chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: High fever; Chills; Sore muscles; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Nov2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Nov2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Breast cancer (remission)" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE. The patient also took other concomitant therapy. The following information was reported: CHILLS (non-serious) with onset 11Nov2024, outcome "not recovered"; PYREXIA (non-serious) with onset 11Nov2024, outcome "not recovered", described as "High fever"; MYALGIA (non-serious) with onset 11Nov2024, outcome "not recovered", described as "Sore muscles". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia.  Additional information: The patient was not received any other vaccines within 4 weeks prior to the vaccine. The patient was not hospitalized for the events. The patient had no known allergies.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484064 same patient, different dose, partial same event;
Age: 72.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthritis
Clinical narrative: Sudden onset arthritis 8 days after vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 at 11:00 as dose 1, single (Lot number: LM2219) at the age of 72 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 03Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Sulfa drugs allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ARTHRITIS (non-serious) with onset 11Oct2024 at 12:00, outcome "recovering", described as "Sudden onset arthritis 8 days after vaccination". Therapeutic measures were taken as a result of arthritis.  Additional information: The patient experienced sudden onset arthritis 8 days after vaccination and received Prednisone as treatment for arthritis. The patient did not received any other vaccines within 4 weeks prior to the suspect vaccines. The patient was not taking any other medications within 2 weeks of the event starting.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/ Ringing in right ear; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),  MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER),  MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 10Nov2024 at 18:00, outcome "not recovered", described as "Tinnitus/ Ringing in right ear". Therapeutic measures were not taken as a result of tinnitus.  Patient did not receive any other vaccines on the same date. Patient did not receive any other vaccines within 4 weeks prior to the vaccine and did not receive any other medications within 2 weeks. No known allergies.  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: Central nervous system inflammation, Migraine, Tinnitus
Clinical narrative: tinnitus worsened; Migraines worsened; Neuroinflammation; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776152 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Headache" (unspecified if ongoing), notes: (Few migraines); "Tinnitus" (ongoing), notes: Tinnitus briefly earlier in the year prior to the first Moderna vaccine.; "Migraine" (ongoing), notes: Migraine (Few migraines). The patient's concomitant medications were not reported. Vaccination history included: Spikevax nos (DOSE 1; event has continued and was classified as a persistent disability), for COVID-19 immunization, reaction(s): "chronic tinnitus/severe tinnitus "; Spikevax nos (DOSE 1; event has continued and was classified as a permanent disability), for COVID-19 immunization, reaction(s): "migraines"; Spikevax nos (DOSE 1), for COVID-19 immunization, reaction(s): "Contracted COVID-19/Subsequent infection", "Neuroinflammation". The following information was reported: TINNITUS (disability), outcome "not recovered", described as "tinnitus worsened"; MIGRAINE (disability), outcome "not recovered", described as "Migraines worsened"; CENTRAL NERVOUS SYSTEM INFLAMMATION (medically significant), outcome "unknown", described as "Neuroinflammation". The clinical course was reported as follows: The patient received a Moderna vaccine during the first rollout, which triggered chronic tinnitus and migraines that have continued. The patient contracted COVID-19 over a year following Moderna vaccine and a Pfizer booster, the tinnitus and migraines worsened. Within the span of about a year and a half, there was an onset of severe tinnitus and migraines with the Moderna vaccine (stage 1), which worsened when contracting COVID-19 (stage 2), and the tinnitus and migraines had remained at that baseline to this date. Over time, a neurologist determined the cause to be neuroinflammation related to the initial vaccine and subsequent infection. The reporter believed that the reaction was likely due to the higher dose compared to Pfizer. Subsequent doses of the Pfizer vaccine did not bump tinnitus and migraines higher.  Moderna comment: The medical history of headache and tinnitus, and event COVID-19 could be confounders for the events. The benefit-risk relationship of product is not affected by this report.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Ovulation delayed
Clinical narrative: it has always messed with my menstral cycle/ the vaccine delayed my ovulation; it has always messed with my menstral cycle/ the vaccine delayed my ovulation; This is a spontaneous report received from a Consumer or other non HCP.  A female 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: MENSTRUAL DISORDER (non-serious), OVULATION DELAYED (non-serious), outcome "unknown" and all described as "it has always messed with my menstral cycle/ the vaccine delayed my ovulation". Additional information: It was reported that patient always got the pfizer vaccine and it has always messed with her menstrual cycle, but she is trying to conceive so she had been tracking ovulation the last 8 months and that is how she knew the vaccine delayed her ovulation.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291980 Same patient, different vaccine dose and event;
Sex: U
Vaccine: COVID19
Symptoms: Pain, Quality of life decreased, Quality of life scale, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; why my quality of life is now gone; I suffer pain daily all day long; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2020 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: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "why my quality of life is now gone"; PAIN (non-serious), outcome "not recovered", described as "I suffer pain daily all day long". The patient underwent the following laboratory tests and procedures: Quality of life scale: Decreased. Clinical course: Because of covid vaccine early 2020 now had rheumatoid arthritis that no one in patient family had, it was cause of vaccine why patient quality of life was now gone and suffered pain daily all day long.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lose hair; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adolescent male patient received BNT162b2 (BNT162B2), in Mar2022 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: ALOPECIA (non-serious) with onset Apr2022, outcome "recovering", described as "lose hair". Therapeutic measures were taken as a result of alopecia which included LITFULO.  Additional information: The patient started to lose hair after the COVID vaccine. The patient now had no hair. It was unknown in the patient receive any other vaccine on the same date as the vaccine. It was unknown if the patient receive any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was taking any other medication within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid again; Covid again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reporter did not know if these events were caused by suspect product. During an inbound call for financial assistance, patient stated, patient just happens to have covid. After a coughing fit, patient apologized for coughing. Patient got it last December, and patient was like. it was free. The agent asked for clarification if this was second bout with it, Patient stated yeah, second time ever, and all of patient's vaccines from the very beginning all were Pfizer's.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: made all of joints hurt except for fingers and toes/ ankles are still hurting; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 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: ARTHRALGIA (non-serious) with onset Nov2024, outcome "not recovered", described as "made all of joints hurt except for fingers and toes/ ankles are still hurting".  Additional information: The patient received a covid vaccine from pharmacy on 07Nov2024. It made all of joints hurt except for fingers and toes. Ankles were still hurting.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: SWEELING, REDNESS, ITCHING AT INJECTION SITE, ADMINISTERED 50 MG OF DIPHENHYDRAMINE, PATIENT WAS FEELING BETTER AFTER, NO SWEELING OR ITCHING.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood immunoglobulin M decreased, Costochondritis, Gastrointestinal pain
Clinical narrative: bowel pains; felt inflamed All over; All my joints feel inflamed and painful; low IgM; had Costochondritis; Sinus infection; All my joints feel inflamed and painful; having bad headaches; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "ear infection" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "MSG Allergy" (unspecified if ongoing); "Few antibiotics allergy" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRITIS (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2024, outcome "not recovered" and all described as "All my joints feel inflamed and painful"; SINUSITIS (non-serious) with onset 16Sep2024, outcome "not recovered", described as "Sinus infection"; GASTROINTESTINAL PAIN (non-serious) with onset 16Sep2024, outcome "not recovered", described as "bowel pains"; INFLAMMATION (non-serious) with onset 16Sep2024, outcome "not recovered", described as "felt inflamed All over"; COSTOCHONDRITIS (non-serious) with onset 16Sep2024, outcome "not recovered", described as "had Costochondritis"; HEADACHE (non-serious) with onset 16Sep2024, outcome "not recovered", described as "having bad headaches"; BLOOD IMMUNOGLOBULIN M DECREASED (non-serious) with onset 16Sep2024, outcome "not recovered", described as "low IgM". Therapeutic measures were taken as a result of gastrointestinal pain, inflammation, arthritis, blood immunoglobulin m decreased, costochondritis, sinusitis, arthralgia, headache.  Additional Information: Vaccine administration: 15Sep2024  00:00. She was fine prior to the vaccine. The day after the vaccine, she started having bad headaches and bowel pains. she felt inflamed All over. All her joints feel inflamed and painful. her lab work reflects low IgM and she had Costochondritis. Sinus infection. All this started with the vaccine Steroids and antibiotics were administered as AE treatment.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Sinusitis
Clinical narrative: bowel pains; felt inflamed All over; All my joints feel inflamed and painful; low IgM; had Costochondritis; Sinus infection; All my joints feel inflamed and painful; having bad headaches; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "ear infection" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "MSG Allergy" (unspecified if ongoing); "Few antibiotics allergy" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRITIS (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2024, outcome "not recovered" and all described as "All my joints feel inflamed and painful"; SINUSITIS (non-serious) with onset 16Sep2024, outcome "not recovered", described as "Sinus infection"; GASTROINTESTINAL PAIN (non-serious) with onset 16Sep2024, outcome "not recovered", described as "bowel pains"; INFLAMMATION (non-serious) with onset 16Sep2024, outcome "not recovered", described as "felt inflamed All over"; COSTOCHONDRITIS (non-serious) with onset 16Sep2024, outcome "not recovered", described as "had Costochondritis"; HEADACHE (non-serious) with onset 16Sep2024, outcome "not recovered", described as "having bad headaches"; BLOOD IMMUNOGLOBULIN M DECREASED (non-serious) with onset 16Sep2024, outcome "not recovered", described as "low IgM". Therapeutic measures were taken as a result of gastrointestinal pain, inflammation, arthritis, blood immunoglobulin m decreased, costochondritis, sinusitis, arthralgia, headache.  Additional Information: Vaccine administration: 15Sep2024  00:00. She was fine prior to the vaccine. The day after the vaccine, she started having bad headaches and bowel pains. she felt inflamed All over. All her joints feel inflamed and painful. her lab work reflects low IgM and she had Costochondritis. Sinus infection. All this started with the vaccine Steroids and antibiotics were administered as AE treatment.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Influenza A virus test negative, Influenza B virus test negative, Pain, Pyrexia
Clinical narrative: Got flu shot on 11/12/24, A day later high fever up to 105, associated bodyaches, bone pain. Seen in the clinic on 11/14/24 and tested negative for Flu A and B , Covid.Pt had similar reaction to Flu shot in 2006
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Got flu shot on 11/12/24, A day later high fever up to 105, associated bodyaches, bone pain. Seen in the clinic on 11/14/24 and tested negative for Flu A and B , Covid.Pt had similar reaction to Flu shot in 2006
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Magnetic resonance imaging head normal
Clinical narrative: Patient started experiencing significant double vision starting on October 31st 2024.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: I administered the Influenza vaccine to the patient above , following  the provider order and not realizing that  patient was previously vaccinated with the first dose  of influenza a little less that 3 weeks ago in another state.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise
Clinical narrative: Patient received a flu vaccine at a group event, patient started to feel dizzy. Patient was given a chair and water bottle and was able to complete event. Patient felt ill after leaving and went to urgent care to follow up.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Papule
Clinical narrative: 9/25/24 - Shingrix vaccine received  9/28/24 to 10/18/24 - got itchy papules on her body, mainly on chest, abdomen, back, also some on ankles and behind knees, none on thighs. Not on face or neck or scalp. Each papule would start to itch, then become raised, and then continue to be itchy + burning for several days, then resolve, and new ones would appear in other locations. Applied clobetasol, which did not help.   Saw her dermatologist, and not sure of reason. Given Rx for oral steroids at day 14, but they self-resolved before she used them.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Muscle contracture, Myalgia, Painful respiration
Clinical narrative: Reports muscle clenching at time of vaccinating, then waking up the following morning with severe muscle pain in her torso, lower back, and ribs. Reported pain with breathing. Denied anaphylaxis.
Sex: M
Vaccine: FLUA4
Symptoms: Syringe issue, Underdose
Clinical narrative: part of the vaccine didn't actually make into his arm; Leaking SYRINGE; This spontaneous case, initially received on 30-Oct-2024, with additional information on 07-Nov-2024, was reported by a health professional and concerns a male patient.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad Quadrivalent for not reported, Dose regimen: .5 ml, route od administration and anatomical location were not reported. Lot number: 388487.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced part of the vaccine didn't actually make into his arm (outcome: Unknown), Leaking SYRINGE (outcome: Not Reported).  Fluad vaccine was given to a patient and part of the vaccine didn't actually make into his arm it kind of came out of the side of where the needle connects it's into the PFS, and reporter don't know if he should receive a second dose, because he didn't receive the full dose. Syringe defect was identified during administering the dose.   Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide a serious or causality opinion.; Reporter's Comments: All events were considered not related.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received duplicate Fluad shots; one in 9/19/24 and one in 11/10/24; Patient has had no adverse reactions to having two flu shots; for reporting only
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Concussion, Dizziness, Eye contusion, Hand fracture, Nausea
Clinical narrative: Extreme nausea and dizziness that resulted in fainting, I landed on my right hand and left forehead. Fall from fainting caused fractures to third and fifth R metacarpal, black eye and concussion.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Syncope, X-ray abnormal
Clinical narrative: Extreme nausea and dizziness that resulted in fainting, I landed on my right hand and left forehead. Fall from fainting caused fractures to third and fifth R metacarpal, black eye and concussion.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Breech presentation, Caesarean section, Exposure during pregnancy, Intensive care, Premature delivery
Clinical narrative: Pre-term birth. Due date November 18, 2024. Actual delivery date 35 weeks and 5 days. Baby girl was 5 lbs, 14 oz. She was breech, which resulted in an emergency c-section. During the c-section, a uterine rupture occurred at a previous c-section site. The hospital stay was 5 days (ICU for 4 days and maternity room for 1 day).
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Uterine rupture
Clinical narrative: Pre-term birth. Due date November 18, 2024. Actual delivery date 35 weeks and 5 days. Baby girl was 5 lbs, 14 oz. She was breech, which resulted in an emergency c-section. During the c-section, a uterine rupture occurred at a previous c-section site. The hospital stay was 5 days (ICU for 4 days and maternity room for 1 day).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: localized swelling , erythema, bruising, hot to touch areas of left arm from shoulder to below elbow.  seen by primary care doctor and instructed to monitor, elevate, use ice packs and wear a sling. patient reports doctor suspects vein or artery puncture.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Left arm - Pain in shoulder, limited to extend your arm. Treatment - physical therapy
Age: 53.0
Sex: F
Vaccine: FLU3, PNC21, VARZOS
Symptoms: Pain
Clinical narrative: Patient states she has pain all over her body from head to toes.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received vaccines here at 2:54pm w/o incident. Mom called office at 4:30pm to report that she developed hives on face + itching. no sob/DIB. no angioedema.  no vomiting. Instructed mom to admin children's benadryl q6h prn itch and apply triamcinolone cream TID prn rash. Additionally, also advised to admin children's zyrtec 10mg po daily.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site rash, Injection site swelling, Lethargy
Clinical narrative: We received a phone call from the patient on 11/13/2024 and she mentioned that she had a terrible reaction to the second shingles shot that she received a couple of days prior. She complained about a pain on the site of injection, tenderness, swelling and she developed a rash on her arm. She also experienced severe fatigue and she said she can't get out of bed. She said she felt extreme lethargy and she did not fell well. She also mentioned that it started to get better the next day (11/13/2024) I advised her to give her doctor a phone call and let her doctor know. And if she thinks that it's getting worse, and it warrants a true emergency (ie anaphylaxis)  to go to the nearest emergency room.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased
Clinical narrative: We received a phone call from the patient on 11/13/2024 and she mentioned that she had a terrible reaction to the second shingles shot that she received a couple of days prior. She complained about a pain on the site of injection, tenderness, swelling and she developed a rash on her arm. She also experienced severe fatigue and she said she can't get out of bed. She said she felt extreme lethargy and she did not fell well. She also mentioned that it started to get better the next day (11/13/2024) I advised her to give her doctor a phone call and let her doctor know. And if she thinks that it's getting worse, and it warrants a true emergency (ie anaphylaxis)  to go to the nearest emergency room.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Malaise
Clinical narrative: patient felt uncomfortable , not feeling well 25 minutes after receiving vaccine. patient felt faint but did not faint. Her adult daughter was with her. Someone called 911, Unknown what treatment was performed but they stayed with patient for close to 1 hour. Patient choose not to go to hospital .
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Magnetic resonance imaging normal, Pain
Clinical narrative: Skin sensitivity down my left arm and shooting pains on right side of my head for 12 days.   Intermittent pains   And mostly when laying down at night but also during the day.  Shot was given in right arm. Symptoms started 4 hours after shot. I was given a cat scan and an MR I and both were fine.  Seems like something in the senior flu shot inflamed some of my nerves. Treated at hospital and by my family Dr.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Injection site pain, Pain in extremity, Pruritus, Sleep disorder
Clinical narrative: The day of the vaccine I had slight soreness on arm. Day 2 had sore arm (not bad) and urticaria (itching) on both palms. Day 3 urticaria on palms and arm only hurt when touched. Day 4 Urticaria spreading to arms but soreness in arm at vaccine site is gone. Day 5 saw Dr., who tested for urticaria and said it was the worst case he's ever seen Wants me to have bloodwork. Said Covid vaccine did not cause urticaria, but my records show it triggers it. Prescribed Zyrtec and Hydroxyzine 25 mg, but my insurance company declined Hydroxyzine so I am taking 1/2 a Benadryl pill. Finally able to sleep through the night last night. Urticaria was also triggered by Emgality injection (for migraines). It was not triggered by flu or pneumonia vaccines.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Urticaria
Clinical narrative: The day of the vaccine I had slight soreness on arm. Day 2 had sore arm (not bad) and urticaria (itching) on both palms. Day 3 urticaria on palms and arm only hurt when touched. Day 4 Urticaria spreading to arms but soreness in arm at vaccine site is gone. Day 5 saw Dr., who tested for urticaria and said it was the worst case he's ever seen Wants me to have bloodwork. Said Covid vaccine did not cause urticaria, but my records show it triggers it. Prescribed Zyrtec and Hydroxyzine 25 mg, but my insurance company declined Hydroxyzine so I am taking 1/2 a Benadryl pill. Finally able to sleep through the night last night. Urticaria was also triggered by Emgality injection (for migraines). It was not triggered by flu or pneumonia vaccines.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient reports a sharp pain in the left arm with limited mobility
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3, RSV, TDAP, VARZOS
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: pt states that the day after they received 5 vaccines, that they developed a fever of about 100-101. They'd been having an issue with shortness of breath, and it got worse after they got the vaccine. They felt very weak and were informed by their cardiologist that they shouldn't have received the RSV vaccine. The side effects were so severe that the patient had to cancel a vacation after getting notice that due to his health, he was not clear to travel.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Amino acid level, Antinuclear antibody, Ataxia, Blood folate, Full blood count
Clinical narrative: Child became mute and started having staring spells. Shortly after had a seizure like event and collapsed. Was unable to walk for several days. Child became Ataxic, unable to clap or use arms as intended. Child has not spoken since that day.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Gait inability, Heavy metal test, Liver function test, Metabolic function test, Musculoskeletal disorder
Clinical narrative: Child became mute and started having staring spells. Shortly after had a seizure like event and collapsed. Was unable to walk for several days. Child became Ataxic, unable to clap or use arms as intended. Child has not spoken since that day.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Mutism, Renal function test, Seizure like phenomena, Smear buccal, Staring
Clinical narrative: Child became mute and started having staring spells. Shortly after had a seizure like event and collapsed. Was unable to walk for several days. Child became Ataxic, unable to clap or use arms as intended. Child has not spoken since that day.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Syncope, Thyroid function test, Vitamin B12
Clinical narrative: Child became mute and started having staring spells. Shortly after had a seizure like event and collapsed. Was unable to walk for several days. Child became Ataxic, unable to clap or use arms as intended. Child has not spoken since that day.
Age: 21.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Dizziness, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Approx 1pm on 11/5/24: i felt dizzy and almost fainted while sitting in a chair. I had a large swollen lymph node at the injection site which was warm to the touch, swollen and extremely itchy. The swollen lymph node lasted for several days and then was replaced with an itchy rash which hasn't disappeared yet.
Age: 21.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Presyncope, Rash pruritic
Clinical narrative: Approx 1pm on 11/5/24: i felt dizzy and almost fainted while sitting in a chair. I had a large swollen lymph node at the injection site which was warm to the touch, swollen and extremely itchy. The swollen lymph node lasted for several days and then was replaced with an itchy rash which hasn't disappeared yet.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Below the bandage, which is below the injection site, pt developed redness and itch macular erythema rash. Size is about 4x7cm. Pt received vaccine on Monday 11/11/2024 afternoon.  This rash started on Tuesday.  Pt reported on Wednesday morning.  The rash area was hot and swollen.  Recommended pt to see her dr to rule out infection.  Pt reported back this morning about her dr appt.  Dr's impression was side effect of the vaccine and prescribed triamciolone ointment and told pt taking 50mg diphenhydramine.  pt took the diphenhydramine dose.  Today, the rash area swollenness is shrinking down and itchiness is getting better. Pt didn't want to use triamciolone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Below the bandage, which is below the injection site, pt developed redness and itch macular erythema rash. Size is about 4x7cm. Pt received vaccine on Monday 11/11/2024 afternoon.  This rash started on Tuesday.  Pt reported on Wednesday morning.  The rash area was hot and swollen.  Recommended pt to see her dr to rule out infection.  Pt reported back this morning about her dr appt.  Dr's impression was side effect of the vaccine and prescribed triamciolone ointment and told pt taking 50mg diphenhydramine.  pt took the diphenhydramine dose.  Today, the rash area swollenness is shrinking down and itchiness is getting better. Pt didn't want to use triamciolone.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Myalgia, Rash erythematous
Clinical narrative: Swollen, red rash across upper left arm, itchy skin in swollen area, deep muscle pain in left arm in both upper and lower parts. Has lasted two days since the shots so far. OTC painkiller to relieve pain.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation
Clinical narrative: COVID vaccine in left arm, flu vaccine in right arm. Day after, blood pressure would not regulate. 165/110 to 115/75 in 30 minutes and back up 30 minutes later. Lasted for three days.
Age: 55.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Blood magnesium decreased, Blood potassium decreased, Computerised tomogram abdomen, Computerised tomogram thorax, Drug screen
Clinical narrative: Patient began having hand weakness and difficulty speaking the day after receiving the COVID and Pneumonia 23 vaccines. She was admitted to the hospital on 10/30/2024 due to stroke like symptoms. MRI of brain and cervical MRI were done. MRI of brain negative for CVA. Patient experienced difficulty walking, numbness of hands, and left sided weakness. Laboratory test done include CBC, metabolic panel, urinalysis, magnesium, PT/INR, Lipase, and urine drug screen. CT Abdomen/Pelvis done 10/30/2024. Patient was admitted to hospital 10/30 - 11/1/2024. She was started on aspirin and her LIPITOR was increased. Potassium and magnesium were low and repeated while in hospital.  Current medications Amlodipine 2.5 mg, Lipitor 20 mg nightly, Wellbutrin 150 mg daily, Hydrochlorothiazide 25g daily, Losartan 100mg daily, Metoprolol succinate 50mg daily; Ozempic 2mg weekly, Vivelle Dot 0.025mg/24 hour one patch twice weekly. Patient was diagnosed with systemic inflammatory response syndrome (SIRS).
Age: 55.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Electrocardiogram, Full blood count, Gait disturbance, Hemiparesis, Hypoaesthesia
Clinical narrative: Patient began having hand weakness and difficulty speaking the day after receiving the COVID and Pneumonia 23 vaccines. She was admitted to the hospital on 10/30/2024 due to stroke like symptoms. MRI of brain and cervical MRI were done. MRI of brain negative for CVA. Patient experienced difficulty walking, numbness of hands, and left sided weakness. Laboratory test done include CBC, metabolic panel, urinalysis, magnesium, PT/INR, Lipase, and urine drug screen. CT Abdomen/Pelvis done 10/30/2024. Patient was admitted to hospital 10/30 - 11/1/2024. She was started on aspirin and her LIPITOR was increased. Potassium and magnesium were low and repeated while in hospital.  Current medications Amlodipine 2.5 mg, Lipitor 20 mg nightly, Wellbutrin 150 mg daily, Hydrochlorothiazide 25g daily, Losartan 100mg daily, Metoprolol succinate 50mg daily; Ozempic 2mg weekly, Vivelle Dot 0.025mg/24 hour one patch twice weekly. Patient was diagnosed with systemic inflammatory response syndrome (SIRS).
Age: 55.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: International normalised ratio, Lipase, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Metabolic function test
Clinical narrative: Patient began having hand weakness and difficulty speaking the day after receiving the COVID and Pneumonia 23 vaccines. She was admitted to the hospital on 10/30/2024 due to stroke like symptoms. MRI of brain and cervical MRI were done. MRI of brain negative for CVA. Patient experienced difficulty walking, numbness of hands, and left sided weakness. Laboratory test done include CBC, metabolic panel, urinalysis, magnesium, PT/INR, Lipase, and urine drug screen. CT Abdomen/Pelvis done 10/30/2024. Patient was admitted to hospital 10/30 - 11/1/2024. She was started on aspirin and her LIPITOR was increased. Potassium and magnesium were low and repeated while in hospital.  Current medications Amlodipine 2.5 mg, Lipitor 20 mg nightly, Wellbutrin 150 mg daily, Hydrochlorothiazide 25g daily, Losartan 100mg daily, Metoprolol succinate 50mg daily; Ozempic 2mg weekly, Vivelle Dot 0.025mg/24 hour one patch twice weekly. Patient was diagnosed with systemic inflammatory response syndrome (SIRS).
Age: 55.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Muscular weakness, Neurological symptom, Prothrombin time, Speech disorder, Systemic inflammatory response syndrome
Clinical narrative: Patient began having hand weakness and difficulty speaking the day after receiving the COVID and Pneumonia 23 vaccines. She was admitted to the hospital on 10/30/2024 due to stroke like symptoms. MRI of brain and cervical MRI were done. MRI of brain negative for CVA. Patient experienced difficulty walking, numbness of hands, and left sided weakness. Laboratory test done include CBC, metabolic panel, urinalysis, magnesium, PT/INR, Lipase, and urine drug screen. CT Abdomen/Pelvis done 10/30/2024. Patient was admitted to hospital 10/30 - 11/1/2024. She was started on aspirin and her LIPITOR was increased. Potassium and magnesium were low and repeated while in hospital.  Current medications Amlodipine 2.5 mg, Lipitor 20 mg nightly, Wellbutrin 150 mg daily, Hydrochlorothiazide 25g daily, Losartan 100mg daily, Metoprolol succinate 50mg daily; Ozempic 2mg weekly, Vivelle Dot 0.025mg/24 hour one patch twice weekly. Patient was diagnosed with systemic inflammatory response syndrome (SIRS).
Age: 55.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Urine analysis
Clinical narrative: Patient began having hand weakness and difficulty speaking the day after receiving the COVID and Pneumonia 23 vaccines. She was admitted to the hospital on 10/30/2024 due to stroke like symptoms. MRI of brain and cervical MRI were done. MRI of brain negative for CVA. Patient experienced difficulty walking, numbness of hands, and left sided weakness. Laboratory test done include CBC, metabolic panel, urinalysis, magnesium, PT/INR, Lipase, and urine drug screen. CT Abdomen/Pelvis done 10/30/2024. Patient was admitted to hospital 10/30 - 11/1/2024. She was started on aspirin and her LIPITOR was increased. Potassium and magnesium were low and repeated while in hospital.  Current medications Amlodipine 2.5 mg, Lipitor 20 mg nightly, Wellbutrin 150 mg daily, Hydrochlorothiazide 25g daily, Losartan 100mg daily, Metoprolol succinate 50mg daily; Ozempic 2mg weekly, Vivelle Dot 0.025mg/24 hour one patch twice weekly. Patient was diagnosed with systemic inflammatory response syndrome (SIRS).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Computerised tomogram head, Echocardiogram, Electrocardiogram
Clinical narrative: Drug ineffective; COVID-19; seizure; Paroxysmal atrial fibrillation; transient ischemic attack; hematuria; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Regulatory number: 2797380-1 (VAERS ID).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), in right arm and on 12Apr2021 as dose 2, single (Lot number: EW0150, Expiration Date: 30Jun2021), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; DRUG INEFFECTIVE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; ATRIAL FIBRILLATION (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "Paroxysmal atrial fibrillation"; HAEMATURIA (hospitalization, disability, life threatening) with onset 01Jul2023, outcome "not recovered", described as "hematuria"; SEIZURE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "transient ischemic attack". The events "drug ineffective", "covid-19", "seizure", "paroxysmal atrial fibrillation", "transient ischemic attack" and "hematuria" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: Unknonw results, notes: implantable cardiac monitor insertion; Computerised tomogram head: Unknonw results; Echocardiogram: Unknonw results; Electrocardiogram: Unknonw results; Exam: Unknonw results; labs/ Laboratory test: Unknonw results. Therapeutic measures were taken as a result of seizure, atrial fibrillation, transient ischaemic attack. Clinical course: Pfizer#01 on 17Mar2021, Pfizer#2 on 12Apr2021, developed covid 19 vaccine induced TIA with associated seizure activity, Paroxysmal atrial fibrillation, hematuria. Treated with aspirin, Eliquis, Lamictal protocol base spike Detoxification. Current Illness was reported as none. Medications at time of Vaccination was none.  No follow-up attempts are possible.  Follow-up (12Nov2024): This is a spontaneous follow-up report received from product quality group Updated information: Dose 2 details updated.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haematuria, Implantable cardiac monitor insertion, Laboratory test, Seizure, Transient ischaemic attack
Clinical narrative: Drug ineffective; COVID-19; seizure; Paroxysmal atrial fibrillation; transient ischemic attack; hematuria; This is a spontaneous report received from a Consumer or other non HCP from product quality group. Regulatory number: 2797380-1 (VAERS ID).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6204), in right arm and on 12Apr2021 as dose 2, single (Lot number: EW0150, Expiration Date: 30Jun2021), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; DRUG INEFFECTIVE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; ATRIAL FIBRILLATION (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "Paroxysmal atrial fibrillation"; HAEMATURIA (hospitalization, disability, life threatening) with onset 01Jul2023, outcome "not recovered", described as "hematuria"; SEIZURE (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability, life threatening, medically significant) with onset 01Jul2023, outcome "not recovered", described as "transient ischemic attack". The events "drug ineffective", "covid-19", "seizure", "paroxysmal atrial fibrillation", "transient ischemic attack" and "hematuria" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: Unknonw results, notes: implantable cardiac monitor insertion; Computerised tomogram head: Unknonw results; Echocardiogram: Unknonw results; Electrocardiogram: Unknonw results; Exam: Unknonw results; labs/ Laboratory test: Unknonw results. Therapeutic measures were taken as a result of seizure, atrial fibrillation, transient ischaemic attack. Clinical course: Pfizer#01 on 17Mar2021, Pfizer#2 on 12Apr2021, developed covid 19 vaccine induced TIA with associated seizure activity, Paroxysmal atrial fibrillation, hematuria. Treated with aspirin, Eliquis, Lamictal protocol base spike Detoxification. Current Illness was reported as none. Medications at time of Vaccination was none.  No follow-up attempts are possible.  Follow-up (12Nov2024): This is a spontaneous follow-up report received from product quality group Updated information: Dose 2 details updated.  No follow-up attempts are possible.