowel requires daily bowel routine and catheters every 4 hours , clonus and wears leg braces.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC21, RV1
Symptoms: Orthosis user, Paralysis, Pyrexia, Spinal cord oedema, Ultrasound scan
Clinical narrative: Experienced very high fever and was directed to administer Tylenol if needed. 60 days later, spinal lesions had progressed and 6 month old was paralyzed from C2-T6  due to spinal cord edema consistent with transverse myelitis. Treatment began with local hospital trying to send us home diagnosing as a virus. Mother pushed back. Local hospital admitted overnight for observation and stated no one was comfortable doing a spinal tap on infant so flight to another hospital with diagnosis of Botulism. Next steps steps were spinal tap and MRI which diagnosed TM. 3 days of steroids, PT and OT. Discharged on 6/7/16 with unknown further consequences. Discovered neurogenic bladder and bowel requires daily bowel routine and catheters every 4 hours , clonus and wears leg braces.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC21, RV1
Symptoms: Urodynamics measurement, X-ray
Clinical narrative: Experienced very high fever and was directed to administer Tylenol if needed. 60 days later, spinal lesions had progressed and 6 month old was paralyzed from C2-T6  due to spinal cord edema consistent with transverse myelitis. Treatment began with local hospital trying to send us home diagnosing as a virus. Mother pushed back. Local hospital admitted overnight for observation and stated no one was comfortable doing a spinal tap on infant so flight to another hospital with diagnosis of Botulism. Next steps steps were spinal tap and MRI which diagnosed TM. 3 days of steroids, PT and OT. Discharged on 6/7/16 with unknown further consequences. Discovered neurogenic bladder and bowel requires daily bowel routine and catheters every 4 hours , clonus and wears leg braces.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Pyrexia, Skin discolouration, Skin warm
Clinical narrative: Patient reported fever, body ache, arm pain, swelling that was hot to touch, started to turn purple later in the evening on the same day of vaccination 11/14/2024. Patient went to urgent care the following day on Saturday and was instructed to take Benadryl. Patient has been taking Benadryl daily without improvement. Went to urgent care again 11/20/2024 and was  informed may be possible infection (abscess).
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient reported fever, body ache, arm pain, swelling that was hot to touch, started to turn purple later in the evening on the same day of vaccination 11/14/2024. Patient went to urgent care the following day on Saturday and was instructed to take Benadryl. Patient has been taking Benadryl daily without improvement. Went to urgent care again 11/20/2024 and was  informed may be possible infection (abscess).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT RECEIVED ONE DOSE IN JULY AND A SECOND DOSE IN NOVEMBER. PT IS FINE AND NO ADVERSE EFFECTS REPORTED
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Vaccination certified pharmacy technician administered an adult dose Covid vaccine to a child accidently. After the vaccine the child stayed in the pharmacy for 20+ mins while we attempted to contact Pfizer for further guidance. When unable to contact pfizer due to after hours we called the doctors office of the patient and poison control for guidance. The Patients mother was contacted by her drs office for monitoring and the mother was given information from poison control on what to look out for
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Haemorrhagic stroke, Ischaemic stroke
Clinical narrative: Ischemic hemorrhagic stroke with bleed; Ischemic hemorrhagic stroke with bleed; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776774 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant), HAEMORRHAGIC STROKE (medically significant), outcome "unknown" and all described as "Ischemic hemorrhagic stroke with bleed". Clinical course: After using the bathroom in the middle of the night, the patient missed the bed by five feet. Two days after taking the FLU and COVID-19 shots, same arm and same day. Diagnose: ischemic hemorrhagic stroke with bleed. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Dehydration, Eye pain, Foaming at mouth, Hypoaesthesia
Clinical narrative: Foaming at mouth; Bacterial Infection; Severe Dehydration/dryness; Pain in extremity; Eye pain; Hypoaesthesia/Numbness in limbs; Pruritus/feet itching; Skin discolouration/Blood reaction turning purple; Skin exfoliation/peeling really bad(painful); Toothache/teeth severe pain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00897 (Novavax).  A 27-year-old female patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 01Apr2023 as dose number unknown, 10 ug/ml single) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Bad blood reaction" (not ongoing); "STI" (ongoing); "Dizziness" (not ongoing); "Weakness" (not ongoing); "Numbness" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: BACTERIAL INFECTION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; EYE PAIN (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; FOAMING AT MOUTH (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; HYPOAESTHESIA (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Hypoaesthesia/Numbness in limbs"; PAIN IN EXTREMITY (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; PRURITUS (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Pruritus/feet itching"; DEHYDRATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Severe Dehydration/dryness"; SKIN DISCOLOURATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Skin discolouration/Blood reaction turning purple"; SKIN EXFOLIATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Skin exfoliation/peeling really bad(painful)"; TOOTHACHE (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Toothache/teeth severe pain".  Causality assessment: Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Bacterial infection, Dehydration, Eye pain, Foaming at mouth, Hypoaesthesia, Pruritus, Skin discolouration, Skin exfoliation, Toothache and Pain in extremity is considered possible.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin discolouration, Skin exfoliation, Toothache
Clinical narrative: Foaming at mouth; Bacterial Infection; Severe Dehydration/dryness; Pain in extremity; Eye pain; Hypoaesthesia/Numbness in limbs; Pruritus/feet itching; Skin discolouration/Blood reaction turning purple; Skin exfoliation/peeling really bad(painful); Toothache/teeth severe pain; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00897 (Novavax).  A 27-year-old female patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 01Apr2023 as dose number unknown, 10 ug/ml single) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Bad blood reaction" (not ongoing); "STI" (ongoing); "Dizziness" (not ongoing); "Weakness" (not ongoing); "Numbness" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: BACTERIAL INFECTION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; EYE PAIN (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; FOAMING AT MOUTH (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; HYPOAESTHESIA (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Hypoaesthesia/Numbness in limbs"; PAIN IN EXTREMITY (hospitalization, disability) with onset 01Apr2023, outcome "not recovered"; PRURITUS (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Pruritus/feet itching"; DEHYDRATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Severe Dehydration/dryness"; SKIN DISCOLOURATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Skin discolouration/Blood reaction turning purple"; SKIN EXFOLIATION (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Skin exfoliation/peeling really bad(painful)"; TOOTHACHE (hospitalization, disability) with onset 01Apr2023, outcome "not recovered", described as "Toothache/teeth severe pain".  Causality assessment: Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Bacterial infection, Dehydration, Eye pain, Foaming at mouth, Hypoaesthesia, Pruritus, Skin discolouration, Skin exfoliation, Toothache and Pain in extremity is considered possible.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Arthropod bite, Localised infection
Clinical narrative: bug bite on her right elbow; bad infection on her arm; This is a spontaneous report received from a Physician. Other Case identifier(s): 02704231 (Merck Case #).  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2018 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Spleen removed" (unspecified if ongoing), notes: when she was 14 years old. The patient's concomitant medications were not reported. The following information was reported: ARTHROPOD BITE (non-serious), outcome "unknown", described as "bug bite on her right elbow"; LOCALISED INFECTION (non-serious), outcome "unknown", described as "bad infection on her arm". Therapeutic measures were taken as a result of arthropod bite, localised infection.  Additional information: The patient who received PREVNAR 13 on an unknown date in 2018. The patient was seen at the business on 11Nov2024 for a bug bite on her right elbow that caused a really bad infection on her arm. The caller said the bug bite was 12 centimeters by 6 centimeters, and she prescribed Augmentin and Bactrim for the infection. The caller said the patient did not report any side effects from PREVNAR 13, but she wanted to know if the patient needs another dose of a pneumococcal vaccine since the patient had her spleen removed when she was 14 years old.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Device leakage, No adverse event
Clinical narrative: medication starting leaking from the luerlock device and onto the patients arm (with no reported adverse event); medication starting leaking from the luerlock device and onto the patients arm (with no reported adverse event); Initial information received on 11-Nov-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 51 years old and unknown gender patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] medication starting leaking from the luerlock device and onto the patients arm (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine(Suspension for injection) lot UT8475JA , Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the arm nos(not specified) and medication starting leaking from the luerlock device and onto the patients arm (with no reported adverse event) (accidental exposure to product) and (exposure via skin contact) (latency : same day).  Reportedly,The needle was removed and safety was engaged. The medication continued to leak from the luerlock device, making the injection unuseable. The injection was wasted and was not able to be administered to the patient and another injection of the fluzone vaccine was given.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Influenza like illness, Pain in extremity
Clinical narrative: Chills; Flu like symptoms; Lots of pain in hands and feet; Initial information received on 15-Nov-2024 regarding an unsolicited valid non-serious Courtesy case received from a consumer/non-health care professional (Patient).  This case involves Adult female patient who experienced chills, flu like symptoms and lots of pain in hands and feet after receiving COVID-19 vaccine and Influenza Vaccine and while treated with Abaloparatide [Tymlos].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in September 2024, the patient started taking Tymlos (Abaloparatide) at a dose of 80 ug (QD ) via subcutaneous route for Osteoporosis. On an unknown date in 2024, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunization) (formulation, strength, expiry date was unknown). On an unknown date, the patient received a unknown dose of suspect COVID-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for COVID-19 Vaccination (Covid-19 Immunization) (formulation, strength, expiry date was unknown).  On an unknown date in 2024, the patient developed chills , flu like symptoms (influenza like illness) and lots of pain in hands and feet (pain in extremity) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of Abaloparatide and (unknown latency) following the administration of Influenza Vaccine and COVID-19 Vaccine.  Action taken with INFLUENZA VACCINE, COVID-19 vaccine (COVID-19 vaccine) was not applicable and Abaloparatide (Tymlos) was Continued.  It was not reported if the patient received a corrective treatment for the events (Chills, Lots of pain in hands and feet, Flu like symptoms).  At time of reporting, the outcome was Unknown for all the events.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: vaccine administered to a patient after it was expired with no reported adverse event; pregnant with no reported adverse event; Initial information received on 12-NOV-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 27 years old pregnant female patient who was exposed to expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-NOV-2024, the pregnant patient received a dose of suspect  expired  INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (unknown strength, dosage, expiry, lot number and route) in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) and (exposure during pregnancy) (latency-same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Nurse states that it was administered yesterday.  At the time of reporting, the outcome of the pregnancy was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Patient reports that he developed a rash on his face the day after receiving Arexvy vaccination.
Age: 47.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Skin lesion, Tooth abscess
Clinical narrative: I got a POX on my penis about 2.5 weeks after the LIVE VACCINE it took almost 2 months to resolve AND I was on antibiotics during the entire time due to a stubborn lower molar abscess.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: The patient did not have any adverse events
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: after receiving her rsv vaccination, patient stated she got a red area around injections site that continued to grow and became warm to touch.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia oral, Pain
Clinical narrative: 11/20/2024 2:40 PM: Administered IM Right Deltoid Spikevax (Moderna Covid Vaccine) administered per protocol at approximately 240 PM. Patient followed protocol and stayed for the 15 minutes of observation. Around 10 minutes into this time she began to report dizziness, a burring sensation in the mouth and numbness of lips and tongue. BP was taken and read at 201/71 HR of 69 (a large cuff was used but an extra large would have been needed for accuracy) A wrist cuff was obtained and BP retaken to be 138/88 HR 67. PCP was called and benadryl 50mg was administered orally. about 20 minutes post immunization. about 10 minutes after administration of benadryl the patient reported that symptoms began to subside. Patient continued to improve and was eventually discharged home in the care of her friend.   11/21/2024 5:20 PM : Spoke with patient. She is very tired today and is noticing a fair amount of aching all over. She has been treating this with tylenol. She has had no more burning sensations or dizziness and does not endorse any difficulty breathing or rashes. Discussed how her current symptoms sound more typical of vaccines and to call back if anything worsens, changes or if she has any questions. Also Instructed her to call back Sunday 11/24 if current symptoms have not significantly improved.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient already received flu vaccine in August of this year. Patient does not speak language but had son call and state patient had not received vaccine and so another one was given on 11/20/24.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Less than 24 hours after Vaccination patient suffered T.I.A (Stroke)
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient already received flu vaccine in August of this year. Patient does not speak language but had son call and state patient had not received vaccine and so another one was given on 11/20/24.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough, approximately 1 month after administration
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough, back pain
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Laryngitis, Muscle spasms, Pain in extremity
Clinical narrative: Severe chills and shaking, severe muscle spasms, sudden onset severe  vomiting, near syncope, dizziness, arm pain and swelling, sudden onset tachycardia, laryngitis.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Presyncope, Tachycardia, Tremor, Vomiting
Clinical narrative: Severe chills and shaking, severe muscle spasms, sudden onset severe  vomiting, near syncope, dizziness, arm pain and swelling, sudden onset tachycardia, laryngitis.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Feeling hot, Paraesthesia, Visual impairment
Clinical narrative: Yesterday I had a young lady get a flu and COVID shot, after went from the vaccine room to the pharmacy waiting area where her friends were waiting for her for 15 minutes observation, after a few minutes she reported that she had some feelings of warmth in her extremities, I went out to sit with her and make assessments, after a few more minutes she said her vision was weird and hands were tingling, denied lightheadedness, placed cold cloth on forehead then cold and 'slightly dizzy' [her words]. Regardless , she decided to lay down on the floor, I suggested she put her legs up, she reported that she felt better very quickly, after 10 minutes, she felt well enough to return to her chair, and said she had anxiety about shots she hadn't declared, and decided she was well enough to leave after another 15minutes. She stated she wasn't driving and was directed to call her physician if she had any additional symptoms, and to call and advise me as well. No medications were administered to her.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects. Patient was given a Tdap today 11/21/2024, vaccines had not been reconciled and Health maintenance in patient's chart was asking for a Tdap vaccine. Patient was asked if they wanted those vaccines since it looked like they were due for tdap, hep b, flu, covid. Patient agreed to all vaccines except covid. Vaccines were ordered and given to patient as well as VIS's. When vaccines were reconciled it looked like she had received a Tdap on 08/2/2022. I informed my supervisor, the patient and filled out an incident report as well as the VAERS.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Patient was removed from pharmacy premises by emergency medical services.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Angiogram pulmonary abnormal, Blood test, Cardiac monitoring, Computerised tomogram heart, Echocardiogram
Clinical narrative: 23 hours after RSV vaccination I was riding my bike and fainted for a short time. Paramedics helped me, vital signs all normal, but when I tried to walk I fainted very briefly for a second time, so was taken to the E.R.  Examined, tested, released: no DX for fainting. Subsequent follow with PCP and cardiologist, several tests, all normal, no other obvious cause for fainting.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Electrocardiogram, Syncope
Clinical narrative: 23 hours after RSV vaccination I was riding my bike and fainted for a short time. Paramedics helped me, vital signs all normal, but when I tried to walk I fainted very briefly for a second time, so was taken to the E.R.  Examined, tested, released: no DX for fainting. Subsequent follow with PCP and cardiologist, several tests, all normal, no other obvious cause for fainting.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Condition aggravated, Headache, Nerve block
Clinical narrative: Chronic, all day, everyday headache
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient came in for covid vaccine and covid vaccine was processed but flu shot was given. Patient received first flu shot on 11/1/2024 making this a second flu shot.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: patient experienced dizziness , nausea and vomiting and sweat..
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe joint and muscle pain in shoulder where injection was given, lasting more than 48 hours so far
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: LEFT ARM NERVE PAIN
Age: 1.25
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Pyrexia, Rash
Clinical narrative: High fever, rash , lethargic and red raised injection site
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: COVID-19 pneumonia, Herpes zoster, Rash
Clinical narrative: the patient reported a rash on her right shoulder which was diagnosed as shingles; FBE called on behalf of HCP who reported a female patient with history of VARIVAX vaccination has experienced COVID pneumonia and shingles.  Patient was administered her first Varivax dose on 10/13/2016 and her second on 10/2/2019.  Reporter only abl; This spontaneous report was received from a physician and refers to a 9 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 13-OCT-2016, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot #, expiration date not provided); and on 02-OCT-2019, she was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot # S019583 confirmed as valid, expiration date not provided but upon internal validation established as 25-JUN-2021); both administered intramuscular (anatomical location not provided for any dose) for prevention of varicella.        On 23-OCT-2024, the patient went to the physician's office experiencing coronavirus disease (COVID)/ COVID related pneumonia; therefore, she was started on unspecified antibiotics. On 28-OCT-2024 (also reported as 5 days later), the patient experienced a rash on her right shoulder which was diagnosed as shingles (herpes zoster); so, she was given unspecified antiviral treatment. At the reporting time, the patient was recovering from both the events.   Causality assessment between both the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not reported.  Upon internal review, the event of COVID related pneumonia was determined to be medically significant.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac flutter, Heart rate, Palpitations
Clinical narrative: fluttering/pounding heartbeat; fluttering/pounding heartbeat; BP 133-81; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Nov2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 07Nov2024 as dose 1, single. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 15Nov2024 at 14:30, outcome "recovered" (15Nov2024), described as "BP 133-81"; CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 15Nov2024 at 14:30, outcome "recovered" (15Nov2024) and all described as "fluttering/pounding heartbeat". The patient noticed a fluttering/pounding heartbeat, while resting on her sofa after eating lunch. She checked her blood pressure and pulse and found both fairly normal: BP 133-81 and pulse 76. She repeated the tests twice until BP was under 120/80. Therapeutic measures were not taken as a result of cardiac flutter, palpitations, blood pressure increased.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Nausea
Clinical narrative: nausea; injection site pain; Initial information received on 14-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 43 years old female patient who had injection site pain and nausea after receiving COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) and Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past vaccination(s) included moderna COVID-19 Vaccine on 18-SEP-2023 and Flucevax Quad on 18-SEP-2023. The patient's past medical history, medical treatment(s) and family history were not provided.   On 20-Sep-2024, the patient received a dose 1 of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection via intramuscular route in unknown administration site for drug use for unknown indication (Product used for unknown indication) (dose, batch and expiry date unknown) and Novavax COVID-19 Vaccine not produced by Sanofi Pasteur injection strength 0.5 ml lot 6024MF012 via intramuscular route in unknown administration site for COVID-19 immunization (dose, expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On 20-SEP-2024 the patient had injection site pain and nausea (latency same day).  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Recovered / Resolved on 21-Sep-2024 for both the events
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: injection site pain; myalgia; headache; malaise; Initial information received on 12-NOV-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old and unknown gender patient who had injection site pain, myalgia, headache and malaise after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (unknown strength, dosage, formulation, expiry, lot number and route) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed injection site pain, myalgia ,headache and malaise (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, nurses administered Fluzone HD to a 63-yearold patient who will turn 64 next month. Most reactions required no action and resolved within 7 days.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.