chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (COMIRNATY NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 omicron (kp.2) (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   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-202500038076 same patient, different vaccine doses;
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (COMIRNATY NOS), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 omicron (kp.2) (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Comirnaty (DOSE 4, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   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-202500038076 same patient, different vaccine doses;
Age: 64.0
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: he vaccinated a 64 year old patient with Fluzone High Dose although the prescribing information says that it is indicated for those 65 and older with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 64 years old and unknown gender patient who had vaccinated with Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] although the prescribing information says that it is indicated for those 65 and older with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine  (Suspension for injection in pre-filled syringe) lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) (strength, expiry date was unknown) and he vaccinated a 64 year old patient with fluzone high dose although the prescribing information says that it is indicated for those 65 and older with no adverse event (off label use) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Action taken was not applicable.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of extra dose of IPOL with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 years old male patient who was administered with an extra dose of poliomyelitis vaccine (INACTIVATED) [IPOL] with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3) (MMR II) for Immunisation.  On 13-Feb-2025, the patient received extra dose with 0.5 ml of IPV (VERO) Suspension for injection with standard strength (lot W1C831M and expiry date- 21-NOV-2025) via intramuscular route in the left thigh as Immunization with no adverse event (extra dose administered) (latency- same day).   Reportedly, reporter said that the patient had already received the full series. They wanted to know what adverse events they should be expecting  Action taken was not applicable.  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: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: pentacel given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case was linked to other cases US-SA-2025SA054065, US-SA-2025SA054013, US-SA-2025SA054381, US-SA-2025SA054097, US-SA-2025SA054040.  This case involves a 5 months old female patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (rotateq) and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20), both for Immunisation.  On 14-Feb-2025, the patient received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength once with lot UK174AB and expiry date 31-Mar-2026 via intramuscular route in right leg for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day)  Action taken was not applicable.  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.; Sender's Comments:  US-SA-2025SA054065:FLUZONE HD Patient 1 US-SA-2025SA054013:FLUZONE HD Patient 2 US-SA-2025SA054381:ADACEL US-SA-2025SA054097:PENTACEL Patient 1 US-SA-2025SA054040:PENTACEL Patient 3
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a 3rd dose of MMR. First 2 doses were given on 11/14/2022 and 09/21/2021. Patient should have only been given Varicella vaccine, not MMRV.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness at the area with no swelling noted
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second dose which was not necessary. No reported adverse reactions
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth, Nervousness
Clinical narrative: Red patch/band on arm surrounding and including injection site. Warm to touch but no itchiness. No discomfort per patient but nervous about the particular reaction. Still red as of 2/24/25 when she patient came in to report side effect.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Accident, Acute sinusitis, Allergic sinusitis, Anxiety, Balanoposthitis
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Brain fog, COVID-19, Conjunctivitis, Cough
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Erectile dysfunction, Exercise tolerance decreased, Fatigue
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Insomnia, Malaise, Mixed anxiety and depressive disorder, Oropharyngeal pain
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test positive, Tinnitus, Upper respiratory tract infection, Uvulitis
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: Fatigue, exercise intolerance, brain fog, tinnitus, and dizziness.  Further, prior to the booster given to me on 10/4/22 I had a very strong immune system.  I never NEVER got ill.  No colds, no flu, no URI or pneumonia... nothing.  After this booster (which the FDA revoked authorization for AFTER I was injected) I get sick all the time.  I'm still getting sick as of today (2/24/25).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient came to the pharmacy tonight and complained of his arm being tender and sore 2 weeks after getting the vaccine.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine 8/24/2024
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Rash
Clinical narrative: Skin rash, heart palpitations, chronic fatigue
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Blood test normal, Cardiac stress test normal, Cerebral cavernous malformation, Dizziness
Clinical narrative: Prior to October 2011, I was a healthy and active teenager with a near-perfect school attendance record. Within 1 month after receiving the first shot of the Gardasil HPV vaccine (original formula, not Gardasil 9) on 10/13/2011, I (the patient) began experiencing chronic fatigue, headaches, and dizziness. I had difficulty waking up for school at 6am and would fall asleep immediately after getting home at 2pm, and would stay asleep throughout the afternoon and night. I visited my primary care doctor, Dr. and was tested for Epstein-Barr virus, which came back negative/normal. Symptoms worsened and I began missing school so a few weeks later, around November/December 2011, I went back to my primary care doctor and had a full blood panel and was re-tested for Epstein-Barr, but results came back normal. Not knowing anything about Gardasil side effects at the time, I received the 2nd shot of Gardasil on 12/28/2011. After the 2nd shot, symptoms worsened and I began experiencing severe migraines, severe chronic fatigue, joint and muscle pain, and syncope (fainting) multiple times per day. After 6 months, I found a doctor that diagnosed me with POTS. My POTS symptoms were severe and disabling for 3 years. I was treated with fludrocortisone 0.1mg, midodrine 10mg, and adderall 20mg. Now, 14 years later, I still have POTS but am able to manage symptoms with daily medication. My symptoms worsen when I stop medication.
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Echocardiogram normal, Electromyogram normal, Epstein-Barr virus test negative, Fatigue, Full blood count normal
Clinical narrative: Prior to October 2011, I was a healthy and active teenager with a near-perfect school attendance record. Within 1 month after receiving the first shot of the Gardasil HPV vaccine (original formula, not Gardasil 9) on 10/13/2011, I (the patient) began experiencing chronic fatigue, headaches, and dizziness. I had difficulty waking up for school at 6am and would fall asleep immediately after getting home at 2pm, and would stay asleep throughout the afternoon and night. I visited my primary care doctor, Dr. and was tested for Epstein-Barr virus, which came back negative/normal. Symptoms worsened and I began missing school so a few weeks later, around November/December 2011, I went back to my primary care doctor and had a full blood panel and was re-tested for Epstein-Barr, but results came back normal. Not knowing anything about Gardasil side effects at the time, I received the 2nd shot of Gardasil on 12/28/2011. After the 2nd shot, symptoms worsened and I began experiencing severe migraines, severe chronic fatigue, joint and muscle pain, and syncope (fainting) multiple times per day. After 6 months, I found a doctor that diagnosed me with POTS. My POTS symptoms were severe and disabling for 3 years. I was treated with fludrocortisone 0.1mg, midodrine 10mg, and adderall 20mg. Now, 14 years later, I still have POTS but am able to manage symptoms with daily medication. My symptoms worsen when I stop medication.
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Headache, Heart rate increased, Hypersomnia, Inflammation, Loss of personal independence in daily activities
Clinical narrative: Prior to October 2011, I was a healthy and active teenager with a near-perfect school attendance record. Within 1 month after receiving the first shot of the Gardasil HPV vaccine (original formula, not Gardasil 9) on 10/13/2011, I (the patient) began experiencing chronic fatigue, headaches, and dizziness. I had difficulty waking up for school at 6am and would fall asleep immediately after getting home at 2pm, and would stay asleep throughout the afternoon and night. I visited my primary care doctor, Dr. and was tested for Epstein-Barr virus, which came back negative/normal. Symptoms worsened and I began missing school so a few weeks later, around November/December 2011, I went back to my primary care doctor and had a full blood panel and was re-tested for Epstein-Barr, but results came back normal. Not knowing anything about Gardasil side effects at the time, I received the 2nd shot of Gardasil on 12/28/2011. After the 2nd shot, symptoms worsened and I began experiencing severe migraines, severe chronic fatigue, joint and muscle pain, and syncope (fainting) multiple times per day. After 6 months, I found a doctor that diagnosed me with POTS. My POTS symptoms were severe and disabling for 3 years. I was treated with fludrocortisone 0.1mg, midodrine 10mg, and adderall 20mg. Now, 14 years later, I still have POTS but am able to manage symptoms with daily medication. My symptoms worsen when I stop medication.
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging normal, Migraine, Myalgia, Postural orthostatic tachycardia syndrome
Clinical narrative: Prior to October 2011, I was a healthy and active teenager with a near-perfect school attendance record. Within 1 month after receiving the first shot of the Gardasil HPV vaccine (original formula, not Gardasil 9) on 10/13/2011, I (the patient) began experiencing chronic fatigue, headaches, and dizziness. I had difficulty waking up for school at 6am and would fall asleep immediately after getting home at 2pm, and would stay asleep throughout the afternoon and night. I visited my primary care doctor, Dr. and was tested for Epstein-Barr virus, which came back negative/normal. Symptoms worsened and I began missing school so a few weeks later, around November/December 2011, I went back to my primary care doctor and had a full blood panel and was re-tested for Epstein-Barr, but results came back normal. Not knowing anything about Gardasil side effects at the time, I received the 2nd shot of Gardasil on 12/28/2011. After the 2nd shot, symptoms worsened and I began experiencing severe migraines, severe chronic fatigue, joint and muscle pain, and syncope (fainting) multiple times per day. After 6 months, I found a doctor that diagnosed me with POTS. My POTS symptoms were severe and disabling for 3 years. I was treated with fludrocortisone 0.1mg, midodrine 10mg, and adderall 20mg. Now, 14 years later, I still have POTS but am able to manage symptoms with daily medication. My symptoms worsen when I stop medication.
Age: 16.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Somnolence, Syncope, Tilt table test positive
Clinical narrative: Prior to October 2011, I was a healthy and active teenager with a near-perfect school attendance record. Within 1 month after receiving the first shot of the Gardasil HPV vaccine (original formula, not Gardasil 9) on 10/13/2011, I (the patient) began experiencing chronic fatigue, headaches, and dizziness. I had difficulty waking up for school at 6am and would fall asleep immediately after getting home at 2pm, and would stay asleep throughout the afternoon and night. I visited my primary care doctor, Dr. and was tested for Epstein-Barr virus, which came back negative/normal. Symptoms worsened and I began missing school so a few weeks later, around November/December 2011, I went back to my primary care doctor and had a full blood panel and was re-tested for Epstein-Barr, but results came back normal. Not knowing anything about Gardasil side effects at the time, I received the 2nd shot of Gardasil on 12/28/2011. After the 2nd shot, symptoms worsened and I began experiencing severe migraines, severe chronic fatigue, joint and muscle pain, and syncope (fainting) multiple times per day. After 6 months, I found a doctor that diagnosed me with POTS. My POTS symptoms were severe and disabling for 3 years. I was treated with fludrocortisone 0.1mg, midodrine 10mg, and adderall 20mg. Now, 14 years later, I still have POTS but am able to manage symptoms with daily medication. My symptoms worsen when I stop medication.
Age: 33.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Arthralgia, Burning sensation, Inflammation, Magnetic resonance imaging joint, Magnetic resonance imaging spinal normal
Clinical narrative: Received 2x IM injections on 27 November. Woke up 1 December AM with onset of severe shoulder pain and pain radiating down/in right arm. Radiculopathy began same day. Shoulder spasms began same day. Transitioned to burner/stinger sensation in forearm over the course of week. Ongoing waves of numbness in December 24 and January 25. Worse shoulder pain at night when sleeping at outset. I believe the injections were given left side, all symptoms have been contralateral (right side) from Dec 24 to Feb 25. During late Feb 25, some indication of burner/stinger in left forearm. Weakness in pinky and thumb in right hand has been present since late December 2024. Shoulder initially felt like it had sustained an impact injury. Acute right shoulder pain with spasms transitioned to bicep, elbow, forearm pain. Pain has mostly subsided, and now mostly left with weakness on right arm/hand. Pectoral and armpit areas very tender during MT at PT.  Pain initially felt like Trapezius and Infraspinatus muscles on right side. Highly spasmodic. Improved with massage and MT. Medical providers initially indicated C Spine Radiculopathy. This was not founded. Hand/Upper Extremity specialist at MGH/MGB states Parsonage Turner Syndrome or Brachial Plexopathy/Neuritis. PMR Physician stated same as well as Shoulder Specialist at  Hospital.
Age: 33.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Muscular weakness, Neuralgic amyotrophy, Pain, Pain in extremity, Pain of skin
Clinical narrative: Received 2x IM injections on 27 November. Woke up 1 December AM with onset of severe shoulder pain and pain radiating down/in right arm. Radiculopathy began same day. Shoulder spasms began same day. Transitioned to burner/stinger sensation in forearm over the course of week. Ongoing waves of numbness in December 24 and January 25. Worse shoulder pain at night when sleeping at outset. I believe the injections were given left side, all symptoms have been contralateral (right side) from Dec 24 to Feb 25. During late Feb 25, some indication of burner/stinger in left forearm. Weakness in pinky and thumb in right hand has been present since late December 2024. Shoulder initially felt like it had sustained an impact injury. Acute right shoulder pain with spasms transitioned to bicep, elbow, forearm pain. Pain has mostly subsided, and now mostly left with weakness on right arm/hand. Pectoral and armpit areas very tender during MT at PT.  Pain initially felt like Trapezius and Infraspinatus muscles on right side. Highly spasmodic. Improved with massage and MT. Medical providers initially indicated C Spine Radiculopathy. This was not founded. Hand/Upper Extremity specialist at MGH/MGB states Parsonage Turner Syndrome or Brachial Plexopathy/Neuritis. PMR Physician stated same as well as Shoulder Specialist at  Hospital.
Age: 33.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Radiculopathy, Tenderness, Tendonitis, X-ray normal
Clinical narrative: Received 2x IM injections on 27 November. Woke up 1 December AM with onset of severe shoulder pain and pain radiating down/in right arm. Radiculopathy began same day. Shoulder spasms began same day. Transitioned to burner/stinger sensation in forearm over the course of week. Ongoing waves of numbness in December 24 and January 25. Worse shoulder pain at night when sleeping at outset. I believe the injections were given left side, all symptoms have been contralateral (right side) from Dec 24 to Feb 25. During late Feb 25, some indication of burner/stinger in left forearm. Weakness in pinky and thumb in right hand has been present since late December 2024. Shoulder initially felt like it had sustained an impact injury. Acute right shoulder pain with spasms transitioned to bicep, elbow, forearm pain. Pain has mostly subsided, and now mostly left with weakness on right arm/hand. Pectoral and armpit areas very tender during MT at PT.  Pain initially felt like Trapezius and Infraspinatus muscles on right side. Highly spasmodic. Improved with massage and MT. Medical providers initially indicated C Spine Radiculopathy. This was not founded. Hand/Upper Extremity specialist at MGH/MGB states Parsonage Turner Syndrome or Brachial Plexopathy/Neuritis. PMR Physician stated same as well as Shoulder Specialist at  Hospital.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: MA had help on getting vaccine ready and when MA was giving Vaccine notice 5/8 need assume it was MMR and was Given Subcutaneous. MA administer several vaccines after all vaccine pt started to feel dizzy MA right away lay down patient and MA let Provider know about pt dizziness pt was given juice and crackers and vital were taken and glucose. provider went to check on patient and spoke to mother pt left home after feeling better.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received another dose of Arexvy, but patient received a dose on 01/11/2024. Discovery of the second dose administration was from our Immunization claim Reviews. Patient was contacted by the pharmacist, but did not answer. Will try to call again tomorrow (2/25/25) to ask patient is there are any side effects. Will follow up with further reporting.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient reported getting swollen and itchy upper arm the night after getting the vaccine. She applied Benadryl cream that evening and it slowly got better.  It took 48 hours to fully clear up.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered outside the ACIP guidelines, patient born after 1957, no adverse effects at this point,  per corporate informed to report
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Photopsia, Vitreous floaters
Clinical narrative: I had Photopsia and Floaters in about 30-60minutes after vaccination and left the store. Photopsia disappeared after about a month, and Floaters stay all the time until today. Suddenly Photopsia returned today. Floaters in two eyes, and Photopsia is only in left eye.
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Haemorrhage in pregnancy, Product use issue
Clinical narrative: female pregnant patient received AREXVY at 33 weeks gestation; female pregnant patient received AREXVY at 33 weeks gestation; Vaginal bleeding; This non-serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaginal bleeding in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 5 days after receiving Arexvy, the patient experienced vaginal bleeding (Verbatim: Vaginal bleeding), vaccine exposure during pregnancy (Verbatim: female pregnant patient received AREXVY at 33 weeks gestation) and drug use in unapproved population (Verbatim: female pregnant patient received AREXVY at 33 weeks gestation). The outcome of the vaginal bleeding was resolved (duration 1 day) and the outcome of the vaccine exposure during pregnancy and drug use in unapproved population were not applicable.   It was unknown if the reporter considered the vaginal bleeding to be related to Arexvy.     It was unknown if the company considered the vaginal bleeding to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 33 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: She delivered at 37 weeks and 1 day   See case US2025021321 for details regarding the baby case.   Additional Information: GSK Receipt Date: 19-FEB-2025 Genetic Counselor who works with an HCP called to report a female pregnant patient received Arexvy at 33 weeks gestation and experienced vaginal bleeding 5 days after vaccination that lasted for a day. She delivered at 37 weeks and 1 day. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025021321:Child case
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Rash, Rash pruritic, Urticaria
Clinical narrative: generalized hives; generalized rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced generalized urticaria (Verbatim: generalized hives) and generalized rash (Verbatim: generalized rash). The outcome of the generalized urticaria and generalized rash were unknown.   It was unknown if the reporter considered the generalized urticaria and generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized urticaria and generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient reported that 2 weeks after she received the second Shingrix vaccine she started to experience generalized hives and rash.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: generalized hives; generalized rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced generalized urticaria (Verbatim: generalized hives) and generalized rash (Verbatim: generalized rash). The outcome of the generalized urticaria and generalized rash were unknown.   It was unknown if the reporter considered the generalized urticaria and generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized urticaria and generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient reported that 2 weeks after she received the second Shingrix vaccine she started to experience generalized hives and rash.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Supraventricular extrasystoles, Urticaria, Ventricular extrasystoles
Clinical narrative: weakness left arm; Premature ventricular contractions; Hives; Injection site redness; Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JAN-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 06-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site redness), injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). On 07-JAN-2025, the patient experienced hives (Verbatim: Hives). On 08-JAN-2025, the patient experienced premature ventricular contractions (Verbatim: Premature ventricular contractions). On 09-JAN-2025, the patient experienced weakness of arms (Verbatim: weakness left arm). On 13-JAN-2025, the outcome of the injection site erythema and injection site swelling were resolved (duration 7 days). The outcome of the injection site pain, hives and weakness of arms were resolving and the outcome of the premature ventricular contractions was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-FEB-2025 1 day after vaccination, the patient had experienced hives. 2 days after vaccination, the patient had  weakness of left arm. 3 days after vaccination, the patient had premature ventricular contractions. Topical antihistamine was used.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Urticaria
Clinical narrative: weakness left arm; Premature ventricular contractions; Hives; Injection site redness; Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JAN-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 06-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site redness), injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). On 07-JAN-2025, the patient experienced hives (Verbatim: Hives). On 08-JAN-2025, the patient experienced premature ventricular contractions (Verbatim: Premature ventricular contractions). On 09-JAN-2025, the patient experienced weakness of arms (Verbatim: weakness left arm). On 13-JAN-2025, the outcome of the injection site erythema and injection site swelling were resolved (duration 7 days). The outcome of the injection site pain, hives and weakness of arms were resolving and the outcome of the premature ventricular contractions was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-FEB-2025 1 day after vaccination, the patient had experienced hives. 2 days after vaccination, the patient had  weakness of left arm. 3 days after vaccination, the patient had premature ventricular contractions. Topical antihistamine was used.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ventricular extrasystoles
Clinical narrative: weakness left arm; Premature ventricular contractions; Hives; Injection site redness; Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JAN-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 06-JAN-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site redness), injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). On 07-JAN-2025, the patient experienced hives (Verbatim: Hives). On 08-JAN-2025, the patient experienced premature ventricular contractions (Verbatim: Premature ventricular contractions). On 09-JAN-2025, the patient experienced weakness of arms (Verbatim: weakness left arm). On 13-JAN-2025, the outcome of the injection site erythema and injection site swelling were resolved (duration 7 days). The outcome of the injection site pain, hives and weakness of arms were resolving and the outcome of the premature ventricular contractions was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site swelling, hives, weakness of arms and premature ventricular contractions to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-FEB-2025 1 day after vaccination, the patient had experienced hives. 2 days after vaccination, the patient had  weakness of left arm. 3 days after vaccination, the patient had premature ventricular contractions. Topical antihistamine was used.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Vulval cancer
Clinical narrative: the HCP believes she is in the "initial stages of vulvar cancer; the patient has had problems; This spontaneous report was received from a physician via company representative and refers to a 34-year-old female patient.    The patient's medical history included vulvectomy, sexual debut in 2005, and had a child in 2008. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unspecified date in 2009, the patient completed the vaccine series with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, dose, frequency, lot #, and expiration date were not reported) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot #, and expiration date were not reported) for prophylaxis (reporter stated she believed, however was unable to confirm which vaccine the patient received).   Since 2016, the patient had had problems. No additional details were provided regarding those problems. The patient was seen on 13-FEB-2025, the healthcare provided (HCP) believed she was in the "initial stages of vulvar cancer."  No additional details provided. At the reporting time, the outcome of the events was unknown.    The causal relationship between the events, Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown.  Lot # is being requested and will be submitted if received.   Upon internal review, the event of vulvar cancer was determined to be medically significant.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: itchy rash like chicken pox or mosquito bites; This non-serious case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 vaccine and Influenza vaccine (Flu vaccine VII).   On 20-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: itchy rash like chicken pox or mosquito bites). The outcome of the varicella-like rash was resolving.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received his first dose of Shingrix in his left arm on 20-JAN-2025, and reported that 24 hours after receiving the vaccine, he got a very itchy rash like chicken pox or mosquito bites, in one area of his lower back, just at the top of his touche.  The patient reported that rash was much less itchy on 27-JAN-2025 and was almost gone.  The patient did not have any lot, expiry, NDC information to provide. The patient reported that he received a Covid vaccine and a high dose Flu vaccine about 3 or 4 weeks ago (Unknown Products Information) (Pre existing Shingrix).
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash like chicken pox or mosquito bites; This non-serious case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 vaccine and Influenza vaccine (Flu vaccine VII).   On 20-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). In JAN-2025, 24 hrs after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: itchy rash like chicken pox or mosquito bites). The outcome of the varicella-like rash was resolving.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2025 The patient received his first dose of Shingrix in his left arm on 20-JAN-2025, and reported that 24 hours after receiving the vaccine, he got a very itchy rash like chicken pox or mosquito bites, in one area of his lower back, just at the top of his touche.  The patient reported that rash was much less itchy on 27-JAN-2025 and was almost gone.  The patient did not have any lot, expiry, NDC information to provide. The patient reported that he received a Covid vaccine and a high dose Flu vaccine about 3 or 4 weeks ago (Unknown Products Information) (Pre existing Shingrix).
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Seizure, Viral infection
Clinical narrative: seizures; This spontaneous serious safety report with reference number 02742982 (Interaction number 02742981) was received by a partner on 27-JAN-2025 and forwarded on 28-JAN-2025 from a health care professional.    A 6-month-old male patient had been vaccinated with unknown dose of Vaxelis (batch number not provided), on an unknown date for prophylaxis.   No medical history was provided.  No concomitant vaccinations were reported.  On an unknown date, the patient experienced seizures after recently having been administered a dose of Vaxelis. The provider reported that the infant was hospitalized, and it was determined that he had a virus. She also stated that the infant recovered and went on to receive additional immunizations.  The event was recovered/resolved.    Action taken with Vaxelis was unknown.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "seizures". It was reported that the patient had a virus (alternative causality).   Further information is expected.  COMPANY COMMENT:  Seizure is assessed as serious due to causing hospitalization.   Seizure is listed for Vaxelis as per the Reference Safety Information.  Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Seizure is assessed as serious due to causing hospitalization.   Seizure is listed for Vaxelis as per the Reference Safety Information.  Considering the current knowledge on Vaxelis (Seizure is listed as per regulatory authority) and that the events appeared after the recent vaccination with Vaxelis, and despite the lack of information (relevant medical history not provided) and no confounding factors (co-suspect vaccines), and the alternate causality (virus positive) provided, the causal relationship between Vaxelis and Seizure cannot be excluded and is assessed as related.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.